Voltaren emulgel 1% gel 50g tuba

Description

Composition
Active substance:
At 100 g diclofenac diethylamine 1.16 g, which corresponds to the content of diclofenac sodium 1 g
Excipients:
carbomers (Carbopol 974P) – 1.2 g, macrogol tsetostearat (cetomacrogol 1000) – 2g, cocoyl kaprilokaprat (tsetiol LC) – 2.5 g, diethylamine – 0.9 g of isopropanol – 20 g paraffin liquid – 2.5 z, aromatic cream 45 (contains benzyl) – 0.1 g of propylene glycol – 5 g water – 64.64 g
Description:
Gel for external application of 1% homogeneous, creamy, white to yellowish.
Product form:
50 g – aluminum tubes (1) – packs cardboard.
Contraindications
– Hypersensitivity to diclofenac or to other components of the formulation; – a tendency to the appearance of bronchial asthma, skin rashes or acute rhinitis application of acetylsalicylic acid or other NSAIDs; – tampering with the skin at the intended site of application; – III trimester of pregnancy; – lactation (breast feeding); – Children up to age 12 years.
Dosage
10 mg / g
Indications
– back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica); – pain in the joints (including joints of the fingers, knees) in rheumatoid arthritis, osteoarthritis; – muscle pain (due to stretching, overvoltage, bruises, injuries); – inflammation and swelling of the soft tissues and joints due to injuries and rheumatic diseases (tendonitis, bursitis, defeat periarticular tissues, CTS).
Interaction with other drugs
Voltaren® Emulgel® can enhance the action of drugs that cause photosensitization. Clinically significant interactions with other drugs has not been described.
Overdose
Due to the low systemic absorption when applied to the gel, overdose unlikely. Symptoms: Accidental ingestion may develop systemic side effects. Treatment of overdose Accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and diuresis are not effective in view of the high degree of binding to plasma proteins diclofenac (about 99%).
pharmachologic effect
Pharmacological group:
M02AA15
Pharmacodynamics:
NSAIDs for external application. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic action. Non-selectively inhibiting the COX-1 and COX-2, gives the metabolism of arachidonic acid. Voltaren® Emulgel® used to eliminate pain and inflammation in the joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with inflammation, increasing joint mobility. Due to its water-alcohol-based Voltaren® Emulgel® providing soothing and cooling effect.
Pharmacokinetics:
Absorption Number diclofenac absorbed through the skin, proportional to the treated surface area and depends on the total dose of drug applied and the degree of skin hydration. After application to the skin surface area of ​​400 cm2 Voltaren® Emulgel® gel for topical application of 2% (two per day application), the concentration of active substance in plasma corresponds to its concentration by using 1% diclofenac gel (4 in the drawing day). On the 7th day relative bioavailability (AUC ratio) is 4.5% (equivalent to doses of diclofenac sodium salt). When wearing moisture-permeable dressings absorption did not change. Distribution When applying the preparation on the area of ​​the affected joint, the concentration of diclofenac in plasma, synovial membrane and synovial fluid. Cmax in the plasma was about 100 times lower than after oral administration of the same amount of diclofenac. diclofenac Binding to plasma proteins is 99.7%, mainly to albumin (99.4%). Diclofenac advantageously distributed and retained in deep tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma. Metabolism Metabolism diclofenac is achieved partly by glucuronidation unmodified molecule, but preferably by means of single and multiple hydroxylation which leads to the formation of several phenolic metabolites, most of which is converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac. Excretion Total systemic plasma clearance of diclofenac is 263 ± 56 mL / min. The final T1 / 2 of 1-2 hours. The T1 / 2 of metabolites including two pharmacologically active, and also of short duration is 1-3 hours. One of the metabolites (3′-hydroxy-4′-metoksidiklofenak) has a longer T1 / 2, however, this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.
Pregnancy and breast-feeding
Due to the lack of use of the drug Voltaren® Emulgel® data in pregnancy, the use of the drug in I and II trimesters of pregnancy is recommended only on prescription by comparing the benefits to the mother and the risk to the fetus. The drug is contraindicated in III trimester due to the possibility of lowering the tone of the uterus, fetal renal function disorders with subsequent development of water scarcity and / or premature closure of the fetal blood flow. In the absence of data on the release of the active drug substance Voltaren® Emulgel® in breast milk, the drug should not be used during breastfeeding. If you need to use the drug, it should not be applied to the breasts or to a large surface of the skin and do not use for a long time. Data on the effect of the drug on fertility are not available.
Conditions of supply of pharmacies
Without recipe
side effects
Adverse reactions generally characterized by moderate and extending cutaneous manifestations at the site of gel. In very rare cases may develop allergic reactions. Determination of the frequency of occurrence of adverse reactions: very often (> 10%), frequent (> 1% but
special instructions
Voltaren® Emulgel® should only be applied to intact skin, avoiding contact with open wounds. After applying the product allowed the imposition of bandage, but it should not impose an airtight occlusive dressings. In the case of skin rash after application of the preparation of its use should be discontinued. Do not allow contact with the drug in the eyes and mucous membranes. The drug contains propylene glycol, which in some people can cause mild local irritation. It also contains butylhydroxytoluene, capable of inducing local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes. Effects on ability to drive vehicles and management mechanisms are not affected.
Storage conditions
The drug should be kept out of reach of children at a temperature not higher than 30 ° C.
Dosing and Administration
The drug is used topically. Adults and children over 12 years of drug applied to the skin 3-4 times / day and slightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose – 4.2 g (that is comparable in volume correspondingly to the size of a walnut or cherry). After applying the drug hands must be washed. The duration of treatment depends on the indications and marks effect (effect for enhancing the gel can be used together with other medicinal forms Voltaren® drug). In the absence of therapeutic effect after 2 weeks should consult a doctor. Laminate tubes: to remove the protective membrane be used as a screw cap key (recess with projections on the outside of the cover). Align the groove on the outside of the lid with shaped protective membrane of the tube and turn. The membrane should be separated from the tube. Laminate tubes can be either a conventional cover (circular shape) and the innovative cover (triangular shape), which is particularly suitable for use with limited hand mobility of joints due to osteoarthritis or other diseases or injuries of joints, and applicator cap. Aluminum tubes: before the first use should pierce the protective membrane tubes with a special protrusion on the outer side of a polypropylene screw cap. It is not recommended to wash the lid applicator water or use abrasive cleaners. After full use of the contents of the tube is recommended to dispose of the lid applicator with the tuba. Do not use the applicator cap on the other tuba.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist