Ortophen gel 5%, 30g

Composition

100 g of gel contains:

Active ingredient:

diclofenac sodium — 5.0 g.

auxiliary substances:

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

< h3>Pharmacological action

The active component of diclofenac is a nonsteroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Orthophene is used to eliminate pain and reduce swelling associated with the inflammatory process.  

is well absorbed through the skin into subcutaneous tissues for 5 minutes. Binding to plasma proteins up to 99%. Penetrates into the synovial fluid, where the concentration remains unchanged for 7 hours. Conjugated metabolites are excreted mainly through the kidneys, a smaller part is excreted with feces. The analgesic effect is achieved 30-60 minutes after applying the ointment and persists for 2.5-5 hours, the maximum effect develops after 1-2 hours.

Indications

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathy), post-traumatic inflammation of soft tissues and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain syndrome and inflammation after operations and injuries, pain syndrome with gout, migraine, algodismenorrhea, pain syndrome with adnexitis, proctitis, colic (biliary and renal), pain syndrome with infectious and inflammatory diseases of the ENT organs.

For topical use: inhibition of myosis during cataract surgery, prevention of cystoid macular edema associated with removal and implantation of the lens, inflammatory processes of the eye of a non-infectious nature, post-traumatic inflammatory process in penetrating and non-penetrating wounds of the eyeball.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, hematopoiesis disorders of unclear etiology, hypersensitivity to diclofenac and components of the dosage form used, or other NSAIDs.

Side effects

Allergic skin reactions (burning, redness); with prolonged use and/or use in large quantities;— systemic side effects characteristic of NSAIDs.

Interaction

With the simultaneous use of antihypertensive drugs with diclofenac, their effect may be weakened.

There are isolated reports of seizures in patients taking NSAIDs and quinolone antibacterial drugs at the same time.

When used simultaneously with GCS, the risk of side effects from the digestive system increases.

With the simultaneous use of diuretics, it is possible to reduce the diuretic effect. With simultaneous use with potassium-sparing diuretics, an increase in the concentration of potassium in the blood is possible.

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

There are reports of the development of hypoglycemia or hyperglycemia in patients with diabetes mellitus, who used diclofenac simultaneously with hypoglycemic drugs.

With simultaneous use with acetylsalicylic acid, it is possible to reduce the concentration of diclofenac in blood plasma.

Although clinical studies have not established the effect of diclofenac on the effect of anticoagulants, isolated cases of bleeding have been described with the simultaneous use of diclofenac and warfarin.

With simultaneous use, it is possible to increase the concentration of digoxin, lithium and phenytoin in blood plasma.

The absorption of diclofenac from the gastrointestinal tract decreases with simultaneous use with colestyramine, to a lesser extent with colestipol.

With simultaneous use, it is possible to increase the concentration of methotrexate in blood plasma and increase its toxicity.

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

With simultaneous use with pentazocine, a case of the development of a large convulsive seizure is described; with rifampicin, a decrease in the concentration of diclofenac in blood plasma is possible; with ceftriaxone, the excretion of ceftriaxone with bile increases; with cyclosporine, an increase in the nephrotoxicity of cyclosporine is possible.

How to take, course of use and dosage

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

Overdose

Symptoms: Due to the low systemic absorption during gel application, overdose is unlikely. With accidental ingestion, the development of systemic adverse reactions is possible.

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

Special instructions

With extreme caution, it is used for diseases of the liver, kidneys, gastrointestinal tract in anamnesis, dyspeptic phenomena, bronchial asthma, arterial hypertension, heart failure, immediately after serious surgical interventions, as well as in elderly patients.

With a history of allergic reactions to NSAIDs and sulfites, diclofenac is used only in urgent cases. In the course of treatment, systematic monitoring of liver and kidney function, peripheral blood patterns is necessary.

Rectal use is not recommended in patients with anorectal diseases or a history of anorectal bleeding. Externally, it should be used only on undamaged areas of the skin.

It is necessary to avoid getting diclofenac in the eyes (with the exception of eye drops) or on the mucous membranes. Patients using contact lenses should apply eye drops no earlier than 5 minutes after lens removal.

It is not recommended for use in children under the age of 6 years.

During the period of treatment with dosage forms for systemic use, alcohol consumption is not recommended.

Influence on the ability to drive vehicles and manage mechanisms

During the treatment period, the rate of psychomotor reactions may decrease. If visual clarity deteriorates after applying eye drops, you should not drive a car and engage in other potentially dangerous activities.

Form of production

Gel for external use.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children.

Shelf life

2 years.

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Pregnant women I and II trimester as prescribed by a doctor, For adults, Children over 12 years

Indications

Rheumatoid arthritis, Sciatica, Tendon inflammation, Myositis, Periarthritis, Bursitis, Osteoarthritis, Sciatica, Arthritis, Lumbago, Swelling after injuries and operations, Dislocations and sprains, Arthrosis