Dulcolax pills 5mg, 30pcs

Composition

Active ingredients:

bisacodyl 5 mg.

Auxiliary substances:

corn starch-8.3 mg,

85% glycerol-0.2 mg,

soluble corn starch-1.5 mg,

lactose-34.9 mg,

magnesium stearate-0.1 mg.

Composition of the enteric shell:

sucrose – 23,3819 mg, talc – 16,1608 mg, acacia gum 1,9354 mg, titanium dioxide – 0,3995 mg, copolymer of methacrylic acid and methyl methacrylate (1: 2) (Eudragit S100) – 2,2147 mg, copolymer of methacrylic acid and methyl methacrylate (1: 1) (Eudragit L100) – 0,9866 mg seed oil, ricinus vulgaris (castor oil) – 0,9762 mg, magnesium stearate – 3,8225 mg, macrogol (polyethylene glycol) 6000 – 0,0462 mg, dye iron oxide yellow (E 172) – 0,0657 mg beeswax white – 0.0015 mg, Carnauba wax – 0,003 mg, shellac – 0,006 mg.

Pharmacological action

Pharmacodynamics

A laxative drug derived from diphenylmethane. As a local laxative with an 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, reduction of evacuation time and softening of the stool.

The time of development of the laxative effect of the drug is 6-12 hours.

Bisacodyl, being a laxative that acts at the level of the colon, stimulates the natural evacuation process in the lower gastrointestinal tract. Therefore, bisacodyl has no effect on the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Pharmacokinetics

Suction and distribution

Absorption is negligible. Tablets coated with an enteric coating are resistant to the action of gastrointestinal juice. Bisacodyl is released in the colon to form the active metabolite, bis-(p-hydroxyphenyl)- pyridyl-2-methane, which has an irritating effect on the mucous membrane of the colon.

Cmax of the active metabolite in plasma after taking the drug is reached in 4-10 hours, the laxative effect develops in 6-12 hours. There is no correlation between the laxative effect of bisacodil and the concentration of the active metabolite in plasma.

Metabolism and elimination

The drug is almost completely metabolized in the intestinal wall and liver to inactive glucuronide. Metabolism occurs under the action of enzymes of the mucous membrane of the large intestine.

T1 / 2 is about 16.5 h. Excretion of the active metabolite occurs mainly in the faeces (up to 51.8%), about 10.5% is excreted in the urine.

Indications

As a laxative in the following cases:

• constipation caused by hypotension of the colon (including chronic ones);
• preoperative preparation, postoperative treatment;
• preparation for instrumental and X-ray examinations;
• medical conditions that require easier defecation.

Use during pregnancy and lactation

During the long-term experience of using the drug, no adverse events during pregnancy were detected. However, due to the lack of research, the use of Dulcolax® during pregnancy is recommended only in cases where the potential benefit to the mother exceeds the possible risk to the fetus.

Bisacodil is not excreted in breast milk.

During pregnancy and lactation, the drug can be used only after consultation with a specialist.

Clinical studies of the effect of the drug on fertility have not been conducted.

Contraindications

• Hypersensitivity to Bisacodyl or auxiliary substances;
• intestinal obstruction;
• obstructive bowel disease;
• acute diseases of the abdominal organs, including appendicitis;
• acute inflammatory bowel disease;
• severe abdominal pain associated with nausea and vomiting that may be a symptom of a more serious condition;
• severe dehydration;
• children up to age 4 years;
• in one tablet (5 mg) of 33.2 mg contains lactose. The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for X-ray examination contains 66.4 mg and 132.8 mg of lactose, respectively. Patients with rare hereditary problems of galactose intolerance, such as galactosemia, should not take the drug;
• one tablet (5 mg) contains 23.4 mg of sucrose. The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for X-ray examination contains 46.8 mg and 93.6 mg of sucrose, respectively. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Caution: the drug should be used in patients with hepatic and / or renal insufficiency.

Side effects

The most frequently reported adverse reactions during the use of the drug are spastic abdominal pain and diarrhea.

From the digestive system: spastic pain or discomfort in the abdominal area, diarrhea (dehydration, muscle weakness, cramps, decreased blood pressure), nausea, vomiting, a small amount of blood in the stool, anorectal discomfort, colitis.

Nervous system disorders: dizziness, fainting. These side effects that occur after the use of the drug are associated with a vasovagal reaction (i. e., due to intestinal spasm, tension during defecation).

Immune system disorders: hypersensitivity, angioedema, anaphylactic reactions.

Interaction

Concomitant use of high-dose Dulcolax and diuretics or corticosteroids increases the risk of electrolyte imbalance (hypokalemia).

Electrolyte imbalance (hypokalemia) increases the effect of cardiac glycosides.

How to take, course of use and dosage

Tablets are taken orally, washed down 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 can be increased 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 get a laxative effect in the morning, it is recommended to take the drug the day before at night.

The drug should not be taken together with products that lower the acidity in the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the intestinal membrane.

When preparing for research, pre – and postoperative treatment, medical conditions that require relief of bowel movements, Dulcolax® should be used under medical supervision.

It is recommended to use 2 tablets at night the day before the study and 2 tablets at night before the operation or study. It can be used in combination with suppositories. For adults, in addition to 2-4 tablets taken the day before, use of 1 suppository in the morning is recommended.

Overdose

Symptoms: acute overdose may include diarrhea, dehydration, decreased blood pressure, impaired water and electrolyte balance, hypokalemia, and convulsions.

Symptoms: in case of chronic overdose-chronic diarrhea, abdominal pain, hypokalemia, hyperaldosteronism, urolithiasis. Chronic laxative abuse can lead to renal tubule damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment: should be symptomatic. There is no specific antidote. To reduce the absorption of the drug after ingestion, you can induce vomiting or perform gastric lavage. It may be necessary to replenish the fluid and correct the electrolyte balance, as well as prescribe antispasmodics.

Special instructions

Do not use the drug, like all laxatives, regularly or for a long period of time without identifying the causes of constipation. Prolonged use of high doses of the drug can lead to fluid loss, electrolyte imbalance, and hypokalemia.

Loss of fluid through the intestines can lead to dehydration, which can be accompanied by symptoms such as thirst and oliguria. Dehydration can be harmful to the body (for example, in renal failure, in elderly patients), so if the above symptoms occur, the drug should be discontinued and can only be resumed under the supervision of a doctor.

Patients may have a small amount of blood in their feces. This manifestation is usually weakly expressed and passes on its own.

Dizziness and / or syncope were observed in patients taking Dulcolax®. Analysis showed that these cases were associated with fainting during defecation (or fainting caused by straining to defecate) or with a vasovagal response to abdominal pain that could be due to 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 their doctor.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Special clinical studies of the effect of the drug on the ability to drive a car and mechanisms have not been conducted. However, patients should be advised that they may experience dizziness and/or fainting due to a vasovagal reaction (i. e., during a bowel spasm).If patients experience bowel spasms, they should avoid potentially dangerous activities, including driving vehicles or operating machinery.

Form of production

Enteric coated tablets

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Bisacodyl

Dosage form

Tablets