Bisacodyl

General characteristics. Structure:

Active ingredient: 5 mg of bisacodyl in each tablet.

Excipients: lactose monohydrate, sugar, potato starch, microcrystallic cellulose, talc, calcium stearate, acryle - from (including methacrylic acid and ethyl acrylate copolymer, talc, triethyl citrate, silicon dioxide colloid anhydrous, sodium a carbonate, sodium the lauryl sulfate painting a pigment (yellow E 172, ferrous oxide red E 172 contains titanium dioxide, ferrous oxide)).

Pharmacological properties:

Pharmacodynamics. Bisacodyl – locally acting laxative from group of derivatives of diphenylmethane. As the local purgative with anti-resorptive effect bisacodyl after hydrolysis in a large intestine increases secretion of water and electrolytes in a large intestine, accelerates and increases its peristaltics. It leads to stimulation of the act of defecation, reduction of time of evacuation and a softening of a chair.

Effect of medicine develops in 5-10 hours.

Pharmacokinetics. After oral administration a small amount of medicine is soaked up. In a system blood-groove and urine are found, generally inactive forms of metabolites. Is pro-medicine, in the alkaline environment of intestines there is a hydrolysis to formation of the metabolite rendering irritant action on a mucous membrane of digestive tract.

Indications to use:

Short-term symptomatic treatment of accidental locks.

Route of administration and doses:

Inside. Adults: 1 or 2 tablets a day (5-10 mg).

Children from 6 to 12 years: 1 tablet (5 mg) a day.

Children from 6 to 12 years with chronic locks have to accept medicine only under observation of the doctor.

For obtaining laxative effect it is recommended to accept medicine the day before for the night in the morning. Tablets are swallowed, washing down with enough liquid.

Tablets should be swallowed, without chewing.

Medicine should not be accepted with the products lowering acidity in an upper part of digestive tract such as milk, antacids or inhibitors of a proton pomp to avoid premature dissolution of a kishechnorastvorimy cover.

Features of use:

At patients with an unstable water balance (for example, patients with a renal failure, patients of advanced age) the risk of dehydration which symptoms are the oliguria and thirst is increased. Before purpose of purgatives it is necessary to recover a water balance, to provide reception of enough liquid.

The following events have to precede drug treatment of locks: adequate physical activity and drinking mode, use of enough food fibers.

Use of purgatives is not recommended more than 10 days. At prolonged use dependence development is possible (need for increase in a dosage and development of a heavy lock after drug withdrawal).

After reception of Bisacodyl messages on cases of dizziness and faints arrived during defecation.

Children should appoint purgatives with extra care in connection with risk of disturbance of a reflex of release of intestines.

To take with caution to patients with a diabetes mellitus.

Use of Bisacodyl is not recommended during pregnancy as these clinical and preclinical trials are not enough.

Bisacodyl gets to breast milk. Use of Bisacodyl is not recommended during breastfeeding.

Influence on ability to driving of motor transport and to control of mechanisms. Researches on impact assessment of reception of medicine on ability to drive the car and to work with the equipment are not conducted. However patients have to be informed that during parasympathetic vascular reaction (for example, abdominal spasms) they can have a dizziness and/or a faint. If patients test abdominal spasms, they have to avoid potentially dangerous types of activity, such as driving or mechanisms.

Side effects:

Side reactions are listed on classes of systems of bodies with the indication of frequency of emergence according to the following classification:                         very often (≥ 1/10), it is frequent (≥ 1/100 to <1/10), infrequently (≥ 1/1 000 to <1/100), is rare (≥ 1/10 000 to <1/1000), is very rare (<1/10 000), it is not known (frequency cannot be estimated on the basis of the available data).

It was most often reported about emergence of abdominal pains and diarrheas.

From immune system: seldom: anaphylactic reactions, Quincke's edema.

From skin and hypodermic cellulose: seldom: generalized itch.

From metabolism: seldom: dehydration; it is not known: hypopotassemia.

From a nervous system: infrequently: dizziness; seldom: syncope. The dizziness and a faint arising after Bisacodyl reception develop together with parasympathetic vascular reaction (for example, a spasm in a stomach, defecation).

From digestive tract: often: abdominal pain, diarrhea; infrequently: a proctorrhagia, anorectal discomfort, burning and pains in anorectal area; seldom: colitis

Interaction with other medicines:

Use of Bisacodyl with medicines which can cause development of arrhythmia like torsadesdepointes is not recommended at the same time:

1) antiarrhytmic means: Amiodaronum, Bretilium, Disopyramidum, Quinidine, Sotalol,

2) other means: Astemizol, Bepridil, Eritromitsin for intravenous administration, Galofantrin, Pentamidin, Sultoprid, Terfenadin, Vinkamin.

Risk factors of development of arrhythmia like torsadesdepointes are the hypopotassemia, bradycardia and lengthening of an interval of QT.

Medicinal combinations which demand care:

1. Cardiac glycosides. The hypopotassemia increases toxic effects of drugs of a foxglove. Monitoring of level of potassium in blood serum and, in case of need, ECG control is necessary.

2. Other medicines leading to potassium removal: potassiumuretic diuretics (separately or in a combination), Amphotericinum In for intravenous administration, corticosteroids, Tetrakozaktid. Control of level of potassium in blood serum is required and at a neokhodimost – correction.

Contraindications:

Absolute contraindications:

- hypersensitivity to Bisacodyl or to any of fillers,

- heavy dehydration with electrolytic disturbances,

- inflammatory diseases of intestines, nonspecific ulcer colitis, disease Krone,

- a syndrome of an acute abdomen, severe pains in a stomach which are followed by nausea and vomiting,

- impassability of intestines of various origin,

- children's age up to 6 years,

- an inborn galactosemia, hereditary intolerance of fructose, disturbance of absorption of glucose and a galactose, deficit of lactase or invertase-isomaltase (see the section "Precautionary measures").

Relative contraindications:

- reception of medicines which can cause development of arrhythmia like torsadesdepointes.

Overdose:

At acute overdose development of diarrhea, spasms in a stomach, losses of liquid, potassium and other electrolytes is possible.

The chronic overdose can lead to development of diarrhea, abdominal pains, a hypopotassemia, muscular weakness.

In case of symptoms of overdose it is necessary to stop reception of medicine and to see a doctor. Correction of electrolytic disturbances and completion of loss of liquid is necessary. These actions are especially important at patients of advanced age and children. Also symptomatic treatment is carried out.

Storage conditions:

In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years. Medicine cannot be used after the term specified on the label.

Issue conditions:

Without recipe

Packaging:

10 tablets in a blister strip packaging, 3 blister strip packagings in a pack from a cardboard together with a leaf insert.