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.

Petsow Amoxycillin Capsules

AMOXYCILLIN CAPSULES

 

PRESENTATION

Maroon/yellow coloured hard gelatin size 1 capsule having petsow and amoxi 250 printed on the capsule shell.

 

PHARMACOLOGY

Amoxycillin is stable in acid and it is rapidly and almost completely absorbed from G.l.T after oral administration.

Food in G.I.T does not interfere with its absorption; peak serum Amoxycillin conc. Of about 5µg/ml are produced two hours after the ingestion of 250mg of Amoxycillin. About 20% of Amoxycillln is protein bound and the rest is available as free drug in the serum; Amoxycillln is mainly excreted in urine in an active form, about 60% of the dose being excreted in 6 hours, after its oral administration. Amoxycillin is bactericidal. It is highly effective against gram positive organisms including streptococci, pneumococci and penicillin sensitive staphylococci it is also active against gram negative organisms such as; Haemophilus, influenzae, Eschericie coli, Neisseria gonorrhea, Neisseria meningitis, proteus mirabilis, shigella sonnei, and salmonella species.

 

INDICATIONS

Acute and chronic bronchitis, pneumonia, bronchopneumonia, lung abscess, tonsillitis, sinusitis, laryngitis, otitis media, pharyngitis, urethritis, cystitis, nephritis, typhoid fever, bacillary dysentery: boils, carbuncle infected wound, impetigo, gonococcal infections, pre and post-operative control of infections; endocarditis, and osteomyelitis.

 

DOSAGE

The usual oral dose is amoxycillin 250mg to 500mg every 8 hours.

Children up to 10 years of age may be given 125 to 250mg every 8 hours; under 20kg body weight, a dose of 20 to 40mg per kg daily has been suggested. For the treatment of Gonorrhea, 6 dose of 3gm is recommended.

 

SIDE EFFECTS

Skin rashes are among the most common side-effects and are generally either urticarial or maculopapular.

Gastro-intestinal adverse effects such as diarrhoea, nausea and vomiting usually occur following the administration by mouth. Pseudomembranous colitis has also been reported.

 

CONTRA-INDICATIONS

Amoxycillin is contra-indicated in patients with a history of allergic reaction to Penicillins. Amoxycillin should be discontinued if skin rashes occur. It should preferably not be given to patients with infections mononucleosis since they are especially susceptible to amoxycillin induced skin rashes. Patients with lymphatic leukaemia or HIV infection may also be at increased risk of developing skin rashes.

 

PRECAUTIONS

As with any potent drug, haemopoietic, hepatic and renal function must be assessed periodically whenever treatment is given over a prolonged period. It should be used with caution in patients with known histories of allergy.

 

USAGE IN PREGNANCY

Safety during pregnancy not established.

 

STORAGE

Store in a cool, dry place at a temperature below 30°C.

 

MANUFACTURED BY

PETSOW LABORATORIES LTD

PLOT 101, EZIAMA INDUSTRIAL ESTATE

EZIAMA ABA ABIA STATE.

Haformox Amoxicillin Antibacterial Capsules

HAFORMOX
AMOXICILLIN CAPSULES
500 mg CAPSULE

ANTIBACTERIAL FORMULATION

Each capsule contains Amoxicillin (as tribydrate) 500 mg

 

PHARMACOKINETICS

Amoxicillin, a penicillinase-susceptible semi-synthetic penicillin, is a close chemical and pharmacological relative of Ampicillin. The drug is stable in acid and is designed for oral use. It is more rapidly absorbed from the gastrointestinal tract. Peak concentrations of Amoxicillin in plasma are two to two and one-half times greater for Amoxicillin than for Ampicillin after oral administration of the same dose; they are reached at two hours and average about 5 µg/mL when 250 mg is administered. Food does not interfere with absorption. About 20% of Amoxicillin are protein-bound in plasma. Most of the dose of the antibiotic is excreted in an active form in the urine.

Probenecid delays excretion of the drug.

 

INDICATIONS

Amoxicillin is used in a variety of susceptible Gram-positive and Gram-negative infections. These include actinomycosis, biliary tract infections, bone and joint infections, bronchitis, endocarditis, gastro-enteritis (including E. coli enteritis and salmonella enteritis, but not shigellosis), gonorrhea, mouth infections, otitis media, pneumonia, spleen disorders, typhoid and paratyphoid fever, and urinary tract infections. Amoxicillin is also used in the treatment of Lyme disease.

 

DOSAGE AND ADMINISTRATION

Amoxicillin is given by mouth as the trihydrate and by injection as the sodium salt. The usual oral dose is 500 mg every 8 hours or as prescribed by the physician.

Children up to 10 years of age may be given 125 to 250 mg every 8 hours, under 20 kg body-weight of a dose of 20 to 40 mg per kg daily has been suggested. Higher oral doses of Amoxicillin, either as a single dose or in short courses are used in some conditions. For uncomplicated gonorrhoea in areas where gonococci have maintained sensitivity, Amoxicillin is given as a single dose of 3 g with Probenecid 1 g. A dose of 3 g repeated once after 8 or 10 to 12 hours may be used for dental abscesses or uncomplicated acute urinary tract infections respectively. For the prophylaxis of endocarditis in susceptible patients, Amoxicillin 3 g is given about 1 hour before procedures such as dental extractions. A high dose regimen of Amoxicillin 3 g twice daily may be used in patients with severe or recurrent infections of the respiratory tract. Children aged 3 to 10 years with otitis media may be given 750 mg twice daily for 2 days.

 

PRECAUTIONS

Amoxicillin should be used with caution in patients with known history of allergy or asthma. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported to patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Safety during pregnancy has not been established. Dose should be reduced in severe renal failure.

It crosses the placenta, small amounts are distributed into breast milk. Little Amoxicillin passes into cerebro-spinal fluid unless the meninges are inflamed.

 

ADVERSE EFFECT

The most common adverse effects are hypersensitivity reactions, especially skin rashes. Anaphylaxis occasionally occurs and has sometimes been fatal. Patients with impaired renal function are also at increased risk. Hepatitis and cholestatic jaundice have been reported rarely, Pseudomembranous colitis has been associated with the use of amoxicillin. Erythema multiforme, including the Steven-Johnson syndrome has also been attributed occasionally to amoxicillin with clavulanic acid.

 

CONTRAINDICATION

Amoxicillin should not be given to patients with infectious mononucleosis since they are especially susceptible to amoxicillin-induced skin rashes; patients with lymphatic Ieukemia or possibly HIV infection may also be at increased risk of developing skin rashes.

 

CAUTION: FOODS, DRUGS, DEVICES AND COSMETICS ACT prohibits dispensing without prescription.

 

AVAILABILITY

Alu-Clear PVC blister pack of 10’s (box of 100’s)

 

STORAGE

Store at temperatures not exceeding 30oC.

 

Distributed by

Chez Resources Pharm. Ltd.

 

Manufactured by

HARBIN PHARMACEUTICAL GROUP CO., LTD.

GENERAL PHARM. FACTORY

No. 109 Xuefu Road, Nangang District, Harbin, People’s Republic of China.