Versatis plaster TTS (terap.transderm.sist.) 5 pcs

Description

Composition
Active substance:
Lidocaine 700 mg / patch ;.
Excipients:
Purified water 3,367 g, 2,520 g of glycerol, 2,800 g of sorbitol, polyacrylic acid solution 20% 1,400 g, sodium polyacrylate 400-600 mPa.s 0.700 g, carmellose sodium 90-168 mPas 0,700 g, 0,700 g of propylene glycol, urea 0.420 g kaolin 0.210 g tartaric acid (tartaric) 0.210 g, 0.147 g of gelatin, polyvinyl alcohol (75,000), 0.0588 g, digidroksiaminoatsetat alumina (aluminum glycinate) 0.0322 g disodium edetate 0.014 g 0.014 g of methyl parahydroxybenzoate, propyl parahydroxybenzoate 0.007 g, 1,750 g of a nonwoven fabric, plastic film (polietelentereftalat PET) 0.742 g
Description:
White to light yellow polymer adhesive (sticky) material with a faint characteristic odor is uniformly distributed on one side of the nonwoven fabric and plastic film closed. In nonwoven engraved «Lidocaine 5%”.
Product form:
Patch. 5 adhesive bandages in a sachet.
Contraindications
Hypersensitivity of allergic and nonallergic origin to the active drug and excipients; hypersensitivity allergic and non-allergic genesis local anesthetics amide group (e.g., bupivacaine, etidocaine, mepivacaine and prilocaine); inflammation or disorder integrity of the skin at the site of patch application (e.g., rashes herpes zoster, atopic dermatitis or wound).
Indications
Neuropathic pain associated with previously transferred herpes infection (herpes zoster), post-herpetic neuralgia.
Interaction with other drugs
In the drug experiences were noted clinically significant interactions with other drugs. Because the maximum concentration of lidocaine in plasma is low, the occurrence of clinically significant pharmacokinetic interaction unlikely. Although lidocaine absorption through the skin is typically low, caution should be exercised when applying a plaster containing 5% lidocaine, patients receiving Class I antiarrhythmic drugs (e.g., tocainide, mexiletine) or other local anesthetics, since there is a risk of additive systemic effect.
Overdose
Overdosing lidocaine patch when applied Versatis unlikely. Overdose can not be excluded due to incorrect use of the drug (e.g., use more than 3 plasters simultaneously applique patch for more than 12 hours, or the use of adhesive in areas of damaged skin), in such cases the lidocaine concentration in plasma may increase. Symptoms of overdose may include: dizziness, vomiting, drowsiness, seizures, mydriasis, bradycardia, arrhythmia and shock. In overdose possible lidocaine interaction with beta-blockers, inhibitors of isoenzyme CYP3A4 (for example, imidazole derivatives, macrolides) and antiarrhythmic drugs.
If you suspect an overdose the plaster should be removed from the skin and measures maintain vital body functions. Antidote to lidocaine no.
pharmachologic effect
Pharmacological group:
Local anesthetic.
Pharmacodynamics:
Versatis contains lidocaine acetamide derivative. The mechanism of action is related to stabilization of neuronal membranes, which is believed to be the result of blockade of sodium channels. When applied topically to intact skin occurs therapeutic effect sufficient to relieve pain.
Pharmacokinetics:
Suction:
Following single or repeated application of the patch Versatis in maximum recommended dose (simultaneous application of three patches duration 12 hours), only 3 ± 2% lidocaine contained in a patch, it enters into the systemic circulation. concentration in plasma after application of the recommended maximum dose in patients without clinical postherpetic neuralgia were 84 – 125 ng / ml. In patients with post-herpetic neuralgia – 52 ng / ml. Distribution: The volume of distribution is independent of age and decreased in patients with chronic heart failure patients, increases in hepatic insufficiency. Since blood plasma proteins bind 70% lidocaine entering the systemic circulation after epicutaneous application. It penetrates the blood-brain and the placental barrier by passive diffusion. Metabolism: Lidocaine is rapidly metabolized in the liver with the formation of several metabolites. The main metabolic pathway N-dealkylation to form monoetilglitsinksilidida (MEGCs) and glitsinksilidida (GK), metabolites are less pharmacologically active than lidocaine and present in lower concentrations. Metabolites are hydrolyzed to 2,6-xylidine, which is converted to conjugation 4-hydroxy-2,6-xylidine. Not identified whether the 2,6-xylidine pharmacological activity, however, the study of biological models for 2,6-xylidine potentially carcinogenic effect. Kinetic analysis revealed that with daily applications of up to one year, the maximum concentration of 2,6-xylidine average of 9 ng / ml. Lidocaine and its metabolites (monoetilglitsinksilidid, glitsinksilidid and 2,6-xylidine) does not accumulate in the body, the equilibrium concentration is reached during the first four days of application.
When the number of simultaneously applied patches with one to three lidocaine concentration in plasma slowly increases proportional relation.
excretion:
Lidocaine and its metabolites are excreted in the urine (greater than 85% as metabolites, at least 10% unchanged). The major metabolite in the urine – conjugate of 4-hydroxy-2,6-xylidine of approximately 70 – 80% of the dose in urine output. 2,6-xylidine metabolite excreted in the urine at concentrations less than 1% of the dose received. The half-life of lidocaine after dermal application of the patch is 7.6 hours.
At heart, kidney or liver failure may slow excretion of lidocaine and its metabolites.
Pregnancy and breast-feeding
Lidocaine crosses the placenta. Data on the use of lidocaine in pregnant women are not available, so during pregnancy, drug use, if the expected benefit to the mother outweighs the potential risk to the fetus. Lidocaine is excreted in breast milk. Because lidocaine is metabolized relatively quickly and primarily in the liver, it can be expected that the extremely small amounts of lidocaine can be displayed in breast milk. Information on the application of the patch Versatis in nursing mothers is not, so the drug is used only during breastfeeding if the expected benefit to the mother outweighs the potential risk to the child.
Conditions of supply of pharmacies
On prescription.
side effects
Since the formulation is applied topically, in most cases undesirable reaction are local in nature and occur in the application of the patch. The most common adverse reactions are local reactions following in the area of ​​the patch application: erythema, rash (to vesicular), pruritus, burning, dermatitis at the site of application.
The frequency of occurrence is defined as follows: “very often” (> 1/10), “often” (> 1/100 – 1/1000 – 1/10000 –
Violations of the skin and subcutaneous tissue
Nechasto- injury and damage to the skin
General disorders and local reactions
Very frequency response at the site of application
The following adverse reactions were observed during post-marketing use of the drug:
Violations by the immune system
Very rarely – anaphylactic reaction, hypersensitivity
General disorders and local reactions
Very rarely – a violation of integrity of the skin
All adverse events were mild or moderate intensity. Less than 5% of cases of adverse reactions was the cause of the cessation of the drug.
With proper use of the drug development of systemic adverse reactions unlikely as in the treatment of a plaster containing 5% lidocaine delivery of active ingredient into the systemic circulation slightly (cm. To “Pharmacokinetics”). Systemic adverse reactions associated with the use of lidocaine are identical reactions characteristic of local anesthetics of the amide group (see. The section “Overdose”).
If you experience any of these side effects in the instructions, or seen any other side effects not mentioned in the instructions, tell your doctor.
special instructions
The patch should not be used on mucous membranes. Avoid contact with the eye area of ​​the patch. The patch comprises propylene glycol, which can 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 plaster in patients with severe heart, kidney or liver failure.
As systemic absorption is minimal, there is no reason to assume the existence of influence on the ability to drive and the ability to use machines.
Storage conditions
Store at a temperature not higher than 25 ° C. Do not store in the refrigerator and do not freeze. Once opened, store the sachet tightly closed and use within 14 days. The drug should not be stored in the refrigerator or freeze. Keep out of the reach of children.
Dosing and Administration
A patch for external use. The patch is adhered to the skin in the area of ​​pain once a day for up to 12 hours. At the same time can be used no more than 3 plasters. If necessary, adhesive can be cut into pieces before removing the protective plastic film. The patch must be adhered to intact, dry, nevospalennuyu skin (after complete healing of herpes sores) covering the area of ​​pain. Then, remove the patch and make a break for at least 12 hours. Do not use the patch again removed.
The patch adheres to the skin immediately after removal from the sachet and removal of plastic film with an adhesive layer. The hair must be cut off with scissors (do not shave). The effectiveness of therapy should be re-assessed after 2-4 weeks of starting treatment. If the response to treatment is insufficient time or therapeutic effect is determined only protective properties of the plaster, treatment should be discontinued. It is necessary to regularly evaluate the effectiveness of the therapy to determine the optimal number of simultaneously applied patches needed to cover the area of ​​pain or for increasing periods of time between applications of the patch.
The use Versatis plaster under the age of 18 years is not recommended. There are no data on the safety and efficacy of Versatis plaster in patients under the age of 18 years.
After sticking plaster to avoid hand contact with the eyes, you should wash your hands immediately. Used the patch contains the active ingredient. Dispose Versatis patch immediately after application.
After removing the skin, the patch should be folded in half with the adhesive side inwards so that the surface containing the active substance was not visible. Used patches should not be accessible to children or pets.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist