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Quinine

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IMPORTANT WARNING:

Posted 12/12/2006 FDA informed healthcare professionals and consumers that the Agency ordered firms to stop marketing unapproved drug products containing quinine, citing serious safety concerns, including deaths associated with quinine products. There are multiple unapproved products containing quinine currently on the market, used off-label to treat leg cramps and similar conditions. Since 1969, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions. Qualaquin, manufactured by Mutual Pharmaceutical Company, is the only quinine product approved by the FDA. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Quinine and http://www.fda.gov/bbs/topics/NEWS/2006/NEW01521.html.

If you are taking quinine and have any questions about your medication after reading this information, you should contact your doctor or pharmacist. Do not change your dose, how often you take your medication, or the length of time you are to take it without first talking to your healthcare provider.

Why is this medication prescribed?

See the MedWatch notification at the beginning of the monograph.

Quinine is used to prevent and treat malaria.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Quinine comes in capsules and tablets to take by mouth. It usually is taken three times a day (every 8 hours) for 3 days for malaria attacks, twice a day for 6 weeks to prevent or suppress malaria, and at bedtime for leg cramps. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take quinine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Since quinine is very bitter, do not chew tablets before swallowing them.

Other uses for this medicine

Quinine is also used to treat nighttime leg muscle cramps. Talk to your doctor about the possible risks of using this drug for your condition.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

Quinamm®

Quiphile®

Notes:

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EditText of this page (last edited February 27, 2008)