Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)
RedPharm Drug Inc.
ciprofloxacin hydrochloride
ciprofloxacin 250 mg
ORAL
PRESCRIPTION DRUG
Ciprofloxacin Tablets are available as round biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word "P" on one side and "250" on reverse side. The 500 mg and 750 mg tablet are available as capsule shaped, white to slightly yellowish film coated tablets with the word "P" embossed on one side and "500" or "750" on reverse side, respectively. Store below 30°C (86°F). Manufactured by: Unique Pharmaceutical Laboratories Neelam Centre, Hind Cycle Road Worli, Mumbai 400 025, India Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089 USA
Abbreviated New Drug Application
CIPROFLOXACIN - CIPROFLOXACIN TABLET RedPharm Drug Inc. ---------- CIPROFLOXACIN TABLETS USP, 250 MG, 500 MG AND 750 MG Read the Medication Guide that comes with Ciprofloxacin Tablets USP before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CIPROFLOXACIN TABLETS USP ? Ciprofloxacin Tablets USP belongs to a class of antibiotics called fluoroquinolones. Ciprofloxacin Tablets USP can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Ciprofloxacin Tablets USP. Tendon rupture or swelling of the tendon (tendinitis) • Tendons are tough cords of tissue that connect muscles to bones. • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including Ciprofloxacin Tablets USP. The risk of getting tendon problems is higher if you: • are over 60 years of age • are taking steroids (corticosteroids) • have had a kidney, heart or lung transplant • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors. • Other reasons for tendon ruptures can include: • physical activity or exercise • kidney failure • tendon problems in the past, such as in people with rheumatoid arthritis (RA) • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking Ciprofloxacin Tablets USP until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pa Pročitajte cijeli dokument
CIPROFLOXACIN - CIPROFLOXACIN TABLET REDPHARM DRUG INC. ---------- CIPROFLOXACIN TABLETS 250 MG, 500 MG AND 750 MG WARNING: Fluoroquinolones, including CIPROFLOXACIN TABLETS USP, 250 mg, 500 mg and 750 mg, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg and other antibacterial drugs Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ciprofloxacin Hydrochloride Tablets USP, 250 mg, 500 mg and 750 mg are synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1- piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C H FN O •HCl•H O and its chemical structure is as follows: Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C H FN O and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows: 17 18 3 3 2 17 18 3 3 Ciprofloxacin Tablets USP are film-coated tablets and are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets are white to slightly yellowish. The inactive ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and purified wate Pročitajte cijeli dokument