CYCLOSERINE Capsules (2018)
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Περιεχόμενα
Name of the medicinal product
CYCLOSERINE.
Qualitative and quantitative composition
Each capsule contains as active ingredient 250 mg of cycloserine.
Pharmaceutical form
Capsule, hard.
Therapeutic indications
Actions Cycloserine inhibits cell wall synthesis in susceptible strains of Gram-positive and Gram-negative bacteria and in Mycobacterium tuberculosis. Indications Cycloserine is indicated in the treatment ...
Posology and method of administration
Posology Adults The usual dosage is 500 mg to 1 g daily in divided doses, monitored by blood level determinations. The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cycloserine is contra-indicated in the presence of any of the following: epilepsy; depression, severe anxiety ...
Special warnings and precautions for use
Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of central nervous system toxicity such as convulsions, psychosis, somnolence, ...
Interaction with other medicinal products and other forms of interaction
Drug interactions Concurrent administration of ethionamide has been reported to potentiate neurotoxic side-effects. Alcohol and cycloserine are incompatible, especially during a regimen calling for large ...
Pregnancy and lactation
Pregnancy Concentrations in fetal blood approach those found in the serum. A study in 2 generations of rats given doses up to 100 mg/kg/day demonstrated no teratogenic effect in offspring. It is not known ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Most side-effects occurring during treatment with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. The following side-effects have been observed: nervous system manifestations, ...
Overdose
Signs and symptoms Acute toxicity can occur if more than 1 g is ingested by an adult. Chronic toxicity is dose related and can occur if more than 500 mg is administered daily. For patients with renal impairment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycobacterials ATC code: J04AB01 Actions Cycloserine inhibits cell wall synthesis (by competing with D-alanine for incorporation into the cell wall) in susceptible strains ...
Pharmacokinetic properties
Cycloserine is rapidly and almost completely absorbed from the GI tract after oral administration. Following the administration of a 250 mg dose plasma levels are detectable within an hour and peak plasma ...
Preclinical safety data
A study in two generations of rats given doses up to 100 mg/kg/day demonstrated no teratogenic effect in offspring.
List of excipients
Talc Erythrosin E127 Carmoisine E122 Yellow FCF E110 Titanium dioxide E171 Black iron oxide E172 Gelatin
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
Cycloserine capsules are red and grey. HDPE bottles of 100 capsules fitted with a child resistant, HDPE/polypropylene cap with an induction heat sealed liner. 1 desiccant disc (HDPE canister containing ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland
Marketing authorization number(s)
PL 14385/0005
Date of first authorization / renewal of the authorization
Date of first authorisation: October 1996 Date of latest renewal: 31 May 2007
Date of revision of the text
07/02/2018
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