Orthofen, gel 5% 30 g

The active ingredient diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. It inhibits indiscriminately cyclooxygenase 1 and 2 types, breaks metabolism of arachidonic acid and synthesis of prostaglandins, which are the main link in inflammation development.
Orthofen is used for pain relief and reduction of edema associated with inflammation.

It is well absorbed through the skin into the subcutaneous tissues within 5 minutes. Binding with plasma proteins is up to 99%. Penetrates into the synovial fluid, where the concentration remains unchanged for 7 h. Conjugated metabolites are excreted mainly through the kidneys, a smaller part is excreted with the faeces. Analgesic effect is achieved 30-60 minutes after application of the ointment and lasts for 2.5-5 hours, the maximum effect is developed after 1-2 hours.

Indications

Preventing pain, Pain after injuries and operationsp>

. Joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathy), post-traumatic inflammation of soft tissue and musculoskeletal system (sprains, bruises). Spine pain, neuralgia, myalgia, arthralgia, pain syndrome and inflammation after surgery and trauma, pain syndrome with gout, migraine, algodysmenorrhea, pain syndrome with adnexitis, proctitis, colic (biliary and renal), pain syndrome with inflammatory diseases of the ENT organs.

For local use: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with removal and implantation of the lens, ocular inflammation of non-infectious nature, post-traumatic inflammatory process with penetrating and non-penetrating wounds of the eyeball.

Active ingredient

Composition

100 g of gel contains:

Active ingredient:

diclofenac sodium – 5.0 g.

Excipients:

propylene glycol – 5.0 g,

ethanol 95% (ethyl alcohol 95%) – 30.0 g,

Hyetellose (hydroxyethylcellulose) – 2.5 g,

Purified water – up to 100.0 g.

How to take, the dosage

Outwardly, 2-4 g of ointment is applied in a thin layer to the painful area 3-4 times a day. Maximum daily dose is 8 g. The course (individual) is 1-14 days.

Interaction

When concomitant use with diclofenac of antihypertensive drugs may weaken their effect.

There have been single reports of seizures in patients who have concomitantly taken NSAIDs and antibacterial quinolones.

The risk of digestive side effects increases with concomitant use of GCS.

Concomitant use of diuretics may decrease the diuretic effect. Concomitant use with potassium-saving diuretics may increase the blood potassium concentration.

Concomitant use with other NSAIDs may increase the risk of side effects.

There have been reports of hypoglycemia or hyperglycemia in patients with diabetes mellitus who have used diclofenac concomitantly with hypoglycemic medications.

Concomitant use with acetylsalicylic acid may decrease the plasma concentration of diclofenac.

While in clinical trials it has not been established the effect of diclofenac on the effect of anticoagulants, there are individual cases of bleeding when concomitant use of diclofenac and warfarin.

Concomitant use may increase plasma concentrations of digoxin, lithium and phenytoin.

Gastrointestinal absorption of diclofenac is decreased with concomitant use with colestiramine, and to a lesser extent with colestipol.

Concomitant use may increase plasma concentrations of methotrexate and increase its toxicity.

Concomitant use of diclofenac may not affect the bioavailability of morphine, but the concentration of the active metabolite of morphine may remain elevated in the presence of diclofenac, which increases the risk of side effects of morphine metabolite, including respiratory depression.

In concomitant use with pentazocine a case of large convulsive seizure has been described; with rifampicin – possible decrease of plasma concentration of diclofenac; with ceftriaxone – excretion of ceftriaxone with bile increases; with cyclosporine – possible increase of nephrotoxicity of cyclosporine.

Special Instructions

With particular caution, use in patients with a history of liver, kidney and gastrointestinal disorders, dyspeptic complaints, bronchial asthma, arterial hypertension, heart failure, immediately after major surgical interventions, as well as in elderly patients.

With indications in the anamnesis of allergic reactions to NSAIDs and sulfites diclofenac is used only in urgent cases. During treatment systematic control of liver and kidney function and peripheral blood count is necessary.

The rectal administration is not recommended in patients with anorectal diseases or anorectal bleeding in the history. Externally, only use on intact areas of skin.

Contact with diclofenac in the eyes (except in eye drops) or on the mucous membranes should be avoided. Patients who use contact lenses should not use eye drops until 5 minutes after removing the lenses.

The use in children under 6 years of age is not recommended.

The consumption of alcohol is not recommended during treatment with dosage forms for systemic use.

Impact on the ability to drive and operate machinery

During treatment, there may be a decrease in the speed of psychomotor reactions. If visual acuity has deteriorated after the use of eye drops, do not drive or engage in other potentially dangerous activities.

Contraindications

Errotic and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, blood disorders of unclear etiology, hypersensitivity to diclofenac and components of the drug formulation used, or other NSAIDs.

Side effects

Allergic skin reactions (burning, redness); with prolonged use and/or large amounts of use – systemic side effects typical of NSAIDs.

Overdose

Symptoms: Due to low systemic absorption by application of the gel, overdose is unlikely. In case of accidental ingestion systemic adverse reactions are possible.

Treatment: gastric lavage, induction of vomiting, activated carbon, forced diuresis, symptomatic therapy. Dialysis is not effective due to the high degree of binding of diclofenac to proteins (about 99%).

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