资料单张
MENOGRAINE DROPS
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
MENOGRAINE DROPS
COMPOSITION:
Every 10 drops (0,50 mL) contain:
Clonidine
hydrochloride 25 micrograms
Preservative:
Sodium benzoate 0,2% m/v
PHARMACOLOGICAL CLASSIFICATION:
A 7.3 Migraine preparations
PHARMACOLOGICAL ACTION:
Clonidine is a centrally acting alpha
2
-agonist. The central inhibiting effect on noradrenergic neurotransmission generally
dominates the peripheral excitatory alpha
2
-effect. The mode of action of clonidine in the prophylaxis of migraine is still
unclear.
Pharmacokinetics:
The pharmacokinetics of clonidine is dose-proportional in the range of 100-600 micrograms. Clonidine is well absorbed
and no first pass effect exists. It is rapidly and extensively distributed into the tissues and crosses the blood-brain barrier
as well as the placenta. The mean plasma half-life of clonidine is about 13 hours ranging between 10 and 20 hours. The
half-life does not depend on the sex or race of the patient but can be prolonged in patients with severely impaired renal
function for up to 41 hours. About 70% of the dose administered is excreted in the urine mainly in the form of the
unchanged parent drug (40-60% of the dose). The main metabolite, p-hydroxy-clonidine is pharmacologically inactive.
Approximately 20% of the total amount is excreted in the faeces.
INDICATIONS:
MENOGRAINE DROPS is indicated for the prevention of migraine and other recurrent vascular headaches.
CONTRA-INDICATIONS:
MENOGRAINE DROPS should not be used in patients with known hypersensitivity to clonidine, and in patients with
severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of the 2nd or 3rd degree.
MENOGRAINE DROPS is not suitable for the treatment of acute migraine attacks or
阅读完整的文件
资料单张 