контрактне виробництво
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виробництво торгова марка
BISACODIL
Release form
Rectal suppositories.
For children
Contraindicated
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Contraindicated
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: bisacodyl; 1 suppository contains bisacodyl 0.01 g (10 mg); excipient: solid fat.
Medicinal form
Rectal suppositories. Main physicochemical properties: suppositories are white or white with a slightly yellowish tint.
Pharmacotherapeutic group
Contact laxatives Code ATX A06A B02.
Pharmacological properties
Pharmacodynamics. Bisacodyl is a laxative that stimulates peristalsis of the colon by irritating the mucous membrane or directly stimulating nerve endings in the submucosal and mucosal nerve plexuses. Pharmacokinetics. Bisacodyl is poorly absorbed from the gastrointestinal tract and affects the absorption of electrolytes. As a result, the increased osmotic pressure in the lumen of the intestine holds more water, which helps soften stools and facilitate their passage through the colon. In addition, the volume of stools increases, which stimulates peristalsis and facilitates defecation. Bacterial enzymes of the large intestine metabolize bisacodyl to the active compound - diphenol, which is subject to conjugation during the first passage through the liver with glucuronic or sulfuric acid and returns to the intestine through the enterohepatic circulation. This process prolongs the effect of the drug. The effect of the drug occurs within the first hour after administration. Absorption of bisacodyl after intrarectal use is minimal. Absorbed bisacodyl undergoes deacetylation in the liver with the formation of a phenol derivative, which is subsequently excreted in the urine. The rest of the drug remaining in the large intestine is excreted with feces.
Indication
Short-term symptomatic treatment of constipation, including habitual constipation and chronic constipation in bedridden and elderly patients; before diagnostic procedures, surgical and obstetric interventions, as well as in the pre- and post-operative period.
Contraindication
Hypersensitivity to bisacodyl and other components of the drug. Intestinal obstruction. Acute diseases of the abdominal organs, including appendicitis and acute inflammatory bowel diseases. Severe abdominal pain associated with nausea and vomiting, which may indicate the above serious conditions. Severe dehydration. Anal fissures or ulcerative proctitis with mucosal damage.
Interaction with other medicinal products and other forms of interaction
Bisacodyl increases the effect of cardiac glycosides due to a decrease in the level of potassium in blood serum. It also enhances the kaliuretic effect of diuretics and glucocorticoids. The simultaneous use of bisacodyl with other laxatives can increase the side effects of the gastrointestinal tract.
Features of use
Duration of treatment Like other laxatives, bisacodyl should not be used continuously for more than 5 days without finding out the cause of constipation. Long-term and excessive use of the drug can cause electrolyte and fluid imbalance, as well as hypokalemia. Intestinal Fluid Loss Intestinal fluid loss can cause dehydration, symptoms of which may include thirst and oliguria. In patients suffering from intestinal fluid loss that can cause dangerous dehydration (eg, patients with renal insufficiency, elderly patients), bisacodyl should be discontinued and restarted only under medical supervision (see Adverse Reactions section). Digestive disorders There have been isolated reports of abdominal pain and bloody diarrhea following the use of bisacodyl. Individual cases were associated with ischemia of the mucous membrane of the large intestine. Some patients may have blood in their stools, which is generally mild and does not require treatment. Dizziness, syncope Dizziness and/or syncope may occur in patients who have used bisacodyl. The available information on these cases suggests that these events are related to defecation syncope (or syncope associated with straining during defecation) or a vasovagal response to abdominal pain, which may be associated with constipation and is not always with the use of bisacodyl as such. Elderly patients Frequent use of bisacodyl in elderly patients can increase asthenia, cause orthostatic hypotension and disorders of coordination of movements associated with loss of fluid and electrolytes. Local reactions When using suppositories, painful sensations and local irritation may occur, especially in the presence of anal fissures and ulcerative proctitis. Does not contribute to weight loss. Solid fat can reduce the effectiveness of latex products (condoms). Use during pregnancy or breastfeeding. Bisacodyl is not recommended for use during pregnancy, especially in the first trimester, unless the expected benefit to the mother outweighs the potential risk to the fetus. Application is possible only on the advice of a doctor. A sufficient number of controlled clinical studies in pregnant women have not been conducted. According to the experience of long-term use of the drug, negative effects during pregnancy have not been detected. Bisacodyl is not recommended for use during breastfeeding, unless the expected benefit to the mother outweighs the potential risk to the fetus and only on the advice of a physician. There are no data on whether bisacodyl is excreted in breast milk. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Studies on the ability of the medicinal product to influence the speed of reaction when driving a motor vehicle or working with other mechanisms have not been conducted. However, patients should be informed
Methods of application
The drug is intended for rectal use. Before use, the suppository should be removed from the strip. Bisacodyl should be used only for the treatment of adult patients: 1 suppository 1 time a day, usually in the morning. Treatment lasts no more than 7 days. Children. The drug should not be used for the treatment of children
Overdose
The use of bisacodyl in high doses can lead to diarrhea, abdominal cramps and clinically significant loss of potassium and electrolytes. Long-term use of laxatives can cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and nephrolithiasis. There have been reports of renal tubular damage, metabolic alkalosis, and muscle weakness secondary to hypokalemia. Treatment: fluid replacement therapy and correction of electrolyte imbalance (especially with hypokalemia). This is especially important for elderly and young patients. It is possible to prescribe antispasmodics.
Side effects
From the side of the immune system: hypersensitivity and allergic reactions, including angioedema and anaphylactic reactions. From the side of metabolism and digestive disorders: dehydration. From the side of the nervous system: dizziness, syncope. From the gastrointestinal tract: discomfort, pain, abdominal cramps, nausea and diarrhea, blood in stools, vomiting, abdominal discomfort, anorectal discomfort, colitis, including ischemic colitis. Local reactions: reactions at the injection site, including pain, irritation.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
5 suppositories in a strip. 2 strips in a cardboard pack.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.