Ketorolac Tablets

Pronunciation: KEE-toe-ROLE-ak
Generic Name: Ketorolac
Brand Name: Toradol

Ketorolac is only intended for short-term (up to 5 days) treatment of moderately severe pain. It should not be used to treat minor or long-term pain. Do not use more of Ketorolac than prescribed. Do not use Ketorolac to treat children.

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Ketorolac for a long time. Do not use Ketorolac right before or after coronary artery bypass graft (CABG).

Ketorolac may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Do not use Ketorolac if:

• you are allergic to Ketorolac, aspirin, or any other NSAIDs (eg, ibuprofen, celecoxib)


• you are taking aspirin or another NSAID (eg, ibuprofen, celecoxib)


• you are breast-feeding or are in labor


• you have recently had or will be having CABG


• you have a stomach ulcer or a history of ulcers or severe stomach problems (eg, bleeding, perforation)


• you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)


• you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or you are at risk of bleeding

Do not use Ketorolac to prevent pain before any major surgery.

Ketorolac is used for:

The short-term (up to 5 days) treatment of moderately severe pain (usually after surgery), alone or in combination with other medicines.

Ketorolac is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes these symptoms.

Do NOT use Ketorolac if:

• you are allergic to any ingredient in Ketorolac


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you are taking pentoxifylline, probenecid, aspirin, or another NSAID (eg, ibuprofen, celecoxib)


• you are in the last 3 months of pregnancy, are breast-feeding, or are in labor


• you have recently had or will be having CABG or you have a stomach ulcer or a history of ulcers or severe stomach problems (eg, bleeding, perforation)


• you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)


• you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or you are at risk of bleeding


• you need to prevent pain before any major surgery

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ketorolac:

Some medical conditions may interact with Ketorolac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, Crohn disease)


• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or you are at risk of any of these diseases


• if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke, drink alcohol, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Ketorolac. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), pentoxifylline, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding may be increased


• Probenecid because it may increase the risk of Ketorolac's side effects


• Cyclosporine, lithium, metformin, methotrexate, oral NSAIDs (eg, ibuprofen), or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Ketorolac


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ketorolac

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ketorolac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ketorolac:

Use Ketorolac as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ketorolac comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ketorolac refilled.


• Take Ketorolac by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.


• Do NOT use this medication for more than 5 days. Ketorolac is not for the treatment of mild to moderate or chronic pain (eg, headache).


• Discard any unused tablets. Do not share Ketorolac with anyone.


• If you miss a dose of Ketorolac and you are taking it regularly, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketorolac.

Important safety information:

• Ketorolac may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ketorolac with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Serious stomach ulcers or bleeding can occur with the use of Ketorolac. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ketorolac with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Ketorolac is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Ketorolac unless your doctor tells you to.


• Check with your doctor or pharmacist before you take acetaminophen while you are taking Ketorolac. The risk of liver problems may be increased.


• Lab tests, including kidney function, liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Ketorolac. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ketorolac with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.


• Ketorolac should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Ketorolac may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketorolac while you are pregnant. Ketorolac is found in breast milk. Do not breast-feed while taking Ketorolac.

Possible side effects of Ketorolac:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; mild stomach pain or upset; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); bloody or black, tarry stools; bloody or cloudy urine; change in the amount of urine produced or trouble urinating; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes; mouth sores; numbness of an arm or leg; one-sided weakness; persistent flu-like symptoms; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the arms, hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Ketorolac:

Store Ketorolac at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketorolac out of the reach of children and away from pets.

General information:

• If you have any questions about Ketorolac, please talk with your doctor, pharmacist, or other health care provider.


• Ketorolac is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ketorolac. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ketorolac resources

• Ketorolac Dosage
• Ketorolac Use in Pregnancy & Breastfeeding
• Drug Images
• Ketorolac Drug Interactions
• Ketorolac Support Group
• 74 Reviews for Ketorolac - Add your own review/rating

Compare Ketorolac with other medications

• Pain
• Postoperative Pain

Klonopin Wafers

Generic Name: clonazepam (Oral route)

kloe-NAZ-e-pam

Commonly used brand name(s)

In the U.S.

• Klonopin


• Klonopin Wafers

Available Dosage Forms:

• Tablet, Disintegrating


• Solution


• Tablet

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Klonopin Wafers

Clonazepam is used alone or together with other medicines to treat certain seizure (convulsive) disorders (e.g., Lennox-Gastaut syndrome, akinetic or myoclonic seizures). It is also used to treat panic disorder in some patients. Clonazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using Klonopin Wafers

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clonazepam in children with seizure disorders. However, safety and efficacy in children with panic disorder have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clonazepam in the elderly. However, elderly patients are more likely to have confusion and severe drowsiness, or age-related heart, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving clonazepam.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone


• Carbamazepine


• Desipramine


• Ginkgo


• Nevirapine


• Ritonavir


• St John's Wort


• Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or


• Lung or breathing problems—Use with caution. May make these conditions worse.

• Glaucoma, acute narrow angle or untreated open-angle or


• Liver disease, severe—Should not be used in patients with these conditions.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of clonazepam

This section provides information on the proper use of a number of products that contain clonazepam. It may not be specific to Klonopin Wafers. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you or your child are using the orally disintegrating tablet (wafer), make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may take a sip of water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets or disintegrating tablets):
  
  • For seizures:
    
    • Adults, teenagers, and children 10 years of age and older—At first, 0.5 milligram (mg) three times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Infants and children younger than 10 years of age and weighing 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
    
    
  
  
  • For panic disorder:
    
    • Adults—At first, 0.25 milligram (mg) two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 4 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Klonopin Wafers

It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly and to allow for changes in the dose. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

If you or your child have been taking this medicine in large doses or for a long time, do not stop taking it without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Klonopin Wafers Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• cough


• difficulty with breathing


• discouragement


• dizziness


• ear congestion


• feeling sad or empty


• fever


• headache


• irritability


• lack of appetite


• loss of interest or pleasure


• loss of voice


• nasal congestion


• poor coordination


• runny nose


• shakiness and unsteady walk


• sleepiness or unusual drowsiness


• sneezing


• sore throat


• tiredness


• trouble with concentrating


• trouble with sleeping


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness

Less common

• Being forgetful


• bladder pain


• bloody or cloudy urine


• changes in patterns and rhythms of speech


• diarrhea


• difficult, burning, or painful urination


• frequent urge to urinate


• general feeling of discomfort or illness


• joint pain


• loss of appetite


• lower back or side pain


• mood or mental changes


• muscle aches and pains


• nausea


• nervousness


• problems in urination or increase in the amount of urine


• shivering


• slurred speech


• sore throat


• sweating


• trouble with speaking


• vomiting

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• changes in skin color


• chest pain or discomfort


• cold sweats


• colds


• confusion


• cough or hoarseness


• difficulty with sleeping


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• excessive dreaming


• excessive muscle tone


• excitement


• falling


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling mad


• feeling of unreality


• flu-like symptoms


• headache, severe and throbbing


• lack of feeling or emotion


• lack or loss of self-control


• muscle stiffness


• muscle tension or tightness


• nightmares


• pain, inflammation, or swelling in the calves, shoulders, or hands


• pain or swelling in the arms or legs without any injury


• pain, tenderness, or swelling of the foot or leg


• partial or slight paralysis


• scaling


• sense of detachment from self or body


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• sleeplessness


• swelling around the eyes


• swelling of the face, ankle, foot, or knees


• thoughts of killing oneself changes in behavior


• tightness in the chest


• trembling or shaking of the hands or feet


• troubled breathing


• unable to sleep


• uncaring


• vision changes


• wheezing

Incidence not known

• Anxiety


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• change in consciousness


• chest congestion


• difficulty with coordination


• double vision


• drowsiness


• dry mouth


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• feeling, seeing, or hearing things that are not there


• hyperventilation


• irregular, fast, slow, or shallow breathing


• irregular, twisting uncontrolled movement of the face, hands, arms, or legs


• loss of consciousness


• loss of interest or pleasure


• loss of memory


• loss of strength or energy


• loss of voice


• muscle weakness


• pale or blue lips, fingernails, or skin


• pinpoint red spots on the skin


• problems with memory


• restlessness


• right upper abdominal pain and fullness


• severe mood or mental changes


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• troubled breathing with exertion


• uncontrolled eye movements


• unusual behavior


• unusual bleeding or bruising


• unusual weak feeling


• vivid dreams


• weight loss or gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Decreased interest in sexual intercourse


• difficulty with swallowing


• dryness or soreness of the throat


• heavy bleeding


• hives


• inability to have or keep an erection


• longer than usual time to ejaculation of semen


• loss in sexual ability, desire, drive, or performance


• pain or tenderness around the eyes and cheekbones


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• voice changes

Rare

• Acid or sour stomach


• ankle, knee, or great toe joint pain


• belching


• bleeding after defecation


• blistering, burning, crusting, dryness, or flaking of the skin


• bloated


• blurred or loss of vision


• decrease or change in vision


• difficulty with moving


• disturbed color perception


• double vision


• dryness of the eyes


• earache


• excess air or gas in stomach or intestines


• feeling of constant movement of self or surroundings


• feeling of warmth


• frequent bowel movements


• full feeling


• hair loss or thinning of the hair


• halos around lights


• heartburn


• increased watering of the mouth


• indigestion


• irregularities in menstruation


• itching in genital or other skin areas


• itching, scaling, severe redness, soreness, or swelling of the skin


• joint stiffness or swelling


• leg or muscle cramps


• loss of taste


• night blindness


• nosebleeds


• overbright appearance of lights


• pain in the breasts or pelvic area


• pain in the leg, nape, or back


• passing gas


• red, sore eyes


• redness of the face, neck, arms, and occasionally, upper chest


• redness or swelling in the ear


• sensation of spinning


• skin rash cracks in the skin at the corners of the mouth


• smaller amount of semen ejaculated than usual


• sore on the edge of the eyelid


• soreness or redness around the fingernails and toenails


• stomach discomfort, upset, or pain


• thickening of the tongue


• thirst


• tooth disorder


• toothache


• tunnel vision


• twitching of the eyes


• uncomfortable swelling around the anus


• worsening of acne

Incidence not known

• Burning feeling in the chest or stomach


• difficulty having a bowel movement (stool)


• increased appetite


• increased hair growth, especially on the face


• increased in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• sore gums


• tenderness in the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Klonopin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Klonopin Wafers resources

• Klonopin Wafers Side Effects (in more detail)
• Klonopin Wafers Use in Pregnancy & Breastfeeding
• Drug Images
• Klonopin Wafers Drug Interactions
• Klonopin Wafers Support Group
• 10 Reviews for Klonopin - Add your own review/rating

Compare Klonopin Wafers with other medications

• Anxiety
• Benzodiazepine Withdrawal
• Bipolar Disorder
• Burning Mouth Syndrome
• Hyperekplexia
• Insomnia
• Migraine Prevention
• Night Terrors
• Panic Disorder
• Periodic Limb Movement Disorder
• Restless Legs Syndrome
• Seizure Prevention

Kerafoam Foam

Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Kerafoam

Kerafoam Foam is used for:

Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, cracked skin, calluses). It may also be used for certain other skin or nail conditions as determined by your doctor.

Kerafoam Foam is a debriding agent. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.

Do NOT use Kerafoam Foam if:

• you are allergic to any ingredient in Kerafoam Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Kerafoam Foam:

Some medical conditions may interact with Kerafoam Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if the affected area is broken or severely irritated

Some MEDICINES MAY INTERACT with Kerafoam Foam. Because little, if any, of Kerafoam Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Kerafoam Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kerafoam Foam:

Use Kerafoam Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands immediately before and after using Kerafoam Foam unless your hands are part of the treated area.


• Prime the container before the first use. To do this, point the container away from yourself and others. Hold it upright. Press down on the actuator for 3 to 5 seconds, or until foam begins to appear.


• Shake well before each use.


• To use Kerafoam Foam, hold the container upright. Apply Kerafoam Foam to the affected skin as directed by your doctor. Rub in gently until the medicine is completely absorbed.


• After you use Kerafoam Foam, wipe any excess foam off of the container.


• If you miss a dose of Kerafoam Foam and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Kerafoam Foam.

Important safety information:

• Kerafoam Foam is for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Kerafoam Foam in your eyes, rinse them right away with cool water.


• Do not apply to broken or severely irritated skin.


• Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not use Kerafoam Foam for other skin conditions at a later time.


• PREGNANCY and BREAST-FEEDING: It is not known if Kerafoam Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Kerafoam Foam while you are pregnant. It is not known if Kerafoam Foam is found in breast milk. If you are or will be breast-feeding while you use Kerafoam Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Kerafoam Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning, itching, irritation, or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; severe or persistent burning or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Kerafoam side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Kerafoam Foam:

Store Kerafoam Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not freeze. Store upright away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Kerafoam Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Kerafoam Foam, please talk with your doctor, pharmacist, or other health care provider.


• Kerafoam Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Kerafoam Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Kerafoam resources

• Kerafoam Side Effects (in more detail)
• Kerafoam Use in Pregnancy & Breastfeeding
• Kerafoam Support Group
• 1 Review for Kerafoam - Add your own review/rating

Compare Kerafoam with other medications

• Dermatological Disorders
• Dry Skin
• Pityriasis rubra pilaris

Proventil

Generic Name: albuterol (al BYOO teh rall)

Brand Names: Proventil, Proventil Repetabs, Ventolin, Volmax

What is albuterol?

Albuterol works by relaxing muscles in the airways to improve breathing.

Albuterol is used to treat bronchospasm (wheezing, shortness of breath) associated with reversible obstructive airway disease such as asthma.

Albuterol may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about albuterol?

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

What should I discuss with my healthcare provider before taking albuterol?

Before taking albuterol, tell your doctor if you have

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  epilepsy or another seizure disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  difficulty swallowing;

  
  


• liver disease; or


• kidney disease.

You may not be able to take albuterol or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Albuterol is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Do not take albuterol without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether albuterol passes into breast milk. Do not take albuterol without first talking to your doctor if you are breast-feeding a baby.

How should I take albuterol?

Take albuterol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. To ensure that you get a correct dose, measure the liquid forms of albuterol with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Do not break, crush, or chew the Volmax or Proventil Repetabs tablets. These are specially formulated to release the medication slowly in the body. The Volmax tablets have an outer shell that is not absorbed by the body. Occasionally, this shell may be seen in the stool. This is not a problem as the medication has been absorbed by the body.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Store the Volmax brand of albuterol tablets in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). Store all other forms of albuterol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an albuterol overdose may include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while taking albuterol?

Avoid situations that may worsen your respiratory condition such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Albuterol side effects

Stop taking albuterol and seek emergency medical attention if you experience any of the following serious side effects:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

  
  


• 
  

  chest pain or irregular heartbeats.

  
  

Other, less serious side effects may be more likely to occur. Continue to take albuterol and talk to your doctor if you experience

• 
  

  headache;

  
  


• 
  

  dizziness or lightheadedness;

  
  


• 
  

  insomnia;

  
  


• 
  

  tremor or nervousness;

  
  


• 
  

  sweating;

  
  


• 
  

  nausea, vomiting, or diarrhea; or

  
  


• 
  

  dry mouth.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect albuterol?

Before taking albuterol, tell your doctor if you are taking any of the following medicines:

• a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL), propranolol (Inderal), acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), or pindolol (Visken);


• a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or protriptyline (Vivactil);


• a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);


• 
  

  another oral or inhaled bronchodilator; or

  
  


• 
  

  caffeine, diet pills, or decongestants.

  
  

You may not be able to take albuterol, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medications listed above.

Drugs other than those listed here may also interact with albuterol or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Proventil resources

• Proventil Side Effects (in more detail)
• Proventil Use in Pregnancy & Breastfeeding
• Drug Images
• Proventil Drug Interactions
• Proventil Support Group
• 6 Reviews for Proventil - Add your own review/rating

Compare Proventil with other medications

• Asthma, acute
• Asthma, Maintenance
• Bronchospasm Prophylaxis
• COPD, Acute
• COPD, Maintenance

Where can I get more information?

• Your pharmacist has additional information about albuterol written for health professionals that you may read.

See also: Proventil side effects (in more detail)

Sulfacetamide Sodium

Sulfacetamide Sodium OPHTHALMIC SOLUTION USP, 10%

DESCRIPTION

Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula:

C8H9N2Na03S • H2O

MW = 254.24

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains:

Active: Sulfacetamide Sodium 10% (100 mg/mL).

Preservative: methylparaben and propylparaben

Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate

CLINICAL PHARMACOLOGY

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

INDICATIONS AND USAGE

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:

Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Contraindications

Sulfacetamide Sodium Ophthalmic Solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

WARNINGS

FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION.

FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

PRECAUTIONS

General

Prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (See WARNINGS).

Information for Patients

To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Drug Interactions

Sulfacetamide preparations are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systematically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children below the age of two months have not been established.

ADVERSE REACTIONS

Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (See WARNINGS).

DOSAGE AND ADMINISTRATION

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is supplied sterile in plastic bottles in the following sizes:

15 mL: NDC 61314-701-01

Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded.

Rx Only

Dist. by:

FALCON Pharmaceuticals, Ltd

Fort Worth, Texas 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Printed in USA

340192-1102

PRINCIPAL DISPLAY PANEL

NDC 61314-701-01           Rx Only

FALCON PHARMACEUTICALS®

Sulfacetamide

Sodium

Ophthalmic

Solution USP

10%

15 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Sulfacetamide Sodium  Sulfacetamide Sodium  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52959-117 (61314-701) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (SULFACETAMIDE) Sulfacetamide Sodium 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength METHYLPARABEN   PROPYLPARABEN   SODIUM THIOSULFATE   METHYLCELLULOSE (4000 CPS)   SODIUM PHOSPHATE, MONOBASIC

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52959-117-01 15 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089560	03/25/2003

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Falcon Pharmaceuticals, Ltd. (874345820)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 11/2011H.J. Harkins Company, Inc.

More Sulfacetamide Sodium resources

• Sulfacetamide Sodium Dosage
• Sulfacetamide Sodium Use in Pregnancy & Breastfeeding
• Sulfacetamide Sodium Drug Interactions
• Sulfacetamide Sodium Support Group
• 0 Reviews for Sulfacetamide Sodium - Add your own review/rating

• AK-Sulf Concise Consumer Information (Cerner Multum)


• Bleph-10 Concise Consumer Information (Cerner Multum)


• Bleph-10 Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sulfacetamide Sodium with other medications

• Conjunctivitis
• Trachoma

Minims Chloramphenicol 0.5%

Generic Name: chloramphenicol (Ophthalmic route)

klor-am-FEN-i-kol

Commonly used brand name(s)

In the U.S.

• Ocu-Chlor

In Canada

• Ak-Chlor


• Chloromycetin


• Chloroptic


• Fenicol


• Isopto Fenicol


• Minims Chloramphenicol 0.5%


• Ophtho-Chloram


• Pentamycetin Ophthalmic Solution 0.25%


• Pentamycetin Ophthalmic Solution 0.5%


• Pms-Chloramphenicol


• Sopamycetin

Available Dosage Forms:

• Solution


• Ointment


• Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Chloramphenicol (class)

Uses For Minims Chloramphenicol 0.5%

Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol ophthalmic preparations are used to treat infections of the eye. This medicine may be given alone or with other medicines that are taken by mouth for eye infections.

Chloramphenicol is available only with your doctor's prescription.

Before Using Minims Chloramphenicol 0.5%

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram


• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ceftazidime


• Chlorpropamide


• Cyclosporine


• Dicumarol


• Fosphenytoin


• Phenytoin


• Rifampin


• Rifapentine


• Tacrolimus


• Tetanus Toxoid


• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of chloramphenicol

This section provides information on the proper use of a number of products that contain chloramphenicol. It may not be specific to Minims Chloramphenicol 0.5%. Please read with care.

For patients using the eye drop form of chloramphenicol:

• Although the bottle may not be full, it contains exactly the amount of medicine your doctor ordered.


• To use:
  
  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to come into contact with the infection.
  
  
  • If you think you did not get the drop of medicine into your eye properly, use another drop.
  
  
  • To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.
  
  

To use the eye ointment form of chloramphenicol:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using chloramphenicol eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For eye infection:
  
  • For ophthalmic ointment dosage form:
    
    • Adults and children—Use every three hours.
    
    
  
  
  • For ophthalmic solution (eye drops) dosage form:
    
    • Adults and children—One drop every one to four hours.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Minims Chloramphenicol 0.5%

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Minims Chloramphenicol 0.5% Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare - may also occur weeks or months after you stop using this medicine

• Pale skin


• sore throat and fever


• unusual bleeding or bruising


• unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Burning or stinging

After application, eye ointments may be expected to cause your vision to blur for a few minutes.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Minims Chloramphenicol 0.5% resources

• Minims Chloramphenicol 0.5% Drug Interactions
• Minims Chloramphenicol 0.5% Support Group
• 0 Reviews for Minims Chloramphenicol 0.5% - Add your own review/rating

Compare Minims Chloramphenicol 0.5% with other medications

• Conjunctivitis, Bacterial

Lice Treatment Maximum Strength

Generic Name: piperonyl butoxide and pyrethrins topical (pi PER o nil bue TOX ide and pye RETH rins)

Brand Names: A-200 Lice Control, A-200 Lice Treatment, Good Sense Lice Killing Shampoo, Step 1, Lice Treatment Maximum Strength, Pronto Lice Kill System, Pronto Shampoo & Cream Rinse, Pronto Shampoo Kit, Pronto Spray, Pronto with Metal Comb, R & C Lice Treatment Kit, Rid Pediculicide, Tegrin-LT Lice Spray, Tegrin-LT Lice Treatment Kit, Tegrin-LT Shampoo, Triple X Pediculicide

What is Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

Piperonyl butoxide and pyrethrins are insecticide chemicals.

Piperonyl butoxide and pyrethrins topical (for the skin) is used to treat lice.

Piperonyl butoxide and pyrethrins topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins, or if you have an allergy to chrysanthemums or ragweed.

Check all household members for signs of lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

What should I discuss with my healthcare provider before using Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins topical, or if you have an allergy to chrysanthemums or ragweed. It is not known whether piperonyl butoxide and pyrethrins topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Piperonyl butoxide and pyrethrins can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Check for signs of lice on all household members. They may also need to be treated for lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Apply the shampoo form of this medication to dry hair. Wetting the hair first may make the medication less effective. Apply the shampoo to all areas of the scalp, including behind the ears and neck. Treat hair from the roots to the ends and leave the shampoo in the hair for 10 minutes. Add warm water to form a lather and shampoo. Then rinse thoroughly with warm water. Piperonyl butoxide and pyrethrins shampoo is usually used once every 7 to 10 days.

You may need to use a larger amount of the shampoo if you have long hair. Follow the directions on the product label.

Keep your eyes tightly closed while using the shampoo, foam, or spray, and while rinsing it out of your hair. You may use a washcloth or towel to protect your eyes while applying the medication to your head.

Do not apply this medication to your eyebrows or eyelashes. Call your doctor if these areas become infected with lice.

Avoid inhaling the vapors from this medication. Use in a well-ventilated area.

You will need to remove any eggs (nits) from the hair shafts with a special comb. Some piperonyl butoxide and pyrethrins products come provided with a nit comb. If you do not have such a comb, ask your pharmacist where you can get one. Nits may not be removed effectively with a regular fine-tooth comb.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or incinerate the can, the contents are under pressure.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

Avoid using other medications or skin products on the areas you treat with piperonyl butoxide and pyrethrins topical, unless you doctor tells you to.

Avoid getting this medication in your eyes, nose, mouth, or vagina. If this does happen, rinse with water. Do not use piperonyl butoxide and pyrethrins topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid close contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, pillows, and other items of personal use. Lice infestations are highly contagious.

Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

Less serious side effects may include:

• 
  

  mild itching, burning, or stinging;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  numbness or tingly feeling.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lice Treatment Maximum Strength (piperonyl butoxide and pyrethrins topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied piperonyl butoxide and pyrethrins. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lice Treatment Maximum Strength resources

• Lice Treatment Maximum Strength Use in Pregnancy & Breastfeeding
• 0 Reviews for Lice Treatment Maximum Strength - Add your own review/rating

Compare Lice Treatment Maximum Strength with other medications

• Head Lice

Where can I get more information?

• Your pharmacist can provide more information about piperonyl butoxide and pyrethrins.

Sumatriptan100mg Tablets

1. Name Of The Medicinal Product

Sumatriptan 100 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablet.

White to off – white, capsule shaped, biconvex, uncoated tablets, debossed with 'C' on one side and '34' on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Sumatriptan is indicated for the acute treatment of migraine attacks with or without aura.

4.2 Posology And Method Of Administration

General recommendations with regard to use and administration:

Sumatriptan should not be used prophylactically.

Sumatriptan is recommended as monotherapy for the acute treatment of a migraine attack and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3).

It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.

The following recommended dosages of Sumatriptan should not be exceeded.

Adults

The recommended dose of oral sumatriptan is a single 50 mg tablet. Some patients may require 100 mg.

Although the recommended oral dose of sumatriptan is 50 mg, it must be taken into account that the severity of migraine attacks varies both within and between patients. Doses of 25 mg-100 mg have shown to be more effective than placebo in clinical trials but 25 mg is statistically significantly less effective than 50 mg and 100 mg.

If the patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. Sumatriptan tablets may be taken for subsequent attacks.

If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 hours, provided that not more than 300 mg is taken in any 24 hour period.

For the different dosage regimens Sumaptriptan Aurobindo is available in the strength of 50 mg also.

• Children and Adolescents (under 18 years of age)

Sumatriptan tablets are not recommended for use in children and adolescents due to insufficient data on safety and efficacy.

• Elderly (over 65 years of age)

Experience of the use of sumatriptan tablets in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of sumatriptan in patients aged over 65 years is not recommended.

Patients with hepatic insufficiency

In patients with mild to moderate hepatic insufficiency low doses of 25-50 mg sumatriptan should be considered.

Method of administration

The tablets should be swallowed whole with water.

4.3 Contraindications

• Hypersensitivity to sumatriptan or to any of the excipients.

• Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease.

• Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

• Sumatriptan should not be administered to patients with severe hepatic impairement.

• The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated.

• The concomitant administration of ergotamine, or ergotamine derivatives (including methysergide) or any triptan/5-hydroxytryptamine₁ (5-HT₁) receptor agonist is contraindicated (see section 4.5).

• Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated.

• Sumatriptan must not be used within 2 weeks of discontinuation of therapy with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Sumatriptan should only be used where there is a clear diagnosis of migraine.

Sumatriptan is not indicated for use in management of, hemiplegic, basilar or ophthalmoplegic migraine.

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

It should be noted that migraineurs may be at increased risk of certain cerebrovascular events (e.g. CVA, TIA).

Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat (see section 4.8). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given, and an appropriate evaluation should be carried out.

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see section 4.5)

Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.

Sumatriptan should be administered with caution to patients with conditions that may affect significantly the absorption, metabolism or excretion of the drug, e.g. impaired hepatic or renal function.

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan (see section 4.8).

Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients.

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John's Wort (Hypericum perforatum).

Prolonged use of any painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequently or daily headaches despite (or because of) the regular use of headache medications.

The recommended dose of sumatriptan should not be exceeded.

Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation (see section 4.3). Special consideration should be give to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol.

There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT₁ receptor agonist. The increased risk of coronary vasospasms is a theoretical possibility and concomitant administration is contraindicated (see section 4.3).

The period of time that should elapse between the use of sumatriptan and ergotamine-containing preparations or another triptan/5-HT₁ receptor agonist is not known. This will also depends on the doses and types of products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine-containing preparations or another triptan/5-HT₁ receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least 6 hours following the use of sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan/5-HT₁ receptor agonist (see section 4.3).

Undesirable effects can occur more frequently in cases of concomitant use of triptans and herbal preparations containing St. John's wort (Hypericum perforatum).

An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated (see section 4.3).

There may be a risk of serotonergic syndrome also if sumatriptan is used concomitantly with lithium.

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs (see section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

Post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congential defects. Experience with the use of sumatriptan in the second and third trimester is limited.

Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri-and postnatal development. However, embryo-foetal viability might be affected in the rabbit (see section 5.3). Administration of sumatriptan should only be considered if the expected benefits to the mother is greater than any possible risk to the foetus.

Lactation

It has been demonstrated that following subcutaneous administration sumatriptan is secreted into breast milk. Infant exposure can be minimised by avoiding breast-feeding for 12 hours after treatment, during which time any breast milk expressed should be discarded.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of a migraine, or its treatment with sumatriptan. This may influence the ability to drive and operate machinery.

4.8 Undesirable Effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000), not known (cannot be estimated from the available data).

Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.

Immune system disorders
Not known:	Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.
Nervous system disorders
Common:	Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.
Not known:	Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent; Tremor, dystonia, nystagmus, scotoma.
Eye disorders
Not known:	Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself.
Cardiac disorders
Not known:	Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see section 4.3 and 4.4).
Vascular disorders
Common:	Transient increases in blood pressure arising soon after treatment. Flushing.
Not known:	Hypotension, Raynaud's phenomenon.
Respiratory, thoracic and mediastinal disorders
Common:	Dyspnoea.
Gastrointestinal disorders
Common:	Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.
Not known:	Ischaemic colitis.
Not known:	Diarrhoea.
Musculoskeletal and connective tissue disorders
Common:	Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia.
Not known:	Neck stiffness.
Not known:	Arthralgia.
General disorders and administration site conditions
Common:	Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).
Investigations
Very rare:	Minor disturbances in liver function tests have occasionally been observed.
Psychiatric disorders
Not known:	Anxiety.
Skin and subcutaneous tissue disorders
Not known:	Hyperhidrosis.

4.9 Overdose

Symptoms and signs

Isolated cases of overdose with sumatriptan have been described.

Single doses up to 200 mg rectally or 40 mg nasally and doses in excess of 400 mg orally and 16 mg subcutaneously were not associated with side effects other than those mentioned. Patients have received single injections of up to 12 mg subcutaneously without significant adverse effects.

Treatment

If overdose occurs, the patient should be monitored for at least 10 hours and standard supportive treatment applied as required.

It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Selective serotonin (5HT₁) agonists

ATC code: N02CC01

Sumatriptan is a specific and selective 5-hydroxytryptamine-1d receptor agonist, and has not demonstrated activity on the other 5HT (5HT₂-5HT₇) receptors.

The vascular 5HT_1d receptor is found predominantly in the cranial blood vessels and has a vasoconstrictor effect. In experimental animals, it has been shown that sumatriptan causes vasoconstriction of the arterioles and the arteriovenous anastomata of the carotid vascular bed. This vascular bed provides the blood supply to the extracranial and intracranial tissues, such as the meninges. It has been proposed that dilatation of these arterial vessels, and the formation of oedema here, is the underlying cause of a migraine attack in humans. There is also evidence from animal experiments to suggest that sumatriptan inhibits the activity of the trigeminal nerve. Both effects (cranial vasoconstriction and inhibition of the activity of the trigeminal nerve) might contribute to the anti-migraine effect of sumatriptan in humans.

A clinical response occurs approximately 30 minutes after oral administration of a dose of 100 mg.

Sumatriptan is effective for the acute treatment of migraine attacks that occur during menstruation in women, i.e. in the period from 3 days before to 5 days after the beginning of menstruation.

A number of placebo-controlled clinical studies assessed the safety and efficacy of oral sumatriptan in 600 adolescent migraineurs aged 12-17 years. These studies failed to demonstrate relevant differences in headache relief at 2 hours between placebo and any sumatriptan dose. The undesirable effects profile of oral sumatriptan in adolescents aged 12-17 years was similar to that reported from studies in the adult population.

5.2 Pharmacokinetic Properties

Following oral administration sumatriptan is rapidly absorbed, the maximum concentration being reached after 2 (0.5-5) hours. Absolute bioavailability after oral administration is on average 14%. This is partly due to presystemic metabolism and partly to incomplete absorption. In patients with hepatic insufficiency, presystemic clearance after oral administration is reduced, resulting in an increase in the plasma levels of sumatriptan.

Protein binding is low (14-21%) and the mean volume of distribution is 170 litres. The elimination half-life is approximately 2 hours. Mean total clearance is 1160 ml/minute and mean renal clearance is approximately 260 ml/minute. Non-renal clearance is approximately 80% of total clearance, suggesting that sumatriptan is primarily cleared through oxidative metabolism mediated by monoamine oxidase A. The major metabolite, the indole acetic acid analogue of sumatriptan, is excreted in the urine as the acid or as the glucuronide conjugate. This metabolite has no known 5HT1 or 5HT2 activity. Minor metabolites have not been identified. The pharmacokinetics of the oral administration of sumatriptan does not appear to be influenced by a migraine attack.

Pharmacokinetics in special groups:

Elderly:

The kinetics in elderly subjects has not been sufficiently studied to permit a statement on possible differences in the kinetics between elderly and young volunteers.

5.3 Preclinical Safety Data

In a fertility study in the rat, a reduction in the success of insemination was seen on exposure to concentrations higher than the maximum exposure in humans. In rabbits embryolethality was observed, without marked teratogenic effects.

Sumatriptan was devoid of genotoxic and carcinogenic activity in in-vitro systems and animal studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Croscarmellose sodium (E468)

Polysorbate 80 (E433)

Calcium hydrogen phosphate anhydrous (E450)

Cellulose microcrystalline (E460)

Sodium hydrogen carbonate (E500)

Magnesium stearate (E470b)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

4 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Sumatriptan tablets are available in Polyamide/PVC/Aluminium blister packs.

Pack sizes:

2, 3, 4, 6, 8, 12, 18, 20, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed off in accordance with local requirements.

7. Marketing Authorisation Holder

Aurobindo Pharma Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 20532/0099

9. Date Of First Authorisation/Renewal Of The Authorisation

28/05/2008

10. Date Of Revision Of The Text

15/06/2010