Trade name: LAZOLEX®
International non-patented name: extract of walnut pericarps (Juglans Regia L.).
Pharmaceutical form: Gel for external application, containing 10% of walnut pericarp extract (Juglans Regia L); it contains natural polyphenols and naphthoquinones, including juglone.
Composition: 1 gram of gel with a concentration of 10% contains 0.1 g of walnut pericarp extract respectively. Excipients: ST-Elastomer-10, Cyclomethicone 5-NF, Emulsifier 10.
Description: Homogeneous transparent opalescent paste with a soft (semi-solid) consistency and a golden ochre colour, with a characteristic mild smell.
Pharmacotherapeutic group: Antiviral, antibacterial and antifungal drug.
Pharmacological properties.
Pharmacodynamics. It has antiviral activity against herpes simplex virus types 1 and 2 (HSV-1, HSV-2) and also against herpes zoster and varicella (Varicella Zoster Virus (VZV/HHV-3)).
In herpes simplex cultures, it blocks virion multiplication; in induced herpes infections in mice, it has a therapeutic action, basically consisting in a reduction in animal viraemia and mortality, and a decrease in pre- and post-implantation mortality of the foetuses of pregnant females infected with herpes virus. It causes irreversible inhibition of the growth of the following microorganism strains, including bacterial strains: Salmonella typhimurium, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Propionibacterium acne, Pseudomonas aeruginosa; fungal: Aspergillus niger, Candida albicans, Malassezia furfur, Trichophyton rubrum.
When applied on intact skin, it promotes keratinisation due to its drying action. In the topical treatment of herpetic eruptions, it stimulates rapid scab formation on herpetic vesicles, promoting their rapid breakdown and epithelisation, and it reduces or completely eliminates the pain and the sensation of discomfort after the eruptions have disappeared.
It does not cause any severe irritant effects or allergic reactions at the application sites. Unlike acyclovir, Lazolex® is active against recurrent herpes forms; its local application on the mucous membranes is also fully acceptable.
Pharmacokinetics. The antimicrobial efficacy of Lazolex® is mediated by some of the components of the crude extract; consequently, it is methodologically unfeasible to perform pharmacokinetic studies due to the impossibility of simultaneously identifying the individual components of the crude extract, which are responsible for the curative effect or their metabolites in the biological media of the organism.
Therapeutic indications
Infections of skin integuments and mucous membranes caused by herpes simplex and herpes zoster, including recurrent forms.
Mycotic skin lesions: Dermatophytoses caused by fungi of the species Trichophyton, Epidermophyton and Microsporum; Pityriasis versicolor; Candidiasis; Onychomycosis.
Bacterial skin infections – any forms of Staphyloderma and Streptococcal impetigo; Acne
Route of administration and dosage
For herpes simplex of any localization, including recurrent forms. Apply 10% gel on the infected parts of the skin or genital mucosa 4-5 times a day, except at night time. Average treatment duration is 5 days; if necessary, treatment course may be extended up to 7 days.
For herpes zoster. Apply 10% gel 2-3 times a day for an average of 20 days; if necessary, treatment course may be extended up to 28 days.
For dermatophytosis of glabrous skin and inguinal region, candidiasis of any localization and pityriasis versicolor. Apply 10% gel by massaging on the infected areas 2-3 times a day. Average treatment duration is 10 days; if necessary, treatment course may be extended up to 16-20 days.
For angular stomatitis caused by candidiasis (moniliasis, perleche). Apply 10% gel on the cracks at the corners of the mouth 2-3 times a day , during 7-10 days.
For mycotic lesions of the pilary part of the head and foot skin. Apply 10% gel by massaging on the infected areas 2-3 times a day. Average treatment duration is 20 days; if necessary, treatment course may be extended up to 28 days.
For mycotic lesions of nail plates. Apply 10% gel by massaging on the infected areas 2-3 times a day. Average treatment duration is 90 days; if necessary, treatment course may be extended up to 140 days.
For bacterial skin infections. Apply 10% gel by massaging on the infected areas 2-3 times a day. Average treatment duration is 10 days; if necessary, treatment course may be extended up to 16 days.
Adverse reactions. Desquamation, dry skin and, rarely, erythema may be observed on the areas where the gel is applied, but these reactions will disappear as soon as treatment is stopped. According to the findings from a pre-clinical experimental study, when the gel is applied on relatively large areas of skin, it may cause systemic effects, mainly granulocytosis and, rarely, atony. All these symptoms are reversible and they disappear when gel application is stopped, however, in clinical trials, similar effects have not been reported.
Contraindications. Hypersensitivity to the components of walnut pericarp extract, namely naphthoquinones and polyphenols, and also to base ingredients.
Interaction with other drugs. None have been described.
Pregnancy and lactation. Clinical data on the safety of use of the preparation during pregnancy and lactation, and also in paediatric practice, are insufficient.
Overdose. Cases of overdosing with the preparation LAZOLEX® have not been reported up to now.
Peculiarities of use. Some slight pigmentation may appear on drug application sites, but it will disappear a few days after treatment completion.
Presentation and packaging. Gel containing 10% of walnut pericarp extract, in polypropylene vials with dosing pump spray nozzle, No.1, 4 g or 12 g each.
Storage. Keep protected from light at room temperature and out of the reach of children.
Shelf life. 3 years. The preparation should not be used after expiry date.
Legal category. Non-prescription drug.
Manufacturer.
Iveriapharma Ltd.
David Agmashenebeli Alley 10th km,
0159 Tbilisi, Georgia
