Avar is a gel used to treat the inflammation and pain of conditions like arthritis. It can be applied directly to the affected area up to four times a day. Avar is typically sold in tubes containing 30 grams of gel.

If you’re looking for relief from arthritis pain, Avar may be a good option for you. This gel can be applied directly to the affected area, providing targeted relief. Plus, it’s easy to use and generally well-tolerated. Talk to your doctor about whether Avar is right for you.

Pharmacokinetics

The pharmacokinetics of diclofenac following topical application has not been determined. Following intramuscular administration, the plasma half-life of diclofenac is approximately 2 hours.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In rats given oral doses of diclofenac up to 150 mg/kg/day (about 0.6 times the maximum recommended human dose of 100 grams on a body surface area basis), no evidence of carcinogenic effects was observed. In mice given subcutaneous doses of diclofenac up to 10 mg/kg/day (about 0.04 times the maximum recommended human dose), no evidence of carcinogenic effects was observed.

Diclofenac was not mutagenic in the Ames test or mouse lymphoma assay, and did not increase chromosomal aberrations in Chinese hamster ovary cells or in human lymphocytes in vitro. No impairment of fertility was observed in rats given subcutaneous doses up to 10 mg/kg/day (about 0.04 times the maximum recommended human dose).

Clinical Studies

The safety and efficacy of Voltaren® Gel were evaluated in 5 randomized, multicenter, controlled clinical trials involving 1104 patients with osteoarthritis of the knee who applied Voltaren® Gel 4 g over a treatment period of up to 4 weeks. Patients were evaluated for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale. The mean change from baseline in the WOMAC pain subscale at Week 4 was used to assess efficacy.

A statistically significantly greater percentage of Voltaren® Gel-treated patients than placebo-treated patients (up to 17.5% versus 10%) reported clinically meaningful improvements in pain as early as Week 1 that persisted throughout the 4-week treatment period. Clinical meaningfulness was defined as a change from baseline in the WOMAC pain subscale score of ≥ 16 points at Week 4, or a ≥ 20% reduction in score from baseline at Week 4, or both.

In all 5 clinical studies, there were more Voltaren® Gel-treated patients than placebo-treated patients who reported improvements in pain on the WOMAC pain subscale at Week 4. The results from the individual studies are summarized as:

  • p-values derived from logistic regression model controlling for treatment center and baseline pain score; adjusted for multiplicity using Holm’s method
  • Treatment difference calculated as relative risk of Voltaren® Gel/placebo-treated patients with at least 1 patient in each group reporting a clinical improvement in pain, relative to those without clinical improvement in pain (95% confidence interval); odds ratio = 1.7 (1.2, 2.4) across all 5 studies

Side Effects

The most common adverse reactions (≥ 1%) reported in Voltaren® Gel clinical trials were application site pain, application site pruritus, and skin rash. The incidence of these side effects was similar to or lower than the incidence seen with placebo. Other less common adverse events that occurred more frequently in Voltaren® Gel- treated patients than in placebo-treated patients included upper respiratory tract infection and nasopharyngitis.

Adverse Reactions Reported by ≥ 1% of Patients Treated With Voltaren ® Gel in Controlled Clinical Trials (%)1

Adverse Reaction Trial Population2 All Trials N=1104 Voltaren ® Gel N=846 Placebo N=258 Application Site Pain 3 4.5 3 1.2 Application Site Pruritus 3 2.6 1 0.4 Skin Rash 3 1.5 1 0.4 Nasopharyngitis 3 4.0 5 2.7

Dosage and Administration

Apply a small amount of Voltaren® Gel (2 g or 4 g) to the affected joint 4 times daily. Massage gently into fully dry skin until the gel is absorbed, taking care not to apply to broken skin or open wounds. If a dressing is applied over Voltaren® Gel, wait at least 1 hour before applying the dressing. Wait at least 30 minutes after applying Voltaren® Gel before bathing, showering, or swimming.

Voltaren® Gel should be used with caution in patients with liver disease as diclofenac and its metabolites are largely excreted through the liver.

No start-up titration is necessary when using Voltaren® Gel. Dose escalation is unnecessary and not recommended.

For patients using Voltaren® Gel for the first time, refer to the Instruction Leaflet that comes with the product for a complete list of ingredients.

Voltaren® Gel is for external use only. Avoid contact with eyes or mucous membranes; in case of accidental contact, wash with water and seek medical advice if irritation persists. Do not apply over large surface areas, open wounds, or irritated skin, and do not wrap or bandage. If excessive skin reactions occur (e.g., burns), discontinue use and institute appropriate treatment. Use caution when applying to skin that has been treated with medicated cosmetics, other topical preparations, or products that could increase skin sensitivity (e.g., harsh soaps or cleansers, strong drying agents). Use only the smallest amount of Voltaren® Gel needed to cover the affected joint area.

Do not use in patients with a known hypersensitivity to diclofenac or any other ingredient in Voltaren® Gel.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Store in the original carton until use, in order to protect from light.