Panthenol aerosol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTHENOL AEROSOL (PANTHENOLAEROSOL)

Composition:

Active substance: dexpanthenol;

1 g of the preparation contains 50 mg of dexpanthenol (excluding propellant) (calculated as 100 % substance);

Excipients: cetostearyl alcohol (type A) emulsified, macrogol glycerol cocoate, methylparahydroxybenzoate (E 218), propylene glycol, potassium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, purified water, tetrafluoroethane.

Pharmaceutical form. Topical foam.

Main physicochemical characteristics: white foam with a faint characteristic odor.

Pharmacotherapeutic group.

Agents for treatment of wounds and ulcers. ATC code D03A X03.

Pharmacological properties.

Pharmacodynamics. Dexpanthenol is an alcohol analogue of pantothenic acid and has the same biological efficacy as pantothenic acid due to intermediate metabolism. Pantothenic acid and its salts are water-soluble vitamins which, as part of coenzyme A, participate in numerous metabolic processes.

Topical application of dexpanthenol may compensate for the increased demand of damaged skin and/or mucous membranes for pantothenic acid.

Pharmacokinetics. The active substance is absorbed through the skin. More detailed studies on the metabolism of the active ingredient in the skin and mucous membranes have not been conducted.

Clinical characteristics.

Indications.

Used for various skin and mucous membrane injuries, including abrasions, burns, aseptic postoperative wounds, skin grafts, and for bullous and pemphigoid dermatitis.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Interaction of the drug „Pantenol aerosol” with other medicinal products is unknown.

Instructions for use.

Pressurized container. Avoid dropping, impacts, exposure to direct sunlight, and heating above 50°C. Do not open or burn even after complete use of the foam; dispose only after complete release of gas. Do not spray near open flames or hot surfaces.

For first-time use, the container must be shaken well, and the first dose should be released until foam appears before applying the medication to the affected area.

Avoid contact of the foam with eyes. In case of accidental contact with eyes, rinse thoroughly with water.

When using "Panthenol aerosol" in patients with bronchial asthma or bronchopulmonary disorders, inhalation of the propellant should be avoided, as it may irritate mucous membranes or even provoke an asthma attack.

Note that cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis), and propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

Pantothenate crosses the placental barrier via active transport and is excreted into breast milk in proportion to its absorption.

Since the systemic availability of dexpanthenol after topical application is unknown, when use of "Panthenol aerosol" is necessary during pregnancy or breastfeeding over large skin areas, the benefit to the mother should be carefully weighed against the potential risk to the fetus/infant. Use during pregnancy is possible under medical supervision. When used to treat nipple fissures during breastfeeding, the product should be washed off before nursing.

Ability to influence reaction rate while driving or operating machinery.

No special precautions are required.

Method of Administration and Dosage

"Panthenol aerosol" should be evenly sprayed onto the affected area one or several times daily.

Hold the container upright with the valve facing upwards when spraying. To obtain a good quality foam, vigorously shake the container before each use, especially if it has not been used for a prolonged period. When using the product for the first time, only the propellant may be released initially before the foam forms.

Bring the nozzle close to the affected area and gently press down to evenly spray the medication onto the affected site from a distance of 10–20 cm for 1–2 seconds.

The duration of treatment depends on the type and course of the condition and should be determined after consultation with a physician.

If "Panthenol aerosol" needs to be applied to the facial area, it should not be sprayed directly onto the face. It is preferable to spray the product onto the hand and then apply it to the appropriate area of the face. Avoid spraying the product into the eyes, directly into the mouth, or nose.

Children. The product should be used in children only as directed by a physician and under adult supervision.

Overdose.

Overdose is unlikely when "Panthenol aerosol" is used according to the instructions.

No toxic effects are expected following ingestion of a large amount of the product. If gastrointestinal disturbances occur, symptomatic treatment should be administered.

Side effects.

Allergic reactions: allergic contact dermatitis and skin irritation may very rarely occur, manifesting as symptoms such as itching, erythema, eczema, rash, urticaria, and blisters.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

58 g or 116 g in a container; 1 container in a cardboard box.

Supply category. Over-the-counter.

Manufacturer: LLC "Micropharm".

Manufacturer's address and place of business.

20 Shevchenka Street, Kharkiv, Ukraine.