Versatis, 700 mg patch 30 pcs

Versatis contains lidocaine, an acetamide derivative.

The mechanism of action is associated with stabilization of neuronal membranes, which is believed to be the result of blockade of sodium channels.

When applied topically to intact skin a therapeutic effect sufficient to relieve pain syndrome occurs.

Pharmacokinetics

Absorption:

When Versatis patch is administered once or repeatedly at the maximum recommended dose (simultaneous application of three patches lasting 12 hours), only 3 ± 2% of the lidocaine contained in the patch enters the systemic bloodstream.

Plasma concentrations after application of the maximum recommended dose of the drug in patients without postherpetic neuralgia clinic were 84 – 125 ng/ml.

In patients with postherpetic neuralgia – 52 ng/ml.

Distribution:

Distribution volume is independent of age and decreased in patients with chronic heart failure, increased in liver failure.

70% of lidocaine is bound to blood plasma proteins and penetrates into the systemic bloodstream after cutaneous application.

It penetrates through the blood-brain and placental barriers by passive diffusion.

Metabolism:

Lidocaine is rapidly metabolized in the liver to form several metabolites.

The main metabolic pathway is N-dealkylation to form monoethylglycinkylidide (MEGC) and glycinkylidide (GC), the metabolites have less pharmacological activity than lidocaine and are present in lower concentrations.

The metabolites are hydrolyzed to 2,6-xylidine, which is converted to 4-hydroxy-2,6-xylidine by conjugation.

It has not been determined whether 2,6-xylidine has pharmacological activity; however, when studied in biological models, 2,6-xylidine is potentially carcinogenic.

Kinetic analysis revealed that with daily applications lasting up to one year, the maximum concentration of 2,6-xylidine averaged 9 ng/mL.

Lidocaine and its metabolites (monoethylglycincylidide, glycincylidide and 2,6-xylidine) do not accumulate in the body, with equilibrium concentration reached within the first four days of application.

As the number of patches used simultaneously increases from one to three, plasma lidocaine concentrations increase more slowly than the proportional ratio.

Excretion:

Lidocaine and its metabolites are excreted in the urine (over 85% as metabolites, less than 10% unchanged).

The main metabolite in the urine is 4-hydroxy-2,6-xylidine conjugate, accounting for approximately 70% to 80% of the dose excreted with the urine.

The metabolite 2,6-xylidine is excreted in the urine at a concentration of less than 1% of the dose received.

The elimination half-life of lidocaine after skin application of the patch is 7.6 h.

Cardiac, renal or hepatic insufficiency may slow the elimination of lidocaine and its metabolites.

Indications

Active ingredient

Composition

One patch contains:

Active Substance:

Lidocaine 700 mg/patch;

Associates:

Purified water 3367 mg,

Glycerol 2520 mg,

Sorbitol 2800 mg,

Polyacrylic acid solution 20% 1400 mg,

Sodium polyacrylate 400-600 mPa-s 700 mg,

Polyacrylate/p>

Sodium carmellose 90-168 mPa-s 700 mg,

Propylene glycol 700 mg,

Urea 420 mg,

Caolin 210 mg,

Tartaric (tartaric) acid 210 mg,

/p>

Gelatin 147 mg,

Polyvinyl alcohol (75,000) 58.8 mg,

Aluminum dihydroxyaminoacetate (aluminum glycinate) 32.2 mg,

Dinodium edetate 14 mg,

p> Methyl parahydroxybenzoate 14 mg,

Propyl parahydroxybenzoate 7 mg,

Non-woven material 1750 mg,

Plastic film (polyethylene terephthalate, PET) 742 g.

Patch size: length 13.3 to 14.7 cm, width 9.5 to 10.5 cm.

How to take, the dosage

Interaction

Special Instructions

Contraindications

Side effects

Overdose

Pregnancy use

Versatis should not be used during pregnancy and lactation (breastfeeding).

Similarities