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

Anesthesia, Pain, trigeminal neuralgia, Myalgia (muscle pain), Joint pain (arthralgia), MyositisNeuropathic pain associated with previous herpes infection (Herpes zoster), postherpetic neuralgia.

Active ingredient

Lidocaine

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

The patch is designed for external use.

The patch is applied to the skin in the area of pain once a day for up to 12 hours.

No more than 3 patches can be applied at a time.

If necessary the patch can be cut into pieces before removing the plastic protective film.

The patch should be stuck on intact, dry, noninflamed skin (after the complete healing of herpetic rashes) covering the pain area.

Then remove the patch and take a break for at least 12 hours. Do not use the removed patch again.

The patch is glued to the skin immediately after removal from the sachet and removing the plastic film from the adhesive layer.

The hair should be cut with scissors (not shaved).

The therapy efficiency should be repeatedly evaluated in 2-4 weeks after the treatment start. If during this time the response to therapy is insufficient or the therapeutic effect is determined only by the protective properties of the patch, the treatment should be stopped.

The effectiveness of therapy should be regularly evaluated to determine the optimal number of simultaneously applied patches needed to cover the area of pain, or to increase the periods between applications of the patch.

The use of Versatis patch under 18 years of age is not recommended. There is no data on the safety and efficacy of Versatis patch in patients under 18 years.

After applying the patch you should avoid hand contact with the eyes, you should wash your hands immediately. The used patch contains the active substance.

Dispose of Versatis patch immediately after use.

After removal from the skin, the patch should be folded in half with the adhesive side inside, so that the surface containing the active substance was not visible.

Used patches should not be accessible to children or pets.

Interaction

In the accumulated experience of using the drug no clinically significant interaction with other drugs was observed.
Since the maximum plasma concentration of lidocaine is low, the occurrence of clinically significant pharmacokinetic interaction is unlikely.

Although absorption of lidocaine through the skin is generally low, caution should be exercised when using the patch containing lidocaine 5% in patients receiving class I antiarrhythmic drugs (e.g., tocainide,

mexiletine) or other local anesthetics because the risk of an additive systemic effect cannot be excluded.

Special Instructions

Versatis patch should not be used on mucous membranes. Avoid contact of the patch with the eye area.

Versatis patch contains propylene glycol, which may cause skin irritation, as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Caution should be exercised when using Versatis patch in patients with severe cardiac, renal or hepatic insufficiency.

After the first opening of the sachet, the drug should be used within 14 days, the opened sachet should be kept tightly closed. The drug should not be stored in the refrigerator or frozen.

Effect on the ability to drive vehicles and operate machinery

Since the systemic absorption is minimal, there is no reason to assume the presence of effects on the ability to drive vehicles and the ability to operate mechanisms.

Contraindications

• High sensitivity of allergic and non-allergic origin to the active and excipients of the product;
• High sensitivity of allergic and non-allergic origin to local amide anesthetic agents (e.g., bupivacaine, etidocaine, mepivacaine and prilocaine);
• inflammation or skin integrity disorders at the site of patch application (e.g., herpes zoster rash, atopic dermatitis or wounds).

With caution
Used with caution in severe cardiac, renal or hepatic failure (see “Special Indications”).

Side effects

• headache,
• dizziness,
• numbness of the tongue and oral mucosa,
• decrease in blood pressure,
• decrease in heart rate,
• sensation of burning sensation when the aerosol hits the anaesthetic surface (stops after a few seconds after the onset of anaesthesia.slow heart rate,
• a burning sensation when the aerosol hits the anesthetic surface (stops a few seconds after the onset of anesthesia).

.

Overdose

Lidocaine overdose with Versatis patch is unlikely.

Overdose cannot be excluded in case of improper use of the drug (e.g., use of more than 3 patches at a time, application of the patch for more than 12 hours or use of the patch on damaged skin), in such cases, the concentration of lidocaine in the blood plasma may increase.

Symptoms of overdose may include: dizziness, vomiting, drowsiness, seizures, mydriasis, bradycardia, arrhythmia and shock. In case of overdose, lidocaine may interact with β-adrenoblockers, CYP3A4 isoenzyme inhibitors (e.g., imidazole derivatives, macrolides) and antiarrhythmic drugs.

If overdose is suspected, the patch should be removed from the skin and measures to maintain body functions should be taken. There is no antidote to lidocaine.

Pregnancy use

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

Similarities

Lidocaine, Versatis, Lidocaine-Vial