Zinerit - instructions for use, dose, side effects, contraindications

Active substanceZinc acetate + ErythromycinZinc acetate + Erythromycin

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powder externally

Dosage form: & nbsp

Powder for the preparation of a solution for external use complete with a solvent and an applicator

Composition:

Packaging of the drug is two bottles, one of which contains the active substances in the form of a powder, and the other is an auxiliary component in the form of a solution. Before mixing, the contents of the vials have the following composition:

Active substances (in the first vial)

	Nominal amount (mg / 30 ml)	* Quantity subject to 3.35%	** Quantity subject to 5%
Erythromycin 100% (Ph.Eur.)	1200	1240	1302
Zinc acetate dihydrate, micronized (Ph.Eur.)	360,0	372,0	389,4

Auxiliary components (in the second vial)

	Nominal amount (g / 30 ml)
Diisopropyl sebacate (monograph)	7.81 (8.36 ml)
Ethanol (Ph.Eur.)	17.1 (21.6 ml)

1 ml of the prepared preparation has the following composition:

- Erythromycin 100% - 40 mg

- Zinc acetate dihydrate, micronized - 12 mg

- Diisopropyl sebacate 0.25 g

- Ethanol 0.55 g

* The amount of active components, erythromycin and zinc acetate dihydrate, is increased by 3.35% in order to compensate for their concentrations in the preparation of the finished product, the nominal volume of which increases when mixing the active components with the solvent (every 1000 mg of powder is equivalent to 0.79 ml).

** an additional increase in the number of active components, erythromycin and zinc acetate dihydrate, by 5% is due to the retention of declared concentrations of the finished product during storage.

Description:

Colorless transparent liquid.

Pharmacotherapeutic group:Acne rash remedy

ATX: & nbsp

D.10.A.F.52 Erythromycin in combination with other drugs

Pharmacodynamics:

Zinerite - erythromycin-zinc complex.

It has anti-inflammatory, antimicrobial and comedogenic effects.

Erythromycin acts bacteriostatically on microorganisms that cause acne: Propionibacterium acne and Streptococcus epidermidis. Zinc reduces the secretion of the secretion of sebaceous glands, has an astringent effect.

Pharmacokinetics:

The complex connection of the components of the preparation ensures a good penetration of active substances into the skin. Zinc mainly binds to the follicular epithelium and is not resorbed into the systemic circulation. A small part of erythromycin undergoes a systemic distribution and is subsequently excreted from the body.

Indications:Treatment of acne.

Contraindications:

Hypersensitivity to erythromycin and other macrolides;
increased sensitivity to zinc.

Pregnancy and lactation:

Now it is established that it is possible to use the drug during pregnancy and lactation (breast-feeding) according to the indications in the recommended doses.

Dosing and Administration:

Outwardly. Using the applied Zinerit applicator, apply a thin layer on the affected area of the skin 2 times a day: in the morning (before applying makeup) and in the evening (after washing). The drug should be applied by tilting the vial with the prepared solution down, with gentle pressure. The speed of application of the solution is regulated by the pressure of the applicator on the skin. Approximate single dose - 0.5 ml. After drying, the solution becomes invisible.

The duration of the course is 10-12 weeks. In some cases, clinical improvement is possible after only 2 weeks.

Instructions for the preparation of the drug Zinerit.

The package contains 2 bottles and an applicator with a soft surface, Remove the caps from both bottles. Do not throw away the lid from the bottle of powder.
Pour the solution (B) into the powder bottle (A) and screw the lid. Empty vial B can be discarded.
Immediately shake the contents of the vial for one minute.
Remove the lid from the vial.
Remove the applicator from the package.
Push the applicator into the neck and tighten the lid.

The prepared solution can be stored for 5 weeks after preparation at a temperature of 15-20 ° C. On the vial should be written expiration date.

Side effects:

Local reactions: Sometimes there may be a burning sensation, irritation, dryness of the skin at the site of application (as a rule, these phenomena are mild and do not require withdrawal of the drug and / or symptomatic therapy).

Overdose:

Accidental overdose is unlikely because of the local application of the drug.

Interaction:

Until now, clinically significant interactions of Zineritis with other drugs have not been established.

Special instructions:

Consider the possibility of developing a cross-resistance to other macrolides, lincomycin, clindamycin.

Avoid contact with eyes, mucous membranes of the mouth and nose (possibly irritation or burns).

Form release / dosage:Powder for the preparation of a solution for external use complete with a solvent.

Packaging:

In bottles of 30 ml and an applicator in a cardboard box with instructions for use.

Storage conditions:At a temperature of 15 to 25 ° C, out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N 013569/01

Date of registration:11.03.2009 / 07.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

ASTELLAS PHARMA EUROPE, B.V. Netherlands

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp14.10.2017

Illustrated instructions

Instructions

Zinerit® (Zineryt®)