Laxygal-Teva (Drops) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

ATC Code

A06AB08 (Sodium picosulfate)

Active Substance

Sodium picosulfate (Rec.INN registered by WHO)

Dosage Form

Laxygal-Teva

Oral drops 7.5 mg/1 ml: 10 ml or 25 ml bottle with dropper

Dosage Form, Packaging, and Composition

Oral drops in the form of a clear, colorless to pale yellow liquid.

Excipients: sorbitol liquid 70% non-crystallizing – 680 mg, sodium ethylparahydroxybenzoate – 0.66 mg, hydrochloric acid 35% – as required, purified water – up to 1 ml.

10 ml – brown glass bottles (1) with a dropper – cardboard packs^×.
25 ml – brown glass bottles (1) with a dropper – cardboard packs^×.

^× protective stickers may be additionally applied.

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. Under the action of intestinal microorganisms, it is hydrolyzed to form an active form, which irritates the receptors of the intestinal mucosa and enhances its peristalsis.

It promotes the accumulation of water and electrolytes in the large intestine, which leads to stimulation of defecation, reduction of evacuation time, and softening of stool.

Pharmacokinetics

After oral administration, it is not absorbed from the gastrointestinal tract and does not undergo enterohepatic circulation.

In the distal part of the large intestine, sodium picosulfate is cleaved to form the active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane.

The time to onset of the laxative effect is determined by the rate of release of the active metabolite and is 6-12 hours.

Approximately 10.4% of the total dose is excreted by the kidneys as a glucuronide within 48 hours.

Indications

Constipation due to atony and hypotension of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation); constipation caused by medication; constipation due to intestinal dysbiosis, dietary disorders; for regulating stool in hemorrhoids, proctitis, anal fissures; gallbladder diseases, irritable bowel syndrome with predominant constipation.

ICD codes

Dosage Regimen

Administer orally. Determine the dose individually based on patient age and clinical response.

Use the provided dropper for accurate measurement. Dilute the required number of drops in a small amount of water immediately before administration.

For adults and children over 10 years, the typical single dose is 13 to 26 drops (equivalent to 5 to 10 mg of sodium picosulfate).

For children aged 4 to 10 years, the typical single dose is 5 to 13 drops (equivalent to 2.5 to 5 mg).

For children under 4 years, determine the dose strictly by a physician.

Take the dose once daily, preferably in the evening before bedtime. The onset of laxative effect typically occurs after 6 to 12 hours.

Limit the duration of use. Do not use daily for more than 10 days without medical supervision.

If constipation persists or if abdominal pain occurs, discontinue use and consult a physician. Adjust fluid and dietary fiber intake during therapy.

Adverse Reactions

From the digestive system dyspepsia, flatulence, nausea, vomiting, abdominal cramps and pain, diarrhea.

From the nervous system dizziness, fainting, drowsiness, increased fatigue.

From the immune system allergic reactions, angioedema, allergic dermatitis.

From the skin and subcutaneous tissues skin rash, urticaria, itching.

From metabolism increased excretion of potassium, sodium and other electrolytes, dehydration.

Contraindications

Hypersensitivity to sodium picosulfate; intestinal obstruction or obstructive bowel diseases; acute diseases of the abdominal organs or severe abdominal pain that may be accompanied by nausea, vomiting, fever, including appendicitis; acute inflammatory bowel diseases; severe dehydration; first trimester of pregnancy; pediatric age – depending on the dosage form.

With caution elderly age, hypokalemia, increased blood magnesium concentration, asthenia, renal failure.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy should only be considered if the intended benefit to the mother outweighs the potential risk to the fetus.

The active metabolite and its glucuronides are not excreted in breast milk. Use during lactation (breastfeeding) is possible according to indications in recommended doses.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the sodium picosulfate drug labels regarding contraindications for the use of specific sodium picosulfate dosage forms in children of different ages.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

The product is tasteless, so it can be added to food for children. Do not use daily without medical supervision for more than 10 days.

Dizziness and fainting occurring after taking sodium picosulfate may be associated with a vasovagal reaction (e.g., straining during defecation, abdominal cramps).

The possibility of spontaneous defecation cannot be excluded. If the nature of the stool does not change for a long time while taking sodium picosulfate, it is necessary to consult a doctor to determine the cause of constipation.

Studies on the effect of sodium picosulfate on fertility have not been conducted. No teratogenic effects were identified.

Effect on ability to drive vehicles and operate machinery

If vasovagal reactions occur in patients while taking the product, they should avoid driving vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with broad-spectrum antibiotics, a decrease in the laxative effect of sodium picosulfate is possible.

With simultaneous use with diuretics and corticosteroids, the risk of electrolyte disturbances may increase.

Electrolyte imbalance occurring while taking sodium picosulfate in high doses may lead to worsened tolerance of cardiac glycosides with their simultaneous use.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.