Spanil10 mg

Spanil is an antimuscarinic (anticholinergic) antispasmodic used to relieve smooth-muscle spasm and colic arising in the gastrointestinal and genitourinary tracts. It is widely used and marketed internationally (including in Bangladesh) for this purpose; it is not an FDA-approved product for human use in the United States, where an antimuscarinic-class oral or injectable equivalent may instead be prescribed.

• Acute gastrointestinal spasm/colic - painful spasm of the stomach and intestine, including spasm associated with irritable bowel syndrome (established/widely used indication).
• Biliary colic - spasm of the bile ducts and gallbladder (established/widely used indication).
• Renal/ureteric colic - spasm of the urinary tract, usually as an adjunct alongside analgesia and definitive management of the underlying cause (adjunct use).
• Primary dysmenorrhoea - painful menstrual cramping (oral tablet formulation; established/widely used indication).
• Muscle relaxation during diagnostic or therapeutic procedures - e.g. endoscopy, colonoscopy, or radiological/imaging studies of the abdomen, where reducing bowel spasm improves visualisation (established adjunct/procedural use, injectable formulation).

Spanil only relieves the spasm and pain; it does not treat the underlying cause, so persistent or recurrent abdominal pain should always be medically investigated.

Each film-coated tablet contains Hyoscine Butylbromide INN 10 mg. Each mL of injection (ampoule) contains Hyoscine Butylbromide INN 20 mg (20 mg/mL). Strength and available dosage forms may vary by manufacturer/brand; refer to the specific product label.

Spanil (also known as N-butylscopolammonium bromide or butylscopolamine) is a semi-synthetic quaternary ammonium derivative of the naturally occurring alkaloid hyoscine (scopolamine). Because it carries a permanent positive charge, Spanil is poorly absorbed and does not readily cross the blood-brain barrier, so its antimuscarinic action is largely confined to peripheral smooth muscle (gastrointestinal, biliary and genitourinary tracts) with minimal central nervous system effect at usual doses. It is available as oral tablets and as a parenteral (injectable) solution.

Spanil belongs to the antimuscarinic (anticholinergic) antispasmodic class of drugs, specifically the synthetic quaternary ammonium antimuscarinics used for smooth-muscle relaxation.

Hyoscine Butylbromide is a competitive antagonist at muscarinic acetylcholine receptors located on the smooth muscle of the gastrointestinal, biliary and genitourinary tracts. By blocking the action of acetylcholine at these receptors, Hyoscine Butylbromide reduces smooth-muscle tone and motility, producing an antispasmodic (spasmolytic) effect that relieves cramping pain associated with visceral spasm. Its quaternary ammonium structure limits oral bioavailability (generally low, estimated under 10%) and restricts penetration across the blood-brain barrier, so systemic anticholinergic and central effects are typically mild at recommended doses compared with tertiary antimuscarinics such as atropine. Onset of action after intravenous administration is rapid (minutes); after oral administration onset is slower. Hyoscine Butylbromide is metabolised mainly by ester hydrolysis and eliminated chiefly via the renal and biliary routes.

Tablets should be swallowed whole with a glass of water, preferably before meals; do not chew. Injections of Spanil should be given slowly (approximately 1 mL/minute for IV administration) by a trained healthcare professional, and the patient should be observed for a short period afterwards because of the small risk of hypersensitivity reactions. Antacids and adsorbent antidiarrhoeal products, if used, should be taken at least 1 hour apart from oral Spanil as they may reduce its absorption.

Spanil has the following clinically significant interactions:

• Other antimuscarinic/anticholinergic drugs (e.g. tricyclic antidepressants, certain antihistamines, antipsychotics/butyrophenones and phenothiazines, amantadine, disopyramide): concurrent use can additively increase anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, tachycardia); dose adjustment or closer monitoring may be needed.
• Dopamine agonist prokinetics (metoclopramide, domperidone): these drugs increase gastrointestinal motility while Spanil reduces it, so their gastrointestinal effects may antagonise each other.
• Beta-adrenergic agonists: may add to the tachycardic (heart-rate-increasing) effect of Spanil.
• MAO inhibitors: may potentiate the anticholinergic effects of Spanil.
• Antacids and adsorbent antidiarrhoeals: can reduce absorption of oral Spanil if taken together; separate dosing by at least 1 hour.

Always tell your physician or pharmacist about all other medicines you are taking before starting Spanil.

Side effects of Spanil arise mainly from its antimuscarinic action and are usually mild and reversible.

• Common: dry mouth, reduced sweating, dizziness, drowsiness.
• Less common: tachycardia (fast heart rate), blurred vision/accommodation disturbance, constipation, urinary hesitancy or retention, skin flushing.
• Rare but serious: hypersensitivity reactions including skin rash, urticaria, angioedema, dyspnoea, and, very rarely, anaphylactic shock (including fatal cases have been reported with the injection); marked hypotension.

Seek urgent medical attention for any signs of a serious allergic reaction (facial/throat swelling, severe rash, breathing difficulty) while using Spanil.

Pregnancy: Data on the use of Spanil in human pregnancy are limited. Animal reproduction studies have not shown teratogenic effects, but human safety has not been firmly established. Spanil should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use, especially in the first trimester.

Lactation: It is not known whether Spanil or its metabolites are excreted in human breast milk in clinically significant amounts. As a precaution, use during breastfeeding should only occur under medical advice, weighing the benefit to the mother against any potential risk to the infant.

Use Spanil with caution in the following situations, under physician supervision:

• Cardiac disease - tachyarrhythmia, cardiac insufficiency, or recent cardiac surgery, because of the risk of increased heart rate.
• Thyrotoxicosis - may be aggravated by tachycardia-inducing effects.
• Prostatic hypertrophy without urinary retention and other conditions predisposing to urinary retention.
• Gastrointestinal conditions such as reflux oesophagitis or ulcerative colitis, where antimuscarinic effects could theoretically worsen the condition.
• Autonomic neuropathy.
• Elderly patients, who may be more susceptible to anticholinergic adverse effects (confusion, urinary retention, constipation).

Spanil may cause blurred vision or dizziness; patients should avoid driving or operating machinery until they know how it affects them, and avoid alcohol. Continuous long-term use to mask unexplained abdominal pain is discouraged - the underlying cause should be investigated. A small risk of hypersensitivity/anaphylactic reactions exists, particularly with the injectable form; patients should be observed after administration and treatment given by trained personnel with resuscitation facilities available. See Contraindications for situations in which Spanil must not be used.

Overdose with Spanil produces an anticholinergic toxidrome: dry mouth and skin, thirst, flushing, tachycardia, blurred vision and dilated pupils, urinary retention, reduced bowel sounds, restlessness or drowsiness. In severe cases this can progress to agitation, hyperthermia, respiratory depression, circulatory collapse and coma.

Suspected overdose of Spanil is a medical emergency: seek immediate medical attention or contact the nearest emergency department/poison control centre. Do not attempt to treat an overdose at home. Management is supportive and must be carried out by medical professionals (which may include gastric decontamination if presenting early, monitoring, and specific antidotal therapy such as a cholinesterase inhibitor when indicated by a physician).

Store at room temperature (below 30°C), away from light and moisture. Do not freeze the injection. Keep out of reach of children.

Renal impairment: No formal dose adjustment guidance is well established, but Spanil should be used cautiously as elimination may be reduced; consult a physician. Hepatic impairment: Use with caution; specific dose-adjustment data are limited. Elderly: More susceptible to anticholinergic adverse effects (urinary retention, constipation, confusion); use the lowest effective dose. Children: Oral use may be considered from 6 years under medical supervision at reduced dose (see Dosage); use in children under 6 years, and injectable use in children generally, is not recommended as safety and efficacy have not been established. Pregnancy and lactation: see the dedicated section above.

Spanil is generally intended for short-term, symptomatic relief of acute spasm or colic - typically a few days, or as directed for a specific short course (e.g. around the menstrual period for dysmenorrhoea, or as a single procedural dose). It should not be used continuously for prolonged periods to mask recurrent or persistent abdominal pain without medical evaluation of the underlying cause. Follow the physician's specific instructions on how long to continue Spanil, and seek medical review if symptoms do not improve within 2-3 days or if they worsen.

Antimuscarinic (anticholinergic) antispasmodic; quaternary ammonium derivative of scopolamine (hyoscine).

Hyoscine Butylbromide acts as a competitive antagonist at muscarinic acetylcholine receptors on gastrointestinal, biliary and genitourinary smooth muscle. By blocking acetylcholine at these receptors it inhibits smooth-muscle contraction, reducing spasm, motility and associated pain. Its quaternary ammonium structure limits systemic absorption and central nervous system penetration, so its action is predominantly peripheral (anti-spasmodic) rather than central.

Oral Spanil may be used in children 6-12 years of age for gastrointestinal spasm at a reduced dose (10 mg three times daily) under medical supervision. Use in children younger than 6 years is not recommended because safety and efficacy have not been established in this age group. The injectable form of Spanil is generally not recommended for use in children; if considered necessary, it should only be given under specialist medical supervision. Parents/caregivers should not give Spanil to a child without a physician's advice.