APR MEFCYP ADVANCE

AF-27:

INFORMATION FOR THE USER

Butylbromide Injection

Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1.COMPOSITION:
Eachml ampoule contains:
Butylbromide IP – 20mg

For IV/IM use only.

2.DESCRIPTION:
Butylbromide is an antispasmodic and helps to control spams associated with the GI system.

3.PHARMACOLOGICAL ACTION:
Butylbromide is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal & pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

4.CLINICAL PHARMACOKINETICS:
After IV administration butylbromide is rapidly distributed (t½α = 4 min, t½β = 29 min) into the tissues. The volume of distribution is 128L (corresponding to approx. 1.7 L/kg). Because of its high affinity for muscarinic receptors & nicotinic receptors, it is mainly distributed on muscle cells of the abdominal & pelvic area as well as in the intramural ganglia of the abdominal organs. Plasma protein binding is approx. 4.4%. It does not pass the blood-brain barrier, but no clinical data to this effect is available. It has been observed to interact with the choline transport (1.4 nM) in epithelial cells of human placenta in vitro. The main metabolic pathway is the hydrolytic cleavage of the ester bond. The half-life of the terminal elimination phase (t½γ) is approx. 5 hrs. The total clearance is 1.2 L/min. Studies with radiolabeledbutylbromide show that after IV injection 42-61% of the dose is excreted renally & 28.3-37% faecally. The portion of unchanged active ingredient excreted in the urine is approx. 50%. Metabolites excreted via the renal route bind poorly to the muscarinic receptors & are not considered to contribute to the effect of butylbromide.
5.INDICATIONS:
Butylbromide injection is indicated for the treatment of:
-Acute spasm, as in renal/biliary colic
-In radiology for differential diagnosis of obstruction & to reduce spasm & pain in pyelography
– Other diagnostic procedures where spasm may be a problem, e.g. gastro-duodenal endoscopy.

6.CONTRAINDICATIONS:
– Hypersensitivity to the active substance or to any of the excipients
– Narrow angle glaucoma
– Hypertrophy of the prostate with urinary retention
– Mechanical stenosis in the GI tract
– Paralytical or obstructive ileus
– Megacolon
– Tachycardia
– Myasthenia gravis
– Should not be given by IM injection to patients being treated with anticoagulant drugs since IM haematoma may occur

7. WARNINGS AND PRECAUTIONS:
In case severe unexplained abdominal pain persists or worsens or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased BP, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the aetiology of the symptoms.
Can cause tachycardia, hypotension & anaphylaxis. Use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease, cardiac arrhythmia or hypertension & in cardiac surgery. Monitoring of these patients is advised. Emergency equipment & personnel trained in its use must be readily available.
Because of the possibility that anticholinergics may reduce sweating it should be administered with caution to patients with pyrexia.
Elevation of IOP may be produced by the administration of anticholinergic agents in patients with undiagnosed & therefore untreated narrow angle glaucoma. Patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision after the injection.
After parenteral administration, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients should be kept under observation.

8.ADVERSE EFFECTS:
Common side effects include: Accomodation disorders, Tachycardia, Dizziness, Dry mouth, Constipation, Pain at injection site,

9.DRUG INTERACTIONS:
The anticholinergic effect of drugs such as tri- & tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. phenothiazines), disopyramide& other anticholinergics (e.g. tiotropium, ipratropium) may be intensified.
The tachycardic effects of beta-adrenergic agents may be enhanced.
Concomitant treatment with dopamine antagonists (ex. Metoclopramide) may result in diminution of the effects of both drugs on the GI tract.
10.DOSAGE:
One ampoule (20mg) IM/IV, repeated after half an hour if necessary. IV injection should be performed ‘slowly’ (in rare cases a marked drop in BP & even shock may be produced). When used in endoscopy this dose may need to be repeated more frequently.
Max. daily dose of 100mg.

11. ADMINISTRATION:
For IV/IM use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile and hospital setting only.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.

13.MANUFACTURED BY:
14.MARKETED BY:

Last revised on August 2020.