Farcorelaxin Ampoule for acute spasm

INDICATIONS: What are the uses of Farcorelaxin injection?

Farcorelaxin ampoules are indicated in acute spasm as:

  • in renal or biliary colic.
  • in radiology for differential diagnosis of obstruction.
  • 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 dosage: 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 Farcorelaxin).
  • When used in endoscopy this dose may need to be repeated more frequently. 
  • Maximum daily dose of 100 mg.

Diluent: Farcorelaxin injection solution may be diluted with dextrose or with sodium chloride 0.9% injection solutions. 

USE IN ELDERLY: 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: When not to use Farcorelaxin?

Farcorelaxin 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.
  • Farcorelaxin ampoules should not be used in patients who have demonstrated prior hypersensitivity to Hyoscine-N-butyl bromide or any other component of the product.
  • Farcorelaxin ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular hematoma may occur. 

SIDE EFFECTS

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Farcorelaxin

  • 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.
  • Renal and urinary disorders: Urinary retention.
  • Injection site pain, particularly after intramuscular use, occurs. 
  • Central nervous system disorders: Hyoscine -N- butyl bromide, the active ingredient of Farcorelaxin, due to its chemical structure as a quaternary ammonium derivative, 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 Farcorelaxin.

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 Farcorelaxin.
  • The tachycardic effects of beta-adrenergic agents may be enhanced by Farcorelaxin.
  • Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract. 

WARNINGS AND PRECAUTIONS

  • Farcorelaxin 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, Farcorelaxin should be administered with caution to patients with pyrexia. 
  • Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Farcorelaxin in patients with undiagnosed and therefore untreated narrow angle glaucoma.Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, redeye with loss of vision after the injection of Farcorelaxin.
  • After parenteral administration of Farcorelaxin, cases of anaphylaxis including episodes of shock have been observed.As with all drugs causing such reactions, patients receiving Farcorelaxin 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 of Farcorelaxin until vision has normalized. 

PREGNANCY AND LACTATION

Although Farcorelaxin 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.
  • transient visual disturbances may occur.
  • Cheynes-Stokes respiration has been reported. 

Therapy: 

  • Symptoms of Farcorelaxin overdose 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.

Other information

  • GENERIC NAME: Hyoscine -N- butyl bromide.
  • COMPOSITION: Each ampoule contains: Active ingredient: Hyoscine -N- butyl bromide 20 mg.
  • PHARMACEUTICAL FORM: Ampoule.
  • PHARMACOLOGICAL ACTION: Farcorelaxin 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 L. The half- life of the terminal elimination phase is approximately 5 hours. The total clearance is 1.2 I/min, approximately half of the clearance is renal. ln rat, highest concentrations of Hyoscine -N-butyl 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.

Patient Information Leaflet

For Arabic Information
Farcorelaxin- Arabic Information

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