CALCORT Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Calcort 6mg Tablets.
Qualitative and quantitative composition
<u>Active substance:</u> Deflazacort 6mg. Excipient(s) with known effect: Lactose monohydrate 153mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Round, white, uncoated tablets, marked with a cross on one face and a 6 on the other face.
Therapeutic indications
A wide range of conditions may sometimes need treatment with glucocorticoids. The indications include: Anaphylaxis, asthma, severe hypersensitivity reactions Rheumatoid arthritis, juvenile chronic arthritis, ...
Posology and method of administration
Deflazacort is a glucocorticoid derived from prednisolone and 6mg of deflazacort has approximately the same anti-inflammatory potency as 5mg prednisolone or prednisone. Doses vary widely in different diseases ...
Contraindications
Systemic infection unless specific anti-infective therapy is employed. Hypersensitivity to the active substance, deflazacort or any of the excipients listed in section 6.1. Patients receiving live virus ...
Special warnings and precautions for use
A patient information leaflet should be supplied with this product. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should ...
Interaction with other medicinal products and other forms of interaction
The same precautions should be exercised as for other glucocorticoids. Deflazacort is metabolised in the liver. It is recommended to increase the maintenance dose of deflazacort if drugs which are liver ...
Fertility, pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, deflazacort does cross the placenta. Administration of corticosteroids to pregnant animals can cause ...
Effects on ability to drive and use machines
The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Vertigo is a possible undesirable effect after treatment with deflazacort. If affected, patients ...
Undesirable effects
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage; timing of administration and the duration ...
Overdose
It is unlikely that treatment is needed in cases of acute overdosage. The LD<sub>50</sub> for the oral dose is greater than 4000 mg/kg in laboratory animals.
Pharmacodynamic properties
Pharmacotherapeutic group: corticosteroids for systemic use; Glucocorticoids ATC code: H02AB13 Deflazacort is a glucocorticoid. Its anti-inflammatory and immunosuppressive effects are used in treating ...
Pharmacokinetic properties
Absorption Orally administered deflazacort appears to be well absorbed. Distribution The active metabolite D 21-OH achieves peak plasma concentrations in 1.5 to 2 hours. It is 40% protein-bound and has ...
Preclinical safety data
Safety studies have been carried out in the rat, dog, mouse and monkey. The findings are consistent with other glucocorticoids at comparable doses. Teratogenic effects demonstrated in rodents and rabbits ...
List of excipients
Microcrystalline cellulose Lactose monohydrate Maize starch Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Store below 25°C. Store in the original package.
Nature and contents of container
Deflazacort is packed in blister packs of polyvinylchloride and aluminium foil presented in cardboard cartons. Each pack contains 60 tablets.
Special precautions for disposal and other handling
No special requirements for disposal or handling are required.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0629
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 April 1994 Date of latest renewal: 30 March 2005
Date of revision of the text
2 January 2021
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