Salicylic Acid Na Nova Argentia 10% Ointment For Corns And Warts 30g

NAME
SALICYL ACID NA

PHARMACOTHERAPEUTIC CATEGORY
Dermatological preparations.

ACTIVE PRINCIPLES
Salicylic acid.

EXCIPIENTS
White petroleum jelly.

INDICATIONS
Treatment of psoriasis, acne vulgaris, seborrhea in adults and children; removal of warts and corns in adults and children; local treatment of some forms of eczema and ichthyosis in adults.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredient, to salicylates or to any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propylsalicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid); children under 2 years of age; diabetes; peripheral vascular disease.

DOSAGE
Apply locally the minimum quantity of ointment in relation to the area to be treated with a light massage. Start the treatment by applying the medicine only on a small portion of the skin or once a day, so as not to irritate the skin.

STORAGE
Do not store above 25 degrees C. Keep the medicine in the container tightly closed away from light, away from sources of heat or open flame.

WARNINGS
The medicine should not be ingested. Salicylic acid is irritating and may cause dermatitis. In the treatment of corns and warts it is necessary to protect the surrounding intact skin to minimize the 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 injured or inflamed skin, as excessive absorption of the active ingredient can cause systemic poisoning by salicylates mainly in children, which it 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. It is possible to observe an improvement of the treated skin after 6 weeks of therapy or after 12 weeks in case of removal of a wart. The medicine may be flammable. Do not use store near open flames or any heat source.

INTERACTIONS
Salicylic acid can interact with the following medicines: coumarin anticoagulants (acenocoumarol, dicumarol, phenprocoumon and warfarin) and the derivatives 1,3-idandioni (anisindione, fenidione), as acidosalicylic can inhibit platelet aggregation and displace them from their binding site with plasma proteins, thus causing an increased risk of bleeding. Inhibitors of activated coagulation factor X (heparins and heparinoids), since in the case of neuraxial anesthesia (spinal or epidural), the simultaneous use of salicylic acid can cause a rapid increase in the risk of bleeding and hematoma. Glyburide, as excessive hypoglycemia could occur due to an unknown mechanism. Probenecid, as salicylic acid can cause the reversal of the uricosuric effects of this drug. Acetazolamide, as there may be an increase in the side effects of salicylate. Varicella vaccine, as salicylic acid can 'cause an increased risk of developing Reye's syndrome. Furthermore, salicylic acid should not be used at the same time as tamarind (tropical tree belonging to the Fabaceae family) and Salvia miltiorrhiza or Tan-Shen (plant from the Labiatae family), as a rapid increase in plasma levels of salicylate with consequent increase in toxicity.

SIDE EFFECTS
The following are the side effects of salicylic acid, organized according to the MedDRA systemic classification. Insufficient data are available to establish the frequency of the individual effects listed. Metabolism and nutrition disorders: hypoglycemia. Skin and subcutaneous tissue disorders: irritation, dermatitis, burning, itching, erythema, peeling of the skin, scarring on the face.

PREGNANCY AND BREASTFEEDING
There are no adequate data from the use of salicylic acid in pregnant and lactating women. Therefore, salicylic acid solutions and ointments should not be used during pregnancy and lactation, unless absolutely necessary. Studies conducted on animals have shown reproductive toxicity. While, the potential risk for humans is not known. However, it should be considered that despite being used locally, salicylic acid is absorbed systemically, easily crosses the placenta, finding itself in higher concentrations in fetal plasma and is excreted in breast milk.