Thursday, September 29, 2016

Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules


Pronunciation: klor-fen-IHR-ah-meen/sue-do-eh-FED-rin
Generic Name: Chlorpheniramine/Pseudoephedrine
Brand Name: Examples include Dynahist ER and Histade CR


Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules are used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.


Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.


Do NOT use Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules if:


  • you are allergic to any ingredient in Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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



Before using Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules:


Some medical conditions may interact with Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules. 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 fast, slow, or irregular heartbeat

  • if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules

  • Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules 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 Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules:


Use Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules by mouth with or without food.

  • Swallow Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • If you miss a dose of Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules.



Important safety information:


  • Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not take diet or appetite control medicines while you are taking Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules without checking with you doctor.

  • Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

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

  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

  • Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules for a few days before the tests.

  • Tell your doctor or dentist that you take Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Use Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules in CHILDREN; they may be more sensitive to its effects.

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


Possible side effects of Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules:


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



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.



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: Chlorpheniramine/Pseudoephedrine 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. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules:

Store Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules are 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 Chlorpheniramine/Pseudoephedrine Sustained-Release Capsules. 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 Chlorpheniramine/Pseudoephedrine resources


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


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  • Sinusitis

ratio-Prednisolone




ratio-Prednisolone may be available in the countries listed below.


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Prednisolone

Prednisolone 21-acetate (a derivative of Prednisolone) is reported as an ingredient of ratio-Prednisolone in the following countries:


  • Canada

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Wednesday, September 28, 2016

Rhinocort


Generic Name: budesonide nasal (byoo DEH so nide)

Brand Names: Rhinocort Aqua


What is Rhinocort (budesonide nasal)?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.


Budesonide nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Budesonide is also used to keep nasal polyps from coming back after surgery to remove them.


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


What is the most important information I should know about Rhinocort (budesonide nasal)?


Before using budesonide, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.


It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.


Budesonide nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using budesonide nasal.


Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using budesonide nasal.


What should I discuss with my healthcare provider before using Rhinocort (budesonide nasal)?


You should not use this medication if you are allergic to budesonide.

Before using budesonide, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use budesonide nasal until you are well.


Also tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease;




  • glaucoma or cataracts;




  • herpes simplex virus of your eyes;




  • tuberculosis or any other infection or illness;




  • sores or ulcers inside your nose; or




  • if you have recently had injury of or surgery on your nose.




FDA pregnancy category B. This medication is not expected to 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 budesonide passes into breast milk or if it could harm a nursing baby. Do not use budesonide nasal without telling your doctor if you are breast-feeding a baby.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using budesonide nasal.


How should I use Rhinocort (budesonide nasal)?


Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.


This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


The usual dose of budesonide nasal is 1 to 4 sprays into each nostril once per day. Follow your doctor's instructions.


Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 8 test sprays into the air and away from your face. Spray until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 2 days. If longer than 2 weeks has passed, rinse the applicator and prime with 2 test sprays.


Shake the medicine bottle well just before each use. It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.


Store this medication in an upright position at room temperature, away from moisture and heat.

Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.


What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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.

An overdose of budesonide nasal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid while using Rhinocort (budesonide nasal)?


Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Budesonide nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using budesonide nasal.


Rhinocort (budesonide nasal) 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. Call your doctor at once if you have any of these serious side effects:

  • severe or ongoing nose bleed;




  • sores in the nose that won't heal;




  • wheezing, trouble breathing;




  • vision problems; or




  • fever, chills, body aches, flu symptoms.



Less serious side effects may include:



  • dry or sore throat, cough;




  • irritation in your nose;




  • pain, swelling, burning, itching, or irritation in your throat;




  • sores or white patches inside or around your nose.



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 Rhinocort (budesonide nasal)?


Before using budesonide nasal, tell your doctor if you are using any of the following drugs:



  • HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);




  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), troleandomycin (Tao);




  • an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);




  • an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or




  • a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).



This list is not complete and here may be other drugs that can interact with budesonide nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Rhinocort resources


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


  • Rhinocort Advanced Consumer (Micromedex) - Includes Dosage Information

  • Rhinocort Aqua Prescribing Information (FDA)

  • Rhinocort Aqua eent Monograph (AHFS DI)

  • Rhinocort Aqua Consumer Overview

  • Rhinocort Aqua Spray MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Rhinocort with other medications


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Where can I get more information?


  • Your pharmacist can provide more information about budesonide nasal.

See also: Rhinocort side effects (in more detail)


Marcen




Marcen may be available in the countries listed below.


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Ketazolam

Ketazolam is reported as an ingredient of Marcen in the following countries:


  • Spain

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Tuesday, September 27, 2016

Arteoptic




Arteoptic may be available in the countries listed below.


Ingredient matches for Arteoptic



Carteolol

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


  • Belgium

  • Czech Republic

  • Germany

  • Hong Kong

  • Luxembourg

  • Netherlands

  • Poland

  • Portugal

  • Slovakia

  • Spain

  • Switzerland

  • Taiwan

  • Thailand

International Drug Name Search

Lactulose Qualimed




Lactulose Qualimed may be available in the countries listed below.


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Lactulose

Lactulose is reported as an ingredient of Lactulose Qualimed in the following countries:


  • France

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Topimark




Topimark may be available in the countries listed below.


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Topiramate

Topiramate is reported as an ingredient of Topimark in the following countries:


  • Bulgaria

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Monday, September 26, 2016

Chloral Hydrate Syrup




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Chloral Hydrate

Chloral Hydrate is reported as an ingredient of Chloral Hydrate Syrup in the following countries:


  • United States

International Drug Name Search

Carbinoxamine/Pseudoephedrine Drops


Pronunciation: kar-bi-NOX-ah-meen/soo-doe-eh-FED-rin
Generic Name: Carbinoxamine/Pseudoephedrine
Brand Name: Examples include Cardec and Rondec


Carbinoxamine/Pseudoephedrine Drops are used for:

Relieving congestion, sneezing, and watery eyes due to colds, flu, or hay fever.


Carbinoxamine/Pseudoephedrine Drops are an antihistamine and decongestant combination. It works by blocking the action of histamine and reducing the symptoms of an allergic reaction. It also relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.


Do NOT use Carbinoxamine/Pseudoephedrine Drops if:


  • you are allergic to any ingredient in Carbinoxamine/Pseudoephedrine Drops

  • you have severe high blood pressure, severe heart disease (coronary artery disease, ischemic heart disease), angle-closure glaucoma, or a peptic ulcer, or if you are unable to urinate due to bladder problems (urinary retention)

  • you are having an asthma attack

  • you are taking sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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



Before using Carbinoxamine/Pseudoephedrine Drops:


Some medical conditions may interact with Carbinoxamine/Pseudoephedrine Drops. 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 asthma; diabetes; heart disease; high blood pressure; increased inner eye pressure; a blockage of your stomach, intestines, or bladder; an overactive thyroid; difficulty urinating; an enlarged prostate; or seizures

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


  • Barbiturates (eg, phenobarbital), furazolidone, MAO inhibitors (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, antacids) because side effects, such as increased drowsiness, headache, high blood pressure, or elevated body temperature, may occur

  • Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur

  • Bromocriptine or droxidopa because the actions and side effects of these medicines may be increased

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbinoxamine/Pseudoephedrine Drops 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 Carbinoxamine/Pseudoephedrine Drops:


Use Carbinoxamine/Pseudoephedrine Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Carbinoxamine/Pseudoephedrine Drops may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Use the dropper that comes with Carbinoxamine/Pseudoephedrine Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Carbinoxamine/Pseudoephedrine Drops and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carbinoxamine/Pseudoephedrine Drops.



Important safety information:


  • Carbinoxamine/Pseudoephedrine Drops may cause drowsiness, dizziness, or change in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Carbinoxamine/Pseudoephedrine Drops. Using Carbinoxamine/Pseudoephedrine Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Carbinoxamine/Pseudoephedrine Drops.

  • Do not take diet or appetite control medicines while you are taking Carbinoxamine/Pseudoephedrine Drops without checking with your doctor.

  • Carbinoxamine/Pseudoephedrine Drops contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Use Carbinoxamine/Pseudoephedrine Drops with caution in the ELDERLY because they may be more sensitive to its effects, especially sleeplessness.

  • Use Carbinoxamine/Pseudoephedrine Drops with extreme caution in CHILDREN younger than 12 months of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Carbinoxamine/Pseudoephedrine Drops, discuss with your doctor the benefits and risks of using Carbinoxamine/Pseudoephedrine Drops during pregnancy. It is unknown if Carbinoxamine/Pseudoephedrine Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Carbinoxamine/Pseudoephedrine Drops, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Carbinoxamine/Pseudoephedrine Drops:


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:



Appetite loss; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; headache; heartburn; nausea; nervousness; trouble sleeping; vomiting.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; double vision; fast or irregular heartbeat; frequent or painful urination; hallucinations; seizures; severe headache and dizziness; severe nervousness; tremor; weakness.



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: Carbinoxamine/Pseudoephedrine 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. Symptoms may include decreased mental alertness; fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sleeplessness; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.


Proper storage of Carbinoxamine/Pseudoephedrine Drops:

Store Carbinoxamine/Pseudoephedrine Drops at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Carbinoxamine/Pseudoephedrine Drops out of the reach of children and away from pets.


General information:


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

  • Carbinoxamine/Pseudoephedrine Drops are 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 Carbinoxamine/Pseudoephedrine Drops. 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 Carbinoxamine/Pseudoephedrine resources


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


Compare Carbinoxamine/Pseudoephedrine with other medications


  • Cold Symptoms
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Cardizem




Generic Name: diltiazem hydrochloride

Dosage Form: tablet, coated
Cardizem®

(diltiazem hydrochloride)

Direct Compression Tablets

Rx only



Cardizem Description


Cardizem® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:



Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet of Cardizem contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride.


Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol.


For oral administration.



Cardizem - Clinical Pharmacology


The therapeutic benefits achieved with Cardizem are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.



Mechanisms of Action


Although precise mechanisms of its antianginal action are still being delineated, Cardizem is believed to act in the following ways:


1.

Angina Due to Coronary Artery Spasm. Cardizem has been shown to be a potent dilator of coronary arteries both epicardial and subendocardial. Spontaneous and ergonovine-induced coronary artery spasm are inhibited by Cardizem.

2.

Exertional Angina. Cardizem has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal exercise workloads.

In animal models, diltiazem interferes with the slow inward (depolarizing) current in excitable tissue. It causes excitation-contraction uncoupling in various myocardial tissues without changes in the configuration of the action potential. Diltiazem produces relaxation of coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels which cause little or no negative inotropic effect. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance.



Hemodynamic and Electrophysiologic Effects


Like other calcium antagonists, diltiazem decreases sinoatrial and atrioventricular conduction in isolated tissues and has a negative inotropic effect in isolated preparations. In the intact animal, prolongation of the AH interval can be seen at higher doses.


In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm. It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure, and in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given workload. Studies to date, primarily in patients with good ventricular function, have not revealed evidence of a negative inotropic effect; cardiac output, ejection fraction, and left ventricular end-diastolic pressure have not been affected. There are as yet few data on the interaction of diltiazem and beta-blockers. Resting heart rate is usually unchanged or slightly reduced by diltiazem.


Intravenous diltiazem in doses of 20 mg prolongs AH conduction time and AV node functional and effective refractory periods approximately 20%. In a study involving single oral doses of 300 mg of Cardizem in six normal volunteers, the average maximum PR prolongation was 14% with no instances of greater than first-degree AV block. Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first-degree heart block. In patients with sick sinus syndrome, diltiazem significantly prolongs sinus cycle length (up to 50% in some cases).


Chronic oral administration of Cardizem in doses of up to 240 mg/day has resulted in small increases in PR interval but has not usually produced abnormal prolongation.



Pharmacokinetics and Metabolism


Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous dosing) of about 40%. Cardizem undergoes extensive metabolism in which 2% to 4% of the unchanged drug appears in the urine. In vitro binding studies show Cardizem is 70% to 80% bound to plasma proteins. Competitive in vitro ligand binding studies have also shown Cardizem binding is not altered by therapeutic concentrations of digoxin, hydrochlorothiazide, phenylbutazone, propranolol, salicylic acid, or warfarin. The plasma elimination half-life following single or multiple drug administration is approximately 3.0 to 4.5 hours. Desacetyl diltiazem is also present in the plasma at levels of 10% to 20% of the parent drug and is 25% to 50% as potent as a coronary vasodilator as diltiazem. Minimum therapeutic plasma levels of Cardizem appear to be in the range of 50 to 200 ng/mL. There is a departure from linearity when dose strengths are increased. A study that compared patients with normal hepatic function to patients with cirrhosis found an increase in half-life and a 69% increase in AUC (area-under-the-plasma concentration vs time curve) in the hepatically impaired patients. A single study in nine patients with severely impaired renal functions showed no difference in the pharmacokinetic profile of diltiazem as compared to patients with normal renal function.


Cardizem Tablets. Diltiazem is absorbed from the tablet formulation to about 98% of a reference solution. Single oral doses of 30 to 120 mg of Cardizem tablets result in detectable plasma levels within 30 to 60 minutes and peak plasma levels 2 to 4 hours after drug administration. As the dose of Cardizem tablets is increased from a daily dose of 120 mg (30 mg qid) to 240 mg (60 mg qid) daily, there is an increase in area-under-the-curve of 2.3 times. When the dose is increased from 240 mg to 360 mg, daily, there is an increase in area-under-the-curve of 1.8 times.



Indications and Usage for Cardizem


Cardizem is indicated for the management of chronic stable angina and angina due to coronary artery spasm.



Contraindications


Cardizem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.



Warnings



1. Cardiac Conduction. Cardizem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (six of 1243 patients for 0.48%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem (see ADVERSE REACTIONS).



2. Congestive Heart Failure. Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). Experience with the use of Cardizem alone or in combination with beta-blockers in patients with impaired ventricular function is very limited. Caution should be exercised when using the drug in such patients.



3. Hypotension. Decreases in blood pressure associated with Cardizem therapy may occasionally result in symptomatic hypotension.



4. Acute Hepatic Injury. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions have been reversible upon discontinuation of drug therapy. The relationship to Cardizem is uncertain in most cases, but probable in some (see PRECAUTIONS).



Precautions



General


Cardizem (diltiazem hydrochloride) is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver, which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. Dermatological events (see ADVERSE REACTIONS) may be transient and may disappear despite continued use of Cardizem. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, the drug should be discontinued.



Drug Interactions


Due to the potential for additive effects, caution and careful titration are warranted in patients receiving Cardizem concomitantly with any agents known to affect cardiac contractility and/or conduction (see WARNINGS).


Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Cardizem (see WARNINGS).


As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.



Anesthetics. The depression of cardiac contractility, conductivity, and automaticity, as well as the vascular dilation associated with anesthetics, may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium blockers should be titrated carefully.



Benzodiazepines. Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5- to 2.5-fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.



Beta-blockers. Controlled and uncontrolled domestic studies suggest that concomitant use of Cardizem and beta-blockers is usually well tolerated. Available data are not sufficient, however, to predict the effects of concomitant treatment, particularly in patients with left ventricular dysfunction or cardiac conduction abnormalities.


Administration of Cardizem (diltiazem hydrochloride) concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects, and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS).



Buspirone. In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.



Carbamazepine. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase) resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.



Cimetidine. A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1-week course of cimetidine at 1200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.



Clonidine. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.



Cyclosporine. A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine trough dose ranging from 15% to 48% was necessary to maintain concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.



Digitalis. Administration of Cardizem with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing Cardizem therapy to avoid possible over- or under-digitalization (see WARNINGS).



Quinidine. Diltiazem significantly increases the AUC (0→∞) of quinidine by 51%, T1/2 by 36%, and decreases its CLoral by 33%. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly.



Rifampin. Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.



Statins. Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin together with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.


In a healthy volunteer cross-over study (N=10), co-administration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If co-administration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.


In a ten-subject randomized, open label, 4-way cross-over study, co-administration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.



Carcinogenesis, Mutagenesis, Impairment of Fertility


A 24-month study in rats and a 21-month study in mice showed no evidence of carcinogenicity. There was also no mutagenic response in in vitro bacterial tests. No intrinsic effect on fertility was observed in rats.



Pregnancy



Category C. Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities. In the perinatal/postnatal studies, there was some reduction in early individual pup weights and survival rates. There was an increased incidence of stillbirths at doses of 20 times the human dose or greater.


There are no well-controlled studies in pregnant women; therefore, use Cardizem in pregnant women only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers


Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Cardizem is deemed essential, an alternative method of infant feeding should be instituted.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.



Adverse Reactions


Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities usually have been excluded.


In domestic placebo-controlled angina trials, the incidence of adverse reactions reported during Cardizem therapy was not greater than that reported during placebo therapy.


The following represent occurrences observed in clinical studies of angina patients. In many cases, the relationship to Cardizem has not been established. The most common occurrences from these studies, as well their frequency of presentation, are edema (2.4%), headache (2.1%), nausea (1.9%), dizziness (1.5%), rash (1.3%), and asthenia (1.2%). In addition, the following events were reported infrequently (less than 1 %):


Cardiovascular: Angina, arrhythmia, AV block (first-degree), AV block (second- or third-degree – see WARNINGS, Cardiac Conduction), bradycardia, bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.


Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor.


Gastrointestinal: Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT, and LDH (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.


Dermatological: Petechiae, photosensitivity, pruritus, urticaria.


Other: Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus.


The following postmarketing events have been reported infrequently in patients receiving Cardizem: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. In addition, events such as myocardial infarction have been observed, which are not readily distinguishable from the natural history of the disease in these patients. A definitive cause and effect relationship between these events and Cardizem therapy cannot yet be established. Exfoliative dermatitis (proven by rechallenge) has also been reported.



Overdosage


The oral LD50s in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50s in these species were 60 and 38 mg/kg, respectively. The oral LD50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.


The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases.


There have been reports of diltiazem overdose in amounts ranging from <1 g to 18 g. Of cases with known outcome, most patients recovered and in cases with a fatal outcome, the majority involved multiple drug ingestion.


Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine, as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with ventilatory support, gastric lavage, activated charcoal, and/or intravenous calcium.


The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes and repeated every 10 to 20 minutes as necessary. Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. Infusions of calcium for 24 hours or more may be required. Patients should be monitored for signs of hypercalcemia.


In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Based on the known pharmacological effects of diltiazem and/or reported clinical experiences, the following measures may be considered:


Bradycardia: Administer atropine (0.60 to 1.0 mg). If there is no response to vagal blockade, administer isoproterenol cautiously.


High-Degree AV Block: Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing.


Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics.


Hypotension: Vasopressors (e.g., dopamine or norepinephrine).


Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.



Cardizem Dosage and Administration



Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm


Dosage must be adjusted to each patient's needs. Starting with 30 mg four times daily, before meals and at bedtime, dosage should be increased gradually (given in divided doses three or four times daily) at 1- to 2-day intervals until optimum response is obtained. Although individual patients may respond to any dosage level, the average optimum dosage range appears to be 180 to 360 mg/day. There are no available data concerning dosage requirements in patients with impaired renal or hepatic function. If the drug must be used in such patients, titration should be carried out with particular caution.



Concomitant Use With Other Cardiovascular Agents


1.

Sublingual NTG may be taken as required to abort acute anginal attacks during Cardizem (diltiazem hydrochloride) therapy.

2.

Prophylactic Nitrate Therapy. Cardizem may be safely coadministered with short- and long-acting nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination.

3.

Beta-blockers. (See WARNINGS and PRECAUTIONS).


How is Cardizem Supplied


Cardizem 30-mg tablets are supplied in bottles of 100 (NDC 0187-0771-47) and 500 (NDC 0187-0771-55). Each green tablet is engraved with MARION on one side and 1771 on the other.


Cardizem 60-mg scored tablets are supplied in bottles of 100 (NDC 0187-0772-47). Each yellow tablet is engraved with MARION on one side and 1772 on the other.


Cardizem 90-mg scored tablets are supplied in bottles of 100 (NDC 0187-0791-47). Each green oblong tablet is engraved with Cardizem on one side and 90 mg on the other.


Cardizem 120-mg scored tablets are supplied in bottles of 100 (NDC 0187-0792-47). Each yellow oblong tablet is engraved with Cardizem on one side and 120 mg on the other.


Store at 25°C (77°); excursions permitted to 15-30°C (59-86°) [see USP Controlled Room Temperature].


Avoid excessive humidity.



Caridizem® is a registered trademark of Valeant International (Barbados) SRL


Manufactured by:

sanofi-aventis U.S. LLC

Kansas City, MO, 64137, USA


For:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ, 08807, USA


LB0078-01

Rev. 11/10



PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label


NDC 0187-0771-47


Cardizem®

(diltiazem HCl)


30 mg


100 Tablets


Rx

ONLY


VALEANT

Pharmaceuticals North America LLC




PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label


NDC 0187-0772-47


Cardizem®

(diltiazem HCl)


60 mg


100 Tablets


Rx

ONLY


VALEANT

Pharmaceuticals North America LLC




PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Label


NDC 0187-0791-47


Cardizem®

(diltiazem HCl)


90 mg


100 Tablets


Rx

ONLY


VALEANT

Pharmaceuticals North America LLC




PRINCIPAL DISPLAY PANEL - 120 mg Tablet Bottle Label


NDC 0187-0792-47


Cardizem®

(diltiazem HCl)


120 mg


100 Tablets


Rx

ONLY


VALEANT

Pharmaceuticals North America LLC










Cardizem 
diltiazem hydrochloride  tablet, coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0187-0771
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diltiazem Hydrochloride (Diltiazem)Diltiazem Hydrochloride30 mg
























Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
hydroxypropyl cellulose 
hypromelloses 
lactose 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
polyethylene glycols 


















Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeMARION;1771
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10187-0771-47100 TABLET In 1 BOTTLENone
20187-0771-55500 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01860212/25/2010







Cardizem 
diltiazem hydrochloride  tablet, coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0187-0772
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diltiazem Hydrochloride (Diltiazem)Diltiazem Hydrochloride60 mg
























Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
hydroxypropyl cellulose 
hypromelloses 
lactose 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
polyethylene glycols 


















Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeMARION;1772
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10187-0772-47100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01860212/25/2010







Cardizem 
diltiazem hydrochloride  tablet, coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0187-0791
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diltiazem Hydrochloride (Diltiazem)Diltiazem Hydrochloride90 mg
























Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
hydroxypropyl cellulose 
hypromelloses 
lactose 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
polyethylene glycols 


















Product Characteristics
ColorGREENScore2 pieces
ShapeBULLET (oblong)Size17mm
FlavorImprint CodeCardizem;90mg
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10187-0791-47100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01860212/25/2010







Cardizem 
diltiazem hydrochloride  tablet, coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0187-0792
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diltiazem Hydrochloride (Diltiazem)Diltiazem Hydrochloride120 mg
























Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
hydroxypropyl cellulose 
hypromelloses 
lactose 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
polyethylene glycols 


















Product Characteristics
ColorYELLOW (YELLOW)Score2 pieces
ShapeBULLET (oblong)Size19mm
FlavorImprint CodeCardizem;120mg
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10187-0792-47100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01860212/25/2010

Labeler - Valeant Ph

Chloroquine Phosphate


Class: Antimalarials
VA Class: AP101
CAS Number: 50-63-5
Brands: Aralen Phosphate

Introduction

Antimalarial; 4-aminoquinoline derivative.136


Uses for Chloroquine Phosphate


Malaria


Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum.136 174 176 178 Recommended by CDC and others as drug of choice for prevention of malaria caused by susceptible Plasmodium; should be used whenever malaria prophylaxis is indicated in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.140 147 148 149 162 163 164 166 174 175 176 177 178 (See Chloroquine-resistant Plasmodium under Cautions.)


Treatment of uncomplicated malaria caused by susceptible P. falciparum.191 Recommended by CDC and others as the drug of choice for treatment of uncomplicated P. falciparum malaria acquired in areas where chloroquine resistance has not been reported.174 183 191 (See Chloroquine-resistant Plasmodium under Cautions.)


Treatment of uncomplicated malaria caused by P. malariae, P. ovale, or chloroquine-susceptible P. vivax.136 174 183 191 Recommended by CDC and others as the drug of choice for treatment of uncomplicated malaria caused by these Plasmodium;174 183 191 do not use for P. vivax malaria acquired in Papua New Guinea or Indonesia.183 191 (See Chloroquine-resistant Plasmodium under Cautions.)


Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure; primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.176 183


Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747) or at .176


Assistance with diagnosis or treatment of malaria available from CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.191


Extraintestinal Amebiasis


Has been used for treatment of extraintestinal amebiasis136 (including liver abscess) caused by Entamoeba histolytica.


Ineffective for treatment of intestinal amebiasis.a


A nitroimidazole derivative (metronidazole, tinidazole) followed by a luminal amebicide (iodoquinol, paromomycin, diloxanide furoate) is usual regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.174 178


Rheumatoid Arthritis


Has been used for treatment of rheumatoid arthritis in patients whose symptoms progress despite an adequate regimen of nonsteroidal anti-inflammatory agents (NSAIAs).a


No longer a recommended disease-modifying antirheumatic drug (DMARD).a Other DMARDs generally preferred,105 106 especially since risk of severe and sometimes irreversible toxicity must be considered if chloroquine is used for prolonged periods in treatment of rheumatoid arthritis. (See Cautions.)a


Lupus Erythematosus


Has been used as an adjunct to topical corticosteroid therapy in treatment of discoid lupus erythematosus and as an adjunct to systemic corticosteroid and/or salicylate therapy in treatment of systemic lupus erythematosus.a


If used for prolonged periods in the treatment of lupus erythematosus, the risk of serious and sometimes irreversible toxicity should be considered.a (See Cautions.)


Porphyria Cutanea Tarda and Polymorphous Light Eruptions


Has been used with some success in treatment of porphyria cutanea tarda.185 186 187 (See Patients with Psoriasis or Porphyria under Cautions.)


Has been effective in some cases when used in treatment of polymorphous light eruptions.


Sarcoidosis


Has been used with some success in the treatment of sarcoidosis.188 189


Chloroquine Phosphate Dosage and Administration


Administration


Administer orally.136


Oral Administration


Administration with meals may minimize adverse GI effects.a


Because tablets have a bitter taste, they have been pulverized and mixed with chocolate or cherry syrup for administration in children or, alternatively, enclosed in gelatin capsules for mixing in food or drink.a Outside the US, the drug is available in many countries as an oral suspension for use in children.176 However, the chloroquine concentration varies depending on the specific oral suspension, and parents should be instructed how to calculate the appropriate volume to be administered based on the child's body weight.176


For prevention of malaria, chloroquine is given once weekly and should be administered on the same day each week.136 148 163 166 If intolerable adverse GI effects occur despite administration with meals, the usual weekly dose can be divided into 2 doses and administered on separate days during the week.a


Dosage


Available as chloroquine phosphate;136 dosage usually expressed in terms of chloroquine.136 Each 100 mg of chloroquine phosphate is equivalent to 60 mg of chloroquine.136


Dosage of chloroquine in children should be calculated in proportion to adult dosage based on body weight.136


Pediatric Patients


Malaria

Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium

Oral

5 mg/kg (8.3 mg/kg of chloroquine phosphate) once weekly on the same day each week.136 163 174 176


Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176


Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of chloroquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.174 176


Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 10 mg/kg of chloroquine (16.7 mg/kg of chloroquine phosphate) followed by 5-mg/kg doses (8.3 mg/kg of chloroquine phosphate) given at 6, 24, and 48 hours after the initial dose.174 183 191


Adults


Malaria

Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium

Oral

300 mg (500 mg of chloroquine phosphate) once weekly.136 163 174 176


Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176


Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of chloroquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.174 176


Treatment of Uncomplicated Chloroquine-susceptible Malaria

Oral

An initial dose of 600 mg of chloroquine (1 g of chloroquine phosphate) followed by 300-mg doses (500 mg of chloroquine phosphate) given at 6, 24, and 48 hours after the initial dose.191


Prophylaxis of P. ovale or P. vivax When Primaquine Is Deferred during Pregnancy

Oral

300 mg (500 mg of chloroquine phosphate) once weekly for the duration of the pregnancy.183 Given after the usual treatment regimen and continued until primaquine can be given to provide a radical cure after delivery.183


Extraintestinal Amebiasis

Oral

600 mg of chloroquine (1 g of chloroquine phosphate) once daily for 2 days, followed by 300 mg (500 mg of chloroquine phosphate) once daily for at least 2–3 weeks; usually used in conjunction with an intestinal amebicide.136


Rheumatoid Arthritis

Oral

150 mg (250 mg of chloroquine phosphate) daily. After remission or maximum improvement occurs, dosage should be reduced.a


A response may not occur until after >4–6 weeks of therapy.a Some clinicians recommend that the drug be continued for 4 months before being considered ineffective for treatment of rheumatoid arthritis.a


Lupus Erythematosus

Oral

150 mg (250 mg of chloroquine phosphate) daily.a


When used in conjunction with topical corticosteroids in treatment of discoid lupus erythematosus, skin lesions may regress within 3–4 weeks and new lesions may not appear.a When systemic and cutaneous manifestations of lupus erythematosus subside, reduce chloroquine dosage gradually over several months, and discontinue as soon as possible.a


Prescribing Limits


Pediatric Patients


Malaria

Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium

Oral

Maximum dosage of 300 mg (500 mg of chloroquine phosphate) daily, regardless of weight.136 174 176


Cautions for Chloroquine Phosphate


Contraindications



  • Hypersensitivity to chloroquine or other 4-aminoquinoline derivatives.136




  • Retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology.136 After weighing the possible benefits and risks to the patient, some clinicians may elect to use chloroquine in these patients for treatment of acute attacks of malaria caused by susceptible Plasmodium.136



Warnings/Precautions


Warnings


Chloroquine-resistant Plasmodium

For prevention of malaria, use only in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.136 140 147 148 149 162 163 164 166 174 175 176 177 178 Malaria-related deaths have been reported in US citizens using chloroquine-containing regimens (i.e., chloroquine alone or in conjunction with proguanil) for malaria prevention in countries with chloroquine-resistant P. falciparum.118


For prevention or treatment of malaria, consider that chloroquine-resistant P. falciparum have been reported in many areas where malaria occurs.140 143 144 174 176 183


Consider that chloroquine-resistant P. vivax has been reported with a high incidence in Papua New Guinea and Indonesia and rarely in Burma (Myanmar), India, and Central and South America.183 191 A treatment regimen effective against chloroquine-resistant P. vivax should be used in those who acquire P. vivax malaria in Papua New Guinea or Indonesia.174 183 191


Malaria patients who do not respond to chloroquine should be switched to a treatment recommended for chloroquine-resistant P. falciparum (e.g., quinine sulfate with doxycycline, tetracycline or clindamycin; fixed combination of atovaquone and proguanil; fixed combination of artemether and lumefantrine) or chloroquine-resistant P. vivax (e.g., quinine sulfate with doxycycline or tetracycline in conjunction with primaquine; mefloquine in conjunction with primaquine; fixed combination of atovaquone and proguanil in conjunction with primaquine).183 191


Ocular Effects

Dose-related retinopathy reported, which may progress even after the drug is discontinued.136 Retinal changes may be reversible if detected early, but usually are permanent and may rarely result in blindness.136


Whenever long-term therapy is contemplated, perform initial (base line) and periodic ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.136


Discontinue drug immediately and closely observe patient for possible progression if there is any indication of abnormalities in visual acuity or visual field, abnormalities in the retinal macular area (such as pigmentary changes or loss of foveal reflex), or if any other visual symptoms (e.g., light flashes and streaks) occur which are not fully explainable by difficulties of accommodation or corneal opacities.136


Neuromuscular Effects

Skeletal muscle myopathy or neuromyopathy occur rarely; neuromyopathy is manifested as slowly progressing weakness which first affects proximal muscles of lower extremities.136


Patients receiving prolonged therapy should be questioned and examined periodically for evidence of muscular weakness; knee and ankle reflexes should be tested.136


Discontinue chloroquine if muscular weakness occurs.136


Patients with Psoriasis or Porphyria

May exacerbate psoriasis and precipitate a severe attack in patients with the disease.136 Use in psoriasis patients only if potential benefits outweigh the risks.136


May exacerbate porphyria.136 Use in patients with porphyria only if potential benefits outweigh the risks.136


General Precautions


Hematologic Effects

Aplastic anemia, reversible agranulocytosis, thrombocytopenia, and neutropenia reported rarely.136


Periodically monitor CBCs in patients receiving prolonged treatment.136 Consider discontinuing chloroquine if any severe blood disorder occurs which is not attributable to the disease being treated.136


Use with caution in patients with G-6-PD deficiency.136


Otic Effects

Nerve-type deafness, tinnitus, and reduced hearing reported rarely in patients with pre-existing auditory damage.136


Use with caution in patients with preexisting auditory damage.136 Discontinue chloroquine immediately and closely observe patient if any hearing defects occur.136


CNS Effects

Seizures may occur; advise patients with a history of epilepsy about the risk.136


Specific Populations


Pregnancy

Category C.c


Avoid use during pregnancy unless the clinician determines that the benefits of prevention or treatment of malaria outweigh the risks.136


Has been used for prophylaxis and treatment of malaria in pregnant women without evidence of adverse effects on the fetus.176


CDC states that the benefits of chloroquine prophylaxis in pregnant women exposed to malaria outweigh the potential risks to the fetus.176


Because malaria infection in pregnant women is associated with high risks of maternal and perinatal morbidity and mortality (e.g., miscarriage, premature delivery, low birth weight, congenital infection and/or perinatal death), CDC recommends prompt chloroquine treatment in pregnant women with uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. falciparum, or chloroquine-susceptible P. vivax.183


Because use of primaquine should be deferred during pregnancy, CDC recommends that pregnant women being treated for P. ovale or P. vivax malaria receive chloroquine prophylaxis for the duration of the pregnancy (after the initial chloroquine treatment regimen) until primaquine can be given after delivery to provide a radical cure.183 191


Lactation

Distributed into milk.122 123 124 Discontinue nursing or the drug.136


Amount of drug present in human milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants.176 When chemoprophylaxis is necessary in such infants, they should receive recommended dosages of the appropriate antimalarial agent(s).176


Pediatric Use

Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.136 Fatalities have been reported following accidental ingestion of relatively small doses.136


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.136


Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.136 Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.136


Hepatic Impairment

Concentrates in the liver; use with caution in patients with hepatic disease or alcoholism and in those receiving known hepatotoxic drugs.136


Common Adverse Effects


Ocular effects; skeletal muscle myopathy or neuromyopathy; GI effects (anorexia, nausea, vomiting, diarrhea, abdominal cramps); dermatologic effects (pleomorphic skin eruptions, skin and mucosal pigmentary changes).136


Interactions for Chloroquine Phosphate


Specific Drugs



























Drug



Interaction



Comments



Ampicillin



Possible reduced bioavailability of ampicillin136



Administer chloroquine at least 2 hours before or after ampicillin136



Antacids



Possible reduced GI absorption of chloroquine136



Administer chloroquine at least 4 hours before or after antacids136



Cimetidine



Possible inhibition of chloroquine metabolism resulting in increased concentrations of the antimalarial136



Avoid concomitant use136



Cyclosporine



Possible increased cyclosporine concentrations136



Closely monitor serum cyclosporine concentrations; if necessary, discontinue chloroquine136



Praziquantel



Possible decreased praziquantel concentrations184



Rabies vaccine



Possible interference with immune response to intradermally administered human diploid-cell rabies vaccine (HDCV) (no longer commercially available in the US)116 117 176 182



Complete preexposure intradermal vaccination with HDCV (no longer commercially available in the US) before initiating chloroquine malaria prophylaxis or administer the vaccine IM in those receiving chloroquine 176 182



Sulfadoxine and pyrimethamine



Possible increased incidence and severity of adverse effects when used concomitantly with chloroquine compared with use of sulfadoxine and pyrimethamine alone190


Chloroquine Phosphate Pharmacokinetics


Absorption


Bioavailability


Rapidly and almost completely absorbed from GI tract following oral administration;a 136 peak plasma concentrations generally attained within 1–2 hours.a


Food


Bioavailability of chloroquine is greater when administered with food;a rate of absorption is unaffected but peak plasma concentrations and AUCs are higher.a


Distribution


Extent


Widely distributed into body tissues.a


Chloroquine binds to melanin-containing cells in the eyes and skin; skin concentrations of the drug are considerably higher than plasma concentrations.a Also concentrates in erythrocytes and binds to platelets and granulocytes.a


Crosses placenta in mice.136 Distributed into milk.122 123 124


Plasma Protein Binding


50–65%.104


Elimination


Metabolism


Partially metabolized; the major metabolite is desethylchloroquine.122 123 124 136 147 Desethylchloroquine also has antiplasmodial activity, but is slightly less active than chloroquine.114


Elimination Route


Chloroquine and its metabolites are slowly excreted by the kidneys; unabsorbed drug is excreted in feces.a


Up to 70% of a dose is excreted unchanged in urine and up to 25% of dose may be excreted in urine as desethylchloroquine.a Small amounts of chloroquine may be present in urine for weeks, months, and occasionally years after the drug is discontinued.a


Half-life


Usually 72–120 hours.a


Serum concentrations decline in a biphasic manner and terminal half-life increases with increasing doses.a Terminal half-life is 3.1 hours after a single 250-mg oral dose, 42.9 hours after a single 500-mg oral dose, and 312 hours after a single 1-g oral dose.a


Stability


Storage


Oral


Tablets

25°C (may be exposed to 15–30°C) in tight container.136


Actions and SpectrumActions



  • A blood schizonticidal agent active against asexual erythrocytic forms of most strains of Plasmodium malariae, P. ovale, P. vivax, and many strains of P. falciparum.a Not active against preerythrocytic or exoerythrocytic forms of plasmodia.a Gametocytocidal for P. malariae and P. vivax, but has no direct activity against the gametocytes of P. falciparum.a




  • Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine and may be cross-resistant to pyrimethamine or quinine.a Chloroquine-resistant P. falciparum may be susceptible to quinine or the fixed combination of sulfadoxine and pyrimethamine, but P. falciparum resistant to both chloroquine and sulfadoxine and pyrimethamine are widespread in certain areas.176




  • Active in vitro against the trophozoite form of Entamoeba histolytica.a Acts as a tissue amebicide.a




  • Has anti-inflammatory activity; mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus has not been determined.a



Advice to Patients



  • Importance of keeping chloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.136




  • Advise patients with a history of epilepsy about the risk of seizures.136




  • Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).140 162 163 164 165 166 176




  • Possibility of contracting malaria during travel, regardless of prophylactic regimen used.140 162 163 164 165 166 176




  • Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure.162 163 166 176




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.136




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.136




  • Importance of informing patients of other important precautionary information. (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























Chloroquine Phosphate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



150 mg (of chloroquine)*



Chloroquine Phosphate Tablets



Global, West-Ward



300 mg (of chloroquine)*



Aralen Phosphate



Sanofi-Aventis



Chloroquine Phosphate Tablets



West-Ward


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Aralen 500MG Tablets (SANOFI-AVENTIS U.S.): 25/$190 or 75/$545.96


Chloroquine Phosphate 250MG Tablets (WEST-WARD): 30/$70.99 or 90/$203.98


Chloroquine Phosphate 500MG Tablets (WEST-WARD): 7/$36.99 or 21/$108.97



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 January 2010. 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


Only references cited for selected revisions after 1984 are available electronically.



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