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| Spasmocin Pamphlet |
Spasmocin
GENERIC NAME:
Hyoscine -N- butyl bromide
COMPOSITION:
Each ampoule contains:
Active ingredient:
Hyoscine -N- butyl bromide 20 mg
Excipients:
Water for injection
PHARMACEUTICAL FORM: Ampoule
PHARMACOLOGICAL ACTION:
Spasmocin 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:
After intravenous administration Hyoscine -N- butyl bromide is rapidly distributed into the tissues.
The volume of distribution (Vss) is 128 I. The half- life of the terminal elimination phase (tY2 j’) is
approximately 5 hours. The total clearance is
1.2 1/mm, approximately half of the clearance is renal.ln rat, highest concentrations of Hyoscine -Nbutyl bromide are found in the tissue of the
gastrointestinal tract, liver and kidneys. Plasma protein binding of Hyoscine -N- butyl bromide is low. Hyoscine -N- butyl bromide does not readily pass the blood-brain barrier.
INDICATIONS:
Spasmocin ampoules are 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 AND ADMINISTRATION:
Not recommended for children.
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 Spasmocin). When used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Diluent:
Spasmocin injection solution may be diluted with dextrose or with sodium chloride 0.9% injection solutions. 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
CONTRAINDICATIONS:
Spasmocin ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal
tract or paralytic ileus. Spasmocin ampoules
should not be used in patients who have
demonstrated prior hypersensitivity to Hyoscine-Nbutyl bromide or any other component of the
product. Spasmocin ampoules should not be
given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
SIDE EFFECTS:
Many of the listed undesirable effects can be
assigned to the anticholinergic properties of
Spasmocin:
Immune system disorders:
Anaphylactic shock including cases with fatal
outcome, anaphylactic reactions, dyspnoea, skin reactions and other hypersensitivity.
Eye disorders: Accommodation disorders
Cardiac disorders: Tachycardia
Vascular disorders: Blood pressure decreased,
GENERIC NAME:
Hyoscine -N- butyl bromide
COMPOSITION:
Each ampoule contains:
Active ingredient:
Hyoscine -N- butyl bromide 20 mg
Excipients:
Water for injection
PHARMACEUTICAL FORM: Ampoule
PHARMACOLOGICAL ACTION:
Spasmocin 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:
After intravenous administration Hyoscine -N- butyl bromide is rapidly distributed into the tissues.
The volume of distribution (Vss) is 128 I. The half- life of the terminal elimination phase (tY2 j’) is
approximately 5 hours. The total clearance is
1.2 1/mm, approximately half of the clearance is renal.ln rat, highest concentrations of Hyoscine -Nbutyl bromide are found in the tissue of the
gastrointestinal tract, liver and kidneys. Plasma protein binding of Hyoscine -N- butyl bromide is low. Hyoscine -N- butyl bromide does not readily pass the blood-brain barrier.
INDICATIONS:
Spasmocin ampoules are 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 AND ADMINISTRATION:
Not recommended for children.
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 Spasmocin). When used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Diluent:
Spasmocin injection solution may be diluted with dextrose or with sodium chloride 0.9% injection solutions. 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
CONTRAINDICATIONS:
Spasmocin ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal
tract or paralytic ileus. Spasmocin ampoules
should not be used in patients who have
demonstrated prior hypersensitivity to Hyoscine-Nbutyl bromide or any other component of the
product. Spasmocin ampoules should not be
given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
SIDE EFFECTS:
Many of the listed undesirable effects can be
assigned to the anticholinergic properties of
Spasmocin:
Immune system disorders:
Anaphylactic shock including cases with fatal
outcome, anaphylactic reactions, dyspnoea, skin reactions and other hypersensitivity.
Eye disorders: Accommodation disorders
Cardiac disorders: Tachycardia
Vascular disorders: Blood pressure decreased,
dizziness, flushing.
Gastrointestinal disorders: Dry mouth, constipation Skin and subcutaneous tissue disorders: Dyshidrosis Rena! and urinary disorders: Urinary retention Injection site pain, particularty after intramuscular use, occurs. Hyoscine -N- butyl bromide, the active ingredient of Spasmocin, due to its chemical structure as a quatemary ammonium derivate, is not expected to enter the central nervous system. Hyoscine-N- butyl bromide 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 Spasmocin.
DRUG INTERACTIONS:
The anticholinergic effect of drugs such as tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenones, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium) may be intensified by Spasmocin. The tachycardic effects of betaadrenergic agents may be enhanced by Spasmocin. Concomitant treatment with dopamine antagonists suclias metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
WARNINGS AND PRECAUTIONS:
Spasmocin ampoules should be used with caution in conditions characterized by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Because of the possibility that anticholinergics may reduce sweating, Spasmocin should be administered with caution to patients with pyrexia. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Spasmocin 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 Spasmocin. After parenteral administration of Spasmocin, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Spasmocin by injection should be kept under observation.
Effect on ability to drive and use machines:
Because of visual accommodation disturbances patients should not drive or operate machinery after parenteral administration ofSpasmocin until vision has-normalized.
PREGNANCY AND LACTATION:
Although Spasmocin has been in wide general use for many years, there is no definitive evidence of ill- consequence during human pregnancy;animal studies have shown no hazard. Nevertheless, medicines should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus. Safety during lactation has not yet been established.
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 Spasmocin 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 and artificial respiration. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required. THERAPEUTIC CATEGORY: Antispasmodic LEGAL CATEGORY: POM
STORAGE: Store at a temperature not exceeding 30°C, Protect from light.
PACKAGE: Carton box containing 6 amber glass ampoules each of I ml.
For single use only, Any unused solution should be discarded.
Gastrointestinal disorders: Dry mouth, constipation Skin and subcutaneous tissue disorders: Dyshidrosis Rena! and urinary disorders: Urinary retention Injection site pain, particularty after intramuscular use, occurs. Hyoscine -N- butyl bromide, the active ingredient of Spasmocin, due to its chemical structure as a quatemary ammonium derivate, is not expected to enter the central nervous system. Hyoscine-N- butyl bromide 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 Spasmocin.
DRUG INTERACTIONS:
The anticholinergic effect of drugs such as tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenones, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium) may be intensified by Spasmocin. The tachycardic effects of betaadrenergic agents may be enhanced by Spasmocin. Concomitant treatment with dopamine antagonists suclias metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
WARNINGS AND PRECAUTIONS:
Spasmocin ampoules should be used with caution in conditions characterized by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Because of the possibility that anticholinergics may reduce sweating, Spasmocin should be administered with caution to patients with pyrexia. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Spasmocin 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 Spasmocin. After parenteral administration of Spasmocin, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Spasmocin by injection should be kept under observation.
Effect on ability to drive and use machines:
Because of visual accommodation disturbances patients should not drive or operate machinery after parenteral administration ofSpasmocin until vision has-normalized.
PREGNANCY AND LACTATION:
Although Spasmocin has been in wide general use for many years, there is no definitive evidence of ill- consequence during human pregnancy;animal studies have shown no hazard. Nevertheless, medicines should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus. Safety during lactation has not yet been established.
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 Spasmocin 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 and artificial respiration. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required. THERAPEUTIC CATEGORY: Antispasmodic LEGAL CATEGORY: POM
STORAGE: Store at a temperature not exceeding 30°C, Protect from light.
PACKAGE: Carton box containing 6 amber glass ampoules each of I ml.
For single use only, Any unused solution should be discarded.
((Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for yo’
- FoIbv strictly the doctors prescription, the method of use and the instructions of the pharmacist who sales the medicament
- The doctor and the pharmacist are experts in medicine. Ws benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
-keep medjcament out of children reach. Council of Arab Health Ministers and Union of Arab Pharmacists
- FoIbv strictly the doctors prescription, the method of use and the instructions of the pharmacist who sales the medicament
- The doctor and the pharmacist are experts in medicine. Ws benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
-keep medjcament out of children reach. Council of Arab Health Ministers and Union of Arab Pharmacists
Memphis Co. For Pharm. & Chemical md. - Cairo - Egypt
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