Ampicillin Capsules 250mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Britcin Capsules 250 mg Ampicillin Capsules 250 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampicillin (Equivalent Ampicillin Trihydrate 289 mg) BP 250.00 mg
3 PHARMACEUTICAL FORM
Hard two-piece two-tone Gelatin Capsule
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of respiratory tract, urinary tract, skin and soft tissue, systemic, gastrointestinal and other infections due to sensitive gram-positive and gram-negative bacteria, including penicillin sensitive staphylococci, streptococci, gonococci, clostridia, Haemophilus influenzae, Brucella species, Escherichia coli, Proteus mirabilis, salmonellae and shigellae.
4.2 Posology and method of administration
Doses should be taken before meals.
Adults:
Respiratory tract infections, skin and soft tissue infections, otitis media: 250 mg six hourly.
Bronchitis: 250 mg six hourly.
Chronic bronchitis, pneumonis: 500 mg six hourly.
Urinary tract infections: 500 mg eight hourly.
Enteric fever acute: 1-2 g six hourly for 14 days.
Enteric fever carriers: 1-2 g six hourly for 4-12 weeks.
Gastro intestinal infections: 500-750 mg six to eight hourly.
Gonorrhoea, males: 2 g single dose with 1 g Probenecid.
Gonorrhoea, females: 2 g with 1 g Probenecid repeated as necessary.
Children:
Normally, capsules would not be administered to children, but where this may be necessary or desirable, the normal dosage schedule would be:
2 - 10 years: Half the adult dose.
The dose should be reduced in renal impairment.
The Elderly:
As Adult dose.
Route of Administration: Oral
4.3 Contraindications
Ampicillin must not be administered to patients with known Penicillin hypersensitivity.
4.4 Special warnings and precautions for use
History of allergy. Serious and occasionally fatal hypersensitivity reactions including anaphylaxis have been reported following treatment with beta-lactam antibiotics. Macropapular rashes commonly occur with ampicillin but are not usually related to true penicillin allergy. They almost always occur in patients with glandular fever; ampicillin should not therefore be used for the ‘blind’ treatment of a sore throat. Rashes are also common in patients with acute or chronic lymphocytic leukemia or in cytomegalovirus infection.
The dosage should be reduced in patients with renal impairment.
4.5 Interaction with other medicinal products and other forms of interaction
Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.
Ampicillin may reduce the effect of combined oral contraceptives only, but the risk is small.
Concommitamt use of allopurinol may increase the risk of allergic rash.
Excretion of penicillins is reduced by probenecid. Excretion of methotrexate is reduced by penicillins thereby increasing the risk of methotrexate toxicity.
It is recommended that when testing the presence of glucose in the urine during ampicillin treatment , enzymatic glucose oxidase method should be used, because die high concentration of ampicillin in the urine, false positive readings are common with chemical methods.
4.6
Pregnancy and lactation
Animal studies with ampicillin have shown no teratogenic effects. Ampicillin has been in extensive clinical use and suitability in human pregnancy has been well documented in clinical studies. Breast feeding is not contraindicated with ampicillin.
Trace amounts of penicillin are found in breast milk. While adverse effects are apparently rare, three potential problems exist for the nursing infant:
• Modification of bowel flora
• Direct effects on the infant such as allergy/sensitisation
• Interference with interpretation of culture results when pyrexia of unknown origin occurs
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Ampicillin is inactivated by penicillinase and should therefore not be used to treat infections which have survived treatment with Penicillin.
Gastro-intestinal symptoms include nausea, vomiting and diarhhoea, when they occur usually resolve rapidly when treatment is stopped. If they persist they may indicate overgrowth of resistant organisms, requiring specific treatment. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.
A rash may be observed which is either urticarial or erythematous. The former is indicative of true Penicillin sensitivity while the latter is generally specific to Ampicillin. The incidence of an erythematous rash is high in patients with infectious mononucleosis and chronic lymphatic leukaemia. Pruritis and purpura have also been reported. Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have also been reported on rare occasions. Rarely, anaphylaxis has occurred. Treatment should be discontinued if any hypersensitivity reaction occurs.
Interstitial nephritis, antibiotic-associated colitis, hepatitis and cholestatic jaundice have been reported following treatment with ampicillin. A moderate rise of transaminase has been reported.
Transient haemolytic anaemia, transient leucopenia, transient thrombocytopenia, haemolytic anaemia and coagulation disorders have been reported rarely.
4.9 Overdose
No known symptoms
5 PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Ampicillin is bactericidal and has a similar mode of action to that of benzylpenicillin. It is effective against gram-positive organisms including streptococcus faecalis. Str. Pneumonia, and haemolytic streptococci but, apart perhaps from Str. Faecalis, it is less potent than benzylpenicillin. Listeria monocytogenes is also highly sensitive. Its action is similar to that of the tetracyclines and chloramphenicol against Gramnegative organisms particularly Haemophilus influenzae, salmonellae, and most strains of Escherichia coli; highly resistant strains of H. influenzae have been reported. Neisseria gonorrhoea, N. meningitidis, Bordetella pertussis, Proteus mirabillis, and Brucella spp. are also sensitive. Ampicillin is effective against some shigellae but strains can acquire resistance rapidly.
Minimum inhibitory concentrations for Gram-positive organisms have been reported to range from 0.02 to 5 ug per ml for Gram-negative organisms from 0.02 to 8 ug per ml. It is inactive against most strains of Pseudomonas aeruginosa.
It has been reported that Ampicillin inhibits side-wall synthesis in susceptible bacteria. Ampicillin is inactivated by penicillinase and complete cross resistance has been reported between Amoxycillin and Ampicillin.
5.2 Pharmacokinetic properties
Ampicillin Trihydrate is rapidly absorbed when given orally. It is widely distributed and is reported to produce peak anti-biotic plasma concentrations that are up to twice as high as those from the same dose of ampicillin. Peak plasma Ampicillin concentrations of about 5 nonagrams per ml have been observed two hours after a dose of 250 mg with detectable amounts present for up to eight hours. Doubling the dose can produce double the concentration.
The presence of food in the stomach does not appear to diminish absorption significantly.
Up to 20% is bound to plasma proteins in the circulation and plasma half-lives of about one hour have been reported. Ampicillin diffuses across the placenta; little appears to be excreted in breast milk. It penetrates well into purulent and mucoid sputum and low concentrations have been found in ocular fluid. Concentrations of the anti-biotic have been detected in the CSF of patients with inflamed mengines when given Ampicillin intra-venously.
About 60% of an oral dose of Ampicillin is excreted unchanged in the urine in 6 hours by glomerular filtration and tubular secretion. Urinary concentrations range from about 0.3 - 1.3 mg per ml after a dose of 250 mg. Up to 75% of a parental dose has been reported to be excreted unchanged in the urine within six hours. High concentrations have been reported in bile.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Magnesium Stearate Gelatin
Iron Oxide Red E172 Iron Oxide black E172 Erythrosine E127 Titanium Dioxide E171
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in a dry place below 25°C.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts.
Pack sizes: 100, 500
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/10/2009
10 DATE OF REVISION OF THE TEXT
26/02/2009