Etoflam Gel

• The use of Etoflam 5% w/w gel is not recommended in children or infants.
• It is recommended that treatment should be reviewed after 14 days. Treatment should not extend beyond 6 weeks. In symptomatic treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

Contraindications

• Etoflam 5% w/w gel contains alcohol and should not be applied to broken skin.
• Use with occlusive dressings.
• Use in patients hypersensitive to any of the ingredients or to non-steroidal anti-inflammatory agents including aspirin.
• Use simultaneously to the same site with any other topical preparation. Use in the presence of local infection.

Special warnings and precautions for use

• Etoflam 5% w/w gel contains alcohol and therefore contact with the eyes or the mucous membranes should be avoided.
• Hands should be thoroughly washed after use of this product.
• This product should not be applied to irritated or broken skin. If skin irritation develops, use of the product should be discontinued.
• If there is no improvement or the condition is aggravated, the doctor should be consulted.

Interaction with other medicinal products and other forms of interaction: None known.

Fertility, pregnancy and lactation

• Etoflam 5% w/w gel is not recommended for use during pregnancy and lactation.
• Etofenamate and some of its metabolites have been shown to cross the placenta in rats (oral and cutaneous) and rabbits (cutaneous). After 10, 30 and 100mg/kg BW per day (rabbits up to the 18th day of gestation) the concentrations in the placentas, uteri, foetuses, organs and bile decreased rapidly after stopping administration; they were below the per mille limit.
• Elimination with the milk has been studied in goats and humans. After 65 mg/kg BW i.m., goats excreted 20-60 microg of etofenamate plus metabolites per litre of milk. After oral administration of 300 mg etofenamate the milk of lactating women contained no etofenamate but only main metabolite flufenamic acid. In total 1-14 microg flufenamic acid was excreted within 2 days. These concentrations have no practical meaning, since they are orders of magnitude below the therapeutic dose.
• No teratogenic effects have been found in laboratory studies but the safety of etofenamate absorbed from Etoflam 5% w/w gel to the foetus, if used during pregnancy, or to the suckling infant if used during lactation, has not been established.

Effects on ability to drive and use machines

• Not applicable.

Undesirable effects

The following undesirable effects have been reported through post-marketing use.
Undesirable effects listed in the table are grouped by MedDRA System Organ Classes and are ranked under heading of frequency, using the following convention, when applicable: very common (
1/10); common (
1/100 to <1/10); uncommon (
1/1,000 to <1/100); rare (
1/10,000 to <1/1000); very rare (<1/10, 000); not known (cannot be estimated from the available data).

Rare

• Contact dermatitis

Overdose

• In view of the topical route of administration overdosage is not considered a practical possibility.

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory/analgesic for the treatment of inflammatory musculoskeletal system disorder.
Mechanism of action: Interactions with the arachidonic acid cascade (inhibition of prostaglandin synthesis) is postulated as the main action mechanism of nonsteroidal anti-inflammatories.
Pharmacodynamic Effect: In vitro studies have clearly shown that etofenamate inhibits both the lipoxygenase pathway and the cyclooxygenase pathway of arachidonic acid metabolism. The IC50 is 1.2 x 105 M for inhibition of leukotriene B4 biosynthesis in polymorphonuclear leucocytes and 2.8 x 107 M for inhibition of PGE2 release from macrophages. These values show that etofenamate has anti-inflammatory/analgesic activity.
Etofenamate is a flufenamic acid derivative, which is readily transported through the skin and concentrated in inflamed tissue, where it exerts anti-inflammatory and analgesic effects by inhibiting the release of histamine, lysosomal enzymes and prostaglandin.

References:

https://www.sdrugs.com/?c=drug&s=etoflam&ingredient=etodolac

https://www.hpra.ie/img/uploaded/swedocuments/2168331.PA1113_002_001.bce377e6-b24d-4fe0-a489-4704edc6b1da.000001Etoflam%20PIL.151120.pdf

https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1113-002-001_07032017090106.pdf

https://phoenixlabs.ie/etoflam/

https://www.drugs.com/international/etoflam.html

https://www.mims.ie/monograph/etoflam/?subsection=1468