- Voltaren Diclofenac Diethylamine 1.16% w/w
- Low systemic absorption
- Muscle pain relief with a no mess applicator
- Supported by the National Institute for Health and Care Excellence Clinical Knowledge Summary for Mild-Moderate Pain
- For patients who are looking for relief from acute back pain
- Voltaren Diclofenac Diethylamine 1.16% w/w product details
Voltaren Diclofenac Diethylamine 1.16% w/w - relieves muscle, back & joint pain1
Relieves pain associated with acute, localized muscle or joint injuries such as sprains, strains or sports injuries.1
Contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID).1
Voltaren Emulgel Back & Muscle Pain is also available with a No Mess applicator.
A formulation designed for absorption1,2
After topical application, diclofenac is absorbed through the skin, and a reservoir is formed in the subdermis, from where it reaches the area of inflammation.1,2 Diclofenac persists in the muscle and other tissues, which are the site of pain and inflammation.1,2
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.3
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).3
*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 pain4,5
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.6
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 1.0.4,5¶
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.7‡
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).4
†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.
Effective relief of acute pain and reduction of inflammation8
In a clinical study by Duteil L, et al. published in the Journal of Clinical & Experimental Dermatology (1990), Voltaren Emulgel 1.16% w/w demonstrated anti-inflammatory effects within the first 4 hours of application and sustained anti-inflammatory effect even 48 hours after the intial application.8*
*Voltaren was compared to 5 other topical NSAIDs and 3 topical corticosteroids. Methyl-nicotinate was rubbed on each subjects forearm to induce skin inflammation. Each application was followed by continuous skin blood flow recordings over 1 hour. Thirty minutes later the laser-Doppler probes were fixed onto the areas to be tested and 5-min baseline skin blood flow measurements were made. Each group of products was evaluated separately with a minimum of 9 days between each session to allow for wash-out.
Voltaren Emulgel Back & Muscle Pain available with a No Mess applicator
Just over a third of patients (31%) say that topical creams and gels are messy.9
The No Mess applicator allows patients to easily apply Voltaren Diclofenac Diethylamine 1.16% w/w at the point of pain, keeping hands and fingers clean.
Voltaren offers low systemic absorption
The low systemic absorption of Voltaren Emulgel (6% systemic absorption) is associated with a low incidence of systemic side effects.1,2,10
For the full list of side effects, please click here for Voltaren (diclofenac diethylamine 1.16% w/w) or here for Voltaren Emulgel Extra Strength (diclofenac diethylamine 2.32% w/w).
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.11
Aisha wants effective relief for her acute back pain
Aisha* balances her full-time job with staying active. She enjoys rock-climbing and hiking with friends.
Now that she has pain in her back, she is struggling to do activities outside of work.
Her pain: back pain; started yesterday
She describes: back pain, which developed while hiking and rock climbing.
Voltaren is applied topically where its anti-inflammatory ingredient penetrates through the skin to provide clinically proven pain relief, so Aisha can get back to doing the things she enjoys!1,2
*Fictional case study.
Voltaren Diclofenac Diethylamine 1.16% w/w
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 Back & Muscle Pain 1.16% w/w formulation contains 11.6 mg of the active ingredient, diclofenac diethylamine.
Also contains non-medicinal ingredients: carbomer, cocoyl caprylocaprate, diethylamine, fragrance (containing benzyl benzoate), isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, propylene glycol, purified water.
Indication & Directions1
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 Diclofenac Diethylamine 1.16% w/w is not for use in children under 16 years of age.
- Apply gel 3 to 4 times a day on the affected area. It should be rubbed gently into the skin.
- The amount needed will vary depending upon the size of the painful or swollen area: 2 g to 4 g (1 g equals a strip approximately 2 cm long) gel will be sufficient to cover a 400 to 800 cm2 area.
- Do not use more than 4 times in 24 hours.
- 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.
Warnings & precautions1
Diclofenac diethylamine gel 1.16% 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 1.16% 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 and benzyl benzoate may cause mild localized skin irritation in some people.
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 iof 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.
Voltaren – for effective relief of acute muscle, back & joint pain1,2
Voltaren Emulgel Extra Strength (Diclofenac Diethylamine 2.32% w/w)
Access information about Voltaren Emulgel Extra Strength Diclofenac Diethylamine 2.32% w/w variant