INSPRA Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
INSPRA 25 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 25 mg of eplerenone. Excipients with known effect: Each 25 mg tablet contains 35.7 mg of lactose monohydrate (see section 4.4). For the full list of excipients see section 6.1.
Pharmaceutical form
Film-coated tablet. 25 mg tablet: yellow tablet with stylized Pfizer on one side of tablet, NSR over "25"on the other side of tablet.
Therapeutic indications
Eplerenone is indicated: In addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular (CV) mortality and morbidity in stable patients with left ventricular dysfunction ...
Posology and method of administration
Posology For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available. The maximum dose regimen is 50 mg daily. For post-MI heart failure patients The recommended maintenance dose ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with serum potassium level >5.0 mmol/L at initiation. Patients with severe renal insufficiency (eGFR ...
Special warnings and precautions for use
Hyperkalaemia: Consistent with its mechanism of action, hyperkalaemia may occur with eplerenone. Serum potassium levels should be monitored in all patients at initiation of treatment and with a change ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Potassium-sparing diuretics and potassium supplements Due to increased risk of hyperkalaemia, eplerenone should not be administered to patients receiving other potassium-sparing ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data on the use of eplerenone in pregnant women. Animal studies did not indicate direct or indirect adverse effects with respect to pregnancy, embryofoetal development, ...
Effects on ability to drive and use machines
No studies on the effect of eplerenone on the ability to drive or use machines have been performed. Eplerenone does not cause drowsiness or impairment of cognitive function but when driving vehicles or ...
Undesirable effects
In two studies (EPHESUS and Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure [EMPHASIS-HF]), the overall incidence of adverse events reported with eplerenone was similar ...
Overdose
No cases of adverse events associated with overdose of eplerenone in humans have been reported. The most likely manifestation of human overdose would be anticipated to be hypotension or hyperkalaemia. ...
Pharmacodynamic properties
Pharmacotherapeutic group: aldosterone antagonists ATC code: C03DA04 Mechanism of action Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its ...
Pharmacokinetic properties
Absorption The absolute bioavailability of eplerenone is 69% following administration of a 100 mg oral tablet. Maximum plasma concentrations are reached after approximately 1.5 to 2 hours. Both peak plasma ...
Preclinical safety data
Preclinical studies of safety pharmacology, genotoxicity, carcinogenic potential and reproductive toxicity revealed no special hazard for humans. In repeated dose toxicity studies, prostate atrophy was ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Hypromellose (E464) Sodium laurilsulfate Talc (E553b) Magnesium stearate (E470b) Tablet coating: Opadry yellow: ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
Opaque PVC/Al blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets. Opaque PVC/Al perforated unit dose blisters containing 10 1, 20 1, 30 1, 50 1, 90 1, 100 1 or 200 1 (10 packs of 20 ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0615
Date of first authorization / renewal of the authorization
21/09/2004
Date of revision of the text
05/2017
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