Each ml contains: Hyoscine N-Butylbromide 20 mg.
Pharmacology: Pharmacodynamics: Fucon Solution for Injection 20mg/ml 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 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, hyoscine butylbromide is mainly distributed on muscle cells of the abdominal and pelvic area as wells as in the intramural ganglia of the abdominal organs. Plasma protein binding (albumin) of hyoscine butylbromide is approximately 4.4%. Hyoscine butylbromide (1mM) has been observed to interact with choline transport (1.4 nM) in epithelial cells of human placenta in vitro.
Metabolism and elimination: The main metabolic pathway is the hydrolic 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. 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 butylbromide.
Pediatric population: No particular pharmacokinetic studies hyoscine butylbromide have been performed in children.
Fucon Solution for Injection 20mg/ml is indicated in acute spasm, as in renal or biliary chronic, in radiology for differential diagnosis of obstruction. It also indicated to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem.
Fucon Solution for Injection 20m/ml may be administered by intramuscular or intravascular injection.
Adults: One ampoule (20mg) should be given IM or IV, 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). When used in endoscopy this may need to be repeated more frequently. Maximum daily doses of 100mg.
Not recommended for children under 12 years old.
Mode of Administration: Intramuscular or intravenous.
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 Fucon Solution for Injection 20mg/ml 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.
Fucon Solution for Injection 20mg/ml 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 stenosis in the gastrointestinal tract, paralytical or obstructive ileus, megacolon, tachycardia, myasthenia gravis.
Fucon Solution for Injection 20mg/ml should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
Fucon Solution for Injection 20mg/ml should not be administered to patients with tachycardia.
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 of blood pressure, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
Fucon Solution for Injection 20mg/ml can cause tachycardia, hypotension and anaphylaxis, therefore use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease or cardiac arrhythmia and patients with cardiovascular disease (e.g. acute myocardial infarction, hypertension and conditions associated with tachycardia 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, Fucon Solution for Injection 20mg/ml should be administered with caution to patients with pyrexia.
Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Fucon Solution for Injection 20mg/ml 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 Fucon Solution for Injection 20mg/ml.
After parenteral administration of Fucon Solution for Injection 20mg/ml, case of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Fucon Solution for Injection 20mg/ml by injection should be kept under observation.
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 Fucon Solution for Injection 20mg/ml. 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 machine.
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 Fucon Solution for Injection 20 mg/ml 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 Fucon Solution for Injection 20mg/ml is not recommended.
Fertility: No studies on the effects on human fertility have been conducted.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Fucon Solution for Injection 20mg/ml.
Immune system disorders: Not known*: anaphylactic shock including cases with fatal outcome, anaphylactic reactions, dyspnea, 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 butylbromide, the active ingredient of Fucon Solution for Injection 20mg/ml, due to its chemical structure as a quaternary ammonium derivative, is not expected to enter the central nervous system. Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstance psychiatric disorders (e.g. confusion) may also occur after administration of Fucon Solution for Injection 20mg/ml.
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 Fucon Solution for Injection 20mg/ml. The tachycardiac effects of beta-adrenergic agents may be enhanced by Fucon Solution for Injection 20mg/ml. Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
Store at temperature below 30°C. Protect from light and moisture.
Shelf-Life: 3 years from the date of manufacture.
A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.
Soln for inj 20 mg/mL (a clear and colorless solution in amp) x 10's.