Galoxin

Hyoscine butylbromide.

Each mL contains Hyoscine Butylbromide 20 mg.
Excipients/Inactive Ingredients: **Sodium chloride, Water for injection.

PHARMACOLOGY: Hyoscine Butylbromide exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genitourinary tracts. As a quarternary ammonium derivative, Hyoscine Butylbromide does not enter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion blocking action within the visceral wall as well as from an antimuscarinic activity.

Acute gastrointestinal, biliary and genitourinary spasm, including biliary and renal colic.
As an aid in diagnostic and therapeutic procedures, where spasm may be a problem, e.g. gastroduodenal endoscopy, and in radiology.

Adults and adolescents over 12 years: 1-2 ampoules of GALOXIN (20-40 mg) may be administered by slow intravenous, intramuscular injection several times daily.
The maximum dose should not exceed 100 mg per day.
GALOXIN injection should not be given continuously for a long time without investigating the cause of the abdominal pain.

Symptoms: In the case of overdose, anticholinergic effects may be observed.
Therapy: If required, parasympathomimetic drugs should be administered. Ophthalmological advice should be sought in cases of glaucoma urgently. 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.

Hyoscine Butylbromide injection are contraindicated in: Patients who have demonstrated prior hypersensitivity to Hyoscine Butylbromide or any other component of the product; Untreated narrow angle glaucoma; Hypertrophy of the prostate with urinary retention; Mechanical stenosis in the gastrointestinal tract; Tachycardia; Paralytic or obstructive ileus; Megacolon; Myasthenia gravis.
By intramuscular injection, Hyoscine Butylbromide injection are contraindicated: In patients being treated with anticoagulants drug since intramuscular haematoma may occur. In these patients, the subcutaneous or intravenous routes may be used.

In case severe, unexplained abdominal pain persist 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, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
Precaution and observation are needed for the use of Hyoscine Butylbromide injection in patients with heart disease.
Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Hyoscine Butylbromide 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 Hyoscine Butylbromide.
After parenteral administration of Hyoscine Butylbromide, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Hyoscine Butylbromide by injection should be kept under observation.
Effects on ability to drive and use machines: There are no studies on the effect on the ability to drive and use machines. However, patients should be advised that they may experience undesirable effects such as accommodation disorders or dizziness during treatment with Hyoscine Butylbromide injection. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience accommodation disorder or dizziness, potentially hazardous tasks such as driving or operating machinery should be avoid.
Use in Pregnancy & Lactation: Data on the use of Hyoscine Butylbromide in pregnant women are limited. Animal studies have shown no direct or indirect adverse effects to reproductive toxicity. Information on the excretion of Hyoscine Butylbromide and its metabolites in human milk is limited.
As a precautionary measure, it is preferable to avoid the use of Hyoscine Butylbromide during pregnancy and lactation.
No studies have been conducted on the effects of human fertility.

Data on the use of Hyoscine Butylbromide in pregnant women are limited. Animal studies have shown no direct or indirect adverse effects to reproductive toxicity. Information on the excretion of Hyoscine Butylbromide and its metabolites in human milk is limited.
As a precautionary measure, it is preferable to avoid the use of Hyoscine Butylbromide during pregnancy and lactation.
No studies have been conducted on the effects of human fertility.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Hyoscine Butylbromide. Anticholinergic side effects of Hyoscine Butylbromide are generally mild and self-limited.
Immune system disorders: Anaphylactic shock including fatal outcome, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity.
Eye disorders: Accomodation disorders, mydriasis, increased ocular hypertension.
Cardiac disorders: Tachycardia.
Vascular disorders: Blood pressure decreased, dizziness, flushing.
Gastrointestinal disorders: Dry mouth.
Skin and subcutaneous tissue disorders: Dyshidrosis.
Renal and urinary disorders: Urinary retention.

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, Quinidine, Amantadine, Disopyramide and other anticholinergics (e.g. Tiotropium, Ipratropium, Atropinelike compounds) may be intensified by Hyoscine Butylbromide.
Concomitant treatment with dopamine antagonists such as Metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
The tachycardiac effects of beta-adrenergic agents may be enhanced by Hyoscine Butylbromide.

Store below 30°C, protect from light.

Antispasmodics

A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.

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