PENBRITIN Capsules (2015)
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Περιεχόμενα
Name of the medicinal product
Penbritin 250mg Capsules.
Ampicillin 250mg Capsules.
Qualitative and quantitative composition
Ampicillin Capsules:
250mg ampicillin as Ampicillin Trihydrate.
Pharmaceutical form
Black and red capsules overprinted Penbritin 250.
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 t...
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 ...
Contraindications
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 warnings and precautions for use
Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Serious and occasionally fatal hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
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 pa...
Pregnancy and 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 clin...
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Undesirable effects
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 ...
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.
Pharmacodynamic properties
Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.
Pharmacokinetic properties
Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.
Preclinical safety data
No further information of relevance to add.
List of excipients
Magnesium stearate
Gelatin
Black and red iron oxides (E172)
Titanium dioxide (E171)
Erythrosine (E127)
Incompatibilities
None.
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
Alumini...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Chemidex Pharma Ltd, T/A Essential Generics or Chemidex Pharma, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom
Marketing authorization number(s)
PL 17736/0071
Date of first authorization / renewal of the authorization
4
th
March 2005
Date of revision of the text
21/10/2015
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