Salicylic acid 10% ointment - treatment of psoriasis, acne, seborrhea, eczema 30 g

Product Description

Marco Viti Salicylic Acid 10% Ointment

Composition:

Marco Viti Salicylic Acid 2% Ointment: 100 g of ointment contains Active ingredient: salicylic acid 2 g. Marco Viti Salicylic Acid 5% Ointment: 100 g of ointment contains Active ingredient: salicylic acid 5 g. Marco Viti Salicylic Acid 10% Ointment: 100 g of ointment contains Active ingredient: salicylic acid 10 g. For a full list of excipients, see section 6.1.

Excipients

White petrolatum.

Therapeutic indications

– Treatment of psoriasis, acne vulgaris, and seborrhea in adults and children; – Removal of warts and calluses in adults and children; – Local treatment of certain forms of eczema and ichthyosis in adults.

Contraindications

– Hypersensitivity to the active substance, salicylates, or to any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propyl salicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid); – ​​Children under 2 years of age; – Diabetes (see section 4.8); – peripheral vascular disease.

Dosage

Apply the smallest amount of ointment locally, massaging gently. Begin treatment by applying the medicine to only a small area of ​​skin or only once a day, so as not to irritate the skin.

Warnings and Precautions

The medicine should not be swallowed. Salicylic acid is an irritant and may cause dermatitis (see section 4.8). When treating corns and warts, protect the surrounding intact skin to minimize absorption of the active ingredient. Salicylic acid should not be used for long periods of time, at high concentrations, on large areas of the body, or on broken or inflamed skin, as excessive absorption of the active ingredient can cause systemic salicylate poisoning (see section 4.9), especially in children, which can be fatal. Avoid contact with mouth, eyes, genitals, and other mucous membranes. Use with caution in children, as experience with the use of salicylic acid in this population is limited. Improvement of treated skin may be observed after 6 weeks of therapy, or after 12 weeks if a wart has been removed.

Interactions

Salicylic acid may interact with the following medications: – Coumarin anticoagulants (acenocoumarol, dicoumarol, phenprocoumon, and warfarin) and 1,3-hydanedione derivatives (anisindione, phenidione), as salicylic acid may inhibit platelet aggregation and displace them from their plasma protein binding site, thus increasing the risk of bleeding. – Inhibitors of coagulation-activated factor X (heparins and heparinoids), since in case of neuraxial anesthesia (spinal or epidural), the concomitant use of salicylic acid may cause a rapid increase in the risk of bleeding and hematoma. – Glyburide, since, by an unknown mechanism, excessive hypoglycemia may occur. – Probenecid, since salicylic acid may cause the reversal of the uricosuric effects of this drug. – Acetazolamide, since an increase in salicylate side effects may occur. – Varicella vaccine, since salicylic acid may cause an increased risk of developing Reye's syndrome. Additionally, salicylic acid should not be used concomitantly with tamarind (a tropical tree belonging to the Fabaceae family) and Salvia miltiorrhiza or Tan-Shen (a plant of the Labiateae family), as this may result in a rapid increase in plasma salicylate levels, resulting in increased toxicity.

Undesirable Effects

The following are the adverse reactions of salicylic acid, organized according to the MedDRA systemic classification. There are insufficient data to determine the frequency of the individual reactions listed. Metabolism and Nutrition Disorders Hypoglycemia. Skin and subcutaneous tissue disorders Irritation, dermatitis, burning, itching, erythema, skin peeling, facial scarring.

Pregnancy and breastfeeding

There are no adequate data regarding the use of salicylic acid in pregnant and breastfeeding women. Therefore, salicylic acid solutions and ointments should not be used during pregnancy and breastfeeding unless clearly necessary. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. However, it should be considered that despite its topical use, salicylic acid is absorbed systemically, readily crosses the placenta, finding higher concentrations in fetal plasma, and is excreted in breast milk.