Saturday, September 14, 2013

Bacticlor (rest of pamphlet)

Hepatic impairment
As cefaclor is not metabolised in the liver, no change in dosage is necessary in patients with hepatic impairment.
Method of preparation of oral suspension
Shake the bottle to loose the powder, add appropriate amount of water (40 mL) in two portions. Invert the bottle and shake it well after each addition. When constituted as specified, the forming suspension is red with a sweet taste and strawberry like flavour, the 5 mL of the resulting suspension cOntains 125 mg or 250 mg of cefaclor activity as the monohydrate. Shake well before using. Keep bottle tightly closed and after mixing store it in a refrigerator. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.
Bacticlor (cefaclor) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
General 1. Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
2. Bacticlor should be given cautiously to penicillin-sensitive patients. There is evidence of partial crossallerginicity between cephalosporins and penicillins. If an allergic reaction occurs during therapy, the drug should be discontinued and the patient should be treated with appropriate medicine such as e.g. antihistamines, corticosteroids, and adrenaline.
Usage in Pregnancy, Labor and Delivery: Reproduction studies using cefaclor have been performed in mice, rats at doses up to -5 times the maximum human dose (1500mg/day) based on mg/m2. These studies have revealed no harm to the fetus due to cefaclor. There are, however, rio adequate and well-controlled studies in pregnant women. Cefaclor should be used during pregnancy only if clearly needed.
The drug has not been studied for use during labor and delivery. Treatment should be given only if clearly needed. Nursing Mothers: Small amounts of cefaclor (</ 0.12 MgImL) have been detected in human milk. Caution should be exercised when the drug is administered to a nursing woman.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential for cefaclor. Reproduction studies have revealed no evidence of impaired fertility.
Drug Interactions: The extent of absorption of Bacticlor is diminished when given within 1 hour with aluminium or magnesium hydroxide-containing antacids. 1-12 blockers do not alter either the rate or the extent of absorption of Bacticlor. The renal excretion of cefaclor is inhibited by probenicid.
Laboratory test interactions: Cephalosporin antibiotics may result in false-positive reaction for glucose in the urine when the test is performed using Benedict’s and Fettling’s solutions and also with Clinitest tablets but not with enzyme-based tests.
Pediatric and Geriatric use: Bacticlor suspension is not recommended for infants less than 1 month. No dosage adjustment is required for geriatric patients with normal renal functions.
The majority of adverse reactions obsercied in clinical trials of Bacticlor were mild and transient. The most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain, and hypersensitivity reactions such as rash and urticaria. Other reported adverse reactions were: slight elevations of SGOT, SGPT, serum creatinine, prolonged prothrombin time, genital pruritis and vaginal moniliasis. Dizziness, somnolence, insomnia have been reported rarely.
The following adverse reactions known to be associated with cephalosporin antibiotics were not observed in clinical trials but rare occurrences have been reported as serum-like sickness and pseudomembranous colitis.
The treatment of ovedosage includes: activated charcoal to decrease the absorption of the drug from the gastrointestinal tract, protection of patient’s airways, support ventilation and perfusion. Monitoring blood gases and serum electrolytes. Although cefaclor is considered dialysable, neither forced diuresis, peritoneal dialysis, hemodialysis, nor charcoal hemoperfusion have been demonstrated to be beneficial in an overdose of cefaclor.
Store below 25 °C, protected from moisture.
Bacticlor capsules 500 mg
Box containing 50 strips of 6 capsules each.
Bacticlor oral suspension
Bottle of 60 mL
125 mg/5mL after reconstitution
250 mg/5 mL after reconstitution
Manufactured by:
Pharco B International under license from Ranbaxy —UK