Supraflox Ciprofloxacin Hydrochloride Tablets

CIPROFLOXACIN TABLETS USP
SUPRAFLOX

 

Each film coated tablet contains:

Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 mg

Colours : Brilliant Blue and Titanium Dioxide BP

Each film coated tablet contains:

Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg

Colours: Ponceau 4R and Titanium Dioxide BP

 

Indications

It is indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms in the conditions listed below:

Acute Sinusitis caused by Haemophilus influenza, Streptococcus pneumoniae, or Moraxella catarrhalis.

Lower Respiratory Tract Infections cause by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Psedomonas aeruginosa, Haemophilus influenza, Haemophilus parainfluenzae or Streptococcus pnuemoniae.

Urinary Tract Infections caused by Eschrichia coli, Klibsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providence rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeroginosa, Staphylococcus saprophyticus, Enterococcus faecalis.

Chronic Bacterial Prostatitis caused by Escherichia coli, or Proteus mirabilis.

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Skin and skin structure Infections caused by Escherichia coli, Klebsella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin susceptible), Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruguinosa.

Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii, ShigeIIa dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.

Typhoid Fever (Enteric Fever) caused by Salmonella typhi.
NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhea.
Inhalation anthrax (post exposure) To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

 

Pharmacology

Ciprofloxacin is a synthetic fluoroquinolone anti-infective agent that has an expanded spectrum of activity and increased antibacterial potency compared with non-fluorinated quinolones.

Ciprofloxacin is bactericidal and acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of becterial DNA. It has a broader spectrum of activity and is more potent in vitro than the non-fluorinated quinolone nalidixic acid. Activity may be reduced in acid media.

Among Gram-negative aerobic bacteria ciprofloxacin is active in-vitro against Enterobacteriaceae including E. coil and Citrobacter, Enterobacter, Klebsiella, Proteus, Providencia, Salmonella, Serratia, Shigella and Yersinia spp.

Among Gram-positive aerobic bacteria reported to be sensitive to ciprofloxacin have included Acinetobacter spp., Campylobacter spp., Gardnerella vaginalis, Helicobacter pyroli, Legionella spp., Pasteurella multocida, and Vibrio spp. Variable activity has been reported against Brucella melitensis.

 

Pharmacokinetics

Ciprofloxacin is rapidly and well absorbed from the gastro-intestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 mg per mL is achieved 1 to 2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food, but is not substantially affected overall. The plasma half-life is about 3.5 to 4.5 hours and there is evidence of modest accumulation. Half-life may be prolonged in severe renal failure – a value of 8 hours has been reported in end stage renal disease – and to some extent in the elderly. There is limited information on the effect of liver dysfunction; in one study the half-life of ciprofloxacin was slightly prolonged in patients with severe cirrhosis of the liver. With one or two exceptions, most studies have shown the pharmacokinetics of ciprofloxacin to be not markedly affected by cystic fibrosis.

Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the CSF, but concentrations are only about 10% of those in plasma when the meninges are not inflamed. Ciprofloxacin crosses the placenta and is distributed into breast milk. High concentrations are achieved in bile.

Ciprofloxacin is eliminated principally by urinary excretion, but non-renal clearance may account for about a third of elimination and includes hepatic metabolism, biliary excretion, and possibly transluminal secretion across the intestinal mucosa. At least 4 active metabolites have been identified. Oxo-ciprofloxacin appears to be the major urinary metabolite and sulphociprofloxacin the primary Faecal metabolite. Urinary excretion is by active tubular secretion as well as glomerular filtration and is reduced by probenecid; it is virtually complete within 24 hours. About 40-50% of an oral dose is excreted unchanged in the urine and about 15% as metabolites. Up to 70% of a parenteral dose may be excreted unchanged within 24 hours and 10% as metabolites. Faecal excretion over 5 days has accounted for 20 to 35% of an oral dose and 15% of an intravenous dose. Only small amounts of ciprofloxacin are removed by hemodialysis or peritoneal dialysis.

 

Dosage and Administration

Ciprofloxacin is administered orally as tablets containing the hydrochloride or as an oral suspension containing the base. Patients receiving ciprofloxacin orally or IV should be well hydrated and should be instructed to drink fluids liberally.

Usual dosage range from 250-500mg every 12 hours for 7-14 days.

Because of the risk of crystalluria, it is recommended that the usual dosage of the drug not be exceeded. Dosage of ciprofloxacin hydrochloride and ciprofloxacin lactate is expressed in terms of ciprofloxacin.

 

Contra-Indications

Ciprofloxacin is contra-indicated in persons with a history of hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents.

 

Adverse Reactions

More Frequent: Diarrhea, Dizziness, Drowsiness, Headache, Insomnia, Nausea, Nervousness, Photosensitivity, Stomach Pain/Cramps, Vomiting.

Rare or Very Rare: Agitation, Allergic Dermatitis, Allergic Reaction, Angioedema, Confusion, Difficulty in Breathing, Erythema, Hallucinations, Interstitial Nephritis, Itching, Psychosis, Skin Rash, Stevens-Johnson Syndrome, Tendon Rupture, Achilles Tendinitis, Tremors.

 

Precautions

Crystalluria has been reported rarely in patients receiving ciprofloxacin. Although crystalluria is not expected to occur under usual conditions with the usual recommended dosages of the drug, patients should be instructed to drink sufficient quantities of fluids to ensure proper hydration and adequate urinary output during ciprofloxacin therapy. Because ciprofloxacin, like other quinolones, may cause CNS stimulation that potentially could result in tremor, restlessness, lightheadedness, mental confusion, toxic psychosis, and/or seizures, the drug should be used with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, seizure disorders) that predispose to seizures or lower the seizure threshold and should be used with caution in the presence of other factors (e.g. certain drug therapies, renal dysfunction) that predispose to seizures or lower the seizure threshold. Patients should be advised that ciprofloxacin may cause dizziness or lightheadedness, and their individual susceptibility to these adverse effects should be determined before operating a motor vehicle or machinery or engaging in activities requiring mental alertness and coordination.

 

Pregnancy and Lactation

There are no adequate and controlled studies to date using ciprofloxacin in pregnant women. Since the drug, like most other quinolones, causes arthropathy in immature animals, ciprofloxacin should not be used in pregnant women except for the treatment or prevention of inhalational anthrax. Ciprofloxacin and other quinolones (e.g. nalidixic acid, ofloxacin) have been shown to distribute into milk. Because of the potential for serious adverse effects of ciprofloxacin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

 

Treatment of Overdosage

In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. Only a small amount of ciprofloxacin is removed from the body after hemodialysis or peritoneal dialysis.

 

Interactions with other drugs or Food

Antacids

Antacids containing magnesium, aluminum, or calcium decrease absorption of oral ciprofloxacin, resulting in decreased serum and urine concentration of the anti-infective agent. The mechanism of this interaction has not been fully elucidated to date, but magnesium, aluminum, and other divalent ions may bind to, and form insoluble complexes with, quinolones in the GI tract Some clinicians suggest that patients be instructed not to ingest antacids containing magnesium, aluminum, or calcium concomitantly with or Within 2-4 hours of a ciprofloxacin dose however, other clinicians state that these antacids should not be used in patients receiving ciprofloxacin and that ciprofloxacin probably should not be used in patients with renal failure who require aluminum hydroxide or aluminum carbonate for intestinal binding of phosphate Ciprofloxacin should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum.

Aminoglycosides

The antibacterial activities of ciprofloxacin and aminoglycosides have been additive or synergistic in vitro against some strains of Enterobacteriaceae and Pseudomonas aeruginosa. However, synergism between the drugs is unpredictable, and indifference generally occurs when ciprofloxacin is used in conjunction with amikacin, gentamicin, or tobramycin against Ps. aeruginosa or Enterobacteriaceae. Indifference also generally occurs when the drug is used in conjuction with tobramycin against Acinetobacter.

β-Lactam Antibiotics

An additive or synergistic effect has occurred occasionally in vitro against some strains of Ps. aeruginosa and Ps. maltophila when ciprofloxacin was used concomitantly with an extended-spectrum penicillin (e.g., mezlocillin, piperacillin). Indifference generally occurs when ciprofloxacin is used in conjunction with an extended-spectrum penicillin against Enterobacteriaceae. Ciprofloxacin used in conjunction with imipenem, cefoxitin, or a cephalosporin (e.g., cefotaxime, ceftazidime, ceftizoxime) has been reported to be additive or synergistic against some strains of Pa. aeruginosa or Enterobacteriaceae; however, these combinations generally are indifferent rather than additive or synergistic against these organisms. Although the clinical importance has not been determined, ciprofloxacin used in conjunction with cefotaxime in vitro resulted in a synergistic effect against many strains of Bacteroides fragilis tested; antagonism did not occur.

Iron and Multivitamin and Mineral Supplements

Oral multivitamin and mineral supplements containing divalent or trivalent cations such as calcium, iron, or zinc may interfere with oral absorption of ciprofloxacin resulting in decreased serum and urine concentrations of the quinolone. Therefore, these multivitamins and/or minerals supplements should not be ingested concomitantly with ciprofloxacin. Ciprofloxacin should be administered at least 2 hours before or 6 hours after preparations containing calcium, iron, or zinc. Usual dietary intake of calcium has not been shown to alter the absorption of ciprofloxacin.

Xanthine Derivatives

Concomitant administration of ciprofloxacin in patients receiving a theophylline derivative may result in higher and prolonged serum theophylline concentrations and may increase the risk of theophylline-related adverse effects. Adverse reactions reported during concomitant therapy with the drugs include nausea, vomiting, dizziness, headache, tremor, restlessness, agitation, confusion, seizures (including status epilepticus), hallucinations, tachycardia, cardiac arrest, respiratory failure and palpitation and apparently occurred as the result of increased serum theophylline concentrations death in at least one patient was associated with seizures and atrial fibrillation during concomitant therapy with the drugs, while similar effects also have been reported in theophylline-treated patients who were not receiving ciprofloxacin concomitantly, the possibility that such toxicity may have been potentiated by ciprofloxacin cannot be excluded. Because of the risk of toxicity if plasma theophylline concentrations are increased, concomitant use of ciprofloxacin and a theophylline derivative should be avoided, if possible.

 

STORAGE

Store in a cool dry place.

 

PRESENTATION

Supraflox 250: Blister of 10’s.

Supraflox 500: Blister of 10’s.

 

NAFDAC Reg. No.: 04-3458

 

Manufactured in India by

Khandelwal Laboratories Pvt. Ltd.

Plot No.20, Sec. 6, IIE, SIDCUL, Pantnagar,

U.S. Nagar-263153 Uttarakhand.

Regd. Office: 79/87, D. Lad Path, Mumbai – 400 033.

 

Marketed by

EDEN U-K PHARMACEUTICAL LTD.

J116 Daminja Avenue Housing Estate

Fegge Onitsha, Anambra State, Nigeria.

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