Composition:
Each 1ml of ampoule contains 20mg hyoscine butyl bromide.
Excipients:
Sodium Chloride and water for injection.
Indications:
Hyscopan is indicated for the relief of acute genitourinary or gastrointestinal spasm (e.g., renal or biliary colic), or to produce smooth muscle relaxation prior to radiological procedures such as pyelography or other diagnostic procedures where spasm may be a problem (e.g., gastro-duodenal endoscopy)
Contraindications:
- Hypersensitivity to hyoscine butylbromide, or atropinics or to any of the product excipients.
- Parenteral administration is contraindicated in patients with myasthenia gravis, untreated narrow angle glaucoma, prostatic hypertrophy with urinary retention, stenotic lesions of the gastrointestinal tract, tachycardia, angina, cardiac failure and megacolon.
- Ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. In these patients, the subcutaneous or intravenous routes may be used.
Warnings and Precautions:
The drug should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
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, medical advice should immediately be sought.
Therapy should be discontinued if the patient reports any unusual visual disturbances or pressure pain within the eye.
After parenteral administration of the drug, cases of anaphylaxis, including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving the drug by injection should be kept under observation.
Hyoscine butylbromide ampoules should be used with caution in patients with prostatic enlargement. The drug may precipitate or aggravate urinary retention in patients with the following conditions: nonobstructive prostatic hypertrophy, urinary retention (or the predisposition to) or obstructive uropathy such as a bladder neck obstruction due prostatic hypertrophy.
Cardiovascular: as large doses of anticholinergics/systemic antispasmodics may cause an increase in heart rate, due care is necessary in patients with cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease and mitral stenosis.
Gastrointestinal: Exercise caution in patients with reflux esophagitis or gastrointestinal tract obstructive disease )pyloroduodenal stenosis)
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 the drug.
Antacids or adsorbent antidiarrheals may reduce the absorption of anticholinergics, resulting in decreased therapeutic effectiveness.
The tachycardic effects of betaadrenergic agents may be enhanced by the drug.
Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
Pregnancy:
There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure the drug is not recommended during Pregnancy.
Lactation:
There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of the drug during breastfeeding is not recommended.
Pediatrics: The drug is not currently recommended for use in children.
Elderly: Geriatric patients are especially susceptible to the anticholinergic side effects of constipation, dryness of mouth and urinary retention (especially in males). If these side effects continue or are severe, discontinuation of medication should be considered.
Administration of anticholinergics/systemic antispasmodics to elderly patients with intestinal atony or in debilitated patients may result in obstruction.
Effects on ability to drive and use machines:
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as accommodation disorder or dizziness during treatment with ampoules. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience accommodation disorder or dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.
Undesirable effects:
Many of the listed undesirable effects can be assigned to the anticholinergic properties of the drug. Anticholinergic side effects of the drug are generally mild and self-limited: xerostomia (dry mouth), dyshidrosis, visual accommodation disorders, mydriasis, increased intraocular pressure, tachycardia, dyspnea, and urinary retention.
There have been rare reports of dizziness, blood pressure decreased and flushing.
Skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity, angioedema.
Adverse events reported during therapy with the drug include increased pulse rate, diarrhea, nausea, retinal pigmentation, and glaucoma.
Dosage and Administration:
Adults: One half (10mg/0.5mL) to one ampoule (20 mg/1mL) administered parenterally by intramuscular, subcutaneous, or intravenous routes, at an injection rate of 1 mL/min. No dilution of the ampoule is necessary prior to administration. Repeated after half an hour if necessary. The maximum dose should not exceed 100 mg/day (5 ampoules).
Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by hyoscine butyl bromide). When used in endoscopy this dose may need to be repeated more frequently.
Ampoules may also be used intramuscularly 10-15 minutes before radiological examinations of the stomach to slow peristaltic movements.
Although dilution prior to administration is not required, ampoule is compatible with the following solutions, should dilution be desirable: Ringers Solution ,Ringers Lactate ,NaCl 0.9% ,Laevulose 5% ,Glucose 10%.
Solutions must be mixed under sterile conditions and are stable for 8 hours.
Paediatric population: Not recommended for children. Hyscopan Ampoules should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. In severe cases: ¼ ampoule of Hyscopan (5mg) to be administered by slow intravenous, intramuscular or by subcutaneous injection 3 times daily. The maximum daily dose of 1,5 mg/kg bodyweight should not be exceeded.
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.
Treatment:
The drug overdose symptoms respond to parasympathomimetics.
For patients with glaucoma, administer pilocarpine locally. If necessary, parasypathomimetics should be administered, e.g. neostigmine 0.5-2.5 mg i.m. or i.v.. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratiory paralysis: intubation, artificial respiration Catheterization may be required for urinary retention.