VOLTAREN Diclofenac 1g / 100g (1.0% w/w) Emulgel 5g
NONRXDRUG-DR-XY27796-5
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Features
Brand
Voltaren
Full Details
Dosage Strength
1g / 100g (1%)
Drug Ingredients
- Diclofenac
Drug Packaging
Emulgel 5g
Generic Name
Diclofenac Sodium
Dosage Form
Emulgel
Registration Number
DR-XY27796
Drug Classification
Over-The-Counter (OTC)
Description
Indications/Uses
Treatment of post-traumatic inflammation of the tendons, ligaments and joints eg, due to sprains, strains and bruises; localized forms of soft tissue rheumatism eg, tendovaginitis, bursitis, shoulder-hand syndrome and periarthropathy; localized forms of degenerative rheumatism eg, osteoarthrosis of the peripheral joints and of the vertebral column.
Dosage/Direction for Use
Apply locally to the skin 3 or 4 times daily and rubbed in gently. The amount needed depends on the size of the painful site. For example, 2-4 g (a quantity ranging from the size of a cherry to the size of a walnut) is sufficient to treat an area of about 400-800 cm2.
The duration of treatment depends on the indication and the response obtained. It is recommended that treatment be reviewed after 2 weeks.
Children: Dosage recommendations and indications for the use of Voltaren Emulgel in children have not been established.
Elderly (≥65 years): There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.
Renal Impairment: There is no evidence to suggest that renally impaired patients require a different dosage.
Hepatic Impairment: There is no evidence to suggest that hepatically impaired patients require a different dosage.
Administration: Voltaren Emulgel should be rubbed in gently into the skin. After application, the hands should be washed, unless they are the site being treated.
The duration of treatment depends on the indication and the response obtained. It is recommended that treatment be reviewed after 2 weeks.
Children: Dosage recommendations and indications for the use of Voltaren Emulgel in children have not been established.
Elderly (≥65 years): There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.
Renal Impairment: There is no evidence to suggest that renally impaired patients require a different dosage.
Hepatic Impairment: There is no evidence to suggest that hepatically impaired patients require a different dosage.
Administration: Voltaren Emulgel should be rubbed in gently into the skin. After application, the hands should be washed, unless they are the site being treated.
Overdosage
The low systemic absorption of topical diclofenac makes an overdose very unlikely.
However, adverse reactions, similar to those observed following an overdose of Voltaren tablets, can be expected if Voltaren Emulgel is inadvertently ingested (1 tube of 100 g contains the equivalent of diclofenac sodium 1000 mg). General supportive measures and symptomatic treatment should be employed as in other cases of intoxication with NSAIDs. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
However, adverse reactions, similar to those observed following an overdose of Voltaren tablets, can be expected if Voltaren Emulgel is inadvertently ingested (1 tube of 100 g contains the equivalent of diclofenac sodium 1000 mg). General supportive measures and symptomatic treatment should be employed as in other cases of intoxication with NSAIDs. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
Special Precautions
General Recommendations: The likelihood of systemic side effects with topical diclofenac is small, compared with the frequency of side effects in patients using oral diclofenac. However, when Voltaren Emulgel is applied to relatively large areas of skin over a prolonged period of time, the possibility of systemic side effects cannot be excluded. In case such usage is planned, the product information on systemic forms of Voltaren should be consulted.
Voltaren Emulgel should be applied only to healthy and intact skin surfaces (those without open wounds or injuries). Avoid contact with the eyes or with mucous membranes.
Voltaren Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Voltaren Emulgel should not be ingested.
Special Excipient: Voltaren Emulgel contains propylene glycol, which may cause mild, localized skin irritation in some people.
Effects on the Ability to Drive or Operate Machinery: None known.
Women of Childbearing Potential: There are no data to suggest any recommendations for women of childbearing potential.
Impairment of Fertility: There are no data available on the use of topical formulation of diclofenac and its effects on fertility in humans.
Use in lactation: It is not known whether topical diclofenac is excreted in human milk, and Voltaren Emulgel is therefore not recommended during breastfeeding. If there are compelling reasons for using Voltaren Emulgel during breastfeeding, it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
Voltaren Emulgel should be applied only to healthy and intact skin surfaces (those without open wounds or injuries). Avoid contact with the eyes or with mucous membranes.
Voltaren Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Voltaren Emulgel should not be ingested.
Special Excipient: Voltaren Emulgel contains propylene glycol, which may cause mild, localized skin irritation in some people.
Effects on the Ability to Drive or Operate Machinery: None known.
Women of Childbearing Potential: There are no data to suggest any recommendations for women of childbearing potential.
Impairment of Fertility: There are no data available on the use of topical formulation of diclofenac and its effects on fertility in humans.
Use in lactation: It is not known whether topical diclofenac is excreted in human milk, and Voltaren Emulgel is therefore not recommended during breastfeeding. If there are compelling reasons for using Voltaren Emulgel during breastfeeding, it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
Use In Pregnancy & Lactation
Use in pregnancy: There are no insufficient data on the use of diclofenac in pregnant women. Voltaren Emulgel should therefore not be used during pregnancy. Diclofenac is contraindicated during the 3rd trimester, owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus (see Pharmacology: Pharmacodynamics: Toxicology: Nonclinical Safety Data under Actions).
Use in lactation: It is not known whether topical diclofenac is excreted in human milk, and Voltaren Emulgel is therefore not recommended during breastfeeding. If there are compelling reasons for using Voltaren Emulgel during breastfeeding, it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
Use in lactation: It is not known whether topical diclofenac is excreted in human milk, and Voltaren Emulgel is therefore not recommended during breastfeeding. If there are compelling reasons for using Voltaren Emulgel during breastfeeding, it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
Adverse Reactions
Adverse drug reactions from clinical trials and/or spontaneous or literature reports are listed as follows, by system organ class in MedDra. Within each system organ class, the adverse drug reactions are ranked by frequency with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), including isolated reports.
Infections and Infestations: Very Rare: Pustular rash.
Immune System Disorders: Very Rare: Hypersensitivity (including urticaria), angioedema.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Asthma.
Skin and Subcutaneous Tissue Disorders: Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Rare: Bullous dermatitis. Very Rare: Photosensitivity reaction.
Infections and Infestations: Very Rare: Pustular rash.
Immune System Disorders: Very Rare: Hypersensitivity (including urticaria), angioedema.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Asthma.
Skin and Subcutaneous Tissue Disorders: Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Rare: Bullous dermatitis. Very Rare: Photosensitivity reaction.
Action
Pharmacotherapeutic Group: Topical products for joint and muscular pain, anti-inflammatory preparations, nonsteroids for topical use.
Pharmacology: Pharmacodynamics: In inflammation of traumatic or rheumatic origin, Voltaren Emulgel has been shown to relieve pain, reduce edema and shorten the time needed to regain normal function.
Mechanism of Action: Diclofenac, the active substance of Voltaren Emulgel, is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties.
Inhibition of prostaglandin biosynthesis by diclofenac has been demonstrated experimentally and is regarded as an important component of its mechanism of action.
Clinical Studies: Diclofenac is a well-established product.
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 the hydration of the skin. Absorption amounts to about 6% of the dose of diclofenac after topical application of Voltaren Emulgel 2.5 g/500 cm2 skin, determined by reference to the total renal elimination compared with Voltaren tablets. Occlusion over a period of 10 hrs leads to a 3-fold increase in the amount of diclofenac absorbed.
Distribution: After topical administration of Voltaren Emulgel to hand and knee joints, diclofenac can be measured in plasma, synovial tissue and synovial fluid. Maximum plasma concentrations (Cmax) of diclofenac after topical administration of Voltaren Emulgel are about 100 times lower than after oral administration of Voltaren tablets. Ninety-nine and seven tenths percent (99.7%) of diclofenac binds to serum proteins, chiefly to albumin (99.4%).
Diclofenac accumulates in the skin which acts as reservoir from where there is a sustained release of drug into underlying tissues. From there, diclofenac is preferentially distributed to and persists in deep inflamed tissues eg, the joint, where it is found in concentrations up to 20 times higher than in plasma.
Biotransformation/Metabolism: This involves partly glucuronidation of the intact molecule, but mainly single and multiple hydroxylation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two (2) of these phenolic metabolites are biologically active, however, to a much smaller extent than diclofenac.
Elimination: The total systemic clearance of diclofenac from the plasma is 263±56 mL/min (mean value±SD). The terminal plasma t½ is 1-2 hrs. Four (4) of the metabolites, including the 2 active ones, also have short plasma t½ of 1-3 hrs. One (1) metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma t½, but is virtually inactive. Diclofenac and its metabolites are excreted mainly in the urine.
Special Populations: No accumulation of diclofenac or its metabolites is to be expected in patients suffering from renal impairment.
The kinetics and metabolism of diclofenac are the same in patients with chronic hepatitis or non-decompensated cirrhosis, as in patients without liver disease.
Toxicology: Nonclinical Safety Data: Preclinical data from acute and repeated-dose toxicity studies, as well as from genotoxicity, mutagenicity and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits. Diclofenac had no influence on the fertility of parent animals in rats. The prenatal, perinatal and postnatal development of the offspring was not affected.
Voltaren Emulgel was well-tolerated in a variety of studies. There was no potential for phototoxicity and Voltaren Emulgel caused no skin sensitization.
Pharmacology: Pharmacodynamics: In inflammation of traumatic or rheumatic origin, Voltaren Emulgel has been shown to relieve pain, reduce edema and shorten the time needed to regain normal function.
Mechanism of Action: Diclofenac, the active substance of Voltaren Emulgel, is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic properties.
Inhibition of prostaglandin biosynthesis by diclofenac has been demonstrated experimentally and is regarded as an important component of its mechanism of action.
Clinical Studies: Diclofenac is a well-established product.
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 the hydration of the skin. Absorption amounts to about 6% of the dose of diclofenac after topical application of Voltaren Emulgel 2.5 g/500 cm2 skin, determined by reference to the total renal elimination compared with Voltaren tablets. Occlusion over a period of 10 hrs leads to a 3-fold increase in the amount of diclofenac absorbed.
Distribution: After topical administration of Voltaren Emulgel to hand and knee joints, diclofenac can be measured in plasma, synovial tissue and synovial fluid. Maximum plasma concentrations (Cmax) of diclofenac after topical administration of Voltaren Emulgel are about 100 times lower than after oral administration of Voltaren tablets. Ninety-nine and seven tenths percent (99.7%) of diclofenac binds to serum proteins, chiefly to albumin (99.4%).
Diclofenac accumulates in the skin which acts as reservoir from where there is a sustained release of drug into underlying tissues. From there, diclofenac is preferentially distributed to and persists in deep inflamed tissues eg, the joint, where it is found in concentrations up to 20 times higher than in plasma.
Biotransformation/Metabolism: This involves partly glucuronidation of the intact molecule, but mainly single and multiple hydroxylation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two (2) of these phenolic metabolites are biologically active, however, to a much smaller extent than diclofenac.
Elimination: The total systemic clearance of diclofenac from the plasma is 263±56 mL/min (mean value±SD). The terminal plasma t½ is 1-2 hrs. Four (4) of the metabolites, including the 2 active ones, also have short plasma t½ of 1-3 hrs. One (1) metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma t½, but is virtually inactive. Diclofenac and its metabolites are excreted mainly in the urine.
Special Populations: No accumulation of diclofenac or its metabolites is to be expected in patients suffering from renal impairment.
The kinetics and metabolism of diclofenac are the same in patients with chronic hepatitis or non-decompensated cirrhosis, as in patients without liver disease.
Toxicology: Nonclinical Safety Data: Preclinical data from acute and repeated-dose toxicity studies, as well as from genotoxicity, mutagenicity and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits. Diclofenac had no influence on the fertility of parent animals in rats. The prenatal, perinatal and postnatal development of the offspring was not affected.
Voltaren Emulgel was well-tolerated in a variety of studies. There was no potential for phototoxicity and Voltaren Emulgel caused no skin sensitization.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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