Serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP), may occur if quinine is used for treatment or prevention of nocturnal leg cramps†.
Chronic renal impairment associated with TTP reported.
Known risks associated with use of quinine, in the absence of evidence of safety and efficacy of the drug for treatment or prevention of nocturnal leg cramps†, outweigh any potential benefits for this unlabeled indication.
(See Use for Treatment or Prevention of Nocturnal Leg Cramps under Cautions.)
REMS:
FDA approved a REMS for quinine sulfate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of quinine sulfate and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. Take with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not skip doses or stop your medicine early even if you feel better. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Let your doctor know if your symptoms do not improve or if you feel worse. Contact your doctor right away if your fevers come back after you finish this medicine.
Some people may have low blood sugar while taking this medicine. Low blood sugar can make you feel lightheaded, dizzy, sweaty, confused, shaky, anxious, or weak. If you feel this way drink some fruit juice or have a snack then call your doctor. If you are diabetic, check your blood sugar as directed.
Avoid antacids with aluminum or magnesium for 2 hours before and after taking a dose of this medicine.
Tell your health care provider that you are taking this medicine before you have any surgery, procedure, or dental work.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 25 and 30 degrees C (77 and 86 degrees F). Keep in a tightly closed container. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
