Polydihydroxyphenylenthiosulfonat sodium (Capsules) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

N07XX (Other drugs for the treatment of nervous system diseases)

Active Substance

Sodium polydihydroxyphenylenethiosulfonate (Grouping name)

Dosage Form

Sodium polydihydroxyphenylenethiosulfonate

Capsules 250 mg: from 1 to 200 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #3, dark brown in color; the capsule contents are a black powder, odorless or with a faint specific odor.

Composition of the capsule body and cap: titanium dioxide (E171) – 0.6528%, iron oxide black (E172) – 0.089%, iron oxide red (E172) – 0.089%, iron oxide yellow (E172) – 0.612%, gelatin – 98.5572%.

From 1 to 20 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply, reducing tissue hypoxia

Pharmacotherapeutic Group

Antihypoxant

Pharmacological Action

Antihypoxic agent, has antioxidant, metabolic, vasodilating, and hypotensive action.

It increases the efficiency of tissue respiration under hypoxic conditions, especially in organs with a high level of metabolism (brain, heart muscle, liver).

It ensures a reduction in oxygen consumption during significant physical exertion, improves tissue respiration, reduces mental and physical fatigue, and facilitates the performance of labor-intensive physical operations.

It optimizes the activity of cell mitochondria and reduces their oxygen consumption.

It possesses powerful electron-acceptor properties and acts directly on the mitochondrial respiratory chain.

The presence of a thiosulfate group in the polymeric molecular structure provides antiradical and antioxidant action.

Indications

Severe traumatic injuries; blood loss; extensive surgical interventions (as part of complex therapy).

For oral administration: extreme and adverse conditions accompanied by a lack of oxygen: high altitude, conditions of the Polar region, underwater work (to increase the body’s performance); overfatigue; increased fatigue; mental and physical overstrain; increased loads; operational activities.

ICD codes

Dosage Regimen

Injectable forms of the drug are administered intravenously slowly, at a rate of 40-60 drops/min, in a single dose of 0.14 g (1 ampoule) 1-3 times/day at equal intervals.

Before use, the contents of the ampoule are diluted in 500 ml of infusion fluid (5% dextrose solution). The course of treatment is 3-5 days.

Capsules are taken orally, before meals or during meals with a small amount of water. A single dose for adults is 0.5-1 g, the daily dose is 1.5-3 g; for children, a single dose is 0.25 g, the daily dose is 0.75 g. The course of treatment is 3-14 days, depending on the conditions the body will be in or the severity of the patient’s condition.

Adverse Reactions

Allergic reactions.

Contraindications

Hypersensitivity; pregnancy; lactation period; hemorrhagic stroke.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Pediatric Use

Use is possible according to the dosing regimen.

Storage Conditions

Store at 2°C (36°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.