Qualaquin

DRUG DESCRIPTION

QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8?, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2•H2SO4•2H2O and a molecular weight of 782.96.

The structural formula of quinine sulfate is:

QUALAQUIN®
  (quinine sulfate) Structural Formula Illustration

Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether.

QUALAQUIN (quinine sulfate capsules) is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.

What are the possible side effects of quinine (Qualaquin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using quinine and call your doctor at once if you have any of these serious side effects:

  • fever, chills, confusion, weakness;
  • severe vomiting, stomach pain, diarrhea;
  • problems with vision or hearing;
  • trouble breathing;
  • urinating less than usual or not at all;
  • chest pain;
  • fast, pounding, or...

Read All Potential Side Effects and See Pictures of Qualaquin »

What are the precautions when taking quinine sulfate capsules (Qualaquin)?

Before taking quinine, tell your doctor or pharmacist if you are allergic to it; or to quinidine or mefloquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous serious side effects with quinine (such as blood problems), family/personal history of a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), a certain eye nerve problem (optic neuritis), hearing problems (such as ringing in the ears), a certain nerve/muscle disease (myasthenia gravis), heart rhythm problems (such as atrial fibrillation/flutter), kidney problems,...

Read All Potential Precautions of Qualaquin »


Qualaquin Consumer (continued)

SIDE EFFECTS: Mild headache, flushing, unusual sweating, nausea, ringing in the ears, decreased hearing, dizziness, blurred vision, and temporary changes in color vision may occur. If any of these effects persist after your treatment is finished, or if these effects worsen while taking the medication, tell your doctor or pharmacist promptly.

Quinine may cause low blood sugar (hypoglycemia), especially during pregnancy. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. If symptoms of low blood sugar occur, increase your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, unusual purple, brown or red spots on the skin, signs of serious infection (such as high fever, severe chills, persistent sore throat), signs of a sudden loss of red blood cells called hemolytic anemia (such as severe tiredness, brown urine, pale lips/nails/skin, rapid breathing at rest), signs of severe liver problems (such as persistent nausea/vomiting, abdominal pain, severe weakness, yellow skin/eyes, unusually dark urine), change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, fast/irregular heartbeat, blindness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking quinine, tell your doctor or pharmacist if you are allergic to it; or to quinidine or mefloquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous serious side effects with quinine (such as blood problems), family/personal history of a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), a certain eye nerve problem (optic neuritis), hearing problems (such as ringing in the ears), a certain nerve/muscle disease (myasthenia gravis), heart rhythm problems (such as atrial fibrillation/flutter), kidney problems, liver problems.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Quinine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using quinine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using quinine safely.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

This drug passes into breast milk. However, this drug is unlikely to harm some nursing infants. Your doctor will test your infant for a certain enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency-G6PD) before you breast-feed. Consult your doctor before breast-feeding.


Qualaquin Patient Information Including Side Effects

Brand Names: Qualaquin

Generic Name: quinine (Pronunciation: KWYE nine)

  • What is quinine (Qualaquin)?
  • What are the possible side effects of quinine (Qualaquin)?
  • What is the most important information I should know about quinine (Qualaquin)?
  • What should I discuss with my healthcare provider before taking quinine (Qualaquin)?
  • How should I take quinine (Qualaquin)?
  • What happens if I miss a dose (Qualaquin)?
  • What happens if I overdose (Qualaquin)?
  • What should I avoid while taking quinine (Qualaquin)?
  • What other drugs will affect quinine (Qualaquin)?
  • Where can I get more information?

What is quinine (Qualaquin)?

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine because of the risk of serious side effects or death. As of December 2006, Qualaquin is the only brand of quinine that is approved by the FDA.

Quinine is used to treat malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Quinine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of quinine (Qualaquin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using quinine and call your doctor at once if you have any of these serious side effects:

  • fever, chills, confusion, weakness;
  • severe vomiting, stomach pain, diarrhea;
  • problems with vision or hearing;
  • trouble breathing;
  • urinating less than usual or not at all;
  • chest pain;
  • fast, pounding, or fluttering heartbeats;
  • weak or shallow breathing, feeling like you might pass out;
  • pale skin, easy bruising, purple or red pinpoint spots under your skin;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; o
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, ringing in your ears, blurred vision;
  • dizziness, spinning sensation;
  • increased sweating;
  • mild nausea, diarrhea, or stomach pain;
  • muscle weakness; or
  • warmth, redness, or tingly feeling under the skin.

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 is the most important information I should know about quinine (Qualaquin)?

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine because of the risk of serious side effects or death. As of December 2006, Qualaquin is the only brand of quinine that is approved by the FDA.

Quinine can cause serious or life-threatening side effects, and is approved for use only in treating malaria. Some people have used quinine to treat leg cramps, but this is not an FDA-approved use.

Do not use quinine to treat any medical condition if your doctor did not prescribe quinine for that condition. Do not purchase quinine on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Do not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine (Lariam) or quinidine (Cardioquin, Quinidex, Quinaglute).

You should not take quinine if you have a history of "Long QT syndrome," or if you have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, myasthenia gravis, or optic neuritis (inflammation of the nerves in your eyes).

Before taking quinine, tell your doctor if you have heart disease or a heart rhythm disorder, low potassium levels in your blood (hypokalemia), kidney disease, or liver disease.

Serious side effects of quinine include fever, chills, confusion weakness, severe vomiting or stomach pain, diarrhea, pale or yellowed skin, dark colored urine, chest pain, pounding or fluttering heartbeats, hearing or vision loss, purple spots under your skin, a blistering or peeling skin rash, or urinating less than usual or not at all.

No medication is 100% effective in treating malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

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