Acne Biotic

Description

1. Name of the medicinal product

ACNE BIOTIC paint

2. Qualitative and quantitative composition

Erythromycin-zinc complex containing the equivalent of 40 mg/ml erythromycin and 12 mg/ml zinc acetate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Topical solution.

4. Clinical particulars

4.1 Therapeutic indications

Acne biotic is indicated in children, adults and the elderly. It is used as topical treatment of acne vulgaris.

4.2 Posology and method of administration

For cutaneous use. Apply twice daily over the whole of the affected area for a period of 10 to 12 weeks.

4.3 Contraindications

Hypersensitivity to the active substance(s), to other macrolide antibiotics, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Cross resistance may occur with other antibiotics of the macrolide group and also with lincomycin and clindamycin. Contact with the eyes or the mucous membranes of the nose and mouth should be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Acne biotic can be used during pregnancy and during breast-feeding (but it should not be used on the chest).

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Tabulated list of adverse reactions

System Organ Class	Rare >1/10,000, <1/1000	Very rare <1/10,000, Not known (cannot be estimated from the available data)
Immune system disorders		Hypersensitivity
Skin and subcutaneous tissue disorders	Pruritus Erythema Skin irritation Skin burning sensation Dry skin Skin exfoliation

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

It is not expected that overdosage would occur in normal use. Patients showing idiosyncratic hypersensitivity should wash the treated area with copious water and simple soap.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-acne

Erythromycin is known to be efficacious, at 4%, in the topical treatment of acne vulgaris. Zinc, topically, is established as an aid to wound healing.

5.2 Pharmacokinetic properties

Absorption

The complex does not survive in the skin, and erythromycin and zinc penetrate independently. The erythromycin penetrates, and is partially systemically absorbed (0 – 10% in vitro, 40 – 50% in animal studies); that portion absorbed is excreted in 24 – 72 hours. The zinc is not absorbed systemically.

5.3 Preclinical safety data

Non-clinical data from repeated dose toxicity and reproduction and developmental toxicity studies reveal no additional hazard other than those described elsewhere.

6. Pharmaceutical particulars

6.1 List of excipients

Propylene glycol, Ethyl alcohol, Ethyl acetate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store at temp. not exceeding 30˚C

Keep out of the reach of children.

6.5 Nature and contents of container

Self-dropper HDPE plastic bottle of 15 ml solution covered by HDPE plastic  dropper and covered by HDPE plastic cover in acarton box with an insert.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Arab Perfume, Chemicals &Pharmaceutical company.

8. manufactured by

Arab drug company