Drapolen cream in the treatment and prevention of diaper dermatitis in children in the first months of life

Drapolene cream 55g No. 1

Name

Drapolene cream dnar.approx. in tubes 55g per pack. No. 1

Description

A homogeneous cream of pink color, small, more intensely colored inclusions are possible.

Main active ingredient

benzalkonium chloride solution 0.2 mg (equivalent to 0.1 mg/g benzalkonium chloride), cetrimide 2.0 mg.

Release form

55.0 g of cream in a laminated tube (polyolefin/foil/polyolefin) with high-density polyethylene “hangers” with a screw-on plastic cap. 1 tube along with instructions for use in a cardboard box.

Dosage

55g

pharmachologic effect

Antiseptic and disinfectants. Quaternary ammonium compounds. ATX code: D08AJ

Pharmacodynamics

Benzalkonium chloride and cetrimide are quaternary ammonium compounds with properties characteristic of cationic surfactants. This drug is useful for the treatment and prevention of diaper dermatitis, due to the fact that Drapolen™ inhibits the development of microorganisms that contribute to the development of diaper dermatitis.

Pharmacokinetics

There are no data on the pharmacokinetics of the active ingredients, cetrimide and benzalkonium chloride, when used as prescribed. Systemic absorption of the active components is unlikely.

Indications for use

Treatment of diaper dermatitis, prevention of diaper dermatitis as an addition to hygienic child care. The drug is also used to relieve symptoms of small superficial burns (limited to the epidermis), small sunburns and the effects of exposure to weather conditions on the skin.

Directions for use and doses

For external use only. Adults (including elderly patients) Before applying Drapolene™, thoroughly wash and dry the affected area. To achieve optimal results, remove any remaining soap from the area where the cream is applied. The cream is applied evenly in a thin layer to the affected area several times a day (as needed). Newborns, infants and children Whenever you change a diaper or diaper, thoroughly wash and dry the area covered by the diaper or diaper. To achieve optimal results, remove any remaining soap from the area where the cream is applied. The cream is applied evenly in a thin layer to the affected area after each diaper change, paying special attention to skin folds. Patients with impaired renal function No special precautions are required. Patients with impaired liver function No special precautions are required.

Use during pregnancy and lactation

Special precautions are not required when using the cream in accordance with the instructions for use during pregnancy and breastfeeding, since systemic absorption of the drug components is unlikely.

Precautionary measures

The cream should be stored out of the reach of children. If you accidentally swallow the cream, consult a doctor. Avoid getting the cream in your eyes or contact lenses. If diaper rash does not go away within 48-72 hours, you should consult a doctor.

Interaction with other drugs

No reports of drug interactions have been received.

Contraindications

Drapolene™ is contraindicated in patients with a history of hypersensitivity to benzalkonium chloride, cetrimide, lanolin or excipients included in the drug. If a hypersensitivity reaction occurs, discontinue use of the drug.

Compound

Active ingredients in 1 g: benzalkonium chloride solution 0.2 mg (equivalent to 0.1 mg/g benzalkonium chloride), cetrimide 2.0 mg. Excipients: white soft paraffin, anhydrous lanolin, cetyl alcohol, polyvax GP 200, chlorocresol, carmoisine E 122, purified water.

Overdose

Overdose is unlikely due to the low concentration of benzalkonium chloride and cetrimide in the drug, however, in case of accidental ingestion, consult a doctor and undergo symptomatic treatment.

Side effect

Skin and subcutaneous tissue disorders: contact dermatitis, local skin reactions. The frequency of these reactions is unknown. Immune system disorders: allergic reactions, skin reactions of immediate or delayed hypersensitivity. The frequency of these reactions is unknown. Patients with sensitivity to one or more components of Drapolen™ cream may experience allergic hypersensitivity reactions. There are rare reports of hypersensitivity to lanolin. In isolated cases, some patients who used an ophthalmic solution that uses benzalkonium chloride as a preservative experienced swelling and conjunctivitis. Cases of contact dermatitis have been reported with the use of benzalkonium chloride in plaster casts. Hypersensitivity to cetrimide may occur in the form of localized contact dermatitis; in severe cases, the rash may become generalized. If the listed adverse reactions occur, as well as reactions not mentioned in the instructions for medical use, you should consult your doctor.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.