Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
NIMODIPINE
BAYER (SOUTH EAST ASIA) PTE LTD
C08CA06
30 mg
TABLET, FILM COATED
NIMODIPINE 30 mg
ORAL
Prescription Only
Bayer AG
ACTIVE
1996-12-28
Nimotop tab_PI_SG_CCDS5_27 July 2012 - 1 - Active ingredient: nimodipine Film-coated tablet COMPOSITION 1 film-coated tablet contains 30 mg nimodipine. Inactive ingredients: poly(1-vinyl-2-pyrrolidone) 25, microcrystalline cellulose, corn starch, crospovidone, magnesium stearate, hydroxypropyl methylcellulose, macrogol 4000, titanium dioxide (E 171), iron oxide yellow (E 172). PHARMACODYNAMIC PROPERTIES ATC Code: C08 CA06 Nimodipine has a pre-dilective cerebral anti-vasoconstrictive and anti-ischaemic activity. Vasoconstrictions provoked in vitro by various vasoactive substances (e.g. serotonin, prostaglandins, and histamine) or by blood and blood degradation products can be prevented or eliminated by nimodipine. Nimodipine also has neuropharmacological and psychopharmacological properties. Investigations in patients with acute cerebral blood flow disturbances have shown that nimodipine dilates the cerebral blood vessels and promotes cerebral blood flow. The increase in perfusion is as a rule greater in previously damaged or underperfused brain region than in healthy regions. The ischaemic neurological damage in patients with subarachnoid haemorrhage and the mortality rate are significantly reduced by nimodipine. PHARMACOKINETIC PROPERTIES ABSORPTION The orally administered active substance nimodipine is practically completely absorbed. The peak plasma concentration and the area under the curve increase proportionally to the dose up to the highest dose under test (90 mg). The distribution volume (V ss , 2-compartment model) for i.v. administration is calculated to be 0.9 - 1.6 l/kg body weight. The total (systemic) clearance is 0.6 - 1.9 l/h/kg. PROTEIN BINDING AND DISTRIBUTION Nimodipine is 97 - 99 % Perskaitykite visą dokumentą
Nimotop tab_PI_SG_CCDS5_Jan 2022 - 1 - Active ingredient: nimodipine Film-coated tablet COMPOSITION 1 film-coated tablet contains 30 mg nimodipine. Inactive ingredients: poly(1-vinyl-2-pyrrolidone) 25, microcrystalline cellulose, corn starch, crospovidone, magnesium stearate, hydroxypropyl methylcellulose, macrogol 4000, titanium dioxide (E 171), iron oxide yellow (E 172). PHARMACODYNAMIC PROPERTIES ATC Code: C08 CA06 Nimodipine has a pre-dilective cerebral anti-vasoconstrictive and anti-ischaemic activity. Vasoconstrictions provoked in vitro by various vasoactive substances (e.g. serotonin, prostaglandins, and histamine) or by blood and blood degradation products can be prevented or eliminated by nimodipine. Nimodipine also has neuropharmacological and psychopharmacological properties. Investigations in patients with acute cerebral blood flow disturbances have shown that nimodipine dilates the cerebral blood vessels and promotes cerebral blood flow. The increase in perfusion is as a rule greater in previously damaged or underperfused brain region than in healthy regions. The ischaemic neurological damage in patients with subarachnoid haemorrhage and the mortality rate are significantly reduced by nimodipine. PHARMACOKINETIC PROPERTIES ABSORPTION The orally administered active substance nimodipine is practically completely absorbed. The peak plasma concentration and the area under the curve increase proportionally to the dose up to the highest dose under test (90 mg). The distribution volume (V ss , 2-compartment model) for i.v. administration is calculated to be 0.9 - 1.6 l/kg body weight. The total (systemic) clearance is 0.6 - 1.9 l/h/kg. PROTEIN BINDING AND DISTRIBUTION Nimodipine is 97 - 99 % bound to plasma proteins. METABOLISM, ELIMINATION AND EXCRETION Nimodipine is eliminated metabolically via the cytochrome P450 3A4 system. BIOAVAILABILITY Attributed to the extensive first-pass metabolism (about 85 - 95 %) the absolute bioavailability is 5 - 15 %. PRECLINICAL SAFETY DATA Preclinical data reveal no speci Perskaitykite visą dokumentą