Diclofenac sodium ointment 10mg/g 30g №1

Name:
Diclofenac sodium ointment dnar.prim.10mg in tubes 30g in pack №1 Form: ointment for external use Dosage: 1% 30 g Quantity in a package: 1 pc. Producer: Borisovsky ZMP INN: Diclofenac FTH: Npvp Composition One tube (30 g of ointment) contains the active substance – sodium diclofenac – 0.3 g, excipients: dimethyl sulfoxide, propylene glycol, macrogol 1500, macrogol 400.
Description:
White or almost white ointment, co weak specific odour. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs for external use. ATX code: M02AA15. Pharmacological properties Pharmacodynamics A non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid, has an anti-inflammatory and analgesic effect. Indiscriminately inhibiting cyclooxygenase 1 and cyclooxygenase 2, it disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins, incl. at the site of inflammation. Pharmacokinetics Absorption The amount of diclofenac sodium that is absorbed through the skin is proportional to the size of the area to which the drug is applied and depends on both the total dose used and the degree of skin hydration. The degree of absorption is about 6% of the applied dose after topical application of 2.5 g of the drug per 500 cm2 of skin, determined taking into account complete renal elimination, in comparison with Diclofenac tablets. A 10-hour occlusion results in a three-fold increase in the amount of absorbed diclofenac. Distribution Concentrations of diclofenac sodium were measured in plasma, synovial tissue and synovial fluid after topical application of the ointment to the joints of the hands and knee. The maximum plasma concentration is approximately 100 times lower than the concentration after oral administration of the same amount of Diclofenac sodium. 99.7% of Diclofenac sodium binds to serum proteins, mainly to albumin (99.4%). Metabolism Biotransformation of diclofenac sodium partially involves glucuronidation of the unchanged molecule, but predominantly single or multiple hydroxylation leads to the formation of several phenolic metabolites, most of which are converted to glucuronic conjugates. Two phenolic metabolites are biologically active, but their activity is significantly lower than that of Diclofenac sodium. Elimination. The total systemic clearance of diclofenac sodium from blood plasma is 263 ± 56 ml / min. The terminal plasma half-life is 1-2 hours. Four of the metabolites, including two active ones, also show a short plasma half-life of 1-3 hours. One metabolite, 3′-hydroxy-4′-methoxy-diclofenac , shows a longer half-life, but is actually inactive. Diclofenac sodium and its metabolites are excreted primarily in the urine. Pharmacokinetics in selected groups of patients Accumulation of diclofenac sodium and its metabolites is not expected in patients who suffer from renal insufficiency. In patients with chronic hepatitis or undecompensated cirrhosis, the kinetics and metabolism of diclofenac sodium are the same as in patients who do not have liver disease. Indications for use Local symptomatic treatment of pain, inflammation and swelling in: injuries of tendons, ligaments, muscles and joints, for example, due to sprains, back pain after overexertion, contusion; localized forms of rheumatic diseases of soft tissues, such as tendonitis, “shoulder- hand, bursitis, periarthropathy; osteoarthritis of small and medium-sized joints and superficially located joints, such as the joints of the fingers or the knee joint. pregnancy (III trimester), lactation period, children’s age (up to 12 years), violation of the integrity of the skin. With caution 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, pregnancy I and II trimester. Method of administration and doses Outwardly, 2-4 g of ointment (which is comparable in volume, respectively, to the size of a cherry or walnut and is sufficient to treat a body surface area of 400-800 cm2) is applied in a thin layer, slightly rubbing into the skin over the inflammation site, 2-3 times per day. After applying the ointment, the hands must be washed if they are not the area of treatment (for arthrosis of the fingers). The maximum daily dose is 8 g. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the ointment can be used together with other dosage forms of diclofenac). It is necessary to consult a doctor after 2 weeks of using the drug. Side effect Frequency “very often” (> 1/10), “often” (> 1/100, <1/10), "sometimes" (> 1/1000, <1/100), "rarely" (> 1/10 10,000, <1/1000), "very rarely" (<1/10000). Immune system disorders Very rare: hypersensitivity reactions (including urticaria), Quincke's edema. Respiratory system Very rare: asthma. Diseases of the skin and subcutaneous tissue General: rash, eczema, erythema, dermatitis (including contact dermatitis), itching. Rare: bullous dermatitis. Very rare: photosensitivity, pustular rash. The likelihood of systemic side effects with topical application of drugs Diclofenac sodium, ointment is small compared with the frequency of side effects with oral treatment with diclofenac sodium. When the drug Diclofenac sodium, ointment is applied over large areas and for a longer period, the frequency of systemic side effects cannot be completely ruled out. In such cases, you should consult with your doctor. Precautionary measureUse only externally. Apply only to intact areas of the skin. After application, an occlusive dressing should not be applied. With prolonged use and / or application to large areas of the skin, the risk of developing systemic side effects increases, incl. there may be an increase in the activity of liver enzymes. To minimize the possible risk of developing adverse reactions from the liver, Diclofenac sodium should be used at the lowest effective dose for the shortest possible period. Avoid getting the ointment in the eyes, mucous membranes or open wounds. The propylene glycol contained in the ointment may cause skin irritation. Use during pregnancy There are no controlled clinical studies in pregnant women, so Diclofenac sodium should not be used during pregnancy. The use is especially dangerous in the third trimester of pregnancy due to the possible early closure of the botallian duct and the likelihood of suppression of labor pains. Application during breastfeeding There is no data on the penetration into breast milk of diclofenac sodium applied topically. Therefore, the drug should not be used in lactating women. For good reasons for prescribing, the drug should not be applied to the chest area, they should not be treated with large areas of the body surface and used for a long time. Overdose Due to the low systemic absorption when applying the ointment, an overdose is unlikely. Interaction with other drugs May enhance the effect of drugs that cause photosensitivity. Use with caution with other drugs known to be hepatotoxic, e.g. antibiotics, antiepileptic drugs. Clinically significant interaction with other medicinal products is unlikely due to negligible systemic absorption. Packing: 30 g in aluminum tubes with bushes. Each tube, together with a leaflet for medical use, is placed in a cardboard box. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Terms of dispensing from pharmaciesWithout a prescription. Buy Diclofenac sodium ointment 10mg/g 30g №1 The price of Diclofenac sodium ointment 10mg/g 30g №1