Name of Medicinal Product
Ampicillin 250mg Capsules BP
Pharmaceutical form – Strength and Pack size
Pharmaceutical form: CAPSULES
Description: White to off white powder filled in ‘2’ size hard gelatin capsule having cylindrical opaque maroon colour cap & cylindrical yellow colour body.
Strength: Ampicillin Trihydrate BP equivalent to Ampicillin …. 250mg, per Capsule
Pack Size: 10 x 10’s
Therapeutic Category
Penicillin Anti-Bacterial
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.
- It is used to kill bacteria that cause infections.
These infections include:
- Respiratory tract infections (e.g. infections of the nose and throat, pneumonia, bronchitis)
- Infections of the ear
- Urinary tract infections (e.g. infections of the bladder and urethra)
- Gastro- intestinal infections (e.g. infections of the intestines)
- Enteric/Typhoid fever (an infectious disease contracted by eating food or drinking water contaminated with Salmonella)
- Gynaecological infections and Gonorrhoea (a sexually transmitted disease)
- Infections of the blood (Septicaemia)
- Skin and soft tissue (e.g. Acne)
- To prevent endocarditis (inflammation of the lining of the heart and its valves) after surgery or a dental procedure
- Peritonitis (an inflammation of the peritoneum, the thin tissue that lines the inner wall of the abdomen)
- Meningitis (inflammation of the protective membranes covering the brain and spinal cord).
Contra-indications
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).
Precautions / Warnings
- 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.
- Dosage should be adjusted in patients with renal impairment.
- Talk to doctor before taking medicine if patient:
- Suffer from kidney problems as you may require a lower dose than normal
- Suffering from glandular fever or cytomegalovirus (CMV) infection
- Suffering from lymphatic leukaemia.
Pregnancy and Lactation
Pregnancy:
Ampicillin have shown no teratogenic effects in pregnancy. The product has been in extensive 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 data on use of ampicillin during lactation are not available.
Side effects / 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, 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 haemorrhagic colitis has 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 time have also been reported rarely.
Common side effects:
- Diarrhoea, Nausea and vomiting (feeling and being sick).
Very rare side effects:
- Temporary blood disorders that could cause more infections such as fever, severe chills, sore throat, mouth ulcers or bruising more easily.
- It can also cause anaemia, this can make your skin pale, cause weakness, breathlessness and tiredness.
Drug Interactions
In common with other oral broad-spectrum antibiotics, ampicillin
- Uricosurics: excretion of penicillin is decreased, giving an increased risk of toxicity e.g. probenecid and sulfinpyrazone.
- Concurrent administration of allopurinol during treatment with ampicillin increases the likelihood of ampicillin induced skin reactions.
- Anti-coagulants: INR can be altered by the administration of ampicillin while on warfarin and phenindione.
- Vaccines: The efficacy of oral typhoid vaccine may be reduced when ampicillin is coadministered
- Cytotoxics: the excretion of methotrexate is reduced.
- Chloroquine: absorption of ampicillin is reduced when taken concomitantly with chloroquine.
- There may be interaction between other bacteriostatic antibacterial such as erythromycin, chloramphenicol and tetracycline may interfere with the bactericidal action of ampicillin.
- Ampicillin may interfere with some diagnostic tests e.g. tests for urinary glucose using copper sulphate and some tests for urinary or serum proteins. 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.
Dosage & Administration
For oral administration.
The recommended doses of Ampicillin in specific diseases are as follows.
Usual Adult Dosage
Ear, nose and throat infections: 250 mg four times a day
Bronchitis: Routine therapy: 250 mg four times daily.
High dose therapy: 1 g four times daily
Pneumonia: 500 mg four times daily
Urinary tract infections: 500 mg three times daily
Gastro-intestinal infections: 500 - 750 mg three to four times daily
Enteric fevers: Acute: 1-2 g four times daily for two weeks
Carriers: 1-2 g four times daily for four to 12 weeks
Gonorrhoea: 2 g orally with 1 g probenecid as a single dose.
Repeated doses are recommended for the treatment of females.
Usual Dosage for the Elderly:
- As for adults; reduced doses may be required in those with impaired renal function.
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 at the direction of the physician. Ampicillin should be given a half to one hour before meals.
- Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Renal impairment: In severe renal impairment (i.e., creatinine clearance <10 mL/min) reduction in dose or extension of the dose interval should be considered. In patients undergoing dialysis, an additional dose should be administered after dialysis.
Over dosage
- 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.
Effects on ability to drive and use machines
Ampicillin has no or negligible influence on the ability to drive and use machines.
Shelf life
24 months from the date of manufacturing
Special precautions for storage
Store in a cool and dry place. Protect from light, heat and moisture.