Spasmodigestin
Enteric Coated Tablets
Composition:
Each tablet contains:
Active Ingredients:
Papain 100 mg
Sanzyme 3500 36mg
Sodium dehydrocholate 10 mg
Dicyclomine hydrochloride 5 mg
Simethicone 30mg
Inactive Ingredients:
Povidone K90, Crospovidone, Microcrystalline cellulose, Colloidal silicon dioxide, Dibasic calcium phosphate dihydrate.
Film Coat:
Hydroxypropylmethylcellulose, Eudragit, Sodium hydroxide, Titanium dioxide, Talc powder, Triethyl citrate, Dimethicone, colouring agent.
Properties:
Spasmodigestin Tablets is a well balanced combination with specific
digestive, choleretic, spasmolytic and antiflatulent properties. Spasmodigestin provides the body with papain, the proteolytic enzyme, in addition to sanzyme 3500 which is a multienzyme complex containing mainly protease, amylase, lipase and cellulase. These enzymes act upon food contents of the GIT and catalyze their conversion into simpler and easily digestible and absorbable components. Spasmodigestin therefore brings to complete hydro~ of proteins into peptones and small peptides; starch into dextrins and simpler sugars, fats into fatty acids and glycerol, and
cellulose into absorbable matter. Spasmodigestin also exerts choleretic effect through sodium dehydrocholate which improves the flow of bile necessary for emulsification and digestion of fats. The spasmolytic effect of Spasmodigestin is due to dicyclomine hydrochloride which rapidly and effectively relieves spastic pain of the GI musculature and intestinal hypermotility. The antimuscarinic and direct antispasmodic actions of dicyciomine hydrochloride account for its high efficacy in irritable bowel syndrome (spastic colon). Tfie antiffalulenl ettecrot Spasmodigestin is due to simethicone, the powerful defoaming agent. Simethicone reduces
surface tension 01 gas bubbles of the GIT causing them to colesce and be easily expelled. At the same time, simethicone prevents formation of mucus surrounded gas pockets in the GIT. These properties collectively make Spasmodigestin the drug 01 choice for rapid relief of indigestion, GI spasms and flatulence. .
Pharmacokinetics:
For Dicyclomine :
Absorption:
Dicyclomine hydrochloride is rapidly absorbed from gastrojntestinal tractc also enter the circulation through the mucosal surfaces 01 the body
Distribution:
It appears to be distributed throughout the entire body and readily cross the blood-brain barrier .
Biotransformation:
Hepatic, by enzymatic hydrolysis.
Half- Life:
Elimination : 1.8 hours (initial phase) and 9 to 10 hours (secondary phase) It is assumed to be’ eliminated unchanged either by renal or lecal.
For Simethicone :
Elimination:
Fecal, as unchanged drug.
Indications :
– Dyspepsia, abdominal discomfort and flatulence.
– Gastro-intestinal spasm particularly, associated with irritable bowel syndrome.
– Following surgery on the stomach, small intestine or pancreas, and
postgastrectomy syndrome.
-Irritable bowel syndrome (spastic colon) with such symptoms as anorexia, intestinal spasm, flatulence, constipation or diarrhea.
– Loss of appetite.
– Anorexia nervosa.
Dosage & Administration:
1 – 2 tablets to be taken immediately, before each meal.
Contraindications :
Hypersensitivity to any ingredients of the product
It is contra-indicated in patients with prostatic enlargement, in whom itmay lead to urinary retention, and in those with paralytic ileus or pyloric stenosis.
Side Effects:
The side effects are dose-related and are usually reversible when therapy is discontinued.
The peripheral sTde effects of antimuscarinics are a consequence of
their inhibitory effect on muscarinic receptors within the autonomic
nervous system. At therapeutic doses, adverse effects include dryness of the mouth with difficulty in swallowing, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipartion
Drug Interactions :
The effects of antimuscarinics may be enhanced by the concomitant
administration of other drugs with anti muscarinic properties, such as amantadine, some antihistaminics, phenothiazine antipsychotics, and tricyclic antidepressants. Inhibition of drug-metabolising enzymes by MAOls may possibly enhance the effects of antimuscarinics. The reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs.
Pregnancy & Lactation:
In retrospective studies there has been no evidence of dicyclomine having any untoward effect on the embryo Although a causal relationship has not been established, the use of dicyclomine in nursing mothers is not recommended.
Precautions & Warnings:
Caution is generally advisable in any patient with diarrhea It should not be gillen to patients with myasthenia gravis except to reduce
adverse muscarinic effects of an anticholinesterase.
Packing:
A box containing 30 enteric coated tablets in ( AI/transparent PVC) strips, each of 10 tablets and an inner leaflet.
Storage:
keep at temperature not exceeding 30 c in dry place away from light keep out of the reach of children
produced by :
pharco Pharmaceuticals – alexandria Union of Arab Pharmacies
