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SPASMOCIN

Hyoscine-N-butyl bromide:


Composition:-

Hyoscine-N-butyl romide Each Tablet Contains Each Amp. Contains Each Supp. Contains
 10 mg 20 mg  15 mg


Pharmacological Properties:-
Hyoscine-N-butyl bromide is a competitive antagonist of acetyl choline at post–ganglionic parasympathetic nerve endings. It has no effect on nicotinic receptors. It does not cross the blood brain barrier and hence has no central effects. The antispasmodic action of spasmocin is most pronounced on the smooth muscles of the gastro-intestinal tract, renal pelvis, ureters and biliary tract.

Pharmacokinetics:-
Following oral administration of Hyoscine-N-butyl bromide few amounts excreted in urine and most of the dose is excreted in the feces. Following intravenous administration, nearly equal amounts of Hyoscine-N-butyl bromide are excreted in urine and feces. Spasmocin has low protein-binding capacity.

Indications:-
•    As antispasmodic agent in the treatment of gastrointestinal spasm, spasm of biliary tract, urinary tract and in spasmodic dysmenorrhea
•    In organophosphorous poisoning.

Contraindications:-
•    Glaucoma.
•    Paralytic ileus.
•    Prostatic hypertrophy.
•    Pyloric stenosis.

Side Effects:-
Side effects that may occur include:
•    Dryness of mouth.
•    Tachycardia.
•    Blurred vision.
•    Constipation.
•    Dilatation and loss of accommodation of the pupil.
•    Transient bradycardia followed by tachycardia palpitation and arrhythmias.
•    Photophobia.
•    Confusion in elderly.
•    Reduced bronchial secretions.
•    Urinary urgency and retention.
•    Nausea, vomiting and giddiness.

Precautions:-
Spasmocin should be taken with caution in the following cases:
•    Down's syndrome.
•    Gastroesophogeal reflux disease.
•    Diarrhoea.
•    Ulcerative colitis.
•    Acute myocardial infarction.
•    Hypertension.
Conditions characterised by tachycardia (hyperthyroidism – Cardiac insufficiency – Cardiac surgery).

Pregnancy:-
There is no evidence of any consequences following its use in pregnancy although the drug should be avoided during the first trimester.

Breast milk:-
No information is available although it is unlikely to enter breast milk in view of the polarity of the compound.

Drug–Interactions:-
The anticholinergic effect of spasmocin may be enhanced by administration of tricyclic antidepressant drugs.

Dosage and administration:-
•    Oral:
Adult dose: 20 mg (two tablets) four times daily.
Children (6-12) years: 10 mg (1 tablet) three times daily.

•    Parenteral: injection (IV, IM):
Adults: Acute spasm and spasm in diagnostic procedures:
             20 mg (one ampoule) repeated after 30 minutes if necessary.

•    Rectal:
Adults & adolescents dose:
15 mg (1 suppository) three times a day (daily dose doesn't exceed 80 mg).

Storage:
Tablet: Store in a dry place at a temperature below 30º C.
Protect from light.

Suppositories & Ampoules: Store at temperature below 30º C.
                                                 Protect from light.

Therapeutic category: Antispasmodic.

Legal category: Prescription only medicine (POM).
How supplied:-
Tablet: Each box contains 20 tablets.
Suppository: Boxes of 6 suppositories each.
Ampoules: Boxes of 6 ampoules each of 1 ml.
Boxes of 3 ampoules each of 5 ml.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.