otilonium bromide


A Menarini


Dexa Medica
Full Prescribing Info
Otilonium bromide.
Pharmacology: Pharmacodynamics: Otilonium bromide is a prototype of class 2-aminoethyl-N-benzyloamino-benzoate quaternary salts. The combination of antimuscarinic effect and calcium channel-blocking effect seemed to be the main action of otilonium bromide.
Spasmomen inhibits the basal gastrointestinal motility or other stimulated parts as the response to agents which cause contraction and acts both chemically or physically to many animal and human species. The spasmolytic action of Spasmomen in the gastrointestinal tract occurs on dose which does not influence the gastric acid secretion or other side effects eg, atropine effect.
The spasmolytic action of Spasmomen, without regard to its original agonist effect, is to work especially on intestinal tract, compared to vascular smooth muscle or respiratory tract. From observation, both in vitro or in vivo, colon is more sensitive than any other gastrointestinal segment to relaxation action of Spasmomen.
Pharmacokinetics: After oral administration at a dose of 10 mg/kg body weight, plasma level is very low and detected most 2-6 hrs after administration. Mean maximal plasma concentration is 10.8 ng Eq/mL which is reached in 2 hrs after administration. Only 0.71% of Spasmomen is excreted via urine after 96 hrs, most of Spasmomen is excreted via feces (97.1% in 7 days). Spasmomen is excreted in feces in complete shape. Total excretion is 97.8% from the administered dose. This showed that after oral administration, Spasmomen is absorbed in very low concentration.
Treatment of irritable colon syndrome and symptomatic treatment of pain and gastrointestinal disorder which is related to smooth muscle spasm.
Dosage/Direction for Use
1 tab 2-3 times daily.
Hypersensitivity to otilonium bromide or to any other component of Spasmomen.
Special Precautions
Caution should be observed on administration to glaucoma patients, benign prostatic hyperplasia and pyloric stenosis.
Use in pregnancy & lactation: Eventhough there is no embryotoxic, teratogenic or mutagenic effects reported in animals during pregnancy and breastfeeding, the use of Spasmomen is only advised if strongly needed but should be monitored by the physician.
Adverse Reactions
In therapeutic dose, there was no serious effect reported. Other side effects which may occur are nausea, fatigue, epigastric pain or vertigo. Spasmomen does not cause any atropine-like side effects.
Store at 25°-30°C. Protect from light and moisture.
ATC Classification
A03AB06 - otilonium bromide ; Belongs to the class of synthetic anticholinergics, quaternary ammonium compounds. Used in the treatment of functional bowel disorders.
Film-coated tab 40 mg x 3 x 10's.
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