Sunday, 11 March 2012

Ephedrine Sulphate Injection




EPHEDRINE SULFATE

Injection, USP

(50 mg/mL)

Preservative-Free

Single Dose Vial

Protect from light.

Keep vials in tray until time of use.



Ephedrine Sulphate Injection Description


Ephedrine Sulfate Injection, USP is a sterile, nonpyrogenic solution containing ephedrine sulfate 50 mg/mL in water for injection. It is administered by subcutaneous, intramuscular or intravenous injection as an adrenergic agent. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.3 (4.5 to 7.0). The osmolar concentration of the 5% solution is 0.35 mOsmol/mL (calc.).


Ephedrine Sulfate, USP is a sympathomimetic amine chemically designated α-[1-(methylamino) ethyl] benzenemethanol sulfate (2:1)(salt). It has the following structural formula:




Ephedrine Sulphate Injection - Clinical Pharmacology


Therapeutic doses of ephedrine produce mainly relaxation of smooth muscle and, if norepinephrine stores are intact, cardiac stimulation and increased systolic and usually increased diastolic blood pressure. Its vasopressor effect results largely from increased cardiac output and to a lesser extent from peripheral vasoconstriction. Pressor responses to parenteral ephedrine are slower but more prolonged than those produced by epinephrine. Ephedrine stimulates both alpha and beta receptors and its peripheral actions are due partly to norepinephrine release and partly to direct effect on receptors. Ephedrine may deplete norepinephrine stores in sympathetic nerve endings, so that tachyphylaxis to cardiac and pressor effects of the drug may develop. Central nervous system effects are similar to those of amphetamine drugs but less pronounced. The central effects of ephedrine are overshadowed to a large extent by its peripheral actions.


Glycogenolysis in the liver is increased by ephedrine but not as much as by epinephrine; usual doses of ephedrine are unlikely to produce hyperglycemia. Ephedrine increases oxygen consumption and metabolic rate as a probable result of central stimulation.


Ephedrine is rapidly and completely absorbed following parenteral injection. Pressor and cardiac responses to ephedrine persist for one hour following intramuscular or subcutaneous administration of 25 to 50 mg.


Small amounts of ephedrine are slowly metabolized in the liver; metabolites have been identified as p-hydroxyephedrine, p-hydroxynorephedrine, norephedrine, and conjugates of these compounds. The drug and its metabolites are excreted in the urine, mostly as unchanged ephedrine. Rate of urinary excretion is dependent on urinary pH. Percentage excretion of the drug and its metabolites is increased by acidification of the urine. Elimination half-life of the drug has been reported to be about three hours when the urine is acidified to pH 5 and about six hours when urinary pH is 6.3.



Indications and Usage for Ephedrine Sulphate Injection


Ephedrine Sulfate Injection, USP is indicated primarily to counteract the hypotensive effects of spinal or other types of nontopical conduction anesthesia. It is also useful as a pressor agent in hypotensive states following sympathectomy, or following overdosage with ganglionic-blocking agents, antiadrenergic agents, veratrum alkaloids or other drugs used for lowering blood pressure in the treatment of arterial hypertension. The drug is sometimes injected to relieve acute bronchospasm, but it is less effective than epinephrine for this purpose.



Contraindications


Ephedrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines and in patients with angle closure glaucoma. It should not be used in patients anesthetized with agents such as cyclopropane or halothane as these agents may sensitize the heart to the arrhythmic action of sympathomimetic drugs.


Ephedrine should not ordinarily be used in those cases where vasopressor drugs may be contraindicated, e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood pressure is in excess of 130/80 and in hypertension and other cardiovascular disorders.



Warnings


Ephedrine may cause hypertension resulting in intracranial hemorrhage. Ephedrine may induce anginal pain in patients with coronary insufficiency or ischemic heart disease. The drug also may induce potentially fatal arrhythmias in patients with organic heart disease or who are receiving drugs that sensitize the myocardium. See CONTRAINDICATIONS.


Initially, parenterally administered ephedrine may produce constriction of renal blood vessels and decreased urine formation.



Precautions


Ephedrine Sulfate Injection, USP is subject to oxidation and should be protected against exposure to light.


Do not administer unless solution is clear and seal is intact. Discard unused portion.


Ephedrine should be used cautiously in patients with hyperthyroidism, hypertension, heart disease (including coronary insufficiency, angina pectoris and patients receiving digitalis), cardiac arrhythmias, diabetes or unstable vasomotor system. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors.


Ephedrine should not be administered concomitantly with other sympathomimetic drugs because of possible additive effects and increased toxicity.


Alpha-adrenergic blocking agents may reduce the vasopressor response to ephedrine by causing vasodilation.


Beta-adrenergic blocking drugs may block the cardiac and bronchodilating effects of ephedrine.


Administration of ephedrine to patients receiving anesthesia with cyclopropane or halogenated hydrocarbons such as halothane which sensitize the myocardium, may induce cardiac arrhythmia. (See CONTRAINDICATIONS). Use of a pressor drug with less cardiac stimulating effects should be considered in patients receiving myocardial sensitizing anesthetics. When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug.


Ephedrine also should be used cautiously with other drugs (e.g., digitalis glycosides) that sensitize the myocardium to the actions of sympathomimetic agents.


Drugs such as reserpine and methyldopa which reduce the amount of norepinephrine in sympathetic nerve endings may reduce the pressor response to ephedrine. Diuretic agents also may decrease vascular response to pressor drugs such as ephedrine.


Ephedrine may antagonize the neuron blockade produced by guanethidine resulting in decreased anti-hypertensive effect and requiring increased dosage of the latter.



Pregnancy Category C


Animal reproduction studies have not been conducted with ephedrine. It is also not known whether ephedrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ephedrine should be given to a pregnant woman only if clearly needed.



Labor and Delivery


Parenteral administration of ephedrine to maintain blood pressure during low or other spinal anesthesia for delivery can cause acceleration of fetal heart rate and should not be used in obstetrics when maternal blood pressure exceeds 130/80. See CONTRAINDICATIONS.



Pediatric Use


The safety and effectiveness of Ephedrine has not been established. Its limited use in pediatric patients has been inadequate to fully define the proper dosage and limitations of use.



Adverse Reactions


Acute toxic effects are usually extensions of the therapeutic actions of the drug and are most often due to overdosage. Excessive doses may cause a sharp rise in blood pressure sufficient to produce cerebral hemorrhage. Other effects (usually transient) include headache, restlessness, anxiety, tension, tremor, weakness, dizziness, confusion, delirium hallucinations, pallor, respiratory difficulty, palpitation, sweating, nausea or vomiting. Repeated injections may cause contraction of the bladder sphincter and interfere with voluntary urination. The possibility of urinary retention, especially in the elderly male, should be kept in mind.



Drug Abuse and Dependence


None known with parenteral form.



Overdosage


Continued injections of ephedrine (after depletion of norepinephrine from the nerve endings with loss of vasopressor effect) may result in hypotension more serious than that existing prior to the use of ephedrine. In the absence of norepinephrine depletion, excessive parenteral dosage produces tachycardia, exaggerated rise in blood pressure, and possible cerebrovascular bleeding, plus central nervous system effects. In the event of adverse blood pressure effects, the drug should be stopped and appropriate corrective measures instituted. See ADVERSE REACTIONS.



Ephedrine Sulphate Injection Dosage and Administration


Depending on the clinical circumstances, Ephedrine Sulfate Injection may be given subcutaneously, intramuscularly or intravenously.


Usual adult dose: 25 to 50 mg (range 10 to 50 mg) injected subcutaneously or intramuscularly (equivalent to 0.2 to 1.0 mL of 5% solution) is usually adequate to prevent or minimize hypotension secondary to spinal anesthesia. Repeat doses should be governed by blood pressure response or, if used as a bronchodilator, according to the degree of improvement. Absorption (onset of action) by the intramuscular route is more rapid (within 10 to 20 minutes) than by subcutaneous injection. The intravenous route may be used if an immediate effect is desired.


When used during labor, administer only sufficient dosage to maintain blood pressure at or below 130/80.


In acute attacks of asthma, the smallest effective dose should be used (usually 0.25 to 0.5 mL) or as otherwise determined by the patient's response.


Usual pediatric dose: 750 micrograms per kg of body weight or 25 mg/M2 of body surface injected intravenously or subcutaneously, four times daily or as otherwise determined by the patient's response.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.



How is Ephedrine Sulphate Injection Supplied


Ephedrine Sulfate Injection, USP (50 mg/mL) is supplied as follows:


SINGLE DOSE VIAL









NDC NumberVolume
66758-008-011 mL fill in 2 mL vial
66758-008-021 mL fill in 2 mL vial, 25 × 2 mL

Store at controlled room temperature 15° to 30°C (59° to 86°F).


Caution: Federal (USA) law prohibits dispensing without prescription.


For Sandoz Inc. Customer Service, call 1-800-525-8747.


Manufactured for:


SANDOZ


Princeton, NJ 08540


L-029-00



Package Label - Principal Display Panel - 50 mg Carton


SANDOZ


25 × 2 mL Vials      NDC 66758-008-02


Ephedrine Sulfate

Injection, USP

50 mg/mL


1 mL fill in a 2 mL Vial

Single Dose Vial

Preservative Free          Rx only










EPHEDRINE SULFATE 
ephedrine sulfate  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66758-008
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ephedrine sulfate (ephedrine)ephedrine sulfate50 mg  in 1 mL






Inactive Ingredients
Ingredient NameStrength
water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
166758-008-0225 VIAL In 1 CARTONcontains a VIAL (66758-008-01)
166758-008-011 mL In 1 VIALThis package is contained within the CARTON (66758-008-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/26/2004


Labeler - Sandoz Inc (005387188)
Revised: 05/2010Sandoz Inc

More Ephedrine Sulphate Injection resources


  • Ephedrine Sulphate Injection Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ephedrine Sulphate Injection Drug Interactions
  • Ephedrine Sulphate Injection Support Group
  • 3 Reviews for Ephedrine Sulphate Injection - Add your own review/rating


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  • Asthma, acute
  • COPD, Acute
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Saturday, 10 March 2012

K-Lyte/Cl


Generic Name: potassium bicarbonate and potassium chloride (poe TASS ee um bye KAR boe nate and poe TASS ee um KLOR ide)

Brand Names: Effervescent Potassium/Chloride, K-Lyte/Cl


What is K-Lyte/Cl (potassium bicarbonate and potassium chloride)?

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.


Potassium bicarbonate and potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.


Potassium bicarbonate and potassium chloride may also be used for other purposes other than those listed in this medication guide.


What is the most important information I should know about K-Lyte/Cl (potassium bicarbonate and potassium chloride)?


You should not use this medication if you have kidney failure, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia). Do not chew the effervescent tablet or swallow it whole. It must be dissolved in water or fruit juice before you take it. Avoid lying down for at least 30 minutes after you take this medication. Take this medication with food or just after a meal.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG), which measures electrical activity of the heart. This will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.


Serious side effects of potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or mouth.


Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking K-Lyte/Cl (potassium bicarbonate and potassium chloride)?


You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

  • high levels of potassium in your blood (hyperkalemia);




  • kidney failure;




  • Addison's disease (an adrenal gland disorder);




  • a large tissue injury such as a severe burn;




  • if you are severely dehydrated; or




  • if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).



Before using potassium bicarbonate and potassium chloride, tell your doctor if you are allergic to any drugs, or if you have:


  • kidney disease;


  • heart disease or high blood pressure;




  • a blockage in your stomach or intestines; or




  • chronic diarrhea (such as ulcerative colitis, Crohn's disease).



If you have any of these conditions, you may need a dose adjustment or special tests to safely take potassium bicarbonate and potassium chloride.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take K-Lyte/Cl (potassium bicarbonate and potassium chloride)?


Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Do not chew the effervescent tablet or swallow it whole. Drop the tablet into a glass and add at least 4 ounces (one-half cup) of cold water or fruit juice. When the tablet has completely dissolved, begin drinking the mixture slowly, over 5 to 10 minutes in all.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.


The powder form of this medication should be mixed with at least 4 ounces (one-half cup) of cold water or fruit juice before taking. Drink the mixture slowly, over 5 to 10 minutes in all. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away. Take this medication with food or just after a meal. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Potassium-rich foods include: squash, baked potatoes (skin on), spinach, lentils, broccoli, brussels sprouts, zucchini, kidney or navy beans, raisins, watermelon, orange juice, bananas, cantaloupe, and low-fat milk or yogurt. Consume only the daily amounts recommended by your doctor or nutrition counselor.


To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.


Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store potassium bicarbonate and potassium chloride at room temperature away from moisture and heat. Keep the medication in a closed container.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include heavy feeling in your arms or legs, confusion, weak or shallow breathing, slow or uneven heartbeat, seizure (convulsions), or feeling like you might pass out.


What should I avoid while taking K-Lyte/Cl (potassium bicarbonate and potassium chloride)?


Avoid lying down for at least 30 minutes after you take this medication.

Avoid taking potassium supplements or using other products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.


K-Lyte/Cl (potassium bicarbonate and potassium chloride) 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 this medication and call your doctor at once if you have any of these serious side effects:

  • confusion, anxiety, feeling like you might pass out;




  • uneven heartbeat;




  • extreme thirst, increased urination;




  • leg discomfort;




  • muscle weakness or limp feeling;




  • numbness or tingly feeling in your hands or feet, or around your mouth;




  • severe stomach pain, ongoing diarrhea or vomiting;




  • black, bloody, or tarry stools; or




  • coughing up blood or vomit that looks like coffee grounds.



Less serious side effects may include:



  • mild nausea or upset stomach;




  • mild or occasional diarrhea; or




  • slight tingling in your hands or feet.



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 K-Lyte/Cl (potassium bicarbonate and potassium chloride)?


The following drugs can interact with potassium bicarbonate and potassium chloride. Tell your doctor if you are using any of these:



  • eplerenone (Inspra);




  • digoxin (digitalis, Lanoxin);




  • quinidine (Quinaglute, Quinidex, Quin-Release);




  • a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);




  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or




  • any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).



This list is not complete and there may be other drugs that can interact with potassium bicarbonate and potassium chloride. 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 K-Lyte/Cl resources


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


Compare K-Lyte/Cl with other medications


  • Hypokalemia
  • Prevention of Hypokalemia


Where can I get more information?


  • Your pharmacist can provide more information about potassium bicarbonate and potassium chloride.

See also: K-Lyte/Cl side effects (in more detail)


Friday, 9 March 2012

Cleocin T Gel


Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Examples include Cleocin T and Clindamax


Cleocin T Gel is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.


Cleocin T Gel is a topical lincomycin antibiotic. It works by killing sensitive bacteria that cause acne and reducing the amount of free fatty acids that irritate the skin surface.


Do NOT use Cleocin T Gel if:


  • you are allergic to any ingredient in Cleocin T Gel or to lincomycin

  • you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

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



Before using Cleocin T Gel:


Some medical conditions may interact with Cleocin T Gel. 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 gastrointestinal (bowel) disease or diarrhea

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


  • Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by Cleocin T Gel

  • Erythromycin because it may decrease Cleocin T Gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cleocin T Gel 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 Cleocin T Gel:


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


  • Cleocin T Gel is for topical use on the skin only.

  • Clean and dry the affected area. Cover the affected and surrounding area with a thin film of medicine.

  • Cleocin T Gel works best if it is used at the same time each day.

  • Continue to use Cleocin T Gel even if your condition improves. Do not miss any doses.

  • If you miss a dose of Cleocin T Gel, 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 Cleocin T Gel.



Important safety information:


  • Cleocin T Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Several weeks may pass before you see improvement in your acne. Continue using Cleocin T Gel for the full time recommended by your doctor.

  • Be sure to use Cleocin T Gel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Do not get Cleocin T Gel in your eyes or on the inside of your nose or mouth. If you accidentally get the medicine in your eye, immediately flush with a large amount of cool tap water.

  • If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Cleocin T Gel, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Cleocin T Gel should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cleocin T Gel while you are pregnant. It is not known if Cleocin T Gel is found in breast milk. Do not breast-feed while taking Cleocin T Gel.


Possible side effects of Cleocin T Gel:


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:



Dryness; itching; oiliness or oily skin.



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); blood or mucus in stools; bloody or severe diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.



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: Cleocin T 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, or emergency room immediately. Cleocin T Gel may be harmful if swallowed.


Proper storage of Cleocin T Gel:

Store Cleocin T Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Protect from freezing. Keep Cleocin T Gel out of the reach of children and away from pets.


General information:


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

  • Cleocin T Gel 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 Cleocin T Gel. 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 Cleocin T resources


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


Compare Cleocin T with other medications


  • Acne
  • Perioral Dermatitis

Thursday, 8 March 2012

Kinrix


Generic Name: diphtheria, pertussis acellular, tetanus, and polio (dif THEER ee a, per TUS is a SEL yoo lar, TET a nus, POE lee oh)

Brand Names: Kinrix


What is diphtheria, pertussis acellular, tetanus, and polio vaccine?

Diphtheria, pertussis acellular, tetanus, and polio are serious diseases caused by bacteria.


Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.


Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.


Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.


Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.


Diphtheria, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.


The diphtheria, pertussis acellular, tetanus, and polio vaccine is used to help prevent these diseases in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series.


This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.


Like any vaccine, the diphtheria, pertussis acellular, tetanus, and polio vaccine may not provide protection from disease in every person.


What is the most important information I should know about this vaccine?


The diphtheria, pertussis acellular, tetanus, and polio vaccine is given as the 5th dose in a series of DTaP immunizations and the 4th dose in a series of IPV immunizations. The shot is usually given to a child who is at least 4 years old or has not yet reached his or her 7th birthday. Your child's individual dose schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.


Be sure your child receives all recommended doses in the DTaP and IPV series. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.


Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.


Your child should not receive this vaccine if he or she had a life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, tetanus, or polio.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.


Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


What should I discuss with my healthcare provider before receiving this vaccine?


Your child should not receive this vaccine if he or she had a life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, tetanus, or polio. Your child should not receive this vaccine if the child has had a decreased level of consciousness within the past 7 days, or if the child has a neurologic disorder or disease affecting the brain.

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following within 48 hours:



  • a very high fever (over 104 degrees);




  • excessive crying for 3 hours or longer;




  • fainting or going into shock;




  • seizure (convulsions); or




  • Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).



Before receiving this vaccine, tell the doctor if your child has:



  • a history of seizures;




  • an allergy to latex rubber;




  • if the child is using steroid medication or receiving cancer chemotherapy or radiation treatment; or




  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments.



Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.


How is this vaccine given?


This vaccine is given as an injection into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.


The diphtheria, pertussis acellular, tetanus, and polio vaccine is given as the 5th dose in a series of DTaP immunizations and the 4th dose in a series of IPV immunizations. The shot is usually given to a child who is at least 4 years old or has not yet reached his or her 7th birthday. Your child's individual dose schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.


Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.


It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?


Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.


Be sure your child receives all recommended doses in the DTaP and IPV series. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.


What happens if I overdose?


An overdose of this vaccine is unlikely to occur.


What should I avoid before or after receiving this vaccine?


Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving the vaccine.


This vaccine side effects


Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.


Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


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.

Call your doctor at once if the child has any of these serious side effects:



  • extreme drowsiness, fainting;




  • fussiness, irritability, crying for an hour or longer;




  • seizure (black-out or convulsions); or




  • high fever.



Less serious side effects may include:



  • redness, pain, tenderness, or swelling where the shot was given;




  • drowsiness;




  • mild fussiness or crying;




  • low fever; or




  • loss of appetite.



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 diphtheria, pertussis acellular, tetanus, and polio vaccine?


Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system, including:



  • an oral, nasal, inhaled, or injectable steroid medicine;




  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or




  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).



If your child is using any of these drugs, this vaccine may not work as well.


This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.



More Kinrix resources


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


  • Kinrix Prescribing Information (FDA)

  • Kinrix Advanced Consumer (Micromedex) - Includes Dosage Information

  • Kinrix MedFacts Consumer Leaflet (Wolters Kluwer)

  • Kinrix Consumer Overview



Compare Kinrix with other medications


  • Diphtheria Prophylaxis
  • Pertussis Prophylaxis
  • Poliomyelitis Prophylaxis
  • Tetanus Prophylaxis


Where can I get more information?


  • Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: Kinrix side effects (in more detail)


Hectorol


Generic Name: Doxercalciferol
Class: Vitamin D
ATC Class: A11CC
VA Class: VT509
Chemical Name: (5Z,7E,22E)-9,10-Secoergosta-5,7,10(19),22-tetraene-1α,3β-diol
Molecular Formula: C28H44O2
CAS Number: 54573-75-0

Introduction

A synthetic vitamin D analog.1 3 4 7


Uses for Hectorol


Hyperparathyroidism Secondary to Chronic Renal Disease


Treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) undergoing dialysis.1 7


Oral doxercalciferol also used in the treatment of secondary hyperparathyroidism in patients with chronic renal disease (stage 3 and 4) who do not yet require maintenance dialysis (predialysis patients).1


Suppresses elevated serum or plasma parathyroid hormone (PTH) concentrations associated with secondary hyperparathyroidism in patients with CKD.1 8 Potential benefits on bone have not been established; however, deficient production of biologically active vitamin D metabolites leads to secondary hyperparathyroidism, which contributes to the development of metabolic bone disease.1


Hectorol Dosage and Administration


Administration


Administration


Doxercalciferol is administered orally1 without regard to meals or by direct IV7 injection.


Dosage


Individualize doxercalciferol dosage based on serum or plasma intact PTH (iPTH) concentrations, with close monitoring of serum calcium and phosphorus concentrations.1 4 7


In dialysis patients, measure serum iPTH, calcium, and phosphorus concentrations prior to initiation of the drug and weekly during first 12 weeks of therapy.1 7 Measure serum iPTH, calcium, phosphorus, and alkaline phosphatase concentrations periodically thereafter.1 7


In predialysis patients, monitor serum calcium, serum phosphorus, and plasma iPTH concentrations at least every 2 weeks for 3 months after initiation of therapy or after subsequent dosage changes, then monthly for 3 months (once dosage is stabilized), and every 3 months thereafter.1


Titrate dosage of doxercalciferol to reduce iPTH concentrations within a target range; specific target ranges based on the degree of renal impairment.1


Based on National Kidney Foundation. KDOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis. 2003; 42 (Suppl 3):1-202.















Target Range of Intact Plasma PTH by Stage of CKD1

CKD Stage



GFR (mL/minute/1.73 m2)



Target iPTH (pg/mL)



3



30–59



35–70



4



15–29



70–110



5



<15 (or dialysis)



150–300


Adults


Dialysis Patients

Hyperparathyroidism Secondary to Chronic Renal Disease

Oral

















Oral Doxercalciferol Dosage Regimen in Dialysis Patients 1

Initial Dosing



iPTH Concentrations



Dosage



>400 pg/mL



10 mcg 3 times weekly at dialysis (approximately every other day)



Dose Titration



iPTH Concentrations



Dosage



>300 pg/mL



Increase by 2.5 mcg at 8-week intervals as necessary


Maximum recommended dosage is 20 mcg 3 times weekly (60 mcg weekly)



150–300 pg/mL



Maintain dosage



<100 pg/mL



Withhold for 1 week, reinitiate at a dose that is at least 2.5 mcg lower than the last dose


If hypercalcemia, hyperphosphatemia, or a serum calcium (in mg/dL) times serum phosphorus (in mg/dL) product >55 mg2/dL2, decrease dosage or withhold therapy and/or adjust dosage of concomitant phosphate binders.1


IV



















IV Doxercalciferol Dosage Regimen in Dialysis Patients 7

Initial Dosing



iPTH Concentrations



Dosage



> 400 pg/mL



4 mcg (as a bolus) 3 times weekly at end of dialysis (approximately every other day)



Dose Titration



iPTH Concentrations



Dosage



Decreased by <50% and exceeding 300 pg/mL



Increase the dose given 3 times weekly by 1–2 mcg at 8-week intervals as necessary


IV dosages exceeding 18 mcg weekly have not been studied



Decreased by >50% and exceeding 300 pg/mL



Maintain dosage



150–300 pg/mL



Maintain dosage



<100 pg/mL



Withhold for 1 week, reinitiate at a dose at least 1 mcg lower than the last dose


If hypercalcemia, hyperphosphatemia, or a serum calcium (in mg/dL) times serum phosphorus (in mg/dL) product >55 mg2/dL2, decrease dosage or withhold therapy and/or adjust dosage of concomitant phosphate binders. 7


Predialysis Patients

Hyperparathyroidism Secondary to Chronic Renal Disease

Oral

















Oral Doxercalciferol Dosage Regimen in Predialysis Patients 1

Initial Dosing



iPTH Concentrations



Dosage



>70 pg/mL (Stage 3) and >110 pg/mL (Stage 4)



1 mcg once daily



Dose Titration



iPTH Concentrations



Dosage



> 70 pg/mL (Stage 3) and >110 pg/mL (Stage 4)



Increase by 0.5 mcg at 2 week intervals as necessary


Maximum recommended dosage is 3.5 mcg once daily



35–70 pg/mL (Stage 3) and 70–110 pg/mL (Stage 4)



Maintain dosage



<35 pg/mL (Stage 3) and <70 pg/mL (Stage 4)



Withhold for 1 week, reinitiate at a dose that is at least 0.5 mcg lower than the last dose


If hypercalcemia, hyperphosphatemia, or a serum calcium (in mg/dL) times phosphorus (in mg/dL) product >55 mg2/dL2, decrease dosage or withhold therapy and/or adjust dosage of concomitant phosphate binders. 1


Prescribing Limits


Adults


Oral

Maximum: 20 mcg 3 times weekly (60 mcg weekly).1


IV

Dosages >18 mcg weekly have not been studied.7


Cautions for Hectorol


Contraindications


Risk or history of hypercalcemia or hyperphosphatemia.1 7


Evidence of vitamin D toxicity.1 7


Known hypersensitivity to doxercalciferol or any ingredient in the formulation.1 7


Warnings/Precautions


Major Toxicities


Hypercalcemia

Risk of vitamin D analog toxicity; may require emergency measures.1 7


Acute hypercalcemia may increase risk of cardiac arrhythmias, seizures, and also synergistic inotropic and toxic effects in presence of cardiac glycosides.1 7


Chronic hypercalcemia increases risk of soft-tissue calcification, including vascular calcification.1 7


Maintain serum calcium-phosphorus product (Ca × P) <55 mg2/dL2 in patients with CKD.1 7


If hypercalcemia develops following initiation of doxercalciferol therapy, decrease dosage of doxercalciferol and/or calcium-containing phosphate binders. 1 7


Use radiographic evaluation of suspected areas for early detection of calcification.1 7


Do not use vitamin D and its analogs during doxercalciferol therapy; possible additive effects.1 7


Hyperphosphatemia

May occur with vitamin D analog toxicity.1 7


In patients with CKD, use calcium-containing or other non-aluminum-containing phosphate binders and a low-phosphate diet to control serum phosphate concentrations.1 7


If hyperphosphatemia develops following initiation of doxercalciferol therapy, decrease dosage of doxercalciferol and/or increase dosage of phosphate binder.1 7


Hypermagnesemia

Do not use magnesium-containing antacids concomitantly with doxercalciferol.1 7


General Precautions


Do not use doxercalciferol for treatment of nutritional vitamin D deficiency.1


Evaluate patients for vitamin D deficiency prior to initiation of doxercalciferol therapy; if indicated, vitamin D deficiency should be treated prior to initiating doxercalciferol.1


Metabolic Effects

Possible risk of hypercalcemia, hyperphosphatemia, hypercalciuria, and excessive suppression of iPTH concentrations; monitor and adjust dosages routinely to minimize risk of such effects. 1 7


Most patients require doxercalciferol dosage titration as well as adjustment of concomitant therapy (e.g., dietary phosphate binders) to effect and sustain iPTH suppression while maintaining serum calcium and phosphorus within prescribed ranges.1 7 (See Dosage under Dosage and Administration.)


Specific Populations


Pregnancy

Category B.1 7


Lactation

Not known if doxercalciferol is distributed into milk; discontinue nursing or drug because of potential risk (e.g., hypercalcemia) in nursing infants.1 7


Pediatric Use

Safety and efficacy not established in children.1 7


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 7


Hepatic Impairment

Use with caution since doxercalciferol may not be metabolized appropriately.1 7 Monitor serum iPTH, calcium, and phosphorus concentrations more frequently.1 7


Common Adverse Effects


In dialysis patients: edema,1 7 headache,1 7 malaise,1 7 nausea/vomiting,1 7 dizziness,1 7 dyspnea,1 7 pruritus,1 7 bradycardia.1 7


In predialysis patients with stage 3 or 4 CKD: infection,1 chest pain,1 constipation,1 dyspepsia,1 anemia,1 dehydration,1 depression,1 hypertonia,1 insomnia,1 paresthesia,1 increased cough,1 dyspnea,1 rhinitis.1


Excessive vitamin D intake (early manifestations): weakness,1 7 headache,1 7 somnolence,1 7 nausea,1 vomiting,7 dry mouth,1 7 constipation,1 7 bone pain,1 7 metallic taste,1 7 anorexia.1 7


Excessive vitamin D intake (late manifestations): polyuria,1 7 polydipsia1 7 anorexia,1 7 weight loss,1 7 nocturia,1 7 calcific conjunctivitis,1 7 pancreatitis,1 7 photophobia,1 7 rhinorrhea,1 7 pruritus,1 7 hyperthermia,1 7 decreased libido,1 7 increased BUN,1 7 albuminuria,1 7 hypercholesterolemia,1 7 increased serum AST and ALT concentrations,1 7 ectopic calcification,1 7 hypertension,1 7 cardiac arrhythmias,1 7 sensory disturbances,1 7 dehydration,1 7 apathy,1 7 growth arrest,1 7 urinary tract infections.1 7


Interactions for Hectorol


Drugs Affecting Hepatic Microsomal Enzymes


Possible pharmacokinetic interaction with hepatic enzyme inducers (e.g., glutethimide, phenobarbital) or inhibitors (e.g., erythromycin, ketoconazole) affecting hepatic hydroxylation (activation) of doxercalciferol.1 7


Specific Drugs




































Drug



Interaction



Comments



Cardiac glycosides



Concurrent use of vitamin D analogs and cardiac glycosides may result in cardiac arrhythmias1



Cholestyramine



Intestinal absorption of oral doxercalciferol may be decreased1



Erythromycin



Serum concentrations of active moiety of doxercalciferol may be reduced1 7



Glutethimide



Metabolism of doxercalciferol may be altered1 7



Dosage adjustment of doxercalciferol may be needed1 7



Ketoconazole



Serum concentrations of active moiety of doxercalciferol may be reduced1 7



Magnesium-containing antacids



Potential pharmacologic effect resulting in hypermagnesemia1 7



Mineral oil



Potential interaction with drugs affecting lipid absorption (e.g., mineral oil), resulting in decreased absorption of oral doxercalciferol1



Orlistat



Potential interaction with drugs affecting lipid absorption (e.g., orlistat), resulting in decreased absorption of oral doxercalciferol1 6



Vitamin D and its analogs



Potential additive pharmacologic effect resulting in increased adverse effects, including hypercalcemia.1 7



Phenobarbital



Metabolism of doxercalciferol may be altered1 7



Dosage adjustment of doxercalciferol may be needed1 7


Hectorol Pharmacokinetics


Absorption


Bioavailability


Absorbed from GI tract, with peak blood concentrations of 1α,25-dihydroxyergocalciferol (major metabolite) usually attained within 11–12 hours after repeated oral dosing.1 Following IV administration, peak blood concentrations of 1,25-dihydroxyergocalciferol are achieved in about 8 hours.7


Elimination


Metabolism


Hydroxylated to the active moiety, 1α,25-dihydroxyergocalciferol (1α,25-dihydroxyvitamin D2) via the hepatic cytochrome P-450 (CYP) isoenzyme 27.1 7


Half-life


Active moiety (1α,25-dihydroxyvitamin D2): 32–37 hours (ranging up to 96 hours).1


Special Populations


Temporary increases in mean concentrations of 1α,25-dihydroxyvitamin D2 (major metabolite) occur in patients undergoing hemodialysis.1


Stability


Storage


Oral


Capsules

20–25°C.1


Parenteral


Injection

Store at 15–25°C.7 Protect from light.7


ActionsActions



  • Activated metabolites and analogs of vitamin D increase the intestinal absorption of dietary calcium and the renal tubular reabsorption of urinary calcium, as well as modulating bone formation and resorption, in conjunction with PTH.1 2 3 7




  • In patients with chronic renal disease,1 decreased metabolic activation of vitamin D in the kidneys results in secondary hyperparathyroidism and osteodystrophy or rickets.1 2 3 4 7




  • Because doxercalciferol,1 does not require renal hydroxylation for activation, this analog can reduce serum or plasma PTH concentrations in patients with chronic renal disease, which contributes to metabolic bone disease in these patients.1 7



Advice to Patients


Importance of diet and calcium supplementation regimen adherence.1 7


Importance of a combined dietary calcium and calcium-containing phosphate binder intake of 1.5–2 g of calcium daily.1


Importance of serum iPTH, calcium, phosphorus, and alkaline phosphatase monitoring prior to initiation of therapy and periodically thereafter.1 7


Importance of immediate reporting of potential manifestations of hypercalcemia.1 7


Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 7


Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 7


Importance of informing patients of other precautionary information.1 7 (See Cautions.)


Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.























Doxercalciferol

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules, liquid-filled



0.5 mcg



Hectorol (with alcohol and coconut oil)



Bone Care



2.5 mcg



Hectorol (with alcohol and coconut oil)



Bone Care



Parenteral



Injection, for IV use only



2 mcg/mL



Hectorol



Bone Care



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Genzyme. Hectorol (doxercalciferol) capsules prescribing information. Cambridge, MA; 2006 Aug.



2. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Vitamin D. In: Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. National Academy of Press: Washington, DC; 1997:250-87.



3. Sakhaee K, Gonzalez GB. Update on renal osteodystrophy: pathogenesis and clinical management. Am J Med Sci. 1999; 317:251-60. [IDIS 427313] [PubMed 10210362]



4. Tan AU Jr, Levine BS, Mazess RB et al. Effective suppression of parathyroid hormone by 1 alpha-hydroxy-vitamin D2 in hemodialysis patients with moderate to severe secondary hyperparathyroidism. Kidney Int. 1997; 51:317-23. [PubMed 8995749]



5. Coburn JW, Tan AU Jr, Levine BS et al. 1 Alpha-hydroxy-vitamin D2: a new look at an “old” compound. Nephrol Dial Transplant. 1996; 11(Suppl 3):153-7. [PubMed 8840332]



6. Roche Pharmaceuticals. Menical (orlistat) capsules prescribing information. Nutley, NJ; 1999 Apr.



7. Genzyme. Hectorol (doxercalciferol) injection prescribing information. Cambridge, MA; 2006 Jan.



8. Coburn JW, Maung HM, Elangovan L et al. Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. Am J Kidney Dis. 2004; 43:877-90. [IDIS 519157] [PubMed 15112179]



b. AHFS drug information 2007. McEvoy GK, ed. Vitamin D Analogs General Statement. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: pages [3634-3640]



More Hectorol resources


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


  • Hectorol Prescribing Information (FDA)

  • Hectorol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hectorol Concise Consumer Information (Cerner Multum)

  • Hectorol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Doxercalciferol Professional Patient Advice (Wolters Kluwer)



Compare Hectorol with other medications


  • Secondary Hyperparathyroidism

Monday, 5 March 2012

Lithium Salts



Class: Antimanic Agents
VA Class: CN750
CAS Number: 554-13-2
Brands: Eskalith, Lithobid



  • Lithium toxicity is closely related to serum lithium concentrations and can occur at dosages close to therapeutic levels.404 428




  • Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy.404 428 (See Renal Effects under Cautions.)




Introduction

Antimanic agent.404 428


Uses for Lithium Salts


Bipolar Disorder


Management of bipolar disorder, 410 422 particularly acute manic or mixed episodes in patients with bipolar 1 or bipolar 2 disorder.401 403 404 405 406 407 409 410 411 412 421 422


A first-line agent in the initial treatment of depressive, manic, or mixed episodes in patients with bipolar disorder.401 421 a


Combination therapy with an atypical antipsychotic, another mood stabilizing agent, and/or antidepressant may be required to adequately treat rapid cycling and more severe depressive, manic, or mixed episodes.401 403 411 412 420 421 422 423


Maintenance therapy has been shown to prevent or diminish the intensity of subsequent manic episodes in patients with bipolar disorder with a history of mania.403 404 405 407 410 412 421 422 424


Major Depression


Should be used only in patients who fail to respond to other antidepressants.a


Schizoaffective and Schizophrenic Disorders


Limited effectiveness when used alone; should be used only after antipsychotic agents have failed.439 a


May be added to existing antipsychotic therapy, but efficacy of such combined therapy has varied in different clinical studies.439 Careful monitoring (e.g., serum lithium concentrations, adverse effects, possible adverse drug interactions) recommended.439 a


Disorders of Impulse Control


Has reduced temper outbursts, impulsive antisocial behavior, and the number of assaultive acts in a small number of adults with disorders of impulse control.a


Psychiatric Disorders in Children


Treatment of children with apparent mixed bipolar disorder symptomatology, hyperactivity with psychotic or neurotic components, or aggressive behavior or aggressive outbursts associated with attention-deficit hyperactivity disorder (ADHD); should be used only after more conservative therapies have failed.a


Neutropenia and Anemia


Treatment of neutropenia or anemia secondary to antineoplastic drugs.a


Routine use not recommended for congenital, idiopathic, or cyclic neutropenias; Felty’s syndrome; or aplastic anemia.a


Hyperthyroidism


Treatment of hyperthyroidism; other treatments (e.g., radioactive iodine, surgery, propylthiouracil, methimazole) currently are preferred.a


SIADH


No longer considered one of the therapies of choice; generally has been replaced with other more effective and/or less toxic therapies (e.g., demeclocycline).a


Lithium Salts Dosage and Administration


General



  • Careful monitoring of serum lithium concentrations and clinical status of the patient is mandatory and patients should be carefully instructed in the safe use of the drug.404 428




  • Carefully review the precautions and contraindications associated with lithium use before initiating therapy.404 428




  • Monitor serum lithium concentrations twice weekly during initiation of the acute phase of therapy and until serum concentration and clinical condition have stabilized;404 405 428 patient’s ability to tolerate high serum lithium concentrations usually decreases as initial manic symptoms begin to subside.a




  • After the patient has been stabilized, monitor serum concentrations at least every 2 months in most patients.404 405 428




  • Onset of acute antimanic effect of lithium usually occurs within 5–7 days; full therapeutic effect often requires 10–21 days.a




  • The manufacturers suggest that steady-state serum lithium concentrations be determined immediately before the next dose (i.e., 8–12 hours after the previous lithium dose).404 405 428 Total reliance must not be placed on serum lithium concentrations alone; accurate patient evaluation requires both careful clinical and laboratory evaluation.404 405 428




  • Serum lithium concentrations of 1–1.2 mEq/L usually are required during acute affective episodes.401 427 Serum concentration should not exceed 1.5 mEq/L during the acute treatment phase.401 427




  • If manifestations of lithium toxicity occur (see Lithium Toxicity under Cautions), temporarily discontinue for 24–48 hours, then resume at a lower dosage.404 405 428



Administration


Oral Administration


Administer orally, preferably with meals in divided doses.404 428


Administer conventional tablets, capsules, or oral solution 3 or 4 times daily;404 428 twice daily administration may be associated with adverse GI or nervous system effects.a Administer extended-release tablets 2 or 3 times daily.404 405 a


Extended-release preparations should be swallowed intact and should not be chewed, crushed, or halved.405


Lithium citrate oral solutions may be useful in patients unable to swallow capsules or tablets; 5 mL of a commercially available solution contains about 8 mEq of lithium and is approximately equivalent to 300 mg of lithium carbonate.404 428


Dosage


Available as lithium carbonate and lithium citrate; dosages expressed in terms of the salts.404 428


Pediatric Patients


Bipolar Disorder

Acute Episodes

Oral

Children ≤11 years of age: Usual dosages not established; lithium carbonate dosages of 15–20 mg/kg (about 0.4–0.5 mEq/kg) daily or equivalent lithium citrate dosages have been given in 2 or 3 divided doses.427 (Do not exceed usual adult dosages.a )


Children ≥12 years of age: Dosages usually are the same as those of adults.427


Maintenance Dosages

Oral

Usual maintenance dosages have not been established; dosage should be adjusted according to serum lithium concentrations, patient tolerance, and clinical response.a


Adults


Bipolar Disorder

Acute Episodes

Oral

Initially, 1.8 g daily as conventional lithium carbonate capsules or tablets, given in 3 or 4 divided doses, or 30 mL (about 48 mEq of lithium) of lithium citrate oral solution daily, given in 3 divided doses.404 428


Alternatively, 900 mg twice daily (morning and evening) or 600 mg 3 times daily as extended-release lithium carbonate tablets.404 405


Maintenance Dosages

Oral

900 mg to 1.2 g daily as conventional lithium carbonate capsules or tablets, given in 3 or 4 divided doses, or 15–20 mL (about 24–32 mEq of lithium) of lithium citrate oral solution daily, given in 3 or 4 divided doses. This dosage generally provides serum lithium concentrations of 0.6–1.2 mEq/L.404 405 427 428


Alternatively, 900 mg to 1.2 g daily as extended-release lithium carbonate tablets, given in 2 or 3 divided doses.404 405


Prescribing Limits


Pediatric Patients


Bipolar Disorder

Oral

When calculating dosage based on weight, do not exceed usual adult dosage.a 428


Adults


Bipolar Disorder

Oral

Maintenance dosage usually should not exceed 2.4 g of lithium carbonate (65 mEq) daily.427


Special Populations


Geriatric Patients


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.405 Lower initial dosages (e.g., ≤900 mg of lithium carbonate daily) and more gradual dosage titration recommended.401 405


May have decreased renal function; monitor renal function and adjust dosage accordingly.405


Dosages that produce serum lithium concentrations at the lower end of therapeutic range may be sufficient for maintenance.401 (See Geriatric Use under Cautions.)


Pregnant Women


Dosages generally need to be increased during pregnancy but should be reduced 1 week before parturition or when labor begins.a (See Fetal/Neonatal Morbidity and Mortality and also see Pregnancy under Cautions.)


Cautions for Lithium Salts


Contraindications



  • Significant renal or cardiovascular disease, severe debilitation, dehydration, sodium depletion, or concomitant therapy with diuretics; very high risk of lithium toxicity under such conditions.404 428




  • Only begin lithium in such patients if psychiatric indication is life-threatening, and other treatments have failed; however, must use with extreme caution, including daily serum lithium determinations and adjustment to usually low doses ordinarily tolerated by these individuals.404 428 In such instances, hospitalization is a necessity.404 428



Warnings/Precautions


Warnings


Fetal/Neonatal Morbidity and Mortality

May cause fetal toxicity (e.g., increase in cardiac and other anomalies, especially Ebstein’s anomaly) when administered to pregnant women, but potential benefits may be acceptable in certain conditions despite the possible risks to the fetus.a 428


If used in women of childbearing potential, during pregnancy, or if a patient becomes pregnant during treatment, the patient should be be informed of the potential hazard to the fetus.428


Whenever possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.428 (See Pregnant Women under Dosage and Administration and see Pregnancy under Cautions.)


Lithium Toxicity

Risk of toxicity increases with increasing serum lithium concentrations.428 Serum concentration should not exceed 1.5 mEq/L during the acute treatment phase.401 427


Serum lithium concentrations >1.5 mEq/L usually carry a greater risk than lower levels. (See General under Dosage and Administration.)428


Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium concentrations <2 mEq/L.428 At higher levels, giddiness, ataxia, blurred vision, tinnitus, and a large output of dilute urine may be seen.428


Serum lithium levels above 3 mEq/L may produce a complex clinical picture involving multiple organs and organ systems.428 (See General under Dosage and Administration.)


Renal Effects

Diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia, possible following chronic lithium therapy.428 Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy also possible.428


Measurement of 24-hour Clcr, renal-concentrating ability, and a urinalysis recommended prior to initiating therapy.a Renal function should then be evaluated every 2–3 months for the first 6 months, then every 6–12 months during therapy or whenever clinically indicated.401 420


If progressive or sudden changes in renal function, even within the normal range, occur during lithium therapy, reevaluate need for therapy with the drug.a


Interactions

Encephalopathic syndrome reported with concomitant use with antipsychotic agents.404 405 428 May be similar to or same as neuroleptic malignant syndrome (NMS).404 405 (See Specific Drugs under Interactions.)


May prolong effects of neuromuscular blocking agents.404 405 428 (See Specific Drugs under Interactions.)


General Precautions


Concomitant Illnesses

Decreased tolerance to lithium has been reported to ensue from protracted sweating, diarrhea, or concomitant infection with elevated temperatures and may necessitate a temporary reduction or cessation of medication.404 428 a Patients should maintain their usual fluid (2.5–3 L/day) and sodium intake, and supplement these in the event of fever (e.g., during infections), vomiting, or diarrhea.404 428 a


Sodium-restricted Diet

Use with caution in patients whose sodium intake is restricted;a stabilize sodium intake and carefully titrate lithium dosage to avoid increased serum lithium concentrations that may occur with sodium depletion.a


Endocrine Effects

Hypothyroidism, with manifestations ranging from mild to severe myxedema, may occur within weeks to years after initiating lithium therapy; rarely, hypothyroidism may persist after discontinuance of the drug.a Geriatric patients and patients with antithyroglobulin antibody, a prior history of Graves’ disease or Hashimoto’s thyroiditis, or those receiving iodine appear most at risk.a Paradoxically, a few cases of hyperthyroidism also have been reported.


Preexisting thyroid disorders are not contraindications to lithium therapy.404 428 Patients with underlying hypothyroidism should have thyroid function (T3, T4, and TSH concentrations) evaluated yearly and be given supplemental thyroid therapy when needed.a


Specific Populations


Pregnancy

Category D.428 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Women of childbearing age receiving lithium should be counseled about methods of birth control.a If used during pregnancy, carefully monitor serum lithium concentrations and adjust dosage accordingly.a (See Pregnant Women under Dosage and Administration.)


Lactation

Lithium is distributed into milk;428 discontinue nursing or the drug, taking into account the importance of the drug to the woman.428


Pediatric Use

Safety and efficacy have not been established in children <12 years of age;404 405 428 a however, the drug has been used in this age group when benefits were thought to outweigh risks.a


Transient acute dystonia and hyperreflexia occurred in a 15-kg child who ingested 300 mg of lithium carbonate.404 405 428


Geriatric Use

Insufficient experience with extended-release tablets in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.405


Age-related differences in response to lithium generally not observed.405


Use with caution; geriatric patients appear more susceptible to adverse effects (e.g., adverse nervous system and neuromuscular effects), even at therapeutic serum concentrations, and more prone to developing lithium-induced goiter and clinical hypothyroidism.404 a Some clinicians recommend that thyroid function tests be performed every 6–12 months in these patients.a


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy; geriatric patients should receive initial lithium dosages in the lower end of the usual range (see Geriatric Patients under Dosage and Administration).405


Lithium is substantially excreted by the kidneys; consider monitoring renal function and adjust dosage if necessary since geriatric patients are more likely to have decreased renal function.405


Common Adverse Effects


Fine hand tremor, polyuria, mild thirst, transient and mild nausea, and general discomfort may appear during the first few days of lithium administration; usually subside with continued treatment, a temporary reduction of dosage, or temporary cessation.405 428 If persistent, a cessation of therapy is indicated.405 428


Interactions for Lithium Salts


Lithium is not metabolized.a


Electroconvulsive Therapy


Acute neurotoxicity with prominent delirium has occurred in patients receiving lithium and electroconvulsive therapy (ECT) concurrently.a Some clinicians recommend decreasing lithium dosage or withdrawing the drug 2 days prior to ECT.a


Specific Drugs




























































Drug



Interaction



Comments



ACE inhibitors



Increased plasma lithium concentrations resulting in several cases of lithium intoxicationa



If used concomitantly, adjust lithium dosages and carefully monitor serum lithium concentrationsa


Some clinicians advise against concomitant ACE inhibitor use in geriatric patients or those patients with CHF, renal insufficiency, or volume depletiona



Alkalinizing agents (e.g., sodium bicarbonate)



May increase renal excretion of lithiuma



Higher lithium dosage may be requireda



Anticonvulsants (e.g., carbamazepine, phenytoin)



Adverse neurologic effects following concomitant therapy with carbamazepine or phenytoina


Concurrent use of lithium and phenytoin may increase serum lithium concentrationsa



Clinical importance not determineda



Antidepressants, SSRIs (e.g., fluoxetine, paroxetine)



Possibly associated with increased serum lithium concentrations, lithium toxicity, and/or serotonin syndrome (e.g., absence seizures, agitation, ataxia, confusion, diarrhea, dizziness, dysarthria, stiffness of the extremities, tremor);404 405 a decreased serum lithium concentrations also reported405



Use with caution and monitor closely404 405



Antipsychotic agents (e.g., haloperidol, phenothiazines)



Acute encephalopathic syndromes or extrapyramidal reactions (e.g., NMS or NMS-type reactions), possibly resulting in irreversible brain damage, parkinsonian movements, and dyskinesiasa 404 405 428


Nausea and vomiting, which are occasionally signs of lithium intoxication, may be masked by the antiemetic effect of some phenothiazines when used concurrentlya



Monitor patients for adverse neurologic effects, especially when large dosages of lithium and an antipsychotic agent are used; combined therapy should be promptly discontinued if such signs or symptoms appear404 405 428 a



β-Adrenergic blocking agents



Absence of tremor may make lithium intoxication more difficult to diagnosea



Monitor for other signs and symptoms of lithium intoxicationa



Baclofen



May cause hyperkinetic movementsa



Calcium-channel blocking agents (e.g., verapamil)



May potentiate the toxic effects of lithium; neurotoxicity (e.g., ataxia, choreoathetosis, tremors, tinnitus), adverse GI effects (e.g., nausea, vomiting, diarrhea), and bradycardia reporteda


Decreased serum lithium concentrations following initiation of verapamil in patients stabilized on lithium therapya



Use with cautiona


Monitor serum lithium concentrations and patient; adjust lithium dosage accordingly when verapamil is initiated or discontinued in patients receiving lithium therapya



Diazepam



Profound hypothermia has been reported in at least one patienta



Widespread use usually without unusual adverse effects indicates that it is safe in most patientsa



Diuretics (e.g., amiloride, aminophylline, furosemide, spironolactone, thiazides, urea)



Decreased lithium clearance resulting in increased serum lithium concentrations and several cases of lithium intoxication have occurred with concomitant thiazide usea


Other diuretics (e.g., aminophylline, furosemide, spironolactone, urea) also may reduce renal clearance of lithiuma


Amiloride does not appear to substantially affect lithium pharmacokinetics in most patientsa



Concomitant use usually is contraindicateda 428


If used in combination with thiazide diuretics, usual initial dosage of lithium should be reduced by about 50% and the patient and serum lithium concentrations should be monitored carefully;a subsequent lithium dosage should be adjusted as necessarya



Iodides



Additive or synergistic hypothyroid effect; may result in hypothyroidisma



Concomitant use is not recommended; if used concomitantly, monitor closely for signs and symptoms of hypothyroidisma



Metronidazole



May increase serum lithium concentrations, resulting in signs of lithium toxicitya



Use with caution; monitor serum lithium concentrations frequentlya



Neuromuscular blocking agents (e.g., pancuronium, succinylcholine)



May prolong the latency of neuromuscular blockadea



Use with caution and carefully monitor patients during concomitant use;a consider temporary discontinuance of lithiuma



NSAIAs (e.g., celecoxib, indomethacin, piroxicam)



Decreased renal clearance of lithium, which may lead to increased serum or plasma lithium concentrations and lithium toxicity404 405 428 a



Monitor serum lithium concentrations and observe patient for signs and symptoms of lithium intoxication404 405 428 a


Adjust lithium dosages as neededa



Opiate agonists



Interferes with opiate-induced euphoria and diminishes the analgesic effect of opiates (narcotic analgesics)a



Sodium



Changes in sodium intake in patients receiving lithium may alter the renal elimination of lithiuma



Patients should be advised to avoid substantial changes in their sodium intakea


When drugs with a high sodium content (e.g., antacids) are used concomitantly with lithium, serum lithium concentrations should be monitoreda



Tetracycline



Increased serum lithium concentrationsa



The clinical importance of this effect has not been determineda


Lithium Salts Pharmacokinetics


Absorption


Bioavailability


Conventional lithium carbonate capsules and tablets are 95–100% absorbed.a


Extended-release lithium carbonate tablets are 60–90% absorbed.a


Lithium citrate oral solutions are essentially 100% absorbed.a


Onset

Acute antimanic effect usually occurs within 5–7 days; full therapeutic effect often requires 10–21 days.a


Food

Food does not appear to affect the bioavailability of lithium.a


Plasma Concentrations

Therapeutic serum lithium concentrations usually range from 1–1.2 mEq/L during acute affective episodes.401 427 428


A 12-hour steady-state serum lithium concentration is used by most clinicians for monitoring serum concentrations; this concentration shows a high intraindividual (but not interindividual) reproducibility.a (See General under Dosage and Administration.)


Distribution


Extent


Widely distributed into most body tissues and fluids, including bone, brain tissue, erythrocytes, saliva, and thyroid.a


Lithium freely crosses the placenta; maternal and fetal serum concentrations are approximately equal.a The milk of nursing women contains lithium concentrations that are approximately 33–50% of those in serum.a


Plasma Protein Binding


Lithium is not bound to plasma proteins.a


Elimination


Metabolism


Lithium is not metabolized.a


Elimination Route


Principally renal.428


Half-life


Approximately 24 hours.428


Special Populations


In geriatric patients and patients with impaired renal function, serum half-lives of 36 and 40–50 hours, respectively, have been reported.a


Clearance and distribution into erythrocytes may be increased during pregnancy.a Immediately postpartum, renal clearance of lithium may decrease to pre-pregnancy levels.a


Lithium is readily removed by hemodialysis but not as readily removed by peritoneal dialysis.a Rebound increases in serum lithium concentration frequently occur 5–8 hours after dialysis.a


Stability


Storage


Oral


Capsules, Tablets, and Extended-release Tablets

Well-closed containers at 15–30°C.404 405 a Protect from moisture.405


Solution

Tight containers at 15–30°C.404 a


ActionsActions



  • Alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown.404 405 428




  • Decreases renal-concentrating ability and water reabsorption and initially increases sodium and potassium excretion.a Some of these effects are overcome by counteracting physiologic mechanisms, while others may persist.a GFR may be slightly decreased in patients receiving prolonged lithium therapy.a




  • Various effects on the thyroid gland; principal effect is to block the release of thyroxine (T4) and triiodothyronine (T3) mediated by thyrotropin.a This results in a decrease in circulating T4 and T3 concentrations and a feedback increase in serum thyrotropin concentration.a Lithium also inhibits thyrotropin-stimulated adenylate cyclase activity and thyrotropin-induced release of thyroidal iodine 131, decreases intrathyroidal iodothyronine-iodotyrosine ratios, and inhibits colloid droplet formation.a



Advice to Patients



  • Importance of avoiding dehydration and maintaining usual sodium and fluid intake; importance of reporting polyuria and any prolonged vomiting, diarrhea, or fever to clinician.404 428




  • Importance of immediately discontinuing lithium therapy and consulting a clinician if signs of lithium intoxication (e.g., muscle twitching, tremor, mild ataxia, drowsiness, muscle weakness, diarrhea, vomiting) occur.404 428




  • Importance of advising patients that lithium may impair their ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).404 428




  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.404 428




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.404 428




  • Importance of informing patients of other important precautionary information.404 405 428 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name






































Lithium Carbonate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



150 mg (4.06 mEq of lithium)



Lithium Carbonate Capsules



Roxane



300 mg (8.12 mEq of lithium)*



Eskalith (with benzyl alcohol and povidone)



GlaxoSmithKline



600 mg (16.24 mEq of lithium)



Lithium Carbonate Capsules



Roxane



Tablets



300 mg (8.12 mEq of lithium)



Lithium Carbonate Tablets (with povidone; scored)



Roxane, Rugby



Tablets, extended-release



450 mg (12.18 mEq of lithium)



Eskalith CR (scored)



GlaxoSmithKline



Tablets, extended-release, film-coated



300 mg (8.12 mEq of lithium)



Lithobid Slow-release (with povidone and propylene glycol)



JDS Pharma













Lithium Citrate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



8 mEq (of lithium) per 5 mL



Lithium Citrate Syrup (with alcohol 0.3%)



Major, Morton Grove, Roxane


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Lithium Carbonate 150MG Capsules (ROXANE): 90/$18.99 or 270/$56.97


Lithium Carbonate 300MG Capsules (ROXANE): 90/$25.99 or 180/$42.97


Lithium Carbonate 300MG Controlled-release Tablets (ROXANE): 30/$17.99 or 90/$35.97


Lithium Carbonate 300MG Tablets (ROXANE): 90/$25.99 or 270/$59.97


Lithium Carbonate 450MG Controlled-release Tablets (ROXANE): 60/$28.99 or 180/$81.97


Lithium Carbonate 600MG Capsules (ROXANE): 90/$39.99 or 270/$119.97


Lithium Citrate 8MEQ/5ML Syrup (ROXANE): 500/$59.99 or 1500/$150.96


Lithobid 300MG Controlled-release Tablets (NOVEN THERAPEUTICS): 90/$222 or 270/$625.95



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 01, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


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428. Roxane Laboratories. Lithium carbonate capsules and tablets and lithium citrate syrup USP prescribing information. Columbus, OH; 2002 May.



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