Posiformin eye ointment 2% tube 5 g

Instructions Posiformin eye ointment 2% tube 5 g

Composition

active ingredient: bibrocatol;

1 g of ointment contains 20 mg of bibrocatol;

excipients: white soft paraffin, mineral oil, lanolin.

Dosage form

Eye ointment.

Main physicochemical properties: homogeneous ointment (in the form of a suspension) from yellow to gray-yellow in color.

Pharmacotherapeutic group

Means used in ophthalmology. Other antimicrobial agents. ATX code S01A X05.

Pharmacological properties

Pharmacodynamics

Bibrokatol is a bismuth compound with antiseptic and astringent properties, which is also able to inhibit the secretory functions of mucous membranes and promote wound healing. Its mechanism of action is due to the structure of bibrokatol, which is a phenolic derivative of tetrabromopyrocatechin and bismuth hydroxide.

On mucous membranes and wounds, bibrokatol causes protein deposition and tightening of the superficial tissue layers. This leads to the formation of a protective layer that prevents the penetration of pathogenic microorganisms. This astringent effect causes nonspecific inhibition of inflammation and secretory functions.

Pharmacokinetics

Bibrokatol is almost insoluble in water and therefore does not penetrate the intraocular fluid. Thus, its use in ophthalmology is limited to the local treatment of nonspecific irritations and inflammations, as well as the treatment of wounds of the outer membranes of the eye.

After topical application to the eye, there is no significant systemic absorption of bibrocatol.

Indication

Nonspecific irritations of the outer membranes of the eye of non-infectious origin, chronic inflammation of the eyelid margin (chronic blepharitis), fresh non-infected corneal wounds.

Contraindication

Hypersensitivity to the active substance or to any of the excipients of the drug.

Interaction with other medicinal products and other types of interactions

No specific drug interaction studies have been conducted.

When using the drug simultaneously with other eye drops or ointments, an interval of at least 15 minutes should be maintained between applications. Posiformin should be applied last.

Application features

The excipient lanolin may cause local skin reactions (e.g. contact dermatitis).

Contact lenses should not be worn during treatment with the drug.

When applying eye ointment, avoid any contact of the tip of the tube with the eye or skin.

Ability to influence reaction speed when driving vehicles or other mechanisms

Due to its oily consistency, immediately after application, the drug may briefly affect visual acuity and, thus, the reaction speed when driving or operating machinery.

Use during pregnancy or breastfeeding

Since there are no clinical data on the use of bibrocatol preparations during pregnancy or breastfeeding, the prescription of Posiformin eye ointment at this time is possible only after a careful assessment of the benefit-risk ratio of such use.

Method of administration and doses

A strip of ointment 0.5 cm long is placed in the conjunctival sac or applied to the affected eyelid 3-5 times a day. The dosage for adults and children aged 6 years and older is the same.

The drug should be used until symptoms disappear. Usually the duration of treatment should not exceed 14 days.

Children

The safety and efficacy of the drug have been confirmed for children aged 6 years and older. There is no experience with the drug in treating younger children.

Overdose

After topical application, systemic effects of the drug are not expected due to the very low degree of penetration of bibrocatol through biological membranes into the inner chamber of the eye.

Adverse reactions

On the part of the immune system

Isolated cases of hypersensitivity reactions (allergy) and eye irritation, accompanied by the following symptoms: itching of the eyes, swelling of the eyes, eye pain, ocular hyperemia, facial swelling, flushing of the face; contact dermatitis.

Expiration date

3 years.

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

Use no more than 4 weeks after first opening the tube.

Storage conditions

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

Packaging

5 g of eye ointment in an aluminum tube with an internal protective lacquer coating, equipped with a tip and a cap with first-opening control (polyethylene). 1 tube in a cardboard box.

Vacation category

According to the recipe.

Producer

URSAPHARM Artsnaimittel GmbH.

Location of the manufacturer and its business address

Industriestrasse 35, D-66129 Saarbrücken, Germany.