panitumumab Intravenous

pan-i-TOOM-ue-mab

Intravenous route(Solution)

Dermatologic toxicities were reported in 89% of patients and were severe in 12% of patients receiving panitumumab monotherapy. Severe infusion reactions occurred in approximately 1% of patients. Fatal infusion reactions occurred in postmarketing experience .

Commonly used brand name(s)

In the U.S.

• Vectibix

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For panitumumab

Panitumumab is used to treat patients with metastatic cancer (cancer that spreads to other parts of the body) of the colon or rectum. panitumumab is given to patients who have already received other cancer treatments. Panitumumab should only be used in patients who have had a KRAS gene mutation test. This test helps the doctor decide whether the medicine will treat their cancer.

Panitumumab interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by panitumumab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

Before you begin treatment with panitumumab, you and your doctor should talk about the good panitumumab will do as well as the risks of using it.

Panitumumab will only be given by or under the immediate supervision of your doctor.

panitumumab is available only with your doctor's prescription.

Before Using panitumumab

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 panitumumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to panitumumab 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 have not been performed on the relationship of age to the effects of panitumumab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of panitumumab in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

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

• Dehydration or


• Diarrhea or


• Electrolyte imbalance (e.g., low magnesium, potassium, or calcium in the blood) or


• Eye disease or


• Lung disease (e.g., interstitial pneumonitis, pulmonary fibrosis), history of or


• Sensitivity to sunlight or


• Skin or nail disorder—Use with caution. May make these conditions worse.

Proper Use of panitumumab

You will receive panitumumab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you panitumumab. panitumumab is given through a needle placed in one of your veins. Panitumumab needs to be given slowly, so the needle will remain in place for at least an hour.

panitumumab sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Precautions While Using panitumumab

It is very important that your doctor check your progress at regular visits to make sure that panitumumab is working properly. Blood tests may be needed to check for unwanted effects.

Using panitumumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 6 months after the last dose of panitumumab. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some patients who use panitumumab develop serious skin problems that may lead to infections that can become life-threatening. Tell your doctor right away if you have skin changes such as pimples; a rash, itchiness, redness, swelling, dryness, peeling, or fissures; or nail changes.

Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while receiving panitumumab.

panitumumab may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have cough, difficulty with swallowing, dizziness, fast heartbeat, wheezing, trouble with breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving panitumumab.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

panitumumab may cause severe kidney disease in patients who have severe diarrhea and dehydration. panitumumab may also increase your risk of having an electrolyte imbalance (e.g., low magnesium or calcium in the blood). Tell your doctor right away if you start having bloating or swelling of the face, arms, hands, lower legs, ankles, or feet; decreased urination; dizziness; headache; lethargy; muscle cramps or twitching; mood or mental changes; nausea; rapid weight gain; or unusual tiredness or weakness while being treated with panitumumab.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are receiving panitumumab and for 2 months after the last dose.

panitumumab 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 or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• anxiety


• bloating or swelling of the face, arms, hands, lower legs, ankles, or feet


• chest pain


• chills


• confusion


• constipation


• convulsions


• cough


• decreased urination


• deep cracks, grooves, or lines in the skin


• diarrhea


• difficulty with swallowing


• discoloration of the fingernails or toenails


• drowsiness


• dry mouth, lips, or skin


• fainting


• fast or irregular heartbeat


• fever


• flushing or redness of the skin


• increased thirst


• itching, pain, and swelling of the eyelid


• itching skin


• loosening of the fingernails


• loss of appetite


• mood or mental changes


• muscle pain or cramps


• muscle spasms or twitching


• nausea


• rapid weight gain


• rapid, shallow breathing


• rash


• redness or soreness around the fingernails


• shortness of breath


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• sudden shortness of breath


• sunken eyes


• swelling or inflammation of the mouth


• tearing of the eyes


• tingling of the hands or feet


• trembling


• troubled breathing


• unusual tiredness or weakness


• unusual weight gain or loss


• unusually warm skin


• vomiting

Less common

• Blurred vision


• burning, dry, or itching eyes


• difficulty with breathing


• discharge from the eyes or excessive tearing


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


• facial swelling


• headache


• hives


• noisy breathing


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


• sweating


• swelling of the eye, eyelid, or inner lining of the eyelid


• tightness in the chest


• wheezing

Rare

• Chest discomfort


• painful breathing


• slight fever


• troubled or quick, shallow breathing

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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: panitumumab Intravenous 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 panitumumab Intravenous resources

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

Compare panitumumab Intravenous with other medications

• Colorectal Cancer

Migrin-A

Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)

eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen

Commonly used brand name(s)

In the U.S.

• Amidrine


• Diacetazone


• Duradrin


• Epidrin


• Iso-Acetazone


• Midrin


• Migquin


• Migratine


• Migrazone


• Migrin-A


• Nodolor


• Va-Zone

Available Dosage Forms:

• Capsule

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: Isometheptene

Uses For Migrin-A

Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

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

Before Using Migrin-A

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 with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

Many medicines have not been tested 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 combination 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Bromocriptine


• Fospropofol

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.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

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

Using this medicine with any of the following may cause an increased risk of certain side effects 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.

• Cabbage

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:

• Alcohol abuse or


• Heart attack (recent) or


• Heart or blood vessel disease or


• Kidney disease or


• Liver disease or


• Stroke (recent) or


• Virus infection of the liver (viral hepatitis)—The chance of side effects may be increased

• Glaucoma, not well controlled, or


• High blood pressure (hypertension), not well controlled—The isometheptene in this combination medicine may make these conditions worse

Proper Use of isometheptene, dichloralphenazone, and acetaminophen

This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Migrin-A. 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 than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.

This medicine works best if you:

• Take it as soon as the headache begins. If you get warning signals of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring.


• Lie down in a quiet, dark room until you are feeling better.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

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 “tension” headaches:
  
  • Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8 capsules a day.
  
  
  • Children: Dose must be determined by the doctor.
  
  


• For migraine headaches:
  
  • Adults: 2 capsules for the first dose, then 1 capsule every hour, as needed. Not more than 5 capsules in 12 hours.
  
  
  • Children: Dose must be determined by the doctor.
  
  

Precautions While Using Migrin-A

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better relief by increasing the dose.


• If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.

Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.

Migrin-A 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 as soon as possible if any of the following side effects occur:

Less common

• Unusual tiredness or weakness

Rare

• Black, tarry stools


• blood in urine or stools


• pinpoint red spots on skin


• skin rash, hives, or itching


• sore throat and fever


• unusual bleeding or bruising


• yellow eyes or skin

Symptoms of dependence on this medicine

• Headaches, more severe and/or more frequent than before

Symptoms of acetaminophen overdose

• Diarrhea


• increased sweating


• loss of appetite


• nausea or vomiting


• pain, tenderness, and/or swelling in the upper abdominal (stomach) area


• stomach cramps or pain

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:

More common

• Drowsiness

Rare

• Dizziness


• fast or irregular heartbeat

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: Migrin-A 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 Migrin-A resources

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

• Duradrin Concise Consumer Information (Cerner Multum)


• Duradrin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Migrin-A with other medications

• Headache

Informin

Informin may be available in the countries listed below.

Ingredient matches for Informin

Phenformin

Phenformin hydrochloride (a derivative of Phenformin) is reported as an ingredient of Informin in the following countries:

• Greece

International Drug Name Search

Keri Lotion

Generic Name: topical emollients (TOP i kal ee MOL i ents)

Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are Keri Lotion (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

There are many brands and forms of topical emollients available and not all are listed on this leaflet.

Topical emollients may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Keri Lotion (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using Keri Lotion (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  deep wounds or open sores;

  
  


• 
  

  swelling, warmth, redness, oozing, or bleeding;

  
  


• 
  

  large areas of skin irritation;

  
  


• 
  

  any type of allergy; or

  
  


• if you are pregnant or breast-feeding.

How should I use Keri Lotion (topical emollients)?

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

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

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 taking Keri Lotion (topical emollients)?

Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays.

Keri Lotion (topical emollients) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

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 Keri Lotion (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. 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 Keri Lotion resources

• Keri Lotion Use in Pregnancy & Breastfeeding
• Keri Lotion Support Group
• 0 Reviews for Keri - Add your own review/rating

• Biafine Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Campath Monograph (AHFS DI)


• Campral Monograph (AHFS DI)


• Camptosar Monograph (AHFS DI)


• Diabinese Monograph (AHFS DI)


• Kinerase Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Neosalus Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Promiseb Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Keri Lotion with other medications

• Dry Skin

Where can I get more information?

• Your pharmacist can provide more information about topical emollients.

Topamax

Generic Name: topiramate (Oral route)

toe-PIR-a-mate

Commonly used brand name(s)

In the U.S.

• Topamax


• Topiragen

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Anticonvulsant

Chemical Class: Fructopyranose Sulfamate

Uses For Topamax

Topiramate is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It is also be used to help prevent migraine headaches in adults.

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

Before Using Topamax

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 have not been performed on the relationship of age to the effects of topiramate for the treatment of seizures in children younger than 2 years of age (when used alone or together with other medicines). Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of topiramate for the prevention of migraine headaches in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving topiramate.

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.

• Citalopram


• Ketorolac


• Metformin


• Naproxen

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.

• Amitriptyline


• Carbamazepine


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Fosphenytoin


• Ginkgo


• Hydrochlorothiazide


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Phenobarbital


• Phenytoin


• Pioglitazone


• Posaconazole


• Valproic Acid

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.

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:

• Bone problems (e.g., osteomalacia, osteoporosis, rickets) or


• Depression, history of or


• Eye or vision problems (e.g., glaucoma) or


• Mental illness, history of or


• Metabolic acidosis (too much acid in the blood), history of—Use with caution. May make these conditions worse.

• Congenital metabolism disorders (born with a disease that affects metabolism)—Use with caution. May increase risk for more serious side effects.

• Diarrhea or


• Ketogenic diet (high-fat, low-protein, low-carbohydrate diet) or


• Kidney problems or


• Lung disease or other breathing problems or


• Status epilepticus (e.g., a state of epilepsy where you have many seizures in a row and do not gain consciousness) or


• Surgery—These problems may make a condition called metabolic acidosis occur or make it worse.

• Kidney disease or


• Liver disease—Use with caution. Higher blood levels of topiramate may result and increase the chance of side effects.

Proper Use of topiramate

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

Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. 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.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Topiramate may be taken with or without food, on a full or an empty stomach.

Swallow the tablets whole. Do not break, crush, or chew them. The bitter taste may be more noticeable if the tablets are held in the mouth or chewed.

The sprinkle capsules may be swallowed whole, or the capsule may be opened and the contents be sprinkled on a small amount (teaspoonful) of soft food (such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt). This mixture must be swallowed immediately without chewing.

It is important that you drink extra water every day while you take topiramate to help prevent kidney stones.

This medicine will be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

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 (capsules or tablets):
  
  • For seizures (taken with other medicines):
    
    • Adults—At first, 25 or 50 milligrams (mg) once a day for the first week. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 400 mg per day.
    
    
    • Children 2 years of age and older—At first, 25 milligrams (mg) nightly for the first week. Your doctor may gradually increase your dose every 1 or 2 weeks to be taken in two divided doses.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For seizures (taken alone):
    
    • Adults, teenagers, and children 10 years of age and older—At first, 50 milligrams (mg) once a day divided in two doses for the first week. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 400 mg per day taken in two divided doses.
    
    
    • Children 2 to 10 years of age—At first, 25 milligrams (mg) nightly for the first week. Your doctor may gradually increase your dose every week to be taken in two divided doses and as tolerated.
    
    
  
  
  • For migraine headaches:
    
    • Adults—At first, 25 milligrams (mg) once a day (in the evening) for the first week. Then, your doctor may increase your dose to 25 mg to be taken in the morning and 25 mg in the evening. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 100 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 Topamax

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. Blood tests may be needed to check for 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 this medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for pregnant patients taking a seizure medicine.

This medicine may cause some people to have blurred vision, double vision, clumsiness or unsteadiness, or to become dizzy, drowsy, or have trouble in thinking or speaking. Make sure you know how you react to this medicine before you drive, use machines, climbing in high places, swimming, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; prescription pain medicines, or sleep medicines. Check with your doctor before taking any of the above while you are using this medicine.

Check with your doctor immediately if you or your child have a decrease in vision, blurred vision, double vision, or pain around the eyes during and after treatment with this medicine. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking topiramate. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are using topiramate. If you have any questions about this, check with your doctor or pharmacist.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine. Overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Topiramate 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 or your child's doctor right away.

This medicine may cause nausea, muscle tremors, fast breathing, problems eating, fast heartbeat, restlessness, and abdominal or stomach pain. Tell your doctor right away if you or your child have any of these symptoms. This may be a sign that you or your child may be having a metabolic acidosis (too much acid in the blood).

This medicine may cause your body temperature to go down especially when taking valproic acid, which is another medicine to control seizures. You may have tiredness, weakness, confusion, and abnormal heartbeat and breathing. Tell your doctor right away if you feel any of these side effects.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Do not stop taking topiramate without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you or your child are having unusual drowsiness, dullness, tiredness, weakness, or feelings of sluggishness; mental depression or anxiety; nightmares or unusually vivid dreams; or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Check with your doctor right away if you or your child have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Tell your doctor if your or your child's skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles", or tingling feeling after using topiramate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Topamax 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

• Any vision problems, especially blurred vision, double vision, eye pain, or rapidly decreasing vision


• burning, prickling, or tingling sensations


• clumsiness or unsteadiness


• confusion


• continuous, uncontrolled back-and-forth or rolling eye movements


• dizziness


• drowsiness


• eye redness


• generalized slowing of mental and physical activity


• increased eye pressure


• memory problems


• menstrual changes


• menstrual pain


• nervousness


• speech or language problems


• trouble in concentrating or paying attention


• unusual tiredness or weakness

Less common

• Abdominal or stomach pain


• fever, chills, or sore throat


• lessening of sensations or perception


• loss of appetite


• mood or mental changes, including aggression, agitation, apathy, irritability, and mental depression


• red, irritated, or bleeding gums


• weight loss

Rare

• Blood in the urine


• decrease in sexual performance or desire


• difficult or painful urination


• eye pain


• frequent urination


• hearing loss


• itching


• loss of bladder control


• lower back or side pain


• nosebleeds


• pale skin


• red or irritated eyes


• ringing or buzzing in the ears


• skin rash


• swelling


• troubled breathing

Incidence not known

• Blistering, peeling, or loosening of the skin


• blisters in the mouth


• blisters on the trunk, scalp, or other areas


• bloating


• clay-colored stools


• constipation


• cough


• diarrhea


• increased rate of breathing


• itching


• joint or muscle pain


• pain or tenderness in upper abdomen or stomach


• red skin lesions, often with a purple center


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


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Decreased awareness or responsiveness


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


• drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• muscle tremors


• nausea


• rapid, deep breathing


• restlessness


• severe sleepiness


• stomach cramps


• sweating unusual

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:

More common

• Breast pain in women


• tremors

Less common

• Back pain


• chest pain


• constipation


• heartburn


• hot flushes


• increased sweating


• leg pain

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: Topamax 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 Topamax resources

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

• Topamax Prescribing Information (FDA)


• Topamax Consumer Overview


• Topamax Monograph (AHFS DI)


• Topamax MedFacts Consumer Leaflet (Wolters Kluwer)


• Topiramate Prescribing Information (FDA)


• Topiramate Professional Patient Advice (Wolters Kluwer)


• Topiragen Prescribing Information (FDA)

Compare Topamax with other medications

• Bipolar Disorder
• Bulimia
• Crohn's Disease
• Diabetic Nerve Damage
• Fibromyalgia
• Migraine Prevention
• Obesity
• Seizure Prevention
• Smoking Cessation
• Tourette's Syndrome
• Trigeminal Neuralgia
• Vulvodynia

Ketalar

Generic Name: ketamine (KET a meen)

Brand Names: Ketalar

What is Ketalar (ketamine)?

Ketamine is an anesthetic medication.

Ketamine is used as a general anesthetic to prevent pain and discomfort during certain medical tests or procedures, or minor surgery.

Ketamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

It may take you longer to recover from anesthesia with ketamine if you have recently used a barbiturate such as phenobarbital (Luminal) or secobarbital (Seconal), or a narcotic medication such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (OxyContin), propoxyphene (Darvocet, Darvon), and others.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

What should I discuss with my health care provider before receiving Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

How is ketamine given?

Ketamine is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a clinic or hospital setting.

Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of ketamine.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

What happens if I miss a dose?

Since ketamine is usually given for anesthesia, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of ketamine is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

What should I avoid after receiving Ketalar (ketamine)?

Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

Ketalar (ketamine) 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. Tell your caregivers at once if you have any of these serious side effects within 24 hours after you receive ketamine:

• 
  

  severe confusion;

  
  


• 
  

  hallucinations;

  
  


• 
  

  unusual thoughts; or

  
  


• 
  

  extreme fear.

  
  

Less serious side effects may include:

• 
  

  dream-like feeling;

  
  


• 
  

  double vision;

  
  


• 
  

  jerky muscle movements;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  nausea, vomiting, loss of appetite; or

  
  


• 
  

  sleep problems (insomnia).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you have recently used any of the following:

• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Percocet, Roxicodone), propoxyphene (Darvocet, Darvon), and others.

  
  

If you are using any of these drugs, it may take you longer to recover from anesthesia with ketamine.

There may be other drugs that can affect ketamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Ketalar resources

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

• Ketalar Prescribing Information (FDA)


• Ketalar MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ketalar with other medications

• Anesthesia

Where can I get more information?

• Your doctor or pharmacist can provide more information about ketamine.

See also: Ketalar side effects (in more detail)

Sumaxin Cleansing Pads

Dosage Form: cloth
sumaxin®

(sodium sulfacetamide 10% & sulfur 4%)

Cleansing Pads

In a vehicle containing Green Tea & Aloe

Rx Only

Sumaxin Cleansing Pads Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each pad of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

Sumaxin Cleansing Pads - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are not to be used by patients with kidney disease.

Warnings

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions

General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY

Category C

Animal reproduction studies have not been conducted with Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads. It is also not known whether Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Sumaxin Cleansing Pads Dosage and Administration

Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

How is Sumaxin Cleansing Pads Supplied

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are available in boxes of 60 cloths (3.7 g), NDC 43538-100-60.

Store at 15°-30° C (59°-86° F).

Manufactured for:

MEDIMETRIKS

PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP001-R3

Rev. 6/11

PRINCIPAL DISPLAY PANEL - 60 Pad Carton

NDC 43538-100-60

Rx Only

sumaxin®

(sodium sulfacetamide 10% & sulfur 4%)

Cleansing Pads

In a vehicle containing Green Tea & Aloe

60 Cleansing Pads

Net wt. 3.7 g Each

MEDIMETRIKS

PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-101-60

Rx Only

sumaxin®

(Sodium Sulfacetamide 10%

& Sulfur 4%) Cleansing Pads

CP

KIT

CONTENTS:

1 -

Sumaxin® (Sodium Sulfacemide 10% & Sulfur 4%)

Cleansing Pads Carton - 60 Pads (Net wt. 3.7 g each)

1 -

Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)

MEDIMETRIKS

PHARMACEUTICALS, INC.

SUMAXIN   CLEANSING PADS sulfacetamide sodium and sulfur  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g Sulfur (sulfur) Sulfur 40 mg  in 1 g

Inactive Ingredients Ingredient Name Strength aloe   butylated hydroxytoluene   cetyl alcohol   disodium oleamido MEA-sulfosuccinate   edetate disodium   glycerin   green tea leaf   methylparaben   propylparaben   water   sodium cocoyl isethionate   sodium lauryl sulfoacetate   sodium thiosulfate   stearyl alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-100-60 60 PACKET In 1 CARTON contains a PACKET 1 3.7 g In 1 PACKET This package is contained within the CARTON (43538-100-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2009

SUMAXIN CP  sulfacetamide sodium and sulfur  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-101

Packaging # NDC Package Description Multilevel Packaging 1 43538-101-60 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 60 PACKET   222 g Part 2 1 BOTTLE, PUMP   454 g

Part 1 of 2 SUMAXIN   CLEANSING PADS sulfacetamide sodium and sulfur  cloth

Product Information       Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g sulfur (sulfur) sulfur 40 mg  in 1 g

Inactive Ingredients Ingredient Name Strength aloe   butylated hydroxytoluene   cetyl alcohol   disodium oleamido MEA-sulfosuccinate   edetate disodium   glycerin   green tea leaf   methylparaben   propylparaben   water   sodium cocoyl isethionate   sodium lauryl sulfoacetate   sodium thiosulfate   stearyl alcohol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 60 PACKET In 1 CARTON contains a PACKET 1 3.7 g In 1 PACKET This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2009

Part 2 of 2 REHYLA WASH  inert  cream

Product Information       Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

Inactive Ingredients Ingredient Name Strength water   glyceryl monostearate   glycerin   cetyl alcohol   disodium oleamido mipa-sulfosuccinate   cholesterol   disodium laureth sulfosuccinate   helianthus annuus seed wax   caprylyl glycol   propylene glycol   phenoxyethanol   sodium cocoyl isethionate   cocamidopropyl betaine   sodium methyl cocoyl taurate   C13-14 isoparaffin   sodium chloride   niacinamide   edetate disodium   hexylene glycol   laureth-7   chamaemelum nobile flower   hyaluronate sodium

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 454 g In 1 BOTTLE, PUMP This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/01/2011

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Operations
IGI Laboratories		011036910	MANUFACTURE

Revised: 12/2011Medimetriks Pharmaceuticals, Inc.