Butylscopolamine Other names: Scopolamine butylbromide Hyoscine

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

Concomitant administration of butylscopolamine with alcohol and other CNS depressants causes an increase in the suppressive action of butylscopolamine.

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics (e.g. butyrophenones, phenothiazines), may be intensified by butylscopolamine.

Concomitant administration of butylscopolamine with cholinergic, cardiotonic glycosides, diphenhydramine, levodopa and neostigmine should be avoided.

The tachycardic effects of beta-adrenergic agents may be enhanced by butylscopolamine.

Butylscopolamine is administered with caution to the injectable form in cases of cardiac arrhythmias, hypertension and bronchial asthma.

Butylspolopolamine is used with caution in people with hepatic failure, renal failure, ulcerative colitis, reflux oesophagitis.

The anticholinergic effect of drugs such as quinidine, amantadine may be intensified by butylscopolamine.

The anticholinergic effect of drugs such as disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds), may be intensified by butylscopolamine.

Concomitant administration of butylscopolamine with promethazine, ephedrine, dextroamphetamine, exacerbates the anti-emetic effect of butylscopolamine.

Because of the possibility that anticholinergics may reduce sweating, butylscopolamine should be administered with caution to patients with pyrexia.

Butylscopolamine should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery, where it may further accelerate the heart rate.

Butylscopolamine should be given with caution in patients undergoing cyclopropane anesthesia.

There are limited data from the use of butylscopolamine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure butylscopolamine is not recommended during pregnancy.

There is insufficient information on the excretion of butylscopolamine and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of butylscopolamine during breastfeeding is not recommended.

Fertility

No studies on the effects on human fertility have been conducted.

No studies on the effects on the ability to drive and use machines have been performed.

However, patients should be advised that they may experience undesirable effects such as accommodation disorder or dizziness during treatment with butylscopolamine. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience accommodation disorder or dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of butylscopolamine.

Adverse events have been ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known – cannot be estimated from the available data.

Immune system disorders

Uncommon: skin reactions (e.g. urticaria, pruritus)

Not known*: anaphylactic shock, anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity

Cardiac disorders

Uncommon: tachycardia

Gastrointestinal disorders

Uncommon: dry mouth

Skin and subcutaneous tissue disorders

Uncommon: dyshidrosis

Renal and urinary disorders

Rare: urinary retention

* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon (3/1,368), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 1,368 patients.