Voltaren Emulgel Extra Strength Diclofenac Diethylamine 2.32% w/w contains a permeation enhancer
Voltaren contains diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID), that relieves inflammation at the site of pain.1
Voltaren Emulgel Extra Strength, containing 2.32% w/w Diclofenac Diethylamine, contains a permeation enhancer Oleyl alcohol2, which belongs to the family of fatty alcohols. Oleyl alcohol is an emulsion stabilizer and acts as a transdermal permeation enhancer, increasing the penetration of diclofenac through the skin.3
A formulation designed for absorption1,4
After topical application, diclofenac is absorbed through the subdermis, and a reservoir is formed in the subdermis, from where it reaches the area of inflammation. Diclofenac persists in the muscle and other tissues, which are the site of pain and inflammation.1,4
When it comes to topical NSAIDs, formulation can be more important than concentration when it comes to absorption:
Results of an in vitro study published by Pradal J, et al. in the Journal of Pain Research (2019), showed that physiochemical properties, such as viscosity, salt, molecular weight and excipients, rather than a higher concentration of active ingredient lead to greater absorption.5
Voltaren Diclofenac Diethylamine 1.16% w/w demonstrated a statistically significant greater permeation through the skin* (Pradal, et al., 2019) at 24 hours vs. diclofenac sodium 5% gel (554 vs. 361 ng/cm2, respectively).5
*Absolute cumulative penetration (ng/cm2) measured over 24 hours. In vitro study on ex vivo skin.
Diclofenac Diethylamine demonstrated a low NNT value, 1.8, for acute musculoskeletal pain6,7
Cochrane reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognized as the highest standard in evidence-based health care.8
In 2015, a Cochrane Review† of 61 studies (>8000 patients) comparing topical NSAIDs in acute musculoskeletal pain reported that Diclofenac Diethylamine demonstrated an NNT value of 1.8.*‡ In comparison, the “ideal treatment” would have an NNT of 1.0.6,7¶
NNT (number needed to treat) is a measure of clinical efficacy and indicates the number of patients that need to be treated in order for one to benefit.9‡
The authors concluded that topical NSAIDs provided good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to that provided by oral NSAIDs (Derry, et al., 2015).6
†The review included randomized, double-blind, active or placebo-controlled trials in which treatments were administered to adults with acute pain resulting from strains, sprains or sports or overuse-type injuries.*1.16 % w/w and 2.32 % w/w Voltaren Emulgel formulations included in the review.¶ Reflects a hypothetical scenario where all the patients in the treatment group have benefitted but no one has in the control arm.‡Substantial clinical benefit with Voltaren defined as at least 50% pain reduction.
Voltaren provides clinically proven pain relief and greater reduction in pain on movement vs. placebo1,10
In a clinical study by Predel, et al. published in Medicine & Science in Sports & Exercise (2012), patients with acute ankle sprain experienced a 50% or greater reduction in pain-on-movement (POM) with Voltaren Emulgel 2.32% w/w vs. placebo.1,10*†
236 patients completed the trial and were randomized to one of 3 groups, diclofenac diethylamine (DDEA) 2.32% bid, DDEA 2.32% tid and placebo.
The study observed that the onset of efficacy was rapid with both bid and tid DDEA 2.32% treatment regimens and improvements in POM were sustained during the entire 7-day treatment period. By day 5 (the primary efficacy variable), the decrease in POM with DDEA 2.32% bid and tid was twice that observed with placebo (p<0.0001). The difference between the DDEA 2.32% bid and tid groups was insignificant.10
When applied twice daily, Voltaren Emulgel Extra Strength 2.32% w/w provided an earlier reduction in POM vs. placebo 4-5 days sooner in patients with uncomplicated acute ankle sprain.10
*Over day 1-5 (p<0.0001).†Voltaren 2.32% or placebo was applied 2-3 times daily for the duration of the clinical trial. The primary efficacy outcome, ankle POM, was assessed by VAS on day 5. POM on VAS was registered by the patient lying down while the investigator, holding the injured ankle leg at 45̊, performed a gentle supination of the injured ankle to reach an angle of approx. 30̊. Secondary efficacy variables (ankle swelling) were assessed on days 3, 5, and 8.
Voltaren provides clinically proven reduction in ankle swelling vs. placebo1,10
In the same clinical study by Predel, et al. published in Medicine & Science in Sports & Exercise (2012), ankle swelling in the Diclofenac Diethylamine 2.32% w/w group, bid & tid, was decreased to one-third of that observed in the placebo group.1,10*†
At all time points, there was a significantly greater decrease in the mean swelling in the groups treated with DDEA 2.32% compared with placebo (p<0.0001), apart from DDEA 2.32% bid at day 3, p=0.0012. The mean change from baseline in the DDEA 2.32% groups was superior to placebo by roughly 0.4 cm at day 3, increasing to roughly 0.6 cm on days 5 and 8. By day 8, the swelling in the DDEA 2.32% bid and tid groups (0.3 cm in both groups) was one third that observed in the placebo group (0.9 cm) p<0.0001.10
*Average reduction in joint swelling with Voltaren at Day 8 vs. averge baseline value (p<0.0001 vs. placebo).
†Voltaren 2.32% or placebo was applied 2-3 times daily for the duration of the clinical trial. Secondary efficacy variables (including ankle swelling) were assessed on days 3, 5, and 8. Ankle swelling was determined by the investigator using the circumference measurement of swelling by the ‘‘figure-of-eight method’’ and subtracting the corresponding measurement of the healthy uninjured ankle.
Voltaren offers low systemic absorption
The low systemic absorption of Voltaren (6% systemic absorption), is associated with a low incidence of systemic side effects.1,4,11
To improve pain, inflammation and recovery after acute injuries such as sprains and strains, the National Institute for Health and Care Exellence has developed a clinical knowledge summary for mild-moderate pain, recommending acetaminophen, or a nonsteroidal anti-inflammatory drug (NSAID), oral or topical, as treatment.12
Terry wants effective pain relief for his acute joint injury
Terry balances the demands of his full-time job with taking care of two young children.
He enjoys going to the gym or exercising outdoors and loves nothing more than playing with his children.
The last thing he needs is pain from a sprain that happened while playing tennis affecting his life.
His pain: joint pain
He describes: a red, swollen left ankle; the pain is a little worse after walking
Voltaren is absorbed through the skin to provide relief from pain and inflammation after soft-tissue injuries, so Terry can get back to doing the activities he enjoys.1,10
*Fictional case study.
Voltaren Emulgel Extra Strength Diclofenac Diethylamine 2.32% w/w
Contains a permeation enhancer to increase penetration of diclofenac through the skin.1,2
For patients looking for the relief of pain associated with acute, localized muscle or joint injuries such as sprains, strains or sports injuries.1
1 g Voltaren Emulgel Extra Strength contains 23.2 mg of the active ingredient, diclofenac diethylamine.
Also contains non-medicinal ingredients: butylhydroxytoluene, carbomer, cocoyl caprylocaprate, diethylamine, fragrance, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, propylene glycol, purified water.
Voltaren Emulgel Extra Strength 2.32% w/w is indicated for the relief of pain associated with recent (acute), localized muscle or joint injuries such as sprains, strains or sports injuries (e.g., sprain of ankle, strain of shoulder or back muscles). This is typically as an adjunct to other measures, such as rest, for the relief of discomfort associated with such injuries.
Voltaren Emulgel Extra Strength Diclofenac Diethylamine 2.32% w/w is indicated for adults between 18-65 years of age.
The safety and efficacy of Voltaren Emulgel Extra Strength 2.32% w/w in children under 18 years of age and adults over 65 years of age have not been demonstrated and established.
- Apply 2 g of gel 2 times a day (morning and evening) on the effected area.
- The amount of gel applied (2 g for each application) should be measured using the dosing card supplied in the product carton. For each application the gel should be squeezed from the tube and measured up to the 2 g line on the dosing card. Clean and dry the dosing card after each use.
- Do not use more than 4 g per day.
Important: Dosing card image is for reference only and is not to scale. Please instruct patients to use the dosing card within the Voltaren Emulgel Extra Strength 2.32% w/w package to ensure the appropriate amount is dispensed.
- After application the hands should be washed.
- The gel should not be used for more than 7 days for muscle and joint injuries, unless recommended by a doctor. Patients should talk to their doctor if their condition does not improve within 7 days, or if it gets worse.
Diclofenac diethylamine gel 2.32% w/w is indicated for topical use only and should be applied only to intact, non-diseased skin and not to skin wounds or open injuries.
It should not be used with occlusion (can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing).
It should not come into contact with the eyes or mucous membranes and should never be taken by mouth.
In diclofenac diethylamine gel 2.32% w/w the systemic availability of diclofenac diethylamine through percutaneous absorption is low compared with plasma levels obtained following oral forms of diclofenac. Nevertheless, the possibility of systemic side effects cannot be completely excluded. Chances of this may be increased where diclofenac diethylamine gel is applied to a relatively large area of skin and/or over an extended period of time (e.g., especially if this goes beyond the maximum duration recommended for use).
Diclofenac diethylamine gel should be used with caution by patients under medication for active peptic ulcers in the stomach or duodenum (e.g. proton pump inhibitors or histamine H2 receptor antagonists)
Diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of bronchial asthma. Asthma has been rarely reported in patients using topical NSAID preparations.
Local irritation, erythema, pruritus or dermatitis may occasionally occur with topical diclofenac diethylamine. Skin photosensitivity, desquamation, discoloration and bullous or vesicular eruptions have been reported in isolated cases. Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
Do not apply to cuts, open wounds or any other area where the skin is damaged.
Propylene glycol may cause mild localized skin irritation in some people. Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Pregnant Women/Infertility: Since no experience has been acquired with diclofenac diethylamine gel in pregnancy, it is not recommended for use in these circumstances.
It is contraindicated during the last trimester of pregnancy, owing to the possibility of uterine inertia, fetal renal impairment with subsequent oligohydramnios and/or premature closure of the ductus arteriosus.
Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy.
If diclofenac is used by woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible and consult your doctor.
Nursing Women: it is not known whether topical diclofenac is excreted in breast milk. However, studies in animals detected diclofenac in milk after oral administration.
Diclofenac should only be used during lactation if the expected benefit justifies the potential risk to the newborn. If there are compelling reasons for using it, it should not be applied to the breasts nor should it be used at a higher dosage or for a longer period of time than recommended. Nursing women should consult their doctor before using the product.
Please consult the Product Monograph for the full description of warnings and precautions. The Product Monograph is available upon request by calling 1-888-788-8181. Always direct the patient to read the label.
- Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
- Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
- Patients with or without chronic asthma in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents.
- Concomitant use of other products containing diclofenac.
- Concomitant use of oral non-steroidal anti-inflammatory drugs (NSAIDs).
- During the last trimester of pregnancy.
- Following coronary artery bypass grafting surgery.
Please consult the Product Monograph for more information on the contraindications.The Product Monograph is available upon request by calling 1-888-788-8181. Always direct the patient to read the label.
The following includes adverse reactions from the clinical trials as well as from the post-marketing experience where causal relationship has been established.
Infections and infestations
Very rare: Rash pustular
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: Dermatitis bullous
Very rare: Photosensitivity reaction
Please consult the Product Monograph for the full description of side effects and infomation to assist in the benefit-risk assessment. Always direct the patient to read the label. The Product Monograph is available upon request by calling 1-888-788-8181.