Buscopan rectal suppositories 10mg, No. 10

• Renal colic,

• biliary colic

• spastic dyskinesia of the biliary tract and gallbladder,

• cholecystitis,

• intestinal colic,

• pylorospasm,

• peptic ulcer of the stomach and duodenum in the acute phase (as part of complex therapy),

• algodismenorrhea.

Rectally.

Unless otherwise prescribed by a doctor, the following dosing regimen is recommended:

Adults and children over 6 years old: rectally 1-2 suppositories 3-5 times a day.

The suppositories should be removed from the packaging and inserted into the rectum with the pointed end.

The drug should not be used daily for more than 3 days without consulting a doctor.

1 suppository contains 10 mg of hyoscine butyl bromide

Excipients: purified water - 10 mg, solid fat W45-1610 mg.

• Myasthenia gravis, megacolon.

• Hypersensitivity to hyoscine butyl bromide or any other component of the drug.

• Children under 6 years old.

• Pregnancy, lactation.

Trademarked name: Buscopan

INN or Generic Name: hyoscine butyl bromide

Dosage form:

rectal suppositories

Composition

1 suppository contains 10 mg of hyoscine butyl bromide

Excipients: purified water - 10 mg, solid fat W45-1610 mg.

Description white or ivory, smooth, oblong suppositories.

Pharmacotherapeutic group:

m-holinoblokator [ј03¬¬01]

Pharmacological properties

It has a local antispasmodic effect on the smooth muscles of the internal organs (gastrointestinal tract, biliary tract, urinary tract), reduces the secretion of the digestive glands. The local antispasmodic effect is explained by the ganglion-blocking and antimuscarinic activity of the drug. As a quaternary ammonium derivative, hyoscine butyl bromide does not cross the blood-brain barrier, therefore there is no anticholinergic effect on the central nervous system.

Pharmacokinetics
Being a quaternary ammonium derivative and having a high polarity, hyoscine butyl bromide is slightly absorbed in the gastrointestinal tract. After rectal administration, the absorption of the drug is 3%. The average absolute bioavailability is less than 1%. Hyoscine butyl bromide, due to its high affinity for muscarinic and nicotinic receptors, is distributed mainly in the muscle cells of the abdominal and pelvic organs, as well as in the intramural ganglia of the abdominal organs. The connection with plasma proteins (albumin) is low and amounts to about 4.4%. It was found that the drug (at a concentration of 1 mmol) in vitro interacts with the transport of choline (1.4 nmol) in the epithelial cells of the human placenta.

After rectal administration of the drug, renal elimination is 0.7-1.6%; elimination occurs mainly through the intestines. Renal excretion of metabolites of hyoscine butyl bromide is less than 0.1% of the dose. Urinary metabolites bind weakly to muscarinic receptors, so they are inactive and have no pharmacological properties.

Indications for use

• Renal colic,

• biliary colic

• spastic dyskinesia of the biliary tract and gallbladder,

• cholecystitis,

• intestinal colic,

• pylorospasm,

• peptic ulcer of the stomach and duodenum in the acute phase (as part of complex therapy),

• algodismenorrhea.

Contraindications

• Myasthenia gravis, megacolon.

• Hypersensitivity to hyoscine butyl bromide or any other component of the drug.

• Children under 6 years old.

• Pregnancy, lactation.

Fertility, pregnancy and lactation

Data on the use of the drug during pregnancy and on the penetration of the drug and its metabolites into breast milk are limited.
Studies on the effect of the drug on fertility have not been conducted.

Method of administration and dosage

Rectally.

Unless otherwise prescribed by a doctor, the following dosing regimen is recommended:

Adults and children over 6 years old: rectally 1-2 suppositories 3-5 times a day.

The suppositories should be removed from the packaging and inserted into the rectum with the pointed end.

The drug should not be used daily for more than 3 days without consulting a doctor.

Side effects

Many of the listed undesirable effects can be associated with the anticholinergic properties of the drug. Anticholinergic side effects are usually mild and go away on their own.

Immune system disorders:
Anaphylactic shock, anaphylactic reactions, shortness of breath, skin reactions (eg, urticaria, rash, erythema, pruritus) and other types of hypersensitivity.

From the side of the cardiovascular system:
Tachycardia.

From the digestive system:
Dry mouth.

Skin and subcutaneous tissue
disorders : Dyshidrotic eczema.

From the urinary system:
urinary retention.

Overdose

Until now, cases of overdose with buscopan have not been described, so the following symptoms and recommendations are theoretical.

Symptoms
Anticholinergic symptoms are possible: urinary retention, dry mouth, skin redness, tachycardia, suppression of gastrointestinal motility, and transient visual impairment.

Treatment
Symptoms of an overdose with buscopan are controlled by cholinomimetics. Glaucoma patients are prescribed pilocarpine in the form of eye drops. If necessary, cholinomimetics are administered systemically, for example, neostigmine 0.5-2.5 mg intramuscularly or intravenously. Cardiovascular complications are treated according to the usual therapeutic guidelines. With paralysis of the respiratory muscles, intubation, artificial ventilation of the lungs is indicated. In case of urinary retention, the bladder is catheterized. Supportive therapy is underway.

Drug interactions

Buscopan can enhance the anticholinergic effect of tricyclic and tetracyclic antidepressants, antihistamines, antipsychotic drugs, quinidine, amantadine and disopyramide and anticholinergic drugs (for example, tiotropium bromide, ipratropium bromide, atropine-like compounds). The simultaneous use of buscopan and dopamine antagonists, for example, metoclopramide, leads to a weakening of the effect of both drugs on the gastrointestinal tract.

Buscopan can increase tachycardia caused by beta-adrenergic drugs.

With caution The
drug should be prescribed with caution in the following clinical situations: suspicion of intestinal obstruction (including pyloric stenosis): obstruction of the urinary tract (including prostatic hyperplasia), tachyarrhythmias (including atrial fibrillation) , angle-closure glaucoma.

In cases where abdominal pain of unknown origin continues or increases, or when symptoms such as fever, nausea, vomiting, changes in stool consistency and frequency of bowel movements, abdominal pain, decreased blood pressure, fainting, or blood in the stool are simultaneously noted, it is necessary immediately seek medical advice.

Effects on the ability to drive vehicles and use machinery

Studies on the effect of the drug on the ability to drive vehicles and use mechanisms have not been conducted.

Release form

Rectal suppositories, 10 mg.
5 suppositories in aluminum foil strips. 2 strips in a cardboard box with instructions for use.

Storage conditions

In a dry place at a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life

5 years
Do not use after the expiration date.

Dispensing from pharmacies

Without recipe