PENBRITIN Capsules Ref.[6182] Active ingredients: Ampicillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Chemidex Pharma Ltd, T/A Essential Generics or Chemidex Pharma, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Therapeutic indications

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Parenteral usage is indicated where oral dosage is inappropriate.

Posology and method of administration

Usual adult dosage (including elderly patients)

Ear, nose and throat infections: 250mg four times a day.

Bronchitis:

Routine therapy: 250mg four times a day.

High-dosage therapy: 1 g four times a day.

Pneumonia: 500 mg four times a day.

Urinary tract infections: 500 mg three times a day.

Gonorrhoea: 2 g orally with 1 g probenecid as a single dose. Repeated doses are recommended for the treatment of females.

Gastro-intestinal infections: 500-750 mg three to four times daily.

Enteric:

Acute: 1-2 g four times a day for two weeks.

Carriers: 1-2 g four times a day for four to twelve weeks.

Usual children’s dosage (under 10 years)

Half adult routine dosage.

All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Ampicillin may be removed from the circulation by haemodialysis.

Shelf life

Shelf life

Blister packs: five years.

Others: three years.

Special precautions for storage

Containers: Do not store above 25°C. Keep the container tightly closed.

Blisters: Do not store above 25°C. Store in the original package.

Nature and contents of container

Aluminium canister.

Glass bottle fitted with a screw cap.

Polypropylene tube with a polyethylene closure.

Aluminium foil pack – 4, 16, 50, 100, 500

Aluminium/PVC tray foil blister pack – 28

Aluminium/PVC/PVdC blister pack – 28

Special precautions for disposal and other handling

None.

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