COMPOSITION
Each
tablet contains
Hyoscine
Butylbromide 10mg
INTRODUCTION
ALSPAN contains Hyoscine Butylbromide, a potent antispasmodic agent.
PHARMACOLOGY
Pharmacodynamics
ALSPAN exerts a spasmolytic action on the smooth muscle of the gastrointestinal,
biliary and urinary tracts. Peripheral anticholinergic effects result from a
ganglion-blocking action within the visceral wall as well as from
anti-muscarinic activity. Relaxation of smooth muscle and reduction of gastric
and intestinal motility and relaxation of renal pelvis and ureters are its main
benefits.
Pharmacokinetics
As
a quaternary ammonium compound, ALSPAN
is highly polar and hence only partially absorbed following oral (8%)
administration and the systemic availability was found to be less than 1%.
Nevertheless, despite the briefly measurable low blood levels, ALSPAN and/or its metabolites have been
observed at the sites of action. ALSPAN
does not pass the blood-brain barrier and plasma protein binding is low.
INDICATION AND USAGE
·
Muscle spasm of
the gastrointestinal, renal and biliary tracts.
·
Spasmodic
dysmenorrhoea.
DOSAGE AND ADMINISTRATION
The
dosage range is 1-4 tablets (10-40 mg) per day depending upon the severity of
the condition. The tablets should be swallowed whole with adequate fluid.
CONTRAINDICATION
·
ALSPAN is
contraindicated in myasthenia gravis, megacolon and in patients who have
demonstrated prior sensitivity to the product.
·
Untreated narrow
angle glaucoma; tachycardia, hypertrophy of the prostate with urinary retention;
and mechanical stenoses of the gastrointestinal tract.
ADVERSE REACTIONS
·
Anticholinergic
side effects including xerostomia, dyshidrosis, tachycardia, and urinary
retention may occur but are generally mild and self-limited.
·
Very rarely
hypersensitivity reaction particularly skin reaction and, in extremely rare
cases, dyspnea have been reported.
DRUG INTERACTIONS
·
The
anticholinergic effect of tricyclic antidepressants, antihistamines, quinidine,
amantadine and disopyramide may be intensified by ALSPAN.
·
Concomitant
treatment with dopamine antagonists such as metoclopramide may result in
diminution of the effects of both drugs on the gastrointestinal tract.
·
The tachycardic
effects of beta-adrenergic agents may be enhanced.
·
Atropine, an
anticholinergic (Parasympatholytic) completely blocks the muscarinic receptors
in peripheral tissues. Atropine due to its vegal activity has thus benefit in
Bradycardia, and in reducing the heart block. While reducing glandular
secretion, Atropine also helps in relaxation of smooth muscle Bronchi and guts.
Thus antispasmodic activity is limited.
·
The mode of action
of Dicyclomine is similar to that of Hyoscine butylbromide. Dicyclomine, a
synthetic antimuscarinic- blocks cholinergic transmission at parasympathetic
postaganglionic nerve endings innervating to smooth muscle, causeing it to
relax.
.
WARNINGS AND PRECAUTIONS
·
Because of the
potential risk of anticholinergic complication, ALSPAN tablets should be administered with caution in patients
susceptible to narrow angle glaucoma, intestinal or urinary outlet obstruction
and those inclined to tachyarrhythmia.
·
Pregnancy and Lactation: Precautions, especially during the first trimester,
should be observed. Safety during lactation has not yet been established;
however, adverse effects on the newborn have not been reported.
