What happens if I overdose Proflaxin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Proflaxin extended-release tablets:
Store Proflaxin extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proflaxin extended-release tablets out of the reach of children and away from pets.
Overdose of Proflaxin in details
In the event of acute overdosage, reversible renal toxicity has been reported in some cases. The stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids, which can reduce the absorption of Proflaxin. Adequate hydration must be maintained. Only a small amount of Proflaxin (< 10%) is removed from the body after hemodialysis or peritoneal dialysis.
Single doses of Proflaxin were relatively non-toxic via the oral route of administration in mice, rats, and dogs. No deaths occurred within a 14-day post treatment observation period at the highest oral doses tested; up to 5000 mg/kg in either rodent species, or up to 2500 mg/kg in the dog. Clinical signs observed included hypoactivity and cyanosis in both rodent species and severe vomiting in dogs. In rabbits, significant mortality was seen at doses of Proflaxin > 2500 mg/kg. Mortality was delayed in these animals, occurring 10 to 14 days after dosing.
In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of Proflaxin between 125 and 300 mg/kg.
What should I avoid while taking Proflaxin?
You may be taking certain other medicines that should not be taken at the same time as Proflaxin. Avoid taking the following medicines within 6 hours before or 2 hours after you take Proflaxin. These other medicines can make Proflaxin much less effective when taken at the same time:
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antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);
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didanosine (Videx) powder or chewable tablets;
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vitamin or mineral supplements that contain calcium, iron, or zinc.
Avoid caffeine while you are taking Proflaxin, because the medication can make the effects of caffeine stronger.
Avoid exposure to sunlight or tanning beds. Proflaxin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Proflaxin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Proflaxin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Proflaxin warnings
Patients should be advised:
· that antibacterial drugs, including Proflaxin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Proflaxin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Proflaxin or other antibacterial drugs in the future.
· that Proflaxin should only be used to treat uncomplicated urinary tract infections (also known as bladder infections). The safety and efficacy of Proflaxin to treat other urinary tract or non-urinary tract infections have not been studied.
· that Proflaxin should be taken with a main meal of the day, preferably the evening meal. The patient should not take more than one Proflaxin tablet per day, even if the patient misses a dose.
· that Proflaxin tablets should be taken whole and never split, crushed, or chewed.
· that concomitant administration of Proflaxin with aluminum or magnesium-containing antacids, sucralfate, VIDEX (didanosine) chewable buffered tablets or pediatric powder, metal cations such as iron and calcium, and multivitamin preparations containing zinc should be avoided. Proflaxin should be administered at least 4 hours before or 2 hours after these products.
· that Proflaxin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, since the absorption of Proflaxin may be significantly reduced. However, Proflaxin may be taken with a meal that contains these products.
· that Proflaxin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue Proflaxin at the first sign of a skin rash or other allergic reaction and contact their physician.
· to avoid excessive sunlight or artificial ultraviolet (UV) light while receiving Proflaxin and to discontinue therapy if phototoxicity occurs.
· that peripheral neuropathies have been associated with Proflaxin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should discontinue treatment and contact their physician.
· that if they experience pain, inflammation, or rupture of a tendon to discontinue treatment, to inform their physician, and to rest and refrain from exercise.
· to contact their doctor if they do not feel better of if they develop fever and back pain while or after taking Proflaxin.
· that Proflaxin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
· that Proflaxin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
· that convulsions have been reported in patients receiving quinolones, including Proflaxin, and to notify their physician before taking this drug if there is a history of this condition.
Proflaxin (Proflaxin hydrochloride) Extended-Release Tablets PROQUIN® XR (prōkwin) (Proflaxin hydrochloride) Extended-Release Tablets, 500 mg This leaflet contains important information about Proflaxin (Proflaxin hydrochloride) extended-release tablets and should be read before you begin treatment. This leaflet does not replace talking with your doctor about your medical condition or your treatment. This leaflet does not list all benefits and risks of Proflaxin. Proflaxin can be prescribed only by a doctor. If you have any questions about Proflaxin, talk to your doctor. Only your doctor can tell you if Proflaxin is right for you. What is Proflaxin? Proflaxin is an antibiotic in the class known as "quinolones" that is used to treat adults with simple (uncomplicated) urinary tract infections (also known as "bladder infections") caused by bacteria. It is not known if Proflaxin will treat infections other than bladder infections. Proflaxin, like all other antibiotics, does not kill viruses. You should contact your doctor if you do not feel better or if you develop fever and back pain while or after taking Proflaxin. Proflaxin tablets are blue and contain 500 mg of active drug. How should I take Proflaxin? · Proflaxin should be taken once a day for 3 days shortly after a main meal of the day, preferably the evening meal. Proflaxin does not work as well if you take it without a meal. You should try to take Proflaxin at about the same time each day. · Take Proflaxin for all 3 days, even if you are feeling better. If you stop taking Proflaxin before all 3 doses, Proflaxin may not cure your bladder infection. · Do not split, crush, or chew Proflaxin tablets. Proflaxin tablets must be swallowed whole. Tell your doctor if you cannot swallow tablets whole. Your doctor will prescribe a different medicine for you. · Do not take more than one Proflaxin tablet a day, even if you miss a dose. · Do not take Proflaxin at the same time that you drink milk or juices with added calcium, unless you drink them with a main meal. · Many antacids and multivitamins may interfere with the absorption of Proflaxin if taken at the same time. Take Proflaxin at least 4 hours before or 2 hours after antacids that contain magnesium or aluminum. Proflaxin should also be taken at least 4 hours before or 2 hours after sucralfate, VIDEX® (didanosine) chewable buffered tablets or pediatric powder, iron, calcium, and vitamins that contain zinc. Who should not take Proflaxin? Do not take Proflaxin if you are allergic to or have ever had a severe reaction to Proflaxin or to any other "quinolone" antibiotics. Proflaxin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant or planning to become pregnant while taking Proflaxin, talk to your doctor before taking this medication. Proflaxin is not recommended for children. What should I tell my doctor before taking Proflaxin? Tell you doctor about all of your medical conditions, including if you have or ever had seizures (epilepsy), asthma, or liver or kidney problems. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Proflaxin and certain other medicines can affect each other. You may have to adjust the times you take certain other medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take: theophylline, VIDEX® (didanosine) chewable buffered tablets or pediatric powder; warfarin (Coumadin®); glyburide (Glucovance®, Micronase®, DiaBeta®); phenytoin (Dilantin®); sucralfate (Carafate®); or antacids or vitamins that contain magnesium, calcium, aluminum, iron, or zinc. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. What are the possible side effects of Proflaxin? Proflaxin is generally well tolerated. The most common side effects with Proflaxin include vaginal yeast infection and headache. Less common side effects include nausea, diarrhea, dizziness, and abdominal pain. You should be careful about driving or operating machinery until you are sure the Proflaxin is not causing dizziness or lightheadedness. Rare cases of allergic reactions have been reported in patients receiving quinolones, including Proflaxin, even after just one dose. Stop taking Proflaxin and call your doctor or get emergency medical attention right away if you develop a rash, hives, swelling of your face or throat, or have trouble breathing. Some patients taking quinolone antibiotics may become more sensitive to sunlight or ultraviolet light such as that used in tanning salons. You should avoid excessive exposure to sunlight or ultraviolet light while taking Proflaxin. Proflaxin has rarely been associated with inflammation of the tendons. Stop taking Proflaxin and call your doctor if you experience pain, swelling, or rupture of a tendon. Convulsions have been reported in patients receiving quinolone antibiotics including Proflaxin. Tell your doctor if you have experienced convulsions in the past. Quinolones, including Proflaxin, have been rarely associated with other central nervous system events including confusion, tremors, hallucinations, and depression. Stop taking Proflaxin and call your doctor right away if you get any of these symptoms. These are not all the side effects with Proflaxin. For more information, ask your doctor or pharmacist. How should I store Proflaxin? · Store Proflaxin at room temperature, 59° to 86° F (15° to 30° C). · Keep Proflaxin and all medicines out of the reach of children. General information about Proflaxin Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Proflaxin for a condition for which it was not prescribed. Do not give Proflaxin to other people, even if they have the same symptoms you have. It may harm them. Keep this medication out of the reach of children. This leaflet summarizes the most important information about Proflaxin. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Proflaxin that is written for health care professionals. Further information is also provided at: 1-800-206-2945 and www. Proquin.com What are the ingredients in Proflaxin? Active Ingredient: Proflaxin hydrochloride Inactive Ingredients: film coating, magnesium stearate, polyethylene oxide, and povidone You should not use Proflaxin if you are allergic to a fluoroquinolone antibiotic, or if you are also taking tizanidine (Zanaflex). To make sure Proflaxin is safe for you, tell your doctor if you have: tendon problems, arthritis or other joint problems (especially in children); a history of myasthenia gravis or other nerve-muscle disorder; a heart rhythm disorder (especially if you take medication to treat it) or history of long QT syndrome; trouble swallowing pills; liver or kidney disease; a history of seizures; diabetes (especially if you take oral diabetes medication); low levels of potassium in your blood (hypokalemia); or if you use a blood thinner (warfarin, Coumadin, Jantoven) and have "INR" or prothrombin time tests. Proflaxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking Proflaxin. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Do not give this medicine to a child without medical advice. Tendon and joint problems may be more likely in a child taking Proflaxin. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Proflaxin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Proflaxin. Tablet: Proflaxin should be used with caution in patients with epilepsy or a history of CNS disorders. Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency or myasthenia gravis. An adequate fluid intake should be maintained during treatment with Proflaxin and excessive alkalinity of the urine avoided because of the risk of crystalluria. Exposure to strong sunlight or sun lamps should also be avoided. Effects on the Ability to Drive or Operate Machinery: The ability to drive or operate machinery may be impaired by Proflaxin, especially when alcohol is also taken. Eye Drops: Proflaxin eye drops is not for injection into the eye. In patients receiving systemic quinolone therapy, serious and occasionally fatal hypersensitivity reactions have been observed following the 1st dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria and itching. Prolonged use of any antibacterial preparation may result in overgrowth of nonsusceptible organisms including fungi; it also holds true with Proflaxin. In case of superinfection, appropriate therapy must be initiated. Proflaxin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. Remove contact lenses before use. Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Reproduction studies in rats and mice at doses up to 6 times the usual daily human oral dose have revealed no evidence of impaired fertility or harm to the fetus due to Proflaxin. In rabbits, as with most antimicrobial agents, Proflaxin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. Proflaxin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Proflaxin eye drops is administered to a nursing mother. It is, however, not known whether topically applied Proflaxin is excreted in human milk. Use in children: Safety and efficacy of Proflaxin eye drops have not been established in pediatric patients <1 year. Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Information checked by Dr. Sachin Kumar, MD PharmacologyPatient Leaflet
What should I discuss with my healthcare provider before taking Proflaxin?
Proflaxin precautions
What happens if I miss a dose of Proflaxin?
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