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Ciprofloxacin (Ciprofloxacin)

Trade Name : ciprofloxacin

NuCare Pharmaceuticals, Inc.

TABLET

Strength 500 mg/1

CIPROFLOXACIN HYDROCHLORIDE Quinolone Antimicrobial [EPC],Quinolones [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ciprofloxacin (Ciprofloxacin) which is also known as ciprofloxacin and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 500 mg/1 per ml. Read more

Ciprofloxacin (Ciprofloxacin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Indications and Usage, Plague (n n n )u00a0u00a0u00a0u00a0u00a003/2015n nn
  • Dosage and Administration, Adults (n n n ), Pediatrics (n n n )u00a0u00a0u00a0u00a0u00a003/2015n nn
  • WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS
  • See full prescribing information for complete boxed warning.
  • Fluoroquinolones, including ciprofloxacin, 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 n n n n
  • Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis n n n n
  • Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.n
  • Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (u226518 years of age) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated.
  • Urinary tract infections (n n n ) and Acute uncomplicated cystitis (n n n ) n n n
  • Chronic bacterial prostatitis (n n n ) n n n
  • Lower respiratory tract infections (n n n ) n n n
  • Acute sinusitis (n n n ) n n n
  • Skin and skin structure infections (n n n ) n n n
  • Bone and joint infections (n n n ) n n n
  • Complicated intra-abdominal infections (n n n ) n n n
  • Infectious diarrhea (n n n ) n n n
  • Typhoid fever (enteric fever) (n n n ) n n n
  • Uncomplicated cervical and urethral gonorrhea (n n n ) n n n
  • Complicated urinary tract infections and pyelonephritis in pediatric patients (n n n ) n n n
  • Inhalational anthrax post-exposure in adult and pediatric patients (n n n ) n n n
  • Plague in adult and pediatric patients (n n n ) n n n
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (n n n ) n n n
  • Ciprofloxacin should be administered orally as described in the appropriate Dosage Guidelines tables.
  • Adults with creatinine clearance 30 - 50 mL/min 250 mg - 500 mg q 12 h
  • Adults with creatinine clearance 5 - 29 mL/min 250 mg - 500 mg q 18 h
  • Patients on hemodialysis or peritoneal dialysis 250 mg - 500 mg q 24 h (after dialysis)
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  • Tablets: 250 mg, 500 mg, 750 mg (n n n ) n n n
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  • Known sensitivity to ciprofloxacin or other quinolones (n n n , n n n ) n n n
  • Concomitant administration with tizanidine (n n n ) n n n
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  • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions may occur after first or subsequent doses. Discontinue at first sign of skin rash, jaundice or any sign of hypersensitivity. (n n n , n n n , n n n ) n n n
  • Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. (n n n ) n n n
  • Central nervous system effects, including convulsions, increased intracranial pressure (pseudotumor cerebri) and toxic psychosis have been reported. Caution should be taken in patients predisposed to seizures. (n n n ) n n n
  • Clostridium difficile
  • Peripheral neuropathy: Discontinue if symptoms occur in order to prevent irreversibility. (n n n ) n n n
  • QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. (n n n , n n n , n n n ) n n n
  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
  • The most common adverse reactions u2265 1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. (n n n ) n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug.
  • See full prescribing information
  • 8.4
  • 8.5
  • In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give 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 ciprofloxacin. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.
  • Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are synthetic 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)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is Cn n n Hn n n FNn n n On n n u2022HCl u2022Hn n n O and its chemical structure is as follows:n nn
  • Ciprofloxacin film-coated Tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths.
  • Ciprofloxacin tablets USP 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 water.
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  • Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 500mg of ciprofloxacin. The 500 mg tablet is embossed with the word u201cPu201d on one side and u201c500u201d on reverse side.
  • NDC 66267-716-02 Bottles of 2
  • NDC 66267-716-04 Bottles of 4
  • NDC 66267-716-06 Bottles of 6
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0 F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0 F) [see USP Controlled Room Temperature].
  • Advise the patient to read the n n n -approved patient labeling (n n n )n nn
  • Antibacterial Resistance
  • Administration with Food, Fluids, and Concomitant Medications
  • Inform patients to drink fluids liberally while taking ciprofloxacin to avoid formation of highly concentrated urine and crystal formation in the urine.
  • Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after ciprofloxacin administration. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.
  • Serious and Potentially Serious Adverse Reactions
  • Drug Interactions Oral Antidiabetic Agents
  • Anthrax and Plague Studies
  • Medication Guide forn- Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg
  • Read this Medication Guide before you start taking ciprofloxacin and each time you get a refill. There may be new information. This information 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?
  • Ciprofloxacin a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects could result in death.
  • If you get any of the following serious side effects while you take ciprofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin.
  • What is ciprofloxacin?
  • Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infection include:
  • Who should not take ciprofloxacin?
  • Do not take ciprofloxacin if you:
  • What should I tell my healthcare provider before taking ciprofloxacin?
  • Before you take ciprofloxacin, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Especially tell your healthcare provider if you take:
  • Ask your healthcare provider for a list of these medicines if you are not sure.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take ciprofloxacin tablets?
  • What should I avoid while taking ciprofloxacin?
  • What are the possible side effects of ciprofloxacin?
  • Ciprofloxacin may cause serious side effects, including:
  • Tell your healthcare provider about any side effect that bothers you, or that does not go away.
  • These are not all the possible side effects of ciprofloxacin. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Rising Pharmaceuticals,Inc.at 1-866-562-4597. n
  • How should I store ciprofloxacin tablets?
  • Keep ciprofloxacin tablets and all medicines out of the reach of children.
  • General Information about the safe & effective use of ciprofloxacin.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin for a condition for which it is not prescribed. Do not give ciprofloxacin to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about ciprofloxacin. If you would like more information about ciprofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin that is written for healthcare professionals.
  • For more information, call 1-866-562-4597
  • What are the ingredients in ciprofloxacin tablets?
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:n n n n n (A Div. of J. B. Chemicals & Pharmaceuticals Ltd)n n n Mumbai 400 030, Indian nn
  • Manufactured for:n n n Rising Pharmaceuticals, Inc. n n n Allendale, NJ 07401n nn
  • Revised: April 2015tttttttxxxxxx
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