Susteffect^® turpentinous (Ointment) Instructions for Use

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

ATC Code

N02 (Analgesics)

Active Substance

Turpentine oil (BP British Pharmacopoeia)

Dosage Form

Susteffect® turpentinous

Ointment for external use 20%: jars 25 g or 50 g, tubes 25 g or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use white with a yellowish tint, with a characteristic odor.

* the content of α-pinene in turpentine oil is not less than 50%.

Excipients: lanolin – 1 g, polysorbate 80 (tween 80) – 0.1 g, petrolatum – 48 g, emulsifier “Solid-2” (T-2), grade “A” – 8 g, purified water – 24 g.

25 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
25 g – composite tubes (1) – cardboard packs.
50 g – composite tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A herbal remedy. It has a local irritant, distracting, and antiseptic effect.

The main active substance of turpentine oil (purified turpentine), the terpene alpha-pinene, is lipophilic, easily penetrates the epidermis and irritates the endings of sensory nerves. A certain contribution is also apparently made by endogenous biologically active substances released under the influence of the oil.

Histamine and other inflammatory mediators cause vasodilation, slight tissue swelling, and hyperemia. Enkephalins and endorphins contribute to pain relief.

The mechanism of the distracting action is explained by the fact that two streams of excitation enter the central nervous system – from pathologically altered internal organs and from the skin surface, with the latter dominating. The perception of afferent impulsation is weakened.

Furthermore, a trophic influence is carried out through the cutaneous-visceral reflex (when irritating the sensitive zones of Head) and by the type of axon reflex (antidromically via postganglionic sympathetic fibers).

With the inhalation route of administration, alpha-pinene reflexively stimulates cough and has an expectorant and mucolytic effect.

Indications

As an auxiliary remedy for rheumatic pains, arthralgia, neuralgia, myalgia, lumbosciatica.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin area two to three times daily.

Rub in the ointment gently until fully absorbed.

Use the minimum effective amount necessary to cover the treatment area.

The standard duration of treatment is up to ten days.

Discontinue use if no improvement is observed within this period.

Do not apply to damaged skin, mucous membranes, or areas with inflammatory skin diseases.

Avoid contact with eyes and other sensitive areas.

Wash hands thoroughly with soap and water after each application.

Do not use occlusive dressings or heating pads over the applied ointment.

Discontinue use immediately and consult a physician if severe skin irritation or an allergic reaction occurs.

Adverse Reactions

Possible allergic reactions, skin hyperemia and itching.

Contraindications

Hypersensitivity to turpentine oil; impaired skin integrity, inflammatory skin diseases at the site of intended application; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

With caution: hepatic and/or renal failure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Should be used with caution in hepatic insufficiency.

Use in Renal Impairment

Should be used with caution in renal insufficiency.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Should not be used with elevated body temperature.

Storage Conditions

Store at 8°C (46°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.