Spasmoson

Spasmoson

hyoscine

Manufacturer:

Jayson Pharma

Distributor:

AGlobal Care
Full Prescribing Info
Contents
Hyoscine-N-butylbromide.
Description
Each mL contains: Hyoscine-N-Butylbromide 20 mg.
Action
Pharmacology: Pharmacodynamics: Hyoscine-N-Butylbromide (Spasmoson) is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.
Pharmacokinetics: Absorption and distribution: After intravenous administration Hyoscine-N-Butylbromide is rapidly distributed (t½α = 4 min, t½β = 29 min) into the tissues. The volume of distribution (Vss) is 128 L (corresponding to approx. 1.7 L/kg). Because of its high affinity for muscarinic receptors and nicotinic receptors, hyoscine butylbromide is mainly distributed on muscle cells of the abdominal and pelvic area as well as in the intramural ganglia of the abdominal organs. Plasma protein binding (albumin) of Hyoscine-N-Butylbromide is approximately 4.4%. Animal studies demonstrate that Hyoscine-N-Butylbromide does not pass the blood-brain barrier, but no clinical data to this effect is available. Hyoscine-N-Butylbromide (1 mM) has been observed to interact with the choline transport (1.4 nM) in epithelial cells of human placenta in vitro.
Metabolism and elimination: The main metabolic pathway is the hydrolytic cleavage of the ester bond. The half-life of the terminal elimination phase (t½γ) is approximately 5 hours. The total clearance is 1.2 L/min.
Clinical studies with radiolabeled Hyoscine-N-Butylbromide show that after intravenous injection 42 to 61% of the radioactive dose is excreted renally and 28.3 to 37% faecally.
The portion of unchanged active ingredient excreted in the urine is approximately 50%. The metabolites excreted via the renal route bind poorly to the muscarinic receptors and are therefore not considered to contribute to the effect of the Hyoscine-N-Butylbromide.
Paediatric population: No particular pharmacokinetic studies concerning Hyoscine-N-Butylbromide have been performed in children.
Indications/Uses
Indicated in acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem, e.g. gastro-duodenal endoscopy.
Dosage/Direction for Use
Adults: One ampoule (20 mg) intramuscularly or intravenously, repeated after half an hour if necessary. Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by Hyoscine-N-Butylbromide (Spasmoson). When used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Special populations: Elderly: No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Paediatric population Not recommended for children.
Hyoscine-N-Butylbromide (Spasmoson) should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
Diluent: Hyoscine-N-Butylbromide (Spasmoson) solution may be diluted with dextrose or with sodium chloride 0.9% injection solutions.
Overdosage
Symptoms: Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.
Therapy: Symptoms of Hyoscine-N-Butylbromide (Spasmoson) overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required.
Contraindications
Hyoscine-N-Butylbromide (Spasmoson) are contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients; Narrow angle glaucoma; Hypertrophy of the prostate with urinary retention; Mechanical stenos is in the gastrointestinal tract; Paralytical or obstructive ileus; Megacolon; Tachycardia; Myasthenia gravis.
Hyoscine-N-Butylbromide (Spasmoson) should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
Special 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 blood pressure, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
Hyoscine-N-Butylbromide (Spasmoson) can cause tachycardia, hypotension and anaphylaxis, therefore use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease, cardiac arrhythmia or hypertension, and in cardiac surgery. Monitoring of these patients is advised. Emergency equipment and personnel trained in its use must be readily available.
Because of the possibility that anticholinergics may reduce sweating, Hyoscine-N-Butylbromide (Spasmoson) should be administered with caution to patients with pyrexia.
Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Hyoscine-N-Butylbromide (Spasmoson) in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision after the injection of Hyoscine-N-Butylbromide (Spasmoson).
After parenteral administration of Hyoscine-N-Butylbromide (Spasmoson), cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Hyoscine-N- Butylbromide (Spasmoson) by injection should be kept under observation.
Use In Pregnancy & Lactation
Pregnancy: There are limited data from the use of Hyoscine-N-Butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure Hyoscine-N-Butylbromide (Spasmoson) is not recommended during pregnancy.
Lactation: There is insufficient information on the excretion of Hyoscine-N-Butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of Hyoscine-N-Butylbromide (Spasmoson) during breastfeeding is not recommended.
Adverse Reactions
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Hyoscine-N-Butylbromide (Spasmoson).
Adverse events have been ranked under headings of frequency using the following convention: Very common ≥1/10; Common ≥1/100, <1/10; Uncommon ≥1/1,000, <1/100; Rare ≥1/10,000 ,<1/1,000; Very rare <1/10,000; Not known cannot be estimated from the available data.
Immune system disorders: Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus)and other hypersensitivity.
Eye disorders: Common: accommodation disorders. Not known*: mydriasis, increased intraocular pressure.
Cardiac disorders: Common: tachycardia.
Vascular disorders: Common: dizziness. Not known*: blood pressure decreased, flushing.
Gastrointestinal disorders: Common: dry mouth, constipation.
Skin and subcutaneous tissue disorders: Not known*: dyshidrosis.
Renal and urinary disorders: Not known*: urinary retention.
Injection site pain, particularly after intramuscular use, occurs.
Hyoscine-N-Butylbromide, the active ingredient of Spasmoson, due to its chemical structure as a quaternary ammonium derivate, is not expected to enter the central nervous system. Hyoscine-N-Butylbromide does not readily pass the blood-brain barrier.
However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur after administration of Hyoscine-N-Butylbromide (Spasmoson).
*This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than common, 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 185 patients.
Drug Interactions
The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. phenothiazines, butyrophenones), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Hyoscine-N-Butylbromide (Spasmoson).
The tachycardic effects of beta-adrenergic agents may be enhanced by Hyoscine-N-Butylbromide (Spasmoson).
Concomitant treatment with dopamine antagonists such as Metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
MIMS Class
ATC Classification
A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Soln for inj (amp) 20 mg/mL (colourless or almost colourless, clear) x 1 mL x 10's.
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