"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"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
RIFAMPIN/ISONIAZID/PYRAZINAMIDE - ORAL
COMMON BRAND NAME(S): Rifater
WARNING: Isoniazid has rarely caused very serious (possibly fatal) liver disease. The risk of liver disease is increased in people who are 35 years and older, who use alcohol or illegal injection drugs, or who currently have long-term liver problems. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, severe stomach/abdominal pain, unusual weakness/tiredness, dark urine, yellowing eyes/skin.
Your doctor should order liver function tests while you are taking this medication. Keep all medical and laboratory appointments.
USES: This product is used to treat tuberculosis (TB) of the lungs. It contains 3 medications: rifampin, isoniazid, and pyrazinamide. These medications are antibiotics. Rifampin is known as a rifamycin antibiotic. This product works by stopping the growth of bacteria.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
HOW TO USE: Take this product by mouth 1 hour before or 2 hours after a meal, usually once daily or as directed by your doctor. Take it with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.
If you also take antacids, take this medication at least 1 hour before the antacid.
The dosage is based on your age, weight, medical condition, and response to treatment.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).
Your doctor may also direct you to take vitamin B6 (pyridoxine) to help prevent certain side effects (such as nerve problems) from isoniazid. Follow your doctor's instructions carefully.
Isoniazid may interact with foods containing tyramine/histamine (such as cheese, red wine, certain types of fish). This interaction may cause increased blood pressure, flushing of the skin, headache, dizziness, or fast/pounding heartbeat. Tell your doctor immediately if any of these symptoms occur. Your doctor may recommend that you follow a special diet while taking this medication. Consult your doctor for more details.
Tell your doctor if your condition persists or worsens.
Additional Rifater Information
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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