Composition, form of production and packaging
? The tablets covered with an enteric-soluble coat of beige-yellow color, round, biconvex, with smooth, smooth, shiny surface and white core.
bisacodyl 5 mg
Excipients: corn starch - 8.3 mg, glycerol 85% - 0.2 mg, corn soluble corn starch - 1.5 mg, lactose - 34.9 mg, magnesium stearate - 0.1 mg.
Ingredients of the enteric coating: sucrose 23.3819 mg, talc 16.1608 mg, acacia gum 1.9354 mg, titanium dioxide 0.3995 mg, methacrylic acid-methyl methacrylate copolymer (1: 2) (Eudragit S100) 2.2147 mg, methacrylic acid-methyl methacrylate copolymer 1: 1) (Eudragit L100) - 0.9866 mg, castor oil common oil (castor oil) 0.9762 mg, magnesium stearate 3.8225 mg, macrogol 6000-0.0462 mg, iron dye oxide yellow (E172) 0.0657 mg, beeswax white - 0.0015 mg, carnauba wax - 0.003 mg, shellac - 0.006 mg.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Laxative drug, a derivative of diphenylmethane. As a local laxative with antiresorptive effect, bisacodyl after hydrolysis in the colon increases the secretion of water and electrolytes in the colon, accelerates and increases its peristalsis. This leads to stimulation of the act of defecation, a decrease in the time of evacuation and softening of the stool.
The time of development of the laxative effect of the drug is 6-12 hours.
Bisacodyl, being a laxative acting at the level of the large intestine, stimulates the natural evacuation process in the lower gastrointestinal tract. Therefore, bisacodyl does not affect the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.
Suction and distribution
Absorption is insignificant. Tablets, covered with enteric coating, are resistant to the action of gastrointestinal juice. Bisacodyl is released in the large intestine with the formation of an active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane, which has an irritant effect on the mucosa of the large intestine.
C max of the active metabolite in plasma after taking the drug is achieved after 4-10 hours, the laxative effect develops after 6-12 hours. There is no correlation between the laxative effect of bisacodyl and the concentration of the active metabolite in the plasma.
Metabolism and excretion
The drug is almost completely metabolized in the wall of the intestine and liver to the inactive glucuronide. Metabolism occurs under the action of enzymes of the mucous membrane of the large intestine.
T 1/2 is about 16.5 hours. The excretion of the active metabolite occurs mainly with feces (up to 51.8%), with urine released around 10.5%.
As a laxative in the following cases:
- Constipation due to hypotension of the colon (including chronic);
- preoperative preparation, postoperative treatment;
- preparation for instrumental and radiographic research;
- medical conditions requiring ease of defecation.
Tablets are taken orally by washing with a sufficient amount of liquid.
For constipation, adults and children over 10 years of age are prescribed 1-2 tablets. (5-10 mg). It is recommended to start with the lowest dose. In order to achieve a regular stool, the dose may rise to the maximum recommended (10 mg). Do not exceed the maximum recommended daily dose .
Children aged 4-10 years - 1 tab. (5 mg). Do not exceed the maximum recommended daily dose (5 mg) .
To obtain a laxative effect in the morning, it is recommended to take the drug the night before.
The drug should not be taken together with products that reduce acidity in the upper GI tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the enteric coating.
When preparing for research, pre- and post-operative treatment, medical conditions that require defecation , Dulcolax В® should be used under medical supervision.
It is recommended to apply 2 tab. at night for the day before the study and 2 tab. for the night before surgery or research. Can be used in combination with suppositories. For adults, in addition to 2-4 tablets taken the day before, it is recommended to administer 1 suppository in the morning.
The most commonly reported adverse reactions during the use of the drug are spastic abdominal pain and diarrhea.
On the part of the digestive system: spasmodic pains or discomfort in the abdomen, diarrhea (dehydration, muscle weakness, convulsions, decreased blood pressure), nausea, vomiting, minor amounts of blood in the stool, anorectal discomfort, colitis.
From the nervous system: dizziness, fainting. These side effects arising from the use of the drug are associated with a vasovagal reaction (i.e., due to intestinal spasm, straining during defecation).
On the part of the immune system: hypersensitivity, angioedema, anaphylactic reactions.
- intestinal obstruction;
- obstructive bowel disease;
- Acute diseases of the abdominal cavity, including appendicitis;
- Acute inflammatory bowel diseases;
- severe abdominal pain associated with nausea and vomiting, which may be a symptom of a more severe condition;
- severe dehydration;
- Children's age up to 4 years;
- Hypersensitivity to bisacodil or excipients.
One tablet (5 mg) contains 33.2 mg of lactose. The maximum recommended daily dose of tablets for adults and children over 10 years for the treatment of constipation and for radiographic examination contains 66.4 mg and 132.8 mg of lactose, respectively. Patients with a rare hereditary intolerance to galactose, for example, galactosemia, should not take the drug.
One tablet (5 mg) contains 23.4 mg sucrose. The maximum recommended daily dose of tablets for adults and children over 10 years for the treatment of constipation and for radiographic examination contains 46.8 mg and 93.6 mg of sucrose, respectively. Patients with a rare hereditary intolerance to fructose should not take the drug.
The drug should be administered with caution to patients with hepatic and / or renal insufficiency.
PREGNANCY AND LACTATION
During the long experience of using the drug of undesirable phenomena during pregnancy, it was not revealed. However, in the absence of studies, the use of DulcolaxВ® in pregnancy is recommended only in cases where the potential benefit to the mother exceeds the possible risk to the fetus.
Bisacodyl is not excreted in breast milk.
During pregnancy and during breastfeeding the drug can be applied only after consulting a specialist.
Clinical studies of the effect of the drug on fertility have not been conducted.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution appoint the drug to patients with kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution appoint the drug to patients with liver disease.
APPLICATION FOR CHILDREN
Contraindicated in children under 4 years.
Do not use the drug, like all laxatives, regularly or for a long period of time without identifying the causes of constipation. Long-term use of high doses of the drug can lead to loss of fluid, a violation of the balance of electrolytes, hypokalemia.
Loss of fluid through the intestines can lead to dehydration, which can be accompanied by symptoms such as thirst and oliguria. Dehydration can harm the body (for example, in renal failure, in elderly patients), therefore, with the above symptoms, taking the drug should be stopped and can be resumed only under medical supervision.
Patients may have a small amount of blood in their stool. This manifestation is usually poorly expressed and passes independently.
Dizziness and / or syncope was observed in patients taking Dulcolax В® . The analysis showed that these cases were associated with fainting during defecation (or a syncope caused by stress during defecation) or with a vasovagal response to abdominal pain that could be caused by constipation and not necessarily associated with taking the drug.
1 tablet (5 mg) corresponds to 0.006 XE.
Children should take the drug after consulting a doctor.
Impact on the ability to drive vehicles and manage mechanisms
Special clinical studies of the effect of the drug on the ability to control the car and mechanisms were not carried out. In spite of this, patients should be informed that dizziness and / or syncope may occur due to vasovagal reaction (i.e., during intestinal spasm). If patients develop a spasm of the intestine, they should avoid potentially dangerous activities, incl. driving vehicles or controlling machinery.
In acute overdosage , diarrhea, dehydration, lowering of blood pressure, violation of water-electrolyte balance, hypokalemia, convulsions are possible.
In chronic overdose: chronic diarrhea, abdominal pain, hypokalemia, hyperaldosteronism, urolithiasis. In connection with chronic abuse of laxatives, renal tubular damage, metabolic alkalosis and muscle weakness associated with hypokalemia can develop.
Treatment should be symptomatic. There is no specific antidote. To reduce the absorption of the drug after ingestion, you can induce vomiting or gastric lavage. It may be necessary to replenish the fluid and balance the balance of electrolytes, as well as the appointment of antispasmodics.
Simultaneous reception of Dulcolax in high doses and diuretics or GCS increases the risk of electrolyte imbalance (hypokalemia).
Violation of the electrolyte balance (hypokalemia) enhances the action of cardiac glycosides.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years.