Buscopan 10 mg

Interactions with herbs have not been established.

Interactions with food have not been established.

Interactions with laboratory tests have not been established.

As hyoscine butylbromide can reduce the motility and secretory activity of the gastrointestinal system, the systemic absorption and pharmacologic effects of other oral medications may be delayed.

Individual response to BUSCOPAN (hyoscine butylbromide) may vary and doses should be adjusted accordingly.

Although dilution prior to administration is not required, BUSCOPAN solution is compatible with the following solutions, should dilution be desirable: Ringers Solution, Ringers Lactate, NaCl 0.9%, Laevulose 5%, Glucose 10%.

Solutions must be mixed under sterile conditions and are stable for 8 hours.

One to two 10 mg tablets per day up to a maximum of 6 tablets per day. In prolonged illness which requires repeated dosing, 1 tablet 3 to 5 times a day is recommended.

Tablets should be swallowed whole with a glass of water.

The rapid action of injected BUSCOPAN is advantageous in acutely ill patients and in those situations where prompt spasmolytic activity facilitates diagnostic procedures such as radiological examinations. BUSCOPAN ampoules may also be used intramuscularly 10-15 minutes before radiological examinations of the stomach to slow peristaltic movements.

In case a dose has been missed, take the next dose as scheduled. Do not double the dose.

One half (10 mg/0.5 mL) to one ampoule (20 mg/1 mL) administered parenterally by intramuscular, subcutaneous, or intravenous routes, at an injection rate of 1 mL/min. No dilution of the ampoule is necessary prior to administration. The maximum dose should not exceed 100 mg/day (5 ampoules).

Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Anticholinergic side effects of BUSCOPAN are generally mild and self-limited.

Accumulated clinical and postmarketing experience indicates that the following adverse reactions can be expected with the use of BUSCOPAN Ampoules and Tablets: xerostomia (dry mouth), dyshidrosis, visual accomodation disorders, tachycardia, dyspnea, and urinary retention.

There have been rare reports of dizziness, blood pressure decreased and flushing.

Skin reactions and other hypersensitivity, angioedema and fixed drug eruptions have been reported rarely.

There have been very rare reports of anaphylactic reactions and anaphylactic shock including fatal outcome.

Adverse events reported during therapy with BUSCOPAN include increased pulse rate, diarrhea, nausea, retinal pigmentation, and glaucoma.

No data is available.

No data is available.

Single oral doses of up to 590 mg and quantities of active drug up to 1090 mg within 5 hours have produced dry mouth, tachycardia, slight drowsiness and transient visual disorders. Other symptoms include urinary retention, reddening of the skin, and inhibition of gastrointestinal motility.

Other symptoms which occurred in animals and which may be encountered in humans include: shock, Cheyne-Stokes respiration, respiratory paralysis, clonic spasms, paresis of the striated muscle, coma, paralytic ileus and cystoparalysis.

In the case of an oral overdose, perform gastric lavage with activated charcoal followed by magnesium sulfate (15%). BUSCOPAN overdose symptoms respond to parasympathomimetics.

For patients with glaucoma, administer pilocarpine locally. If necessary, parasypathomimetics should be administered, e.g. neostigmine 0.5-2.5 mg i.m. or i.v. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratiory paralysis: intubation, artificial respiration.

Catheterisation may be required for urinary retention.

Other overdosage symptoms should be treated with standard supportive therapy.

Each round, white, sugar-coated tablet contains: hyoscine butylbromide 10 mg. Nonmedicinal ingredients: acacia, carnauba wax, castor oil, lactose, magnesium stearate, maize starch, polyethylene glycol, shellac, sucrose, talc, tartaric acid, titanium dioxide, and white wax. Bottles of 100 and 500.

Each mL contains: hyoscine butylbromide 20 mg. Nonmedicinal ingredients: sodium chloride and water for injection. Sodium: <1 mmol (<10 mg)/dose. Ampuls of 1 mL. Packages of 10.

Geriatric patients are especially susceptible to the anticholinergic side effects of constipation, dryness of mouth and urinary retention (especially in males). If these side effects continue or are severe, discontinuation of medication should be considered.

Due care is necessary when anticholinergics are administered to geriatric patients due to the danger of precipitating undiagnosed glaucoma.

Administration of anticholinergics/systemic antispasmodics to elderly patients with intestinal atony or in debilitated patients may result in obstruction.

Exercise caution in patients with reflux esophagitis or gastrointestinal tract obstructive disease (i.e., achalasia and pyloroduodenal stenosis) due to the ability of anticholinergics/systemic antispasmodics to decrease smooth muscle motility and tone resulting in gastric retention.

Anticholinergics may aggravate hiatal hernia associated with reflux esophagitis, myasthenia gravis or pyloric obstruction.

In patients with ulcerative colitis, large anticholinergic doses may suppress intestinal motility, possibly causing paralytic ileus or resulting in obstruction; also, use may precipitate or aggravate toxic megacolon.

Therapy should be discontinued if the patient reports any unusual visual disturbances or pressure pain within the eye.

Patients intolerant of one belladonna alkaloid or derivative may also be intolerant of other belladonna alkaloids or derivatives such as hyoscine butylbromide.

After parenteral administration of BUSCOPAN, cases of anaphylaxis, including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving BUSCOPAN by injection should be kept under observation.

BUSCOPAN (hyoscine butylbromide) tablets and ampoules should be used with caution in patients with prostatic enlargement. BUSCOPAN may precipitate or aggravate urinary retention in patients with the following conditions: nonobstructive prostatic hypertrophy, urinary retention (or the predisposition to) or obstructive uropathy such as a bladder neck obstruction due to prostatic hypertrophy (see Contraindications). In addition, exercise caution in patients inclined to tachyarrhythmia.

One sugar-coated tablet of 10 mg contains 41.2 mg sucrose, resulting in 411.8 mg sucrose per maximum recommended daily dose. Patients with the rare hereditary condition of fructose intolerance should not take this medicine.

The parenteral administration of hyoscine butylbromide, particularly of higher doses, has been reported to cause transient disturbances of accommodation which recede spontaneously. Therefore, patients should be cautioned about potential visual problems and the need to exercise care while driving or operating machinery after receiving BUSCOPAN ampoules.

The mydriatic effect of anticholinergics/systemic antispasmodics may result in increased intraocular pressure. BUSCOPAN should be used with caution in patients with angle-closure glaucoma or with this predisposition, as anticholinergics/systemic antispasmodics may precipitate an acute angle-closure glaucoma attack (see Contraindications).

Patients should seek urgent ophthalmological advice in case they should develop a painful eye with loss of vision after injection of BUSCOPAN.

Safety during pregnancy has not yet been established. Limited preclinical data has not indicated a hazard; nevertheless, the usual precautions regarding the use of drugs during pregnancy, especially during the first trimester, should be observed.

BUSCOPAN is not currently recommended for use in children.

Safety during lactation has not been established. No specific studies have been conducted on the excretion of this drug in breast milk. The benefits of hyoscine butylbromide use during lactation should therefore be weighed against possible effects on the infant.

As large doses of anticholinergics/systemic antispasmodics may cause an increase in heart rate, due care is necessary in patients with cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease and mitral stenosis. The increase in heart rate may also be undesirable in patients with unstable cardiovascular status in an acute hemorrhage situation.

The high tissue affinity of the substance is further reflected in the extremely short distribution half-life (t_1/2α) in the plasma of approximately 2-3 minutes. Despite low systemic bioavailability, hyoscine butylbromide remains available in high concentrations at the site of action. Plasma levels of radioactivity in man peak within 3 hours of enteral administration.

BUSCOPAN undergoes rapid tissue absorption after oral administration. In the rat, it concentrates in the gastrointestinal tract, liver and kidney tissues.

BUSCOPAN (hyoscine butylbromide) is an antispasmodic agent which relaxes the smooth muscle of the gastrointestinal, biliary and urinary tracts. It is believed to act predominantly at the parasympathetic ganglia in the walls of the viscera of these organs. Structurally, BUSCOPAN exists as a quaternary ammonium compound and as a single positively charged cation throughout the entire pH range.

A high portion of the absorbed hyoscine butylbromide (¹⁴C) undergoes elimination in an unchanged form within the first few hours of administration in man and animals. Later in elimination, the metabolized portion predominates. In man, following the administration of intravenous ¹⁴C-labelled substance, the elimination followed a three-phase course: t_1/2α=3.5 min., t_1/2β=0.8 hours; t_1/2=14.0 hours. Following oral administration, the terminal elimination half-life is 4.8 hours. Metabolites from rat urine detected in quantities ranging from 4 to 44% include three main metabolites (phenyl acetic acid-scopine ester-butochloride, 4-hydroxytropic acid-scopine ester-butochloride, scopine butobromide) and four minor metabolites (including AD 12 and Ba 790).

Protein binding in the human plasma occurs at 8-13% and in a 4.4% human serum albumin solution at 3-11%. Hyoscine butylbromide does not readily cross the blood brain barrier.