Hyosincap

Hyoscine butylbromide.

Sugar-coated tablet: Each sugar-coated tablet contain: Hyoscine Butylbromide 10 mg.
Inj: Each mL contains: Hyoscine Butylbromide 20 mg.
Excipients/Inactive Ingredients: Inj: Sodium chloride, Water for injection.

Pharmacology: Sugar-coated tablet: Hyoscine Butylbromide has a specific antispasmodic effect on smooth muscle of the gastrointestinal tract, bile tract, and genito-urinary tract. As a quaternary ammonium derivative, Hyoscine-N-Butylbromide does not penetrate the central nervous system. Therefore, there are no anticholinergic side effects on the central nervous system. The peripheral anticholinergic effect of Hyoscine Butylbromide is due to inhibition of the ganglion in the visceral wall and its antimuscarinic effect.
Inj: Hyoscine Butylbromide exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genitourinary tracts. As a quaternary 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.

Sugar-coated tablet: Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genitourinary tract spasm.
Inj: 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.

Sugar-coated tablet: Unless the doctor prescribes otherwise, the recommended dosage:
Over 12 years: 1-2 tablets 3 or 4 times a day.
The sugar coated tablet should be swallowed whole with sufficient liquid.
HYOSINCAP SCT is not recommended to be used continuously for a long time. If the pain persists, contact a doctor.
Inj: Adults and adolescents over 12 years: 1-2 ampoules of HYOSINCAP (20-40 mg) may be administered by slow intravenous, intramuscular injection several times daily.
The maximum daily dose of 100 mg should not be exceeded.
HYOSINCAP Injection should not be given continuously for a long time without investigating the cause of the abdominal pain.

Symptoms: Sugar-coated tablet: Serious signs of poisoning following overdosage have not been observed in human.
In that case, anticholinergic effect such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes resporation has been reported.
Inj: In the case of overdose, anticholinergic effects may be observed.
Therapy: Sugar-coated tablet: In the case of oral poisoning, gastric lavage with carbone activated should be followed by magnesium sulphate (15%). Symptoms of Hyoscine Butylbromide overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally.
Inj: If required, parasympathomimetic drugs should be administered. Ophthalmological advice should be sought in cases of glaucoma urgently. Cardiovascular complications shuld 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 is contraindicated in:
1. Patients who have demonstrated prior hypersensitivity to Hyoscine Butylbromide or any other component of the product.
2. Myasthenia gravis
3. Megacolon
4. Mechanical stenosis of gastrointestinal tract
5. Urinary retention with subvesical obstruction (e.g.benign prostatic hyperplasia)
6. Untreated narrow angle glaucoma
7. Tachycardia
8. Tachyarrhytmia (sugar-coated tablet only)
9. Paralytic or obstructive ileus (inj only)
Sugar-coated tablet: In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to Precautions) the use of this product is contraindications.
Inj: By intramuscular injection, Hyoscine Butylbromide injection are contraindicated: In patients being treated with anticoagulant drug since intramuscular haematoma may occur. In these patients, the subcutaneous or intravenous routes may be used.

Sugar-coated tablet: In severe and unexplained cases persist or worsen, or occur together with symptoms such as fever, nausea, vomiting, change in bowel behavior, abdominal pain, drop in blood pressure, fainting or blood in the stool, medical action should be given immediately.
Hyoscine Butylbromide should be used with caution in conditions characterized by tachycardia, such as thyrotoxicosis, cardiac insufficiency or cardiac surgery failure in which Hyoscine Butylbromide can accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be given to patients prone to intestinal or urinary tract obstruction. Due to the possibility that anticholinergics may reduce sweat production, Hyoscine Butylbromide should be used with caution against pyrexia patients.
The increase in intraocular pressure can be caused by the use of an anticholinergic agent such as Hyoscine Butylbromide in a patient with untreated narrow angle glaucoma. Therefore, if there is pain and reddening of the eyes accompanied by reduced vision after administering Hyoscine Butylbromide, the patient must immediately seek advice from an ophthalmologist.
Inj: 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 is 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.
Effect on ability to drive and operate machinery: Sugar-coated tablet: There are no studies regarding the effect on the ability to drive and operate machinery.
Inj: 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.

Data on the use of Hyoscine-N-Butylbromide in pregnant women are limited.
Animal studies have shown no direct or indirect harmful effects with respect to reproductive toxicity.
Information on the excretion of Hyoscine Butylbromide and its metabolites in breast milk is limited.
As a precaution, during pregnancy and breastfeeding patient should avoid using Hyoscine Butylbromide.
No studies have been conducted on the effects of human fertility.

Sugar-coated tablet: Many of the listed adverse effects of Hyoscine Butylbromide can have anticholinergic effects.
Immune system disorders: Rarely: hypersensitive reactions.
Unknown: anaphylactic reaction with dyspnea and anaphylactic shock with decreased blood pressure and redness.
Usual: skin reactions such as urticaria, rash, erythema, pruritus, and other hypersensitivity.
Heart disorders: Usual: tachycardia, dizziness and drowsiness.
Gastrointestinal disorders: Usual: dry mouth (inhibition of salivary secretion),diarrhea, nausea, vomiting, stomach pain.
Skin and subcutaneous tissue disorders: Usual: dyshidrosis, inhibition of sweat secretion.
Kidney and bladder disorders: Rarely: urinary retention, urinary disorders such as dysuria.
Visual disturbances: Very rare: impaired accommodation, especially in patients with long visibility and who have not received sufficient visual aid; glaucoma attacks.
Inj: 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: Accommodation 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, Disopiramide and other anticholinergics (such as Tiotropium, Ipratropium, compounds such as Atropine) can be strengthened by Hyoscine Butylbromide. Co-administration with Dopamine antagonists such as Metoclopramide will exert a mutually neutralizing effect on the gastrointestinal tract. The tachycardic effect of beta-adrenergic drugs will be amplified by Hyoscine Butylbromide.

Store below 30°C, away 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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