Ciplavasc 5 mg AND 10 mg Tablets

Cefotaxime is indicated for use primarily in the treatment of infections of the genito-urinary, gastro-intestinal and respiratory tracts, and in the skin and soft tissues and meningitis in children caused by susceptible strains of the following organism, Staphylococcal infections (including infections caused by both penicillinase producing and non-penicillinase producing strains): abscess, furunculosis, bronchitis and impetigo. Streptococcal infections: (both-hemolytic and group D streptococci), cellulitis, pneumonia, follicular tonsillitis, otitis media, pharyngitis, sinusitis, scarlet fever, septic sore throat, urinary tract infections (Enterococci) and meningitis in children. Pneumococcal infections: Lobar pneumonia, bronchitis, cellulites and otitis media. Haemophilus inflenzae infections: Otis media, laryngotracheobronchitis and meningitis in children. E. coli infections: Lobar pneumonia, urinary tract infections and meningitis in children. Shigella infections: Bacillary dysentery Salmonella infections: Enteritis Sensitive strains of Pseudomonas aeruginosa: Sepsis Gonococcus: Gonorrhoea Neisseria meningitis: Meningitis in children Bacteriological studies to determine the causative organism and their sensitivity to cefotaxime should be performed. Prophylactic uses: The administration of cefotaxime pre-operatively may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as potentially contaminated. The minimum effective dose has been found to be 1 g cefotaxime 30-90 minutes prior to surgery.

Cefotaxime is given as deep intramuscular injection or by slow intravenous injection over 3-5 minutes or by infusion over 20-60 minutes. Adults Dosage and route of administration be determined by susceptible organisms, severity of the infection, and the condition of the patient. The maximum daily dose should not exceed 12 grams. The usual dose is 2 g daily in 2 X 1 g injections. Severe cases may be given 3-4 daily in 2 to 4 administrations. In the treatment of gonorrhoea a single 1 g dose of cefotaxime is given. To prevent post-operative infection, the recommended dose is a single dose of 1 g IM or IV administered 30 to 90 minutes before surgery. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dose must be administered for at least 10 days. Neonates, Infants and Children Children and Infants 50 mg/kg/day in 2-4 divided doses. A maximum dose of 200 mg/kg/day in 2-4 divided doses may be given in exceptional cases. Neonates The following dosage schedule is recommended u2022 Up to 1 week of age 50 mg (base)/kg IV every 12 hourly. u2022 1-4 weeks of age 50 mg (base)/kg IV every 8 hourly Renal Failure It is suggested that the dosage of cefotaxime be halved in patients with creatinine clearance less than 20 ml/min. The dosage interval should be modified Method of Preparation Reconstitute the contents with sterile water for injection. Shake well until dissolved and then withdrawn the entire contents of the vial into the syringe and use immediately. The dilution table is given below: Vial size Volume of water for injection to be added IM IV* 500 mg 2 ml 10 ml 1 g 4 ml 10 ml *For direct intravenous use, the resulting solution should be administered over 3 to 5 minutes period. Intravenous infusion: Cefotaxime may be administered by intravenous infusion 1 to 2 g are dissolved in 40 to 100 ml of water for injection or in the infusion fluids (see u201cStabilityu201d). The prepared infusion should be administered over 20 to 60 minutes. Warning: Do not mix cefotaxime with another antibiotic in the same syringe or infusion. Stability: The stability of cefotaxime in a concentration of 1 g per 250 ml in the following infusions is satisfactory for 24 hours in a refrigerator or 12 hours at a temperature not exceeding 25u02daC: 0.9 % sodium chloride, 5 % dextrose, Ringeru2019s sterile solutions.

Cefotaxime is contraindicated in patients who are allergic to the cephalosporin group of antibiotics.

Before therapy with cefotaxime is instituted, careful enquiry should be made to determine whether the patient had previous hypersensitivity reactions to cefotaxime sodium, cephalosporins or penicillin. If an allergic reaction to cefotaxime occurs, discontinue treatment with the drug. Strict medical supervision is required throughout the treatment. Pseudomembranous colitis has been reported with the use of cephalosporins (and other broad-spectrum antibiotics) therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotics use.

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics. There is also some evidence for enhanced nephrotoxicity with a loop diuretic like furosemide. Concomitant administration of probenecid with cephalosporins decreases tubular secretion of cephalosporins resulting in their increased and prolonged serum concentration. There may be antagonism between cefotaxime and bacteriostatic antibacterial agents. Cefotaxime may interfere with the Jaffe method of measuring creatine concentrations and may produce falsely high values; this should be borne in mind when measuring renal functions.

Pregnancy: There are no well controlled studies pertaining to the use of cefotaxime in pregnant woman, although animal studies have not shown any teratogenic effect. Lactation: Cefotaxime is excreted in human milk in low concentrations. Caution should be exercised when cefotaxime is administered to a nursing woman.

Not specified in the provided text.

The most common adverse effects are hypersensitivity reactions including skin rashes, skin eruptions, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis. Acute interstitial nephritis is also a possibility as a manifestation of hypersensitivity. There may be a positive response to Coombsu2019 test although hemolytic anemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported with cefotaxime. Agranulocytosis has been associated rarely with some cephalosporins including cefotaxime. As in the case of some other cephalosporins, bleeding complications related to hypoprothrombinemia and/or platelet dysfunction may occur. Transient increase in liver enzyme values including transaminases and alkaline phosphatases have been reported. Gastrointestinal adverse effects such as nausea, vomiting and diarrhea have been reported rarely. Prolonged use may result in overgrowth of non-susceptible organism and, as with other broad-spectrum antibiotics, pseudomembranous colitis may develop. Deep phlebitis after IV injection has been reported occasionally.

See side effects. Treatment is symptomatic and supportive.