The Glory Medicina
Full Prescribing Info
Ampicillin trihydrate.
Each 500 mg capsule contains ampicillin 500 mg as Ampicillin Trihydrate BP.
Excipients/Inactive Ingredients: Magnesium stearate, gelatin, black and red iron oxides (E172), titanium dioxide (E171) and erythrosine (E127).
Pharmacology: Pharmacodynamics: Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.
Pharmacokinetics: Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.
Reichlin 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.
Dosage/Direction for Use
Usual adult dosage (including elderly patients): Ear, nose and throat infections: 250 mg four times a day.
Bronchitis: Routine therapy: 250 mg 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 fever: Acute: 1-2 g four times a day for two 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 should be given by injection. Oral doses of Reichlin should be taken half to one hour before meals.
Renal Impairment: In the presence of severe renal impairment (creatinine clearance <10 ml/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.
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.
Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.
Special Precautions
Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.
Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Effects on ability to drive and use machines: Adverse effects on the ability to drive or operate machinery have not been observed.
Use In Pregnancy & Lactation
Pregnancy: Animal studies with ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin may be considered appropriate.
Lactation: During lactation, trace quantities of penicillins can be detected in breast milk.
Adequate human and animal data on use of ampicillin during lactation are not available.
Adverse Reactions
Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be discontinued. Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
As with other antibiotics, anaphylaxis has been reported rarely.
Renal effects: Interstitial nephritis can occur rarely.
Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea.
Pseudomembraneous colitis and haemorhagic colitis have been reported rarely.
Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.
Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.
Drug Interactions
Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.
In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.
Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.
Caution For Usage
Incompatibilities: None.
Store below 25°C.
MIMS Class
ATC Classification
J01CA01 - ampicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Cap 500 mg (black and red) x 10 x 10's.
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