Mefenat

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEFENAT (MEFENAT)

Composition:

Active substances: sodium mefenamate, vinyline;

100 g of ointment contain 0.5 g of sodium mefenamate calculated as dry substance, 10 g of vinyline;

Excipients: polyethylene glycol (400), cetostearyl alcohol (type A) emulsified, purified water.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: ointment of white or white with a yellowish tint, with a weak specific odor.

Pharmacotherapeutic group.

Agents for the treatment of wounds and ulcerative lesions. ATC code D03A X.

Pharmacological Properties

Pharmacodynamics

Sodium mefenamate, the main active ingredient of the ointment, belongs to non-steroidal anti-inflammatory drugs (NSAIDs). It exerts anti-inflammatory action by preventing the formation and release from tissues of inflammatory mediators (serotonin, histamine, prostaglandins, kinins), and also inhibits the synthesis of reactive oxygen species (peroxide, hydroxyl radical). By predominantly blocking the enzyme cyclooxygenase-2 (COX-2), it suppresses granulation tissue proliferation at the site of inflammation while simultaneously stimulating regenerative processes. It inhibits immediate and delayed-type hypersensitivity allergic reactions. It provides analgesic effect in muscle and joint pain, which exceeds the analgesic effect of salicylic acid. It increases the level of local interferon and other cytokines.

Vinilin acts bacteriostatically, promotes epithelialization, and accelerates wound healing.

The combination of these ingredients enhances the anti-inflammatory, analgesic, and wound-healing effects of the ointment and prolongs its action. As a result of ointment application, the number of leukocytes in the wound increases and their phagocytic capacity improves.

Pharmacokinetics

The ointment acts predominantly locally, is poorly absorbed through mucous membranes and skin, and practically does not produce systemic effects. The duration of effect may vary depending on the amount of purulent exudate and the nature of infectious agents present on the skin and mucous membranes, and on the wound surface. On average, the therapeutic effect lasts within 8–20 hours.

Clinical characteristics.

Indications.

Ulcerative-necrotic and inflammatory diseases of the skin and mucous membranes: exfoliative cheilitis; slowly healing fissures; traumatic ulcers of the lips; acute and chronic ulcerative gingivitis; aphthous stomatitis; nonspecific oral ulcers; carbuncles, furuncles, granulating wounds, trophic ulcers, eczema, traumatic skin injuries, burn injuries, myositis, rheumatoid arthritis.

Contraindications.

Individual hypersensitivity to the components of the ointment. History of bronchial asthma attacks, urticaria, or acute rhinitis induced by acetylsalicylic acid or other NSAIDs.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with salicylates, pyrazolone derivatives, and other anti-inflammatory agents, therapeutic effects and analgesic action are enhanced.

Special precautions for use.

Use with caution during prolonged treatment in patients with blood disorders, kidney diseases, and also when using anticoagulants.

Use during pregnancy or breastfeeding.

Not studied.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Apply Mefenat to damaged areas of the skin or mucous membranes using a special glass spatula, scraper, or with gauze (cotton) swabs (pads) 1–3 times daily. After applying the ointment to affected skin areas, apply an aseptic dressing.

Treatment duration is 7–15 days, but may be extended if necessary.

Children. Do not use in pediatric practice.

Overdose.

Cases of overdose have not been reported.

Side effects.

When treating damaged oral mucosa, short-term irritation at the site of ointment application may occur – redness of the application area, burning sensation followed by numbness (mild local anesthetic effect), itching, swelling.

Shelf life.

3 years.

Do not use the medication after the expiry date stated on the package.

Storage conditions.

Store in a protected from light place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 g or 40 g in a tube. 1 tube per carton.

Availability category. Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.