Laxigal-Teva - instructions for use, dose, side effects, contraindications

In 1 ml of the drug contains: active substance sodium picosulphate monohydrate (in terms of 100% substance) 7.50 mg; Excipients: sorbitol liquid 70% non-crystallized 680.0 mg, ethyl parahydroxybenzoate sodium 0.66 mg, hydrochloric acid 35% to the required amount, water up to 1 ml.

Description:Transparent from a colorless or slightly yellow liquid.

Pharmacotherapeutic group:Laxative

ATX: & nbsp

A.06.A.B.08 Sodium picosulphate

Pharmacodynamics:Sodium picosulfate is a laxative. Lipophilic active metabolite of sodium picosulfate binds to intestinal wall receptors,blocks the absorption of water and electrolytes and strengthens their secretion in the lumen of the intestine, as a result of increased peristalsis, accelerates the movement of intestinal contents. Laxative action occurs 10-12 hours after ingestion.

Pharmacokinetics:

Sodium picosulfate as a hydrophilic substance is practically not absorbed through the lipophilic membranes of intestinal cells. Therefore, after oral administration sodium picosulphate comparatively quickly passes through the stomach and small intestine in an unchanged form. Approximately 70% of the dose is taken to the large intestine3 hours after admission. In the large intestineby hydrolysis of sodium picosulphate - under the influence of intestinal microorganisms a lipophilic active metabolite is formed, which easily penetrates the biological membranes of cells, stimulating the neuroreceptors of the mucous membrane of the large intestine. 12 hours after admission drug only 8% of the administered dose remains in the large intestine. Within 72 hours, 21% of the active metabolite is excreted through the kidneys and 72% through the intestine.

Indications:

Constipation of various etiologies due to hypotension and flaccid peristalsis of the colon.

Contraindications:Hypersensitivity to sodium picosulphate, triarylmethane, paraben and other components of the drug, intestinal obstruction, strangulated hernia, appendicitis, peritonitis, acute inflammatory diseases of the abdominal cavity, including pancreatitis and acute enterocolitis, gastrointestinal and uterine bleeding, abdominal pain of unknown origin , nausea, vomiting of unclear genesis, cystitis, severe dehydration, spastic constipation, condition after operations on the abdominal organs, pregnancy I trimester, breastfeeding period, etsky age under 4 years old.

Carefully:

Children age over 4 years.

Pregnancy and lactation:

In the II and III trimesters of pregnancy, the drug can be taken only in cases where the potential benefit of therapy for the mother significantly exceeds the potential risk to the fetus.

Dosing and Administration:

Inside, dilute in a small amount of water, before going to bed.

Adults and children over 10 years of age: for 12-24 drops (5-10 mg).

Children from 4 years to 10 years: 6-12 drops (2.5-5 mg).

Depending on the effect, the dose in subsequent techniques is increased or decreased.

Side effects:

As a rule, with short-term use sodium picosulphate practically does not have side effects. Side effects develop with prolonged use of the drug.

From the digestive system: aggravation of constipation, megacolon. With increasing doses - colic, diarrhea, intestinal spasms.

From the side of metabolism: violation of water-electrolyte balance, dehydration, hyponatremia.

From the side of the cardiovascular system: lowering of blood pressure.

From the nervous system: convulsions.

Overdose:

Symptoms: see the section "Side effect", as well as paroxysmal pains in the abdomen, ischemia of the mucous membrane of the colon, hyperaldosteronism, urolithiasis, lesion of the renal tubules.

Treatment: gastric lavage, correction of water-electrolyte balance disorders, antispasmodics.

Interaction:

Antibiotics of a wide spectrum of action reduce a laxative effect; diuretics and glucocorticoids increase the likelihood of a water-electrolyte imbalance; possibly increased sensitivity to cardiac glycosides.

Special instructions:

It is not recommended to use more than 10 days without a doctor's supervision.When sodium picosulfate is used in high doses and for a long time, symptoms of water-electrolyte imbalance, including hyponatremia, may appear. It is impossible to exclude the possibility of developing spontaneous defecation. If the nature of the stool when taking sodium picosulphate does not change for a long time, it is necessary to consult a doctor to find out the cause of constipation.

Effect on the ability to drive transp. cf. and fur:

Sodium picosulphate does not affect the ability to drive vehicles and other technique.

Form release / dosage:

Drops for oral administration 7.5 mg / ml.

Packaging:

10 ml or 25 ml of the preparation are placed in a bottle of brown glass, equipped with a dropper and a lid with the control of the first opening.

1 bottle with instructions for use is placed in a cardboard box.

Storage conditions:

At temperatures from +15 ° С to +25 ° С. Do not freeze!

Keep out of the reach of children.

Shelf life:

2 years. The vial is opened for 18 months. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012803 / 01

Date of registration:30.11.2011 / 22.08.2017

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Czech Industries, s.r.o. Czech Republic

Representation: & nbspTeva Teva Israel

Information update date: & nbsp10.02.2018

Illustrated instructions

Instructions

Laxigal-Teva (Laxygal-Teva)