Amoxycillin Trihydrate BP

FIMOXYL

Presentation

FIMOXYL Capsules: Orange and black capsules imprinted with company logo and ‘FlMOXYL 250 mg’; each capsule contains amoxycillin trihydrate BP equivalent to 250 mg amoxycillin. FIMOXYL Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, banana flavoured syrup; when reconstituted each 5 ml contains amoxycillin trihydrate BP equivalent to 125 mg amoxycillin. FIMOXYL Paediatric Drops: Bottles containing powder for preparation of 15 ml of yellow coloured banana flavoured drops; when reconstituted each 1.25 ml contains amoxycillin trihydrate BP equivalent to 125 mg amoxicillin. A dropper to measure the 1.25 ml dose is provided. FIMOXYL 250 mg Injection: Powder in vials containing amoxycillin sodium BP equivalent to 250 mg amoxicillin. FIMOXYL 500 mg injection: Powder in vials containing amoxycillin sodium BP equivalent to 500 mg amoxycillin.

Uses

FlMOXYL is a broad spectrum antibiotic used to treat a wide range of infections caused by susceptible Gram-positive and Gram-negative organisms. It is indicated for the treatment of the following bacterial infections: Respiratory tract, ENT infections: Acute and chronic bronchitis, pneumonia, otitis media, sinusitis, tonsillitis, pharyngitis, and laryngitis. Urinary tract infections: Pyelonephritis, cystitis, and Urethritis. Obstetric and gynaecological infections: Bacteriuria in pregnancy, septic abortion, intra-abdominal sepsis. and puerperal sepsis Gastro intestinal infections: Typhoid and paratyphoid. Skin and soft tissue infections: Cellulitis, infected wounds and abscesses. Generalised infections: Septicaemia, bacterial endocarditis, meningitis, peritonitis and osteomyelitis. Venereal infections: Gonorrhoea and syphilis FIMOXYL may also be used as prophylactic cover for patients at risk of developing endocarditis when undergoing surgery.

Dosage and administration

Usual adult dosage:

Oral: 250 mg three times daily increasing to 500 mg three times daily for more severe infections. Injectables: 250- 500 mg lM every 8 hourly (or more frequently, if found necessary by the physician) for moderate infections. 500 mg-1g IV every 6 hourly for severe infections.Usual children’s dosage Oral 2 to 10 years: Half of the adult dose. Under two years: 1/4th of the adult dose. lnjectables (upto 10 years): 50-100 mg/kg body weight IM or IV (depending on the severity) in three to four equal divided doses. Specific dosage recommendation: Typhoid and Paratyphoid Adult: 4 g daily in divided doses for 14-21 days. Children: 100 mg/ kg/ day in divided doses for 14-21 days. Typhoid Carrier States: 3 to 4 g in divided doses for a minimum of one month. Syphilis: 250 mg every 6 hours for 1 month to 5 months according to the stage of the disease and serological response. Simple Acute Urinary Tract Infection: Short course therapy: Two 3 g doses with 10-12 hours between the doses. Meningitis: Adults: 150 mg/kg/day IV in equally divided doses. Children: 100-150 mg/kg/day IV in equally divided doses. Gonorrhoea: A single 3 g dose. Dental abscess (as an adjunct to surgical management): Two 3 g doses with 8 hours between the doses. Severe or recurrent acute otitis media: 3 to 10 years: 750 mg twice a day for two days may be used as an alternative course of treatment. Prophylaxis of Endocarditis: Adults: 3 g orally 1 hour before and 6 hours after procedure or 1 g IM with induction of anaesthesia and 500 mg orally 6 hours later. Children: Half the adult dose. Patients with prosthetic heart valves or with a history of endocarditis will require gentamicin in addition. Administration: Oral: Using capsule, syrup or paediatric drops. Intramuscular: 250 mg: Add 1.5 ml Water for Injection BP and shake vigorously. 500 mg: Add 2.5 ml Water for Injection BP and shake vigorously. If pain is experienced on intramuscular injection, a sterile 1% solution of lignocaine hydrochloride or 0.5% solution of procaine hydrochloride may be used in place of Water for Injection. Intravenous: 250 mg: Dissolve in 5 ml Water for Injection BP. 500 mg: Dissolve in 5-10 ml Water for Injection BP FIMOXYL Injection, suitably diluted, may be injected directly into a vein or drip tube, taking 3 to 4 minutes. Intravenous Infusion: Solutions may be prepared as described for intravenous injections and then added to an intravenous solution and administered over a period of 30 to 60 minutes.

Note: A transient pink colouration or slight opalescence may appear during reconstitution.Reconstituted solutions are normally a pale straw Colour.

Contra-indications, warnings, etc.

Contra- indications: Amoxycillin is contra-indicated in penicillin hypersensitive patients. It should not be given to patients with infectious mononucleosis (glandular fever). Precautions: In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage. Side-effects: Side-effects are usually of a mild transitory nature, they may include diarrhoea, indigestion, or occasionally rash, either urticarial or erythematous. In either cases of rash, the treatment should be Discontinued.

Pharmaceutical precautions

FIMOXYL Syrup and Drops should be freshly prepared, stored in a cool dry 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. FIMOXYL solution for injection should be used immediately after preparation. FiMOXYL 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, FlMOXYL injection should be infused within one hour of preparation. Storage: All the dosage forms of FlMOXYL should be kept in a cool dry place. FIMOXYL injection vials should be stored at a temperature not exceeding 25°C.

Package quantities

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

Ref: FISONS (BANGLADESH) LIMITED