MAGNESIUM SULFATE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MAGNESIUM SULFATE

Composition:

Active substance: magnesium sulfate heptahydrate;

1 sachet contains 10 g or 25 g of magnesium sulfate heptahydrate;

1 container contains 25 g of magnesium sulfate heptahydrate.

Pharmaceutical form. Powder.

Main physicochemical properties: white crystalline powder or colorless shiny crystals.

Pharmacotherapeutic group. Osmotic laxatives. ATC code A06AD04.

Pharmacological properties.

Pharmacodynamics.

Oral administration causes a laxative effect. The medicinal product also has choleretic and diuretic actions.

Pharmacokinetics.

The laxative effect is due to changes in osmotic pressure, inhibition of water absorption from the intestine, dilution and increase in the volume of intestinal contents, and stimulation of enteroreceptors, facilitating defecation.

Clinical characteristics.

Indications.

Constipation. As an antidote in barium salt poisoning.

Contraindications.

Increased individual sensitivity, acute inflammatory gastrointestinal diseases, intestinal obstruction, cholelithiasis, biliary tract obstruction, acute life-threatening conditions, arterial hypotension, conditions associated with calcium deficiency and respiratory center depression, severe renal failure.

Special precautions.

The drug is not recommended for systematic use.

Interaction with other medicinal products and other forms of interaction.

Reduces the effect of oral anticoagulants, cardiac glycosides, phenothiazines. Decreases absorption of ciprofloxacin, tetracyclines; weakens the action of streptomycin and tobramycin.

Pharmaceutically incompatible (precipitate forms) with calcium preparations, ethanol (at high concentrations), carbonates, alkali metal phosphates, arsenic acid salts, barium, strontium, clindamycin phosphate, sodium hydrocortisone succinate, polymyxin sulfate, procaine hydrochloride, salicylates, and tartrates.

Special precautions for use.

"Magnesium sulfate" is a traditional medicinal product used according to indications supported by long-term experience.

The patient should consult a physician if symptoms of the disease do not disappear during the use of the medicinal product or if adverse reactions occur that are not listed in the instructions for medical use.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy.

During breastfeeding, it should be used under medical supervision only if the benefit to the mother outweighs the potential risk to the infant.

Effect on the ability to drive and use machinery.

Has no effect.

Method of Administration and Dosage

As a laxative, magnesium sulfate is administered orally (at night or on an empty stomach, 30 minutes before meals) once daily:

• Adults: 10–30 g in ½ glass of water.
• Children aged 12 years and older: 10 g in ½ glass of water.
• Children aged 6–12 years: 5–10 g (i.e., half to the full volume of the solution prepared from 10 g in ½ glass of water).

For chronic constipation, administer as enemas: dissolve contents of 1 packet (10 g) in 500 mL of water and use in the amount prescribed by a physician.

In barium salt poisoning, administer orally to adults 20–25 g of powder dissolved in 200 mL of water.

Children
Can be administered to children aged 6 years and older only as prescribed by a physician.

Overdose

In case of overdose, diarrhea and vomiting may occur.

Treatment: intravenous administration of calcium chloride or calcium gluconate solution – 5–10 mL of 10% solution; oxygen therapy, inhalation of carbogen, artificial ventilation, peritoneal dialysis or hemodialysis. Symptomatic therapy.

Side effects.

Termination of pregnancy, exacerbation of inflammatory processes in the gastrointestinal tract, nausea, vomiting, allergic reactions. With prolonged use, disturbance of water-salt balance, nutritional deficiencies, and colon atony may occur.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 g or 25 g in sachets, 25 g in containers.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Street, Zaporizhzhia, Zaporizhzhia region, 69063, Ukraine.

Applicant. JSC "Pharmaceutical Factory "Viola".

Applicant's address.

75 Amosova Street, Zaporizhzhia, Zaporizhzhia region, 69063, Ukraine.