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Bisakodil-Darnitsa, the tab. п / about 0,005 No. 30

Препарат Бисакодил-Дарница, табл. п/о 0,005 №30. ЗАО "Фармацевтическая фирма "Дарница" Украина


Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine

Code of automatic telephone exchange: A06AB02

Release form: Firm dosage forms. Tablets.

Indications to use: Lock.


General characteristics. Structure:

Active ingredient: bisacodyl;
1 tablet contains 5 mg of bisacodyl in terms of 100% dry matter;
excipients: potato starch; lactose, monohydrate; cellulose microcrystallic; povidone (polyvinylpirrolidone low-molecular medical); calcium stearate; methacrylate copolymer dispersion; talc; titanium E 171 dioxide; polyethyleneglycol (macrogoal 4000); quinolinic yellow E 104.



Pharmacological properties:

Bisakodil-Darnitsa renders the laxative effect which is shown a softening or fluidifying of fecal masses. The mechanism of laxative action is caused by increase in penetration of water into a cavity of intestines and reduction of its absorption, and also acceleration of a vermicular movement of intestines. The important place in the mechanism of action is taken by splitting of bisacodyl in alkaline contents of intestines that leads to formation of the substances irritating receptors of a mucous membrane.

After reception of Bisakodil-Darnitsa appears in a blood plasma in 4 hours. Drug substantially is not soaked up in a system blood stream, transformed in a liver, and is removed from an organism by kidneys.


Indications to use:

Short-term treatment of locks of a different etiology: usual locks at elderly people, usual and chronic locks at a long bed rest; locks after change of a diet.

The previous preparation of intestines for its final clarification by means of an enema before surgeries. Need of urgent purgation, for example, by preparation for childbirth. Locks in the postoperative period.

Preparation of intestines for diagnostic testings.


Route of administration and doses:

The tablets Bisakodil-Darnitsa apply inside. Swallow of a tablet whole, without chewing and without crushing, washing down with enough water.

The usual dose for adults and children is more senior than 10 years makes 1-2 tablets    (5-10 mg) of 1 times a day before going to bed.

To children at the age of 4-10 years appoint 1 tablet a day before going to bed.

And kidneys dose adjustment is not required to elderly persons and patients with abnormal liver functions.

More than 7-10 days are not recommended to use drug.


Features of use:

At use of Bisakodila-Darnitsa it is necessary to remember that the tablet is covered with a kishechnorastvorimy cover because of what it cannot be divided and chewed.

With care apply to treatment of patients with a disease of a liver and kidneys.

Drug cannot be washed down with alkaline mineral water, to apply for one hour together with milk, antacids or H2 blockers.

It is necessary to avoid long, more than 7 days, and systematic use of Bisakodila-Darnitsa as it can lead to an atony of intestines and impossibility of emptying without use of stronger purgatives.

Not to apply at abdominal pains of an unknown origin which are followed by nausea and vomiting.

At elderly people because of frequent use of drug emergence of an adynamy, orthostatic hypotension, lack of coordination of movements is possible. Unsatisfactory stimulation of the act of defecation by drug can testify to the organic nature of a lock.

Drug contains lactose therefore to patients with rare hereditary intolerance of a galactose, lactose deficit of Lapp or glyukozo-galaktozny malabsorption it is not necessary to accept drug.

Use during pregnancy or feeding by a breast.

There are no reliable data about influence of bisacodyl during pregnancy or feeding by a breast therefore during these periods use of drug is possible if, according to the doctor, the advantage of use for mother surpasses potential risk for the fruit/child.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Considering that sensitive patients at use of drug can have side reactions (loss of coordination of movements, dizziness), for the period of administration of drug it is necessary to refrain from control of vehicles and performance of other works which demand concentration of attention and movements.

Children. Not to apply to treatment of children under 4 years.


Side effects:

From the central and peripheral nervous system: dizziness, weakness, a lack of coordination of movements, orthostatic hypotension, periodic spasms of gastrocnemius muscles (krampa), in hard cases – a vasospasm.

From digestive tract: the discomfort in an abdominal cavity, a spastic abdominal pain, nausea, vomiting, diarrhea, feeling of thirst, dryness in a mouth, can arise intestinal colic, the irritation of a rectum, prolonged use can lead to an intestines atony, a melanosis of a large intestine, colitis.

Metabolic frustration: disturbance of water and electrolytic balance (metabolic acidosis / alkalosis, a hypopotassemia, a hypocalcemia) especially at elderly people.

Allergic reactions: anaphylactic reactions, hypersensitivity reactions, skin rashes, itch, Quincke's disease.


Interaction with other medicines:

At simultaneous use of antiacid means, alkaline mineral water, milk, blockers of H2-histamine receptors with Bisakodilom-Darnitsa the kishechnorastvorimy cover collapses in a gastric cavity because of what the irritation of a mucous membrane of a stomach which can be shown by pain in epigastric area, nausea, vomiting develops.

Antiacid means weaken effect of bisacodyl. It is recommended to use drug in an hour after reception of antiacid means or reception of milk.

Laxative effect of bisacodyl can cause a lack of potassium therefore it is necessary to be careful at simultaneous use with bisacodyl of the following drugs: diuretics, beta-adrenergic agonists, corticosteroids (mineralokortikoida and glucocorticoids), Amphotericinum In, тетракозадиктид or means which toxicity increases at a lack of potassium of an organism (for example, cardiac glycosides).

Astemizol, терфенадин, erythromycin, Amiodaronum, соталол, it is not recommended to combine drugs of quinidine with bisacodyl.

Bisacodyl can cause decrease in level of calcium.

Drug can strengthen the existing lack of water and electrolytes.


Contraindications:

Hypersensitivity to bisacodyl or any other component of drug.

Intestinal impassability, the restrained hernia, acute inflammatory diseases of abdominal organs, appendicitis, disease Krone, nonspecific ulcer colitis, an abdominal pain of not clear origin, nausea and vomiting of an unknown etiology, peritonitis, bleeding from digestive tract, uterine bleeding, a spastic lock, an acute proctitis, acute hemorrhoids, cystitis; heavy abdominal pain which is associated with nausea and vomiting; heavy dehydration.

Children's age up to 4 years.


Overdose:

Use of high doses is shown by a diarrhea, intestinal gripes, arterial hypotension and considerable loss of potassium and other electrolytes.

The chronic overdose by laxative medicines can cause a chronic diarrhea, abdominal pains, a hypopotassemia, a secondary hyper aldosteronism, renal gripes. Development of a metabolic alkalosis, muscular weakness, local or generalized spasms at chronic overdose of purgatives is result of development of a hypopotassemia.

Treatment. Termination of administration of drug; gastric lavage, cleansing enema; correction of water and electrolytic balance and acid-base equilibrium. If necessary to apply anticonvulsants.


Storage conditions:

Period of validity. 2 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.


Issue conditions:

Without recipe


Packaging:

On 10 tablets in a blister strip packaging, on the 3rd blister strip packagings in a pack.



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