COMPOSITION :
Hyoscinox® Injection 20 mg/ml, each ml contains : Hyoscine butylbromide 20 mg.
DESCRIPTIONS :
Hyoscinox® with Hyoscine butylbromide as active ingredient is available in 20 mg/ml injection.
INDICATIONS :
Acute spasms in the gastrointestinal, biliary and genito-urinary tracts, include biliary colic and renal colic. As an additional procedure in diagnostics and therapy, where spasm may be a problem, for example in the gastro-duodenal endoscopy and on radiology.
DOSAGE AND ADMINISTRATIONS :
Adults and children over 12 years :
1 – 2 ampoules Hyoscinox® (20 – 40 mg) may be administered by slow IV or IM injections several times a day.
The maximum dose should not exceed 100 mg/day.
Hyoscinox® ampoules should not be administered continuously in the long term period without investigating the cause of the abdominal pain.
OVERDOSAGE :
- Symptoms : In case of overdose, anticholinergic effects have been found.
- Treatment : If needed, parasympathomimetic may be given. Should contact an ophthalmologist in case of glaucoma. Cardiac complications should be treated according to the principle of therapy in general. In case of respiratory paralysis : Intubation and artificial respiration may be performed. Catheterization may be performed in case of urinary retention. Where appropriate should be given appropriate support therapy.
CONTRAINDICATIONS :
- Patients who demonstrate hypersensitivity to Hyoscine butylbromide or other components of this product.
- Narrow-angle glaucoma untreated.
- Prostate hypertrophy with urinary retention.
- Mechanical stenosis in the gastrointestinal tract.
- Tachycardia
- Megacolon
- Myasthenia gravis.
- With IM injection of Hyoscine butylbromide ampoules are contraindicated in patients being treated with anticoagulant drugs because intramuscular hematoma may occur. In these patients, subcutaneous or intravenous routes may be used.
- Paralytic or obstructive ileus.
WARNINGS AND PRECAUTIONS :
- In cases of explained or unexplained abdominal pain persists or worsens, or occurs simultaneously with symptoms such as fever, nausea, vomiting, changes in bowel behavior, abdominal pain, decreased blood pressure, fainting or blood in faeces, appropriate diagnostic measures are needed to investigate the etiology of these symptoms.
- Increased intraocular pressure can be generated by the use of anticholinergic agents such as Hyoscine butylbromide in patients with narrow-angle glaucoma are undiagnosed and untreated. Therefore, when there is pain and reddened eyes are accompanied by diminished vision after administration of Hyoscine butylbromide Injection, patients should immediately seek advice from an ophthalmologist.
- After parenteral administration of Hyoscine butylbromide, has been found cases of anaphylaxis including shock. As with all medications that cause these reactions, patients who received the Hyoscine butylbromide Injection should be under the supervision.
- Attention and supervision required for use Hyoscine butylbromide Injection in patients with cardiac disorders conditions.
- Fertility, pregnancy and lactation :
There is limited data from the use of Hyoscine butylbromide in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
There is insufficient information on the excretion of Hyoscine butylbromide and its metabolites in human milk.
As a precautionary measure, it is preferable to avoid the use of Hyoscine butylbromide during pregnancy and lactation.
No studies on the effects on human fertility have been conducted. - 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 Hyoscine butylbromide 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.
PRESENTATION :
Hyoscinox® Injection 20 mg/ml Box, 5 ampoules @ 1 ml Reg. No. DKL1902360843A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
