"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
- Clinician Information:
Quinidine Gluconate Consumer (continued)
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.
Seek immediate medical attention if any of these unlikely but serious side effects occur: severe dizziness, fainting, sudden change in heartbeat (faster/slower/more irregular).
Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye pain, muscle pain, unusual sweating or shakiness (signs of low blood sugar).
Tell your doctor immediately if any of these rare but very serious side effects occur: unexplained fever/signs of infection (e.g., persistent sore throat), easy bruising/bleeding, extreme tiredness, dark urine, persistent nausea/vomiting, yellowing eyes/skin, lupus-like symptoms (joint/muscle pain, chest pain, change in the amount of urine).
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.
One type of reaction (cinchonism) can occur after even a single dose of this drug. Contact your doctor of pharmacist promptly if you notice symptoms such as ringing in the ears, sudden hearing problems, headache, blurred vision, confusion. Your dosage may need to be adjusted.
Certain long-acting brands of quinidine may appear as a whole tablet in the stool. This is the empty shell left after the medicine has been absorbed by the body. It is harmless.
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.
Read the Quinidine Gluconate (quinidine gluconate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking quinidine, tell your doctor or pharmacist if you are allergic to it; or to quinine; 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart disease (e.g., incomplete or complete heart block without an artificial pacemaker, torsades-type irregular heartbeats, digitalis toxicity), very low blood pressure, history of easy bruising/bleeding (thrombocytopenic purpura) with use of quinine or quinidine, severe muscle weakness (myasthenia gravis).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain blood disorder (G6PD deficiency), asthma, current infection with fever.
Quinidine 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 right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using quinidine, tell your doctor or pharmacist of all the drugs you take and 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 quinidine safely.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor that you are using this medication.
Older adults may be more sensitive to the side effects of this drug, especially dizziness and QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Quinidine Gluconate Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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