Voltaren Emulgel

Voltaren Emulgel

diclofenac

Manufacturer:

GlaxoSmithKline Consumer

Distributor:

DKSH
Full Prescribing Info
Contents
Diclofenac diethylammonium.
Description
Each 100-g Voltaren Emulgel contains diclofenac diethylamine 1.16 g in an amount corresponding to diclofenac sodium 1 g.
Voltaren Emulgel is a fatty emulsion in an aqueous gel to which propylene glycol and isopropanol as flavouring agent have been added.
Action
Voltaren Emulgel is an anti-inflammatory and analgesic preparation designed for external application. It contains an active substance equivalent to 1% diclofenac sodium. The preparation can easily be rubbed into the skin, and due to its aqueous-alcoholic base, it exerts a soothing and cooling effect.
Diclofenac has been shown in experiments to inhibit prostaglandin biosynthesis, and this is regarded as an important factor in its mechanism of action.
In inflammation of traumatic or rheumatic origin, Voltaren Emulgel relieves pain, reduces oedema and shortens the time to return of normal function.
Pharmacokinetics: Absorption: The amount of diclofenac absorbed through the skin is proportional to the contact time and skin area covered with Voltaren Emulgel, and depends on the total topical dose and on skin hydration. About 6% of the active substance is absorbed after topical application of 2.5 g/500 cm2, as determined by reference to total renal elimination compared with Voltaren tablets. Absorption of diclofenac increases 3-fold if an occlusive dressing is applied for 10 hrs.
Distribution: Diclofenac can be detected in the plasma, synovial tissue and synovial fluid after topical application of Voltaren Emulgel to the wrists and knees. Peak plasma concentrations of diclofenac are about 100 times lower after topical application of Voltaren Emulgel than after oral administration of Voltaren tablets. 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%).
Metabolism: Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single or multiple hydroxylation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to much lesser extent than diclofenac.
Elimination: Total systemic clearance of diclofenac from the plasma is 263 ± 56 mL/min (mean value ± standard deviation). The terminal plasma half-life is 1-2 hrs. Four of the metabolites, including the 2 active metabolites, also have a short plasma half-life (1-3 hrs). One metabolite, 3'-hydroxy-4'-methoxydiclofenac, has a much longer half-life, but this metabolite is virtually inactive.
Diclofenac and its metabolites are excreted mainly in the urine.
Kinetics in Special Clinical Situations: No accumulation of diclofenac and its metabolites should occur in patients with renal insufficiency.
In patients with chronic hepatitis or nondecompensated liver cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.
Indications/Uses
Treatment of localised forms of soft-tissue rheumatism, eg tendovaginitis, shoulder-hand syndrome, bursitis and periarthropathy; localised rheumatic diseases, eg osteoarthritis of the spine and peripheral joints; post-traumatic inflammation of the tendons, ligaments, muscles and joints, eg due to sprains, strains or bruises.
Dosage/Direction for Use
Depending on the size of the painful site to be treated, apply 2-4 g Voltaren Emulgel (a quantity ranging in size from a cherry to walnut which is enough for an area of about 400-800 cm2) 3-4 times daily to the affected sites and rub-in gently. The duration of treatment depends on the indication and the patient's response. It is advisable to review the treatment after 2 weeks.
Voltaren Emulgel can also be employed as accompanying treatment together with other dosage forms of Voltaren.
Overdosage
The low systemic absorption of diclofenac when applied topically makes overdosage very unlikely. Significant systemic reactions resulting from improper use on accidental overdosage (eg, in children) should be treated with the usual measures employed to manage poisoning with NSAIDs.
Contraindications
Hypersensitivity to diclofenac, acetylsalicylic acid and other NSAIDs, as well as to isopropanol or propylene glycol.
Special Precautions
Voltaren Emulgel should be applied only to intact skin surfaces, and not to broken skin or open wounds. It should not be allowed to come into contact with the eyes or with mucous membranes.
Use in Pregnancy & Lactation: 1st and 2nd Trimesters: Pregnancy Category B: Animal studies have shown no risk to the fetus, but no controlled studies are available in pregnant women.
3rd Trimester: Pregnancy Category D: Voltaren Emulgel should not be used owing to risk of premature closure of the ductus arteriosus and suppression of uterine contractility.
Measurable quantities of the diclofenac diethylammonium should not be seen in the breast milk, but no experience is available with Voltaren Emulgel in breastfeeding women.
Use in Children: No dosage recommendations and indications have been established to date for the use of Voltaren Emulgel in children.
Use In Pregnancy & Lactation
1st and 2nd Trimesters: Pregnancy Category B: Animal studies have shown no risk to the fetus, but no controlled studies are available in pregnant women.
3rd Trimester: Pregnancy Category D: Voltaren Emulgel should not be used owing to risk of premature closure of the ductus arteriosus and suppression of uterine contractility.
Measurable quantities of the diclofenac diethylammonium should not be seen in the breast milk, but no experience is available with Voltaren Emulgel in breastfeeding women.
Side Effects
Local Reactions: Occasional: Allergic or non-allergic contact dermatitis (with symptoms and signs, eg itching, reddening of the skin, oedema, papules, vesicles, bullae or scaling).
Systemic Reactions: Isolated Cases: Generalised rash; hypersensitivity reactions (eg, asthma attack, angioedema); photosensitivity reactions.
The likelihood of systemic reactions occuring during topical treatment with diclofenac is small compared with the frequency of side effects seen during oral administration. If Voltaren Emulgel is applied to large areas for prolonged periods, the possibility of systemic reactions cannot be completely ruled out.
Drug Interactions
No drug interactions during treatment with Voltaren Emulgel have yet been reported.
Storage
Protect from heat.
ATC Classification
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Emulgel 1% (white, creamy, non-greasy) x 10 g, 25 g, 50 g, 100 g.
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