Properties
What is it?
International Nonproprietary Name - Hyoscine butylbromide Composition: 1 ampoule (1 ml) contains: Active substance: Hyoscine butylbromide – 20 mg Excipients: Sodium chloride, water for injection. Description: Clear, colorless or almost colorless solution, practically odorless, free from visible particles. Pharmacological group: M-cholino blocker. Indications: Acute spastic conditions of the gastrointestinal, biliary, and genitourinary tracts (including biliary and renal colic). Diagnostic and therapeutic procedures complicated by the presence of spasms (gastroduodenoscopy, X-ray examination, and others). Dosage and Administration: Adults and children over 12 years of age: 1-2 ampoules (20-40 mg) IV slowly, IM or SC several times a day. Maximum daily dose is 100 mg. Children under 12 years of age: In severe cases: 0.3-0.6 mg/kg IV slowly, IM or SC several times a day. Maximum dose is 1.5 mg/kg. Side effects: Anticholinergic side effects may occur: dry mouth, anhidrosis, tachycardia, possible urinary retention, which is usually not pronounced and resolves spontaneously. In rare cases, dizziness, a drop in blood pressure and facial flushing are observed. Very rarely, hypersensitivity reactions have occurred, including skin reactions, breathing difficulties, anaphylactic reactions and anaphylactic shock. Contraindications: • Hypersensitivity to hyoscine butylbromide or other components of the preparation; • Angle-closure glaucoma (untreated); • Benign prostatic hyperplasia with urinary retention; • Mechanical intestinal obstruction; • Tachycardia; • Megacolon; • Myasthenia gravis. Pregnancy and lactation: No data is provided on the use of the preparation during pregnancy. However, as with the use of other preparations, it is advisable to administer the preparation with particular caution during pregnancy, especially during the first trimester. The safety of the preparation during lactation has not been established. However, no data are available on the adverse effects of the drug on infants.