FLUDROCORTISONE ACETATE Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Fludrocortisone Acetate 0.1 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 0.1 mg fludrocortisone acetate. Excipient(s) with known effect: Each tablet also contains 93.4mg of lactose monohydrate. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white round tablet, marked with FL 0.1 on one side and a break-line on the other side. The break-line is only to facilitate breaking for ease of swallowing and not to divide into equal ...
Therapeutic indications
For partial replacement therapy for primary and secondary adrenocortical insufficiency in Addisons disease and for the treatment of salt-losing adrenogenital syndrome.
Posology and method of administration
Adults A daily dosage range of 0.05-0.3mg Fludrocortisone Acetate tablets orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Systemic infections unless specific anti-infective therapy is employed. Because of its marked effect on sodium ...
Special warnings and precautions for use
Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary. Recent intestinal anastomoses, diverticulitis, ...
Interaction with other medicinal products and other forms of interaction
Amphotericin B injection and potassium-depleting agents Patients should be observed for hypokalemia. Anticholinesterases Effects of anticholinesterase agents may be antogonised. Anticoagulants, oral Corticosteroids ...
Fertility, pregnancy and lactation
Pregnancy It may be decided to continue a pregnancy in a woman requiring replacement mineralocorticoid therapy, despite the risk to the foetus. When corticosteroids are essential however, patients with ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Where adverse reactions occur they are usually reversible on cessation of therapy. The incidence of predictable side-effects, including hypothalamic-pituitary-adrenal suppression correlate with the relative ...
Overdose
A single large dose should be treated with plenty of water by mouth. Careful monitoring of serum electrolytes is essential, with particular consideration being given to the need for administration of potassium ...
Pharmacodynamic properties
Pharmacotherapeutic group: Mineralocorticoids ATC code: H02AA02 Qualitatively, the physiological action of fludrocortisone acetate is similar to hydrocortisone. In very small doses, fludrocortisone maintains ...
Pharmacokinetic properties
Fludrocortisone is rapidly and completely absorbed after oral administration. Man, dog, rat, monkey and guinea-pig were studied after i.v. and intraduodenal administration. Depending on species, 50% or ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium starch glycolate Lactose monohydrate Talc Magnesium stearate
Incompatibilities
None applicable.
Shelf life
24 months.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from light.
Nature and contents of container
PVC/PVdC/Al blisters. Available in pack sizes of 30, 50 and 100 tablets.
Special precautions for disposal and other handling
No special requirement.
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0089
Date of first authorization / renewal of the authorization
09/11/2015
Date of revision of the text
25/08/2017
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