Bisacodyl

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BISACODYL (BISACODYL)

Composition:

Active ingredient: bisacodyl;

1 suppository contains 0.01 g (10 mg) of bisacodyl;

Excipient: hard fat.

Dosage form. Rectal suppositories.

Main physicochemical properties: white or white with a slightly yellowish tint suppositories.

Pharmacotherapeutic group. Stimulant laxatives. ATC code A06AB02.

Pharmacological properties.

Pharmacodynamics.

Bisacodyl is a stimulant laxative that enhances colonic peristalsis by irritating the mucosa or by directly stimulating nerve endings in the submucosal and mucosal nerve plexuses.

Pharmacokinetics.

Bisacodyl is poorly absorbed from the gastrointestinal tract and itself does not affect electrolyte absorption. As a result, the increased osmotic pressure in the intestinal lumen retains a larger amount of water, promoting softening of the stool and facilitating its passage through the colon. In addition, the stool volume increases, which stimulates peristalsis and facilitates defecation.

Bacterial enzymes in the colon metabolize bisacodyl into its active compound – diphenol, which undergoes conjugation during the first pass through the liver with glucuronic or sulfuric acid and returns to the intestine via enterohepatic circulation. This process prolongs the drug's effect. The drug's action begins within the first hour after administration.

Absorption of bisacodyl after intrarectal administration is minimal. The absorbed bisacodyl undergoes deacetylation in the liver to form a phenolic derivative, which is subsequently excreted in the urine. The remaining portion of the drug that stays in the colon is excreted with feces.

Clinical characteristics.

Indications.

Short-term symptomatic treatment of constipation, including habitual and chronic constipation in bedridden patients and elderly patients; prior to diagnostic procedures, surgical and obstetric interventions, as well as in pre- and postoperative periods.

Contraindications.

Hypersensitivity to bisacodyl and to other components of the medicinal product. Intestinal obstruction.

Acute diseases of the abdominal cavity organs, including appendicitis and acute inflammatory bowel diseases.

Severe abdominal pain associated with nausea and vomiting, which may indicate the above-mentioned serious conditions.

Severe dehydration.

Anal fissures or ulcerative proctitis with mucosal damage.

Interaction with other medicinal products and other forms of interaction.

Bisacodyl enhances the effect of cardiac glycosides due to decreased serum potassium levels. It also enhances the potassium-excreting effect of diuretics and glucocorticoids.

Concomitant use of bisacodyl with other laxatives may intensify gastrointestinal adverse reactions.

Special precautions for use.

Duration of treatment

Like other laxatives, bisacodyl should not be used continuously for more than 5 days without identifying the cause of constipation. Prolonged and excessive use of the medicinal product may lead to fluid and electrolyte imbalance, as well as hypokalemia.

Loss of intestinal fluid

Loss of fluid in the intestine may cause dehydration, which may manifest as thirst and oliguria. Bisacodyl should be discontinued in patients suffering from intestinal fluid loss that may lead to dangerous dehydration (e.g. patients with renal insufficiency, elderly patients), and treatment should be resumed only under medical supervision (see section "Adverse reactions").

Gastrointestinal disturbances

There have been isolated reports of abdominal pain and bloody diarrhea following bisacodyl use. Some cases were associated with ischemia of the colonic mucosa. Some patients may experience blood in the stool, which is generally mild and does not require treatment.

Dizziness, syncope

Dizziness and/or syncope may occur in patients using bisacodyl. Based on available information, these events may be related to defecation syncope (or syncope associated with straining during defecation) or vasovagal response to abdominal pain, which may be associated with constipation, and not necessarily with bisacodyl use itself.

Elderly patients

Frequent use of bisacodyl in elderly patients may exacerbate asthenia and cause orthostatic hypotension and coordination disorders related to fluid and electrolyte loss.

Local reactions

When using suppositories, pain and local irritation may occur, especially in the presence of anal fissures and ulcerative proctitis.

Does not promote weight loss.

Hard fat may reduce the effectiveness of latex products (e.g. condoms).

Use during pregnancy or breastfeeding.

Bisacodyl is not recommended during pregnancy, especially during the first trimester, except when the expected benefit to the mother outweighs the potential risk to the fetus. Use is possible only on medical advice. Adequate controlled clinical studies in pregnant women have not been conducted. However, long-term use experience has not revealed any adverse effects during pregnancy.

Bisacodyl is not recommended during breastfeeding, except when the expected benefit to the mother outweighs the potential risk to the infant, and only under medical supervision. There are no data on whether bisacodyl is excreted in breast milk.

Ability to affect reaction speed when driving or operating machinery.

There have been no studies investigating the effect of the medicinal product on the ability to drive or operate machinery. However, patients should be advised that, due to the possible occurrence of dizziness and/or syncope, they should refrain from driving or operating machinery.

Method of Administration and Dosage

The medicinal product is intended for rectal administration. Before use, the suppository should be removed from the strip.

Bisacodyl should be used only for the treatment of adult patients: 1 suppository once daily, usually in the morning.

The treatment duration should not exceed 7 days.

Children.

The drug is not intended for use in children.

Overdose.

Administration of bisacodyl in high doses may lead to diarrhea, abdominal cramps, and clinically significant loss of potassium and electrolytes.

Prolonged use of laxatives may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and nephrolithiasis. Cases of renal tubular damage, metabolic alkalosis, and muscle weakness as a consequence of hypokalemia have been reported.

Treatment: fluid replacement therapy and correction of electrolyte imbalance (especially in cases of hypokalemia). This is particularly important for elderly and young patients. Spasmolytics may be prescribed if necessary.

Side effects.

Immune system disorders: hypersensitivity and allergic reactions, including angioedema and anaphylactic reactions.

Metabolism and nutrition disorders: dehydration.

Nervous system disorders: dizziness, syncope.

Gastrointestinal disorders: discomfort, pain, abdominal cramps, nausea and diarrhea, blood in stools, vomiting, abdominal discomfort, anorectal discomfort, colitis, including ischemic colitis.

Local reactions: reactions at the site of administration, including pain and irritation.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 suppositories per strip. 2 strips per cardboard box.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

JSC "Monfarm".

Manufacturer's address and location of business activity.

8, Zavodska Str., village Avramivka, Uman district, Cherkasy region, 19161, Ukraine.