FAQs: Tequin

Frequently Asked Questions About Tequin®

• What is Tequin®?
• Who made Tequin®?
• What are Side Effects of Tequin®?
• What are the Risks of Tequin®?
• Who should not take Tequin®?
• What patients should know?
• Can other Medications or Food Affect Tequin®?
• What else should I Know?
• What are useful Tequin® Resources?

What is Tequin®?

Tequin® is an antibiotic used to treat adults with lung, sinus, or urinary tract infections and also to treat certain sexually transmitted diseases caused by germs called bacteria.  Sometimes viruses, rather than bacteria, may infect the lungs and sinuses (for example, the common cold).  Tequin®, like all other antibiotics, does not kill viruses.

The sexually transmitted disease called gonorrhea is treated by Tequin®.  Other sexually transmitted diseases including syphilis and nongonococcal diseases are not treated by Tequin®.

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Who made Tequin®?

Tequin® was manufactured by Bristol-Myers Squibb Company.  Tequin® was approved by the United Stats Food and Drug Administration(FDA) in late 1999.  Tequin® was sold in the United States until May 2006 when it was withdrawn from the market after being linked to serious life threatening blood sugar abnormalities.  Bristol-Myers Squibb Co.had obtained the rights to manufacture and sell Tequin® from Kyorin Pharmaceutical Company in Japan.

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What are the side effects of Tequin®?

• 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 Tequin® and call your doctor at once if you have any of these serious side effects:
• fast pounding, or uneven heartbeats
• feeling light-headed, fainting;
• seizure (convulsions);
• numbness, tingly feeling, burning pain;
• skin rash that is red and blisters or peels;
• diarrhea this is watery or bloody;
• nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• sudden pain or swelling near your joints (especially in your arm or ankle); or a skin rash
• Less serious side effects include:
• mild nausea, vomiting, stomach pain, diarrhea;
• feeling dizzy, restless, or confused
• vaginal discharge or itching;
• sleep problems (insomnia or nightmares); or
• headache.
• Side effects other than those listed here may also occur.  Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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What are the Risks of Tequin®?

The following are the major potential risks and side effects of Tequin® therapy.  However, this list is not complete.

If you have any of the following side effects, stop taking Tequin® and call your doctor:

• Serious blood sugar changes including low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).  See FDA Alert.
• Severe allergic reactions (trouble breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
• Central Nervous System (CNS) side effects including: seizures, dizziness, confusion, tremors, hallucinations, depression, or suicidal thoughts.
• Pain, inflammation, or rupture of a tendon.

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You should not take Tequin® if you?

• Are allergic to Tequin® or any “quinolones” such as:
• Ciprofloxacin (CIPRO)
• GATIFLOXACIN (Tequin®, ZYMAR)
• Levofloxacin (LEVAQUIN)
• Lomefloxacin (MAXAQUIN)
• Moxifloxacin (AVELOX, VIGAMOX)
• Gemifloxacin (FACTIVE)
• Norfloxacin (NOROXIN)
• Ofloxacin (FLOXIN)
• Have a rare heart condition called congenital prolongation of the QTc interval.  If any of your family members have this condition, tell your healthcare professional.
• Have low blood potassium (hypokalemia).  Low blood potassium may be caused by medicines called diuretics or “water pills”.
• Are taking medicines to treat an irregular heartbeat.
• Have diabetes or high blood sugar.
• If you are pregnant or nursing, talk to your healthcare professional before taking.

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What Patients Should Know

Patients, even non-diabetic patients, should be counseled about the signs and symptoms of hyperglycemia and hypoglycemia and possible treatments options.  Patients should stop taking Gatifloxacin if they experience excessive thirst, frequent urination, dry mouth, increased sweating, dizziness or mental status changes.  Patients should be sure that any physician or pharmacist caring for them is aware of all the medications they are taking.

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Can Other Medicines or Food Affect Tequin®?

Tequin® and certain other medicines can interact with each other.  Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Know the medicines you take.  Keep a list of them with you to show your healthcare professional.

Especially tell your healthcare professional if you take:

• Medicine to control blood sugar (insulin, glyburide, other hypoglycemic drugs) or steroids;
• Medicines to treat an irregular heartbeat;
• Cisapride, erythromycin, antidepressant medicines, or antipsychotic medicines.  These medicines may increase the chance of heart beat problems when taken with Tequin®;
• Medicines called diuretics or “water pills” because they can sometimes cause low blood potassium;
• Diabetes medicines;
• Videx (didanosine): Tequin® should be taken 4 hours before your dose of Videx;
• Antacids and multivitamins that contain zinc, magnesium, or iron.  These may stop Tequin® from passing into your body.  Take Tequin® 4 hours before taking any of these products.

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What Else Should I Know?

• Do not drive or operate dangerous machines until you know how Tequin® affects you.  Tequin® can cause dizziness.
• Avoid long exposure to sunlight.  Tequin® may make your skin more sensitive to sunlight.  You may get severe sunburn.  Call your healthcare professional if you have severe burning, redness, itching, rash, or swelling after being in the sun while taking Tequin®.
• Tequin® for Oral Suspension contains phenylalanine.  This is important to know if you have a condition called Phenylketonuria.

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Tequin® Resources

Letter to healthcare providers from BMS: www.fda.gov/medwatch/safety/2006/Tequin

FDA Drug Information: druginfo@cder.fda.gov

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