Ampicillin Trihydrate BP

FICILLIN

Presentation

FICILLIN Capsules: Scarlet and black capsules imprinted with company logo and ‘FICILLIN 250 mg’; each capsule contains ampicillin trihydrate BP equivalent to 250 mg ampicillin. FICILLIN Syrup: Bottles containing powder for preparation of 100 ml of creamy white, raspberry flavoured syrup; when reconstituted each 5 ml contains ampicillin trihydrate BP equivalent to 125 mg ampicillin. FICILLIN Paediatric Drops: Bottles containing powder for preparation of 15 ml of creamy white raspberry flavoured drops; when reconstituted each 1.25 ml contains ampicillin trihydrate BP equivalent to 125 mg ampicillin. A dropper to measure the 1.25 ml dose is provided.FICILLIN 250 mg Injection: Powder in vials containing ampicillin sodium BP equivalent to 250 mg ampicillin.FICILLIN 500 mg Injection: Powder in vials containing ampicillin sodium BP equivalent to 500 mg ampicillin.

Uses

FICILLIN is a broad spectrum semi-synthetic antibiotic indicated for the treatment of infections due to susceptible Gram positive organisms including streptococci, penicillin sensifive taphylocooci and enterococci and susceptible strains of Gram- negative bacteria including Haemophilus influenza, Esoherichia coli, Proteus mirabilis, Neisseria gonomhoeae, N Meningitidis, Shigellae, Salmonella typhi and other Salmonellae Typical indications include: Ear, nose and throatInfections; Bronchitis; Pneumonia; Urinary tract Infections; Gonorrhoea, Obstetric and gynaecological infections; Septicaemia; Peritonitis; Meningitis; Enteric fever; Gastro-intestinal infections; and Biliary tract infections.

Dosage and administration

Usual adult dosage (oral except where stated): Ear, nose and throat infections: 250 mg four times daily. Bronchitis: Routine therapy: 250 to 500 mg four times daily. High dosage therapy: 1 g four times daily. Pneumonia: 500 mg four times daily. Urinary tract infections: 500 to 750 mg three times daily. Gonorrhoea: 3.5 g orally with 1 g probenecid as a single dose. Repeated doses are recommended for the treatment of females. Gastro-intestinal infections: 500 to 750 mg three to four times daily. Enteric fever: Acute: 1 to 2 g four times daily for two weeks. Carrier: 1 to 2 g four times daily for four to twelve weeks Septicaemia, endocarditis, osteomyelitis: 500 mg four to six times daily lM or IV for one to six weeks. Peritonitis, intra-abdominal sepsis: 500 mg four times daily IM or IV. Meningitis: Adult dosage: 2 g six hourly IV for two days; 500 mg to 1 g six hourly lM from third day onwards. Children’s dosage for meningitis :150 mg/kg body weight daily iv for two days in divided doses;100 mg/kg body weight daily in divided doses from third day onwards. Usual children’s dosage (oral except where stated): 2 to 10 years: 112 adult dose. Under 2 years: ¼ adult dose. in severe infections dosages may be increased, or FICILLIN be given by injection. oral doses of FicILLIN should be taken half to one hour before or three hours after a meal. Administration: intramuscular: 250 mg or 500 mg dissolved in 1.5 ml Water for Injection BP. Ntravenous: 250 mg or 500 mg dissolved in 5-10 ml Water for injection BP given by slow injection( three to four minutes). FICILLIN may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Intraperitoneal: At least 500 mg per 5-10 mlWater for Injection BP daily. Intrapleural:500 mg daily in 5-10 ml Water for injection BP. Intra articular: 500 mg daily, dissolved in up to 5 ml Water for Injection BP or 0.5% procaine hydrochloride solution. Local use in surgery: 1 g sterile powder sprinkled into the wound extra-peritoneally or into muscle layers to prevent wound infection post-operatively.

Contra-indications, warnings, etc.

Contra-indications: Contra-indicated in patients known to be hypersensitive to penicillin and it should be used with caution in patients with known histories of allergy. It should preferably not be used in patients with infectious mononucleosis. Precautions: In renal impairment the excretion of antibiotic will be delayed and depending on the degree of mpairment it may be necessary to reduce the total daily dosage. Side-effects: Side-effects are rare and usually of a mild, transitory nature. Skin rashes, either urticarial or erythematous have been observed; the urticarial reactions are typical of penicillin hypersensitivity while the erythematous rashes are specific to ampicillin. Most patients with infectious mononucleosis develop a skin rash. It is advisable to discontinue treatment when a rash is reported. Diarrhoea, nausea, and vomiting have occasionally Occurred.

Pharmaceutical precautions

FICILLIN Syrup and Drops should be freshly prepared, stored in a cool place, preferably in a refrigerator. Reconstituted syrup and drops should be used within 5 days if kept at room temperature, or within 7 days if kept in a refrigerator. FlClLLIN solution for injection should be used immediately after preparation. FICILLIN may be added to most intravenous fluids but should not be mixed with blood products or other proteinaceous fluids (e.g., protein hydrolysates). In intravenous solutions containing dextrose or other carbohydrates, FICILLIN injection should be infused within one hour of preparation. Storage: All the dosage forms of FICILLIN should be stored in airtight containers and kept in a cool dry place. FICILLIN injection vials should be stored at a temperature not exceeding 25°C.

Package quantities

FICILLIN Capsules: Cartons of 100 capsules in strip. FICILLIN Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. FICILLIN Paediatric Drops: Bottles containing powder to produce 15 ml of drops when reconstituted. FICILLIN 250 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution. FICILLIN 500 mg Injection: Cartons of 10 combipacks. Each comipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref: FISONS (BANGLADESH) LIMITED