NIMOTOP TABLET 30 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NIMODIPINE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

C08CA06

Dosage:

30 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

NIMODIPINE 30 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Bayer AG

Authorization status:

ACTIVE

Authorization date:

1996-12-28

Patient Information leaflet

 
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 %

Summary of Product characteristics

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