Buscogast Amp

BUSCOGAST AMP

Name: Buscogast Ampoules (Brand Name). The common name for the active ingredient is Hyoscine Butylbromide.

Composition: Each 1 ml ampoule contains Hyoscine Butylbromide IP 20 mg, with excipients q.s..

Uses: BUSCOGAST AMP is an antispasmodic medication primarily used to relieve acute spasms of the gastrointestinal, biliary, and genito-urinary tracts, including conditions like renal and biliary colic. It is also indicated for targeted relief from abdominal pain and cramps associated with conditions such as irritable bowel syndrome (IBS). Additionally, it may be used as an aid in diagnostic and therapeutic procedures where spasm can be an issue, such as gastro-duodenal endoscopy and radiological procedures like pyelography.

Dosage and Administration:

• Adults and adolescents over 12 years: 1-2 ampoules (20-40 mg) may be administered several times daily by slow intravenous, intramuscular, or subcutaneous injection. The maximum daily dose should not exceed 100 mg.
• Infants and children (in severe cases): 0.3-0.6 mg/kg bodyweight, administered by slow intravenous, intramuscular, or subcutaneous injection several times daily. The maximum daily dose of 1.5 mg/kg bodyweight should not be exceeded.
• BUSCOGAST AMP should be administered by a doctor. Continuous daily use or extended periods without investigating the cause of abdominal pain are not recommended.

Side Effects: Many listed undesirable effects are related to the anticholinergic properties of BUSCOGAST AMP.

• Common: Dry mouth, accommodation disorders (blurred vision), dizziness, tachycardia (increased heart rate), constipation, and decreased blood pressure.
• Serious: Cases of anaphylaxis, including shock, have been observed after parenteral administration. Patients receiving the injection should be kept under observation.

Precautions:

• Warnings: Seek immediate medical advice if severe, unexplained abdominal pain persists or worsens, or occurs with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool. Patients with undiagnosed narrow-angle glaucoma should seek urgent ophthalmological advice if they develop a painful, red eye with loss of vision after injection. Caution is advised in patients with cardiac conditions, and monitoring is recommended.
• Contraindications: Hypersensitivity to hyoscine butylbromide, untreated narrow-angle glaucoma, hypertrophy of the prostate with urinary retention, mechanical stenosis in the gastrointestinal tract, paralytic or obstructive ileus, megacolon, tachycardia, and myasthenia gravis. Intramuscular injection is contraindicated in patients on anticoagulant therapy due to the risk of haematoma; subcutaneous or intravenous routes may be used instead.
• Interactions: The anticholinergic effects of other drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics) may be intensified. Concomitant use with dopamine antagonists (e.g., metoclopramide) may diminish effects on the gastrointestinal tract. Tachycardic effects of beta-adrenergic agents may be enhanced.
• Pregnancy and Lactation: Limited data is available. It is preferable to avoid use during pregnancy and lactation as a precautionary measure.
• Driving and Machinery: May cause accommodation disorder or dizziness; caution is recommended.

Storage: Store at a temperature not exceeding 30°C, protected from light and moisture. Keep out of reach of children.

Frequently Asked Questions about BUSCOGAST AMP

BUSCOGAST AMP (Hyoscine Butylbromide) is an antispasmodic medication manufactured by SANOFI INDIA LIMITED. It works by relaxing the smooth muscles in the body. Here are some frequently asked questions about this medicine:

What is BUSCOGAST AMP used for?

BUSCOGAST AMP is primarily used for the relief of smooth muscle spasms in the gastrointestinal, biliary, and genitourinary tracts. This includes treating abdominal pain and cramps, symptoms associated with irritable bowel syndrome (IBS) such as cramping, bloating, and discomfort, and spasms of the bladder and ureter, for example, those related to kidney stones. It can also be used as an aid in diagnostic procedures, such as radiological examinations (like pyelography) or endoscopy, to reduce spasm.

How does BUSCOGAST AMP work?

The active ingredient in BUSCOGAST AMP is Hyoscine Butylbromide, which is an antispasmodic and anticholinergic agent. It works by directly relaxing the smooth muscles in the stomach, intestines, bladder, and uterus. This action occurs by blocking certain nerve signals that cause muscle contractions, specifically through a ganglion-blocking effect within the visceral wall and anti-muscarinic activity. Because it is a quaternary ammonium compound, it does not readily cross the blood-brain barrier, thereby avoiding central nervous system side effects.

What is the usual dosage of BUSCOGAST AMP?

For adults and adolescents over 12 years, the typical dose is one to two ampoules (20-40 mg) administered via slow intravenous, intramuscular, or subcutaneous injection several times daily. The maximum daily dose should not exceed 100 mg (equivalent to five ampoules). For infants and children in severe cases, the dosage is 0.3-0.6 mg/kg bodyweight several times daily, with a maximum daily dose of 1.5 mg/kg bodyweight. It's important that intravenous injections are performed slowly. BUSCOGAST AMP should not be used continuously for extended periods without a doctor investigating the cause of the abdominal pain.

What are the possible side effects of BUSCOGAST AMP?

Many of the side effects are related to its anticholinergic properties. Common side effects may include dry mouth, increased heart rate (tachycardia), blurred vision (accommodation disorders), difficulty passing urine (urinary retention), feeling hot, decreased sweating, dizziness, decreased blood pressure (hypotension), and constipation. More serious but rare side effects can include anaphylaxis (a severe allergic reaction, including shock) and injection site pain. Patients with underlying cardiac conditions should be closely monitored due to the potential for tachycardia and hypotension.

Is BUSCOGAST AMP safe during pregnancy or breastfeeding?

During Pregnancy: There is limited data on the use of Hyoscine Butylbromide in pregnant women, and animal studies do not indicate direct or indirect harmful effects on reproductive toxicity. However, as a precautionary measure, it is generally preferable to avoid its use during pregnancy. Your doctor will weigh the benefits and risks if it is deemed necessary.

During Breastfeeding: Insufficient information is available regarding the excretion of BUSCOGAST AMP or its metabolites in human milk. While some sources suggest that small amounts are unlikely to harm a nursing infant, it is generally recommended to avoid its use as a precautionary measure. If used, the infant should be monitored for any signs of unusual drowsiness, dry mouth, or feeding difficulties.

Can BUSCOGAST AMP be taken with other medications?

BUSCOGAST AMP can interact with other medications. It should be used with caution or avoided with:

• Anticoagulant drugs: Intramuscular injection is contraindicated due to the risk of hematoma; subcutaneous or intravenous routes may be considered.
• Dopamine antagonists (e.g., metoclopramide): These can diminish the effects of both drugs on the gastrointestinal tract.
• Other anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide, tiotropium, ipratropium, atropine-like compounds): Concomitant use may intensify anticholinergic side effects.
• Beta-adrenergic agents: May enhance the tachycardic effects of these agents.
• Other Irritable Bowel Syndrome (IBS) remedies: Generally, avoid taking with other IBS remedies unless specifically advised by your doctor, as they may work similarly and increase side effects.

Always inform your doctor or pharmacist about all medications, vitamins, and herbal supplements you are currently taking.

What precautions should be taken while using BUSCOGAST AMP?

• Seek immediate medical attention if you experience severe, unexplained abdominal pain that persists or worsens, or if it occurs alongside symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool.
• Use with caution if you have prostatic enlargement, as it may increase the risk of urinary retention.
• Patients with undiagnosed or untreated narrow-angle glaucoma should use it cautiously, as it can elevate intraocular pressure. Seek urgent ophthalmological advice if you develop a painful, red eye with loss of vision after injection.
• Caution is also needed in patients susceptible to intestinal or urinary outlet obstructions, or those prone to tachyarrhythmia.
• Avoid driving or operating machinery if you experience blurred vision or dizziness.
• Avoid alcohol consumption during treatment, as it may intensify dizziness and drowsiness.
• It is contraindicated in conditions such as mechanical stenosis in the gastrointestinal tract, paralytic or obstructive ileus, megacolon, tachycardia, myasthenia gravis, or known hypersensitivity to the drug components.

What happens if a dose of BUSCOGAST AMP is missed?

If a dose has been missed, take the next dose as scheduled. Do not double the dose to make up for a missed one.

How should BUSCOGAST AMP be stored?

BUSCOGAST AMP ampoules should be stored at a temperature not exceeding 30°C. They must be protected from light and moisture. Keep the medicine out of reach of children. It is recommended to store the ampoules in their outer carton to protect them from light. Once an ampoule is opened, its contents should be used immediately, and any unused portion must be discarded.