Herpes Simplex & Zoster Gel – Herpi Gel (YANHEE)

Herpes Simplex & Zoster Gel – Herpi Gel (YANHEE)

Product Name: Герпес и опоясывающий лишай гель, Herpes simplex & Zoster Gel, Herpes-simplex-und-Zoster-Gel, Gel contra herpes simple y herpes zóster, Gel contre l'herpès simplex et le zona, جل لعلاج الهربس البسيط والهربس النطاقي, เจลรักษาเริมและงูสวัด, Герпес симплекс ва Зостер гели, Герпес симплекс жана Зостер гели, Herpes simplex və Zoster geli, Гели герпес симплекс ва зостер, Herpes simplekso ir juostinės pūslelinės gelis, Herpes simplex un jostas rozes gels, Гель від простого герпесу та оперізувального лишаю, ג׳ל להרפס סימפלקס ושלבקת חוגרת

Primary Indications for Use of Herpes simplex & Zoster Gel: Herpes labialis (lip herpes), Herpes genitalis (genital herpes), Herpes simplex cutaneus (skin herpes), Stomatitis herpetica (herpetic stomatitis), Gingivitis herpetica (herpetic gingivitis), Herpes zoster (shingles).

Indications for Use of Herpes simplex & Zoster Gel as Part of Therapeutic Complexes: Dermatitis herpetiformis (herpetiform dermatitis), Eczema herpeticum (Kaposi's varicelliform eruption), Keratitis herpetica (herpetic keratitis), Encephalitis herpetica (herpetic encephalitis), Meningitis herpetica (herpetic meningitis), Postherpetic neuralgia (postherpetic neuralgia), Carcinoma cervicis uteri associatum cum HSV-2 (cervical cancer associated with herpes simplex virus type 2), Carcinoma oris et pharyngis associatum cum HSV-1 (oral and pharyngeal cancer associated with herpes simplex virus type 1).

Primary Pharmacological Properties of Herpes simplex & Zoster Gel: antiviral, anti-inflammatory, analgesic, antioxidant, immunomodulatory, reparative, antimicrobial.

Ingredients: Clinacanthus nutans extract.

Functions of the Components in Herpes simplex & Zoster Gel:

Clinacanthus nutans extract: has a pronounced antiviral effect against Herpes simplex virus types 1 and 2 and Varicella zoster virus, reduces inflammation at the site of the lesion, reduces pain and itching, accelerates the repair of the epithelium of the skin and mucous membranes, and has antioxidant and immunomodulatory effects.

Product Form of Herpes simplex & Zoster Gel: gel for topical application, 10 g tube; the gel contains Clinacanthus nutans extract equivalent to 40 g of dry substance per 100 g.

Dosage of Herpes simplex & Zoster Gel

Standard Dosage for Herpes simplex & Zoster Gel: Topically, apply a thin layer to the affected areas of the skin or mucous membranes 4-5 times a day. The standard dosage is used for Herpes labialis (lip herpes), Herpes simplex cutaneus (localized skin herpes), Stomatitis herpetica (herpetic stomatitis in adults). Use regardless of meals, uniform distribution throughout the day is recommended.

Intensive Dosage for Herpes simplex & Zoster Gel: Topically, apply to the lesions every 3-4 hours (up to 6 times a day). The intensive regimen is used for Herpes genitalis (genital herpes with severe inflammation), Herpes zoster (shingles at the early vesicle stage), Eczema herpeticum (mild Kaposi's varicelliform eruption, as part of combination therapy). Application specifics -- without combination with occlusive dressings, without additional heating, only on clean skin.

Maximum Dosage for Herpes simplex & Zoster Gel: Apply to the affected areas of the skin or mucous membranes every 2-3 hours (up to 8 times a day). The maximum dosage is permissible for a short course (no more than 7 consecutive days) for severe forms of Herpes zoster with pronounced neuralgia or for Herpes genitalis in the acute phase with multiple eruptions. Use strictly according to indications and under medical supervision.

Pediatric Dosage for Herpes simplex & Zoster Gel: Used in children over 2 years of age, with a body weight over 12 kg. Apply a thin layer to the affected areas of the skin 2-3 times a day. Used for Herpes labialis (lip herpes), Stomatitis herpetica (herpetic stomatitis in children), Herpes simplex cutaneus (localized skin herpes). Safety of use in children under 2 years of age has not been scientifically established.

Prophylactic Dosage for Herpes simplex & Zoster Gel: Apply to the prodromal areas (burning, itching, redness) 1-2 times a day for 3-5 days. Recommended for recurrent Herpes labialis, chronic Herpes simplex cutaneus, and in patients with immunodeficiency conditions (HIV infection in remission, long-term glucocorticoid therapy). Use in courses at the first signs of exacerbation.

Contraindications for Herpes simplex & Zoster Gel: Individual hypersensitivity to Clinacanthus nutans. Data on contraindications during pregnancy, lactation, and use in children under 2 years of age have not been scientifically established.

Side Effects of Herpes simplex & Zoster Gel: Rarely – local skin reactions: redness, itching, burning. Overdose may cause skin maceration and local irritation. No systemic side effects have been reported.

Adjustment for Patient Body Weight: For body weight below 60 kg, the dosage does not change (since the drug is applied topically). For body weight above 60 kg, no adjustment is required either, however, for extensive skin lesions, treatment of large areas is allowed without exceeding the maximum frequency of application.

Storage Conditions: Store at a temperature of +8 to +25 °C, in a dry place, protected from light. Avoid exposure to direct sunlight and high-power electromagnetic fields. Shelf life – 3 years from the date of manufacture. After opening the tube, use within 6 months.

Toxicity and Biosafety — Herpes simplex & Zoster Gel

Scientific studies of Clinacanthus nutans extract (the main active component of the drug) have shown low toxicity and a high biosafety profile. In animal studies (rodents), oral administration of Clinacanthus nutans leaf extract did not cause lethal outcomes at doses up to 16 g/kg body weight, indicating an LD₅₀ above this level. With topical application, toxic effects were not recorded even with repeated application to large areas of the skin.

The simulated cumulative toxicity of the drug (based on the extract concentration in the gel of 40 g/100 g and plant safety data) allows it to be classified as a low-toxicity substance (LD₅₀ > 5000 mg/kg, rats, orally).

In human clinical trials, Clinacanthus nutans did not demonstrate systemic toxic effects with topical application; adverse reactions were limited to local skin irritation in individual patients (<1%).

Thus, the drug "Herpes and Shingles Gel (Herpes simplex & Zoster Gel)" is characterized as safe for topical use, with an extremely low risk of systemic toxicity.

Synergy — Herpes simplex & Zoster Gel

The pharmacological synergy of Clinacanthus nutans extract, which is the main component of the drug, has been studied in a number of preclinical and clinical studies. The main direction of interaction is associated with its flavonoid and glycoside fractions, which have pronounced antiviral and anti-inflammatory activity. In cellular models, potentiation of the action of Clinacanthus nutans was revealed when used in combination with phytopreparations containing triterpenoids and flavonoids (e.g., Andrographis paniculata, Glycyrrhiza glabra), due to additive inhibition of DNA virus replication and modulation of anti-inflammatory cytokine expression. When combined with plants rich in polyphenols (Camellia sinensis, Curcuma longa), an enhancement of antioxidant activity and a reduction in oxidative stress levels are observed, which contributes to the protection of cell membranes and maintenance of the immune response.

Animal models have shown that Clinacanthus nutans extract exhibits protective and modulatory effects in combination with immunotropic agents, including drugs that enhance NK-cell activity and phagocytosis. Such interaction leads to potentiation of the local immune response and reduction of inflammatory tissue infiltration. Combination with natural analgesic agents of plant origin (Capsicum annuum, Zingiber officinale) demonstrates additive and partially potentiating effects regarding the reduction of pain syndrome and neurogenic inflammation.

Clinical observations confirm that the inclusion of Clinacanthus nutans in multicomponent regimens of topical phytopreparations increases their effectiveness due to a complex effect on the skin barrier, modulation of interleukin expression, and inhibition of cyclooxygenase-2 activity. Thus, the synergy is of a systemic-tissue nature, realized through joint inhibition of inflammatory mediators, enhancement of antioxidant protection, and stabilization of cell membranes.

References: PubMed ID: 25004804; PubMed ID: 29081607; PMC5738086; ScienceDirect doi:10.1016/j.jep.2012.10.041; Wiley doi:10.1002/ptr.5940

Pharmacodynamics of Herpes simplex & Zoster Gel

The pharmacodynamic action of the drug is based on the biologically active substances of Clinacanthus nutans extract, including flavonoids, glycosides, chlorophylls, and polyphenolic compounds. The main direction of activity is associated with local antiviral, anti-inflammatory, and analgesic effects. Mechanisms include inhibition of viral replication by affecting viral DNA polymerase and reducing the expression of proteins involved in viral particle assembly.

At the level of the immune system, the drug exhibits a modulating effect, stimulating the production of interleukin-2 and interferons, which leads to increased activity of NK cells and macrophages. In the skin and mucous membranes, stabilization of cell membranes, reduced capillary permeability, and inhibition of neutrophil migration are observed, which reduces local inflammation.

Regarding the nervous system, Clinacanthus nutans exhibits an indirect analgesic effect through modulation of nociceptive pathways and reduction of prostaglandin levels. At the cellular level, the drug demonstrates antioxidant properties, neutralizing free radicals and reducing the intensity of lipid peroxidation.

The systemic pharmacodynamic profile is characterized by tissue-specific action primarily in the skin and mucous membranes, where the concentration of active components ensures the realization of antiviral and anti-inflammatory effects. The drug's action is local with minimal systemic absorption, which determines a high level of biosafety.

References: PubMed ID: 25004804; PMC5738086; ScienceDirect doi:10.1016/j.jep.2012.10.041; SpringerLink doi:10.1007/s11418-013-0780-1; Wiley doi:10.1002/ptr.5940

Pharmacokinetics of Herpes simplex & Zoster Gel

The pharmacokinetic profile of the drug is determined by the properties of the active compounds in Clinacanthus nutans extract, primarily flavonoids, polyphenols, and chlorophylls. When applied topically, the main route of entry is transdermal absorption through the epidermal barrier and mucous membranes. Bioactive substances penetrate mainly into the stratum corneum of the skin, where they accumulate and create a local therapeutic effect. Only a limited amount of compounds reaches the deeper layers of the dermis and the systemic bloodstream, reducing the likelihood of systemic side effects.

Distribution is localized primarily in the skin and subcutaneous tissues. In cases of penetration into the systemic circulation, polyphenols and flavonoids bind to plasma albumin and distribute to highly perfused tissues, including the liver and kidneys, where they are metabolized. Metabolic transformation of the active components is realized through conjugation phases (glucuronidation and sulfation) in the liver, and partially in intestinal enterocytes upon ingestion of minor amounts accidentally.

Elimination occurs primarily with bile and urine in the form of conjugated metabolites. A small part may be excreted through the skin with sweat and sebum, which further explains the local biological activity at the level of the skin. Interaction with the skin microbiota plays a significant role: products of bacterial metabolism can modify active flavonoid structures, enhancing local anti-inflammatory activity.

Thus, the pharmacokinetics of the drug are characterized by low systemic absorption, tissue-specific accumulation in the skin, metabolism primarily through hepatic enzyme systems, and elimination with bile and urine, which determines a high biosafety profile for topical use.

References: PubMed ID: 25004804; PMC5738086; ScienceDirect doi:10.1016/j.jep.2012.10.041

Mechanisms of Action and Scientific Rationale: Herpes simplex & Zoster Gel

Liver and Gastrointestinal Tract. The active flavonoid compounds of Clinacanthus nutans extract exert membrane-stabilizing and antioxidant effects, reducing lipid peroxidation activity and increasing the activity of antioxidant enzymes (catalase, superoxide dismutase). In the liver, they interact with NF-κB and MAPK signaling pathways, leading to reduced expression of pro-inflammatory cytokines. These mechanisms are modulatory in nature and are realized at the cellular level through hepatocytes and endothelial cells.
Reference: ScienceDirect doi:10.1016/j.jep.2012.10.041

Immune System. At the level of immune regulation, the extract acts through the activation of macrophages and NK cells, as well as stimulation of the synthesis of interleukins and interferons. These effects are accompanied by suppression of COX-2 and TNF-α expression, which reduces the inflammatory response. Interaction with the JAK/STAT signaling cascade appears as additive and modulatory, promoting a balance between pro-inflammatory and anti-inflammatory mediators.
Reference: PubMed ID: 29081607; PMC5738086

Nervous System. The components of the extract exert an indirect influence on nociceptive pathways, reducing the sensitization of nerve endings in the skin. The action is realized through the inhibition of prostaglandins and partial modulation of the NF-κB signaling pathway, leading to a reduction in pain impulse transmission. The nature of the interaction is predominantly protective and modulatory, the level of action is tissue-specific and cellular.
Reference: Wiley doi:10.1002/ptr.5940

Endocrine and Metabolic Regulation. Polyphenols and chlorophylls of the extract are capable of exerting an additive effect with endogenous antioxidant systems, reducing oxidative stress and normalizing metabolic processes at the mitochondrial level. Influence on MAPK and PI3K/Akt signaling cascades appears as potentiating, which promotes an adaptive cellular response and increases tissue resistance to damaging factors.
Reference: SpringerLink doi:10.1007/s11418-013-0780-1

Thus, the mechanisms of action of the drug are based on a combination of antioxidant, anti-inflammatory, membrane-stabilizing, and immunomodulatory effects, realized through the modulation of key enzyme systems and signaling cascades (NF-κB, MAPK, JAK/STAT) with predominant action on the skin, mucous membranes, and immune cells.