Altanova ointment

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT A LTAN OINTMENT (ALTAN OINTMENT)

Composition:

Active substances: 1 g of ointment contains altan, calculated as 100 % content of elagotannins and dry matter – 20 mg, dimethyl sulfoxide – 30 mg;

Excipients: propylparahydroxybenzoate (E 216), polyethylene glycol (macrogol 400), mineral oil, macrogol cetylstearyl ether, cetylstearyl alcohol, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of light brown to brown color, of homogeneous consistency, with a weak specific odor.

Pharmacotherapeutic group. Agents for the treatment of wounds and ulcerative lesions. Preparations promoting wound healing. ATC Code D03A X.

Pharmacological properties.

Pharmacodynamics.

Altan is a combination drug composed of polyphenolic substances – ellagitannin derivatives – that exert antimicrobial, anti-inflammatory, and wound-healing (reparative) effects. Ellagitannin derivatives also possess membrane-stabilizing and antioxidant properties. The second component of Altan ointment, dimethyl sulfoxide, ensures solubility of polyphenols and their deep penetration into the damaged wound areas. In addition, dimethyl sulfoxide exerts pronounced anti-edematous, spasmolytic, anti-aggregant, analgesic, as well as moderate antiseptic, anti-inflammatory, and local anesthetic effects.

The most sensitive pathogens of purulent-septic wound infections to this drug include Staphylococcus aureus, Proteus vulgaris, and Klebsiella pneumoniae.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Pyoderma infected with staphylococci;
• Trophic ulcers of the leg complicated by purulent infection;
• Mild to moderate burns;
• Purulent wounds in the first phase of the wound process;
• Dermatoses complicated by pyococcal infection;
• Generalized periodontitis of degree I–II.

Contraindications.

Hypersensitivity to the components of the drug and/or to other tannin-containing medicinal products.

Contraindications associated with dimethyl sulfoxide: cardiac and vascular insufficiency, severe atherosclerosis, angina pectoris, impaired kidney or liver function, stroke, myocardial infarction, comatose states, glaucoma, cataract.

Interaction with other medicinal products and other types of interactions.

Altan ointment should not be combined with topical preparations containing heavy metal salts due to the possibility of forming poorly soluble complexes.

Interaction related to dimethyl sulfoxide: dimethyl sulfoxide enhances the effects of ethanol (alcohol inhibits elimination of the drug) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin), chloramphenicol, rifampicin, griseofulvin, and sensitizes the body to anesthetic agents. Enhanced specific activity and toxicity of medicinal products due to dimethyl sulfoxide should be taken into account.

Special precautions for use

Do not apply to skin exhibiting signs of allergy. Do not apply to facial skin.

Avoid contact of the medication with the eyes. In case of accidental contact with the eyes, immediately rinse thoroughly with running water.

Altanova ointment contains propylparahydroxybenzoate (E 216), cetostearyl alcohol, and dimethyl sulfoxide. Propylparahydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis). Dimethyl sulfoxide may cause skin irritation.

Elderly patients may use the medication after prior consultation with a physician.

Use during pregnancy or breastfeeding

Do not use during pregnancy. Breastfeeding should be discontinued during treatment.

Ability to affect reaction speed when driving or operating machinery

Use with caution, taking into account the effect on the central nervous system, particularly the possibility of dizziness occurring.

Method of Administration and Dosage.

Before applying the ointment, pus and necrotic tissue residues should be removed, and the wound should be treated with antiseptic agents. Then apply the ointment with a sterile spatula under a dressing. At the beginning of treatment, change the dressing daily; later, every 1–2 days.

For the treatment of pyoderma, apply the ointment to the affected area daily.

For burn areas, apply the ointment 2–3 times a day.

The duration of treatment depends on the severity of the condition and may last from 10 to 30 days.

For periodontitis, apply the ointment by instillation into periodontal pockets in combination with applications of the ointment on the gums for 15–20 minutes daily, after procedures eliminating local traumatic factors and after basic antiseptic therapy.

Treatment course – 10 days (1 instillation-application daily).

Children.

The efficacy and safety of the drug in children have not been established; therefore, the drug should not be used in this patient category.

Overdose.

There have been no reports of overdose. However, in case of overdose, an intensification of adverse reactions may occur.

Side effects.

When the ointment is used correctly, side effects occur rarely.

Immune system: in case of signs of individual hypersensitivity to the components of the drug, namely allergic reactions including dermatitis (skin rashes), irritation, hyperemia, itching, angioneurotic edema, urticaria, erythema, dryness of the skin, burning sensation, treatment should be discontinued and a doctor should be consulted.

Gastrointestinal tract: nausea, vomiting, diarrhea.

Central and peripheral nervous system: headache, dizziness, insomnia, adynamia.

Respiratory system: bronchospasm.

Shelf life.

2 years. The drug should not be used after the expiry date stated on the packaging.

Storage conditions.

In the original packaging at a temperature not exceeding 25 °C; freezing must be avoided. Keep out of reach of children.

Packaging. 25 g in a tube and carton.

Availability. Over-the-counter.

Manufacturer.

Public Joint-Stock Company "Scientific-Production Center "Borshchagovskiy Chemical-Pharmaceutical Plant".

Manufacturer's address and place of business.

17 Miru Street, Kyiv, 03134, Ukraine.