Valid Ghana · FDA Ghana

LAWPAN INJECTION (Each ampule contains Hyosaine Butylbromide 20mg)

Hyosaine Butylbromide

FDA/SD.265-030246 Hyosaine Butylbromide 20mg

What it does

Butylbromide is a medication used to relieve cramps and spasms in the stomach and intestines.

Commonly used for: stomach cramps, abdominal spasms

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.265-030246
Registration date
2026-03-05
Expiry date
2031-04-01
Status
Valid
Active ingredient
Hyosaine Butylbromide
Dosage form
Hyosaine Butylbromide
Strength
20mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Atlantic Lifesciences
Applicant / LTR
PHARMANOVA LIMITED
Country of origin
GHANA
Manufacturer location
Accra - Aflao Rd, Accra, Ghana

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:38 · updated 2026-10-20 04:00:07

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About butylbromide

Butylbromide is a medication used to relieve cramps and spasms in the stomach and intestines.

What it treats

  • stomach cramps
  • abdominal spasms

How it works

It helps relax the muscles in the stomach and intestines, which can reduce pain and discomfort.

Who it's for

This medication is typically for adults and may be used for children under medical supervision.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About hyosaine

Hyoscine is a medication used to relieve spasms in the stomach and intestines, as well as to reduce nausea and vomiting.

What it treats

  • nausea and vomiting
  • abdominal cramps
  • motion sickness

How it works

Hyoscine works by relaxing the muscles in the stomach and intestines, which helps prevent cramps and reduces feelings of nausea.

Who it's for

Hyoscine is suitable for adults and children suffering from stomach cramps, nausea, or those experiencing motion sickness.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: butyl

BNF-referenced

Butyl is a term that generally refers to a group of organic compounds derived from butane, a four-carbon alkane. The butyl group is commonly found in various chemical structures, often as alkyl substituents in organic compounds. It is used in various applications, including as solvents, in the manufacture of plastics, and in pharmaceuticals. However, its specific clinical applications and pharmacological details may vary depending on the exact butyl compound in question.

Mechanism of action

Butyl compounds act by interacting with various biological pathways depending on their specific structure. For example, in the context of pharmaceutical use, they may function as solvents for drugs, enhancing solubility and bioavailability, or may have specific receptor interactions based on their functional groups. The precise mechanism of action would vary with the specific butyl derivative.

Pharmacodynamics

The pharmacodynamics of butyl compounds can vary widely. Generally, they may affect various physiological processes depending on their chemical nature. For example, butyl derivatives may exhibit anti-inflammatory, analgesic, or even anesthetic properties in certain contexts. The pharmacodynamic profile is largely dependent on the specific butyl compound and its interactions with cellular receptors and enzymes.

Pharmacokinetics

The pharmacokinetics of butyl compounds vary significantly among different derivatives. Commonly, these compounds are absorbed through various routes, depending on their formulation. They may undergo metabolic processes in the liver before being excreted primarily via urine. The exact absorption rates, half-lives, and clearance rates would depend on the specific butyl derivative and its formulation.

Pregnancy

There are no specific studies regarding the use of butyl compounds in pregnancy. Caution should be exercised.

Breast-feeding

There is limited information on the excretion of butyl compounds in human breast milk. Caution is advised.

Storage

Store in a well-closed container, protected from light and moisture.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: butylbromide

BNF-referenced

Butylbromide, with the molecular formula C4H9Br, is an anticholinergic agent primarily used for its muscle relaxant properties. It is indicated for the relief of smooth muscle spasms in conditions such as irritable bowel syndrome and other gastrointestinal disorders. By reducing the activity of acetylcholine, it helps alleviate spasticity in the gastrointestinal tract.

Indications

  • Irritable bowel syndrome
  • Other gastrointestinal disorders associated with smooth muscle spasms

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Butylbromide acts as a competitive antagonist of muscarinic acetylcholine receptors. This inhibition decreases the contractility of smooth muscle in the gastrointestinal tract, leading to reduced spasms and discomfort. It predominantly affects the parasympathetic nervous system, which regulates involuntary bodily functions.

Pharmacodynamics

The pharmacodynamic effects of butylbromide include relaxation of smooth muscle and reduction of secretions in the gastrointestinal tract. This results in decreased gastrointestinal motility and relief from cramping and pain associated with smooth muscle contractions. The onset of action is typically rapid, making it effective for acute symptoms.

Pharmacokinetics

Butylbromide is absorbed from the gastrointestinal tract following oral administration. It is distributed throughout the body, with a preference for tissues with high cholinergic activity. The drug undergoes hepatic metabolism, and its metabolites are excreted primarily through the urine. The half-life and exact pharmacokinetic parameters can vary depending on individual patient factors.

Pregnancy

Butylbromide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether butylbromide is excreted in human milk. Caution should be exercised when administering to breastfeeding mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: hyosaine

Hyoscine, also known as scopolamine, is an anticholinergic medication used primarily for its effects on the gastrointestinal system and as an antiemetic. It is derived from the plant species Hyoscyamus niger and is commonly used to prevent motion sickness, manage gastrointestinal spasms, and alleviate symptoms of various conditions including irritable bowel syndrome.

Indications

  • Motion sickness
  • Nausea and vomiting
  • Irritable bowel syndrome
  • Gastrointestinal spasms
  • Preoperative sedation

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on age and weight.

Adults: Dosing varies based on the specific condition being treated. For motion sickness, 0.3 to 0.6 mg is typically administered 30 minutes before travel, with repeat doses every 6 to 8 hours as needed. For gastrointestinal spasms, 0.6 to 1.2 mg can be given 3 to 4 times daily.

Mechanism of action

Hyoscine exerts its effects by blocking muscarinic acetylcholine receptors in the central nervous system and peripheral tissues. This action inhibits parasympathetic nerve impulses, leading to decreased gastrointestinal motility, increased heart rate, and reduced secretions. In the central nervous system, it also has sedative properties, which can help reduce anxiety and motion sickness.

Pharmacodynamics

Hyoscine's anticholinergic properties result in muscle relaxation in the gastrointestinal tract, reducing spasms and discomfort. In addition to its gastrointestinal effects, it also has a central nervous system depressant effect, which can help mitigate nausea and vomiting associated with motion sickness. The onset of action is typically rapid, with effects lasting several hours depending on the route of administration.

Pharmacokinetics

Hyoscine is well absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It undergoes extensive hepatic metabolism, primarily through ester hydrolysis and oxidative pathways. The elimination half-life ranges from 3 to 6 hours, and the drug is excreted mainly in the urine, both as unchanged drug and metabolites. Its distribution is widespread, with penetration into the central nervous system due to its lipophilic nature.

Contra-indications

  • Hypersensitivity to hyoscine or any of its components
  • Myasthenia gravis
  • Glaucoma
  • Prostatic hypertrophy
  • Gastrointestinal obstruction

Adverse effects

  • Dry mouth
  • Dizziness
  • Drowsiness
  • Constipation
  • Blurred vision
  • Tachycardia
  • Urinary retention

Interactions

  • Anticholinergic drugs may enhance the effects of hyoscine
  • CNS depressants may increase sedation
  • Antihistamines may increase anticholinergic side effects

Precautions

  • Use with caution in patients with cardiovascular disease
  • Use with caution in elderly patients due to increased risk of side effects
  • May impair the ability to drive or operate machinery

Pregnancy

Hyoscine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is classified as Category C by the FDA.

Breast-feeding

Hyoscine is excreted in breast milk; caution should be exercised when administered to nursing mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Tablets
  • Injection
  • Transdermal patches
  • Oral solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: butyl

PubChem CID 137616

Molecular formula: C4H9

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: butylbromide

PubChem CID 8002

Molecular formula: C4H9Br

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.