Voltaren transdermal patch 30 mg day N2
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Active ingredients
Diclofenac
Release form
Patch
Composition
Each transdermal patch 30 mg / day (140 cm2) contains: Active substance: 30 mg diclofenac sodium (1%). Excipients: levomenthol 45.0 mg, methyl pyrrolidone 120.0 mg, propylene glycol fatty acid esters 60.0 mg, citric acid 12.0 mg, isoprenstyrene copolymer 1072.2 mg, polyisobutylene 60.0 mg, esterized gum 600.0 mg, mercaptobenzimidazole 7.4 mg, butylhydroxytoluene 7.4 mg, liquid paraffin to 3000.00 mg; polyester fiber base (50 den) 140 cm2; polyester protective film (thickness 75 μm) 140 cm2.
Pharmacological effect
Voltaren in the form of a transdermal patch is a base coated with an adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties. The basis of the mechanisms of diclofenac is inhibiting the synthesis of prostaglandins. swelling associated with inflammation.
Pharmacokinetics
Absorption and distribution in the body: The amount of diclofenac absorbed systemically from the Voltaren patch over 24 hours is similar to that when using an equivalent amount of Voltaren Emulgel (gel for external use 1%). 99.7% of diclofenac binds to serum proteins, mainly albumin (99.4%). Elimination: Total systemic clearance of diclofenac from plasma is 263 ± 56 ml / min. The final half-life in plasma is 1-2 hours. Four metabolites, including two active, also have a short half-life of -1-3 hours. One metabolite, 3'-hydroxy-4'-methoxydiclofenac, has a longer half-life, however, is inactive. Diclofenac and its metabolites are mainly excreted in the urine. In patients with impaired renal function, there is no accumulation of diclofenac and its metabolites. In patients suffering from chronic hepatitis or non-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as patients who do not have liver disease. Preclinical studies have shown the safety of the use of the drug.
Indications
Back pain in inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica). Pain in the joints (joints of the fingers, knee, etc.) in rheumatoid arthritis, osteoarthritis. Muscle pain (due to sprains, overvoltages, bruises, injuries). Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, periarticular tissue lesions).
Contraindications
Hypersensitivity to kdiclofenaku or other components of the drug; a tendency to the occurrence of asthma attacks, skin rashes or acute rhinitis with the use of acetylsalicylic acid or other NSAIDs; pregnancy (III trimester); breast-feeding; children's age (up to 15 years); violation of the integrity of the skin in the place of alleged sticking the patch.
Precautionary measures
With care: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidneys, chronic heart failure, bronchial asthma, old age.
Use during pregnancy and lactation
The use of the drug in pregnant women has not been studied, so the Voltaren plaster should not be used during pregnancy, especially in the third trimester due to the possibility of lowering the tone of the uterus and / or premature closure of the fetal arterial duct. Animal studies have not revealed any direct or indirect negative effects on pregnancy, childbirth, fetal and postembryonic development. There is no data on the penetration of the drug into breast milk, so the Voltaren plaster is not recommended for use during breastfeeding.
Dosage and administration
Externally in the form of applications on the skin. Adults and adolescents over 15 years of age: Voltaren plaster is applied on the skin over the painful area for 24 hours. During the day, only 1 patch is allowed. Voltaren plaster 30 mg / day (140 cm2) is intended for sticking to extensive painful areas. In the treatment of soft tissue injuries, Voltaren plaster is used for no more than 14 days, and in the treatment of diseases of muscles and joints - no more than 21 days if there are no special recommendations of the doctor. Children: The use of Voltaren patch is not recommended for children under the age of 15 years. Elderly: Similar to the method of use and doses for adults.
Side effects
Undesirable reactions are mainly characterized by moderately pronounced and passing skin manifestations at the site of application of the patch.
Overdose
Extremely low systemic absorption of active ingredients and the dosage form of the drug for external use makes overdose almost impossible.
Interaction with other drugs
Voltaren plaster can enhance the effect of drugs that cause photosensitization. Clinically significant interactions with other drugs are not described. Influence on the ability to drive vehicles and control mechanisms The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.
special instructions
Voltaren's plaster should be glued only on intact skin, avoiding contact with open wounds. Do not allow the drug to come into contact with eyes and mucous membranes. When using Voltaren plaster for too long a time, the possibility of developing systemic adverse reactions cannot be ruled out. (150 mg / day).