COMPOSITION
Each
tablet contains
Drotaverine
Hydrochloride 80mg
DESCRIPTION
SPASONIL-DS contains
Drotaverine Hydrochloride, a novel and exciting isoquinoline anti–spasmodic
molecule, which is useful for relieving painfully spasm in a large variety of
diseases of Gastroenterological & obstetrical origin. Drotaverine is a
highly potent & safe spasmolytic agent having a direct action on smooth
muscles.
PHARMACOLOGY
Pharmacodynamics
Pharmacological
action of Drotaverine is due to its surface activity with which it binds to the
surface of the smooth muscle & alters its membrane potential &
permeability. It
exerts a two fold anti–spasmodic action on the smooth muscles of the gut, one
being a direct inhibition of smooth muscle contraction by inhibiting the
calcium–calmodulin complex and the other being mediated via an inhibitory
effect on the Phosphodiesterase (PDE) enzyme–IV, which play a regulatory role
in the relaxation of smooth muscles of the gastrointestinal tract via
regulation (elevation) of intracellular cAMP.
Pharmacokinetics
After oral
administration it is rapidly absorbed. Drotaverine
binds fast & firmly to smooth muscle tissue, and is released slowly &
in small amount. It is mainly excreted by non-renal route.
INDICATIONS
In Gastro Enterology:
1.
Gastrointestinal
colic, Irritable Bowel Syndrome.
2.
Billiary Colic due
to Cholangitis, Cholecystitis, Choledocholithiasis, Cholelithiasis etc.
3.
Pancreatic duct
stone.
In Urology:
1.
Nephrolithiasis
2.
Ureterolithiasis
In Gynecology & Obstetrics:
1. Dysmenorrhoes
2. Instrumentation like:
i.
Dilatation and curattage (D & C) with spasm.
ii.
Hysterosalpingography (HSG) with spam.
iii.
IUCD related
DOSAGE
Adults: 80mg 3 times daily. (SPASONIL-DS: 1 TAB 3
times daily)
Children: 1 – 6 years: 20mg thrice daily (SPASONIL-DS: ¼ TAB 3 times daily)
6 – 12 years: 40mg thrice
daily (SPASONIL-DS: ½ TAB.3 times daily)
CONTRAINDICATION
Hypersensitivity.
ADVERSE
EFFECT
Hypotonia,
Vertigo, Nausea and Palpitation.
DRUG INTERACTION
·
Drotaverine
may decrease the clinical effects of Levodopa when both drugs are given
simultaneously.
·
Confers additional benefits when combined with
analgesics, antimuscarinics or benzodiazepines.