Sunday, January 10, 2010

Buscopan Tablet

Buscopan® Tablet
Hyoscine-N-butylbromide

Composition
1 sugar-coated tablet contains: Hyoscine-N-butylbromide 10 mg

Properties
BUSCOPAN exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genitourinary tracts. As a quarternary ammonium derivative, Hyoscine-N-butylbromide does not enter the central nervous system. Therefore, anti-cholinergic side effects at the central nervous system do not occur. Peripheral anti-cholinergic action results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity.


Indications
Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genitourinary tract spasm


Contraindications
BUSCOPAN is contraindicated in myasthenia gravis and megacolon. In addition, it should not be used in patients who have demonstrated prior sensitivity to hyoscine-N-butylbromide or any other component of the product.
  • Urinary retention associated with mechanical stenosis of the urinary tract (e.g. in the case of prostatic adenoma)
  • Narrow angle glaucoma
  • Tachycardia
Side Effects
Anti-cholinergic side effects including xerostomia, dyshidrosis, tachycardia and potentially urinary retention may occur but are generally mild and self limited. Very rarely hypersensitivity reactions, particularly skin reactions have been reported. Isolated cases of anaphylaxis with episodes of dyspnoea and shock have been observed.


Special Precautions
Because of the potential risk of anti-cholinergic complications, caution should be used in patients prone to narrow angle glaucoma as well as in patients susceptible to intestinal or urinary outlet obstructions and in those inclined to tachyarrhytmia. Because of the possibility that anti-cholinergic may reduce sweating. BUSCOPAN should be administered with cautions to patients with pyrexia and in situations where the ambient temperature is high.


Pregnancy and Lactation
Long experience has shown no evidence of ill-effects during human pregnancy. Preclinical studies in rats and rabbits did not show either embryo-toxic or teratogenic effects. However the usual precautions regarding the use of drugs in pregnancy, especially during the first trimester, should be observed.
Safety during lactation has not yet been established.


Drug Interactions
The anti-cholinergic effect of tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenons and disopyramide may be intensified by BUSCOPAN.
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 by BUSCOPAN.


Dosage and Administration
Unless otherwise prescribed by the physician, the following dosages are recommended:
Oral
Sugar-coated tablets:
Adults and children over 6 years: 4 times daily 1-2 s.c. tablets.
The sugar-coated tablets should be swallowed whole with adequate fluid.

Over dosage
Symptoms
In the cases of over dosage, anti-cholinergic effects may be observed.

Therapy
If required, parasympathomimetic drugs should be administered. Ophthalmological advice should be shought in cases of glaucoma urgently.
Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterization may be required for urinary retention. In addition, appropriate supportive measures should be used as required.

Availability
Sugar-coated tablets Reg. No. DKL0133700U6A1
Box contains 10 strips of 10 tablets-

Store in 25-30° C, protect from light. Store in a safe place, out of the reach of children.

Only on doctor's prescriptions

Harus dengan resep dokter

Manufactured by:
PT. Boehringer lngelheim Indonesia
Bogor, Indonesia

Under license from:
Boehringer Ingelheim International GmbH
Ingelheim am Rhein
Germany

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