Ortophen gel 5%, 50g

Composition

Active ingredient:

diclofenac

Pharmacological action

Orthophen is a nonsteroidal anti-inflammatory drug (NSAID) derived from phenylacetic acid. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of arachidonic acid metabolism, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is caused by two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous systems).

Inhibits the synthesis of proteoglycan in cartilage.

In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the volume of movement. Reduces post-traumatic and post-operative pain, as well as inflammatory edema.

Inhibits platelet aggregation. With prolonged use, it has a desensitizing effect.

When applied topically in ophthalmology, it reduces swelling and pain in inflammatory processes of non-infectious etiology.

Pharmacokinetics

After oral use, it is absorbed from the gastrointestinal tract. Food intake slows down the rate of absorption, but the degree of absorption does not change. With rectal use, absorption is slower. It doesn’t accumulate. Penetrates the synovial fluid. It is largely metabolized with the formation of several metabolites, among which two are pharmacologically active, but to a lesser extent than diclofenac. Approximately 60% of the dose is excreted as metabolites by the kidneys, less than 1% is excreted unchanged in the urine, and the remainder is excreted as metabolites in the bile.

Indications

• Inflammatory and degenerative diseases of the joints;
• rheumatism of soft tissues;
• traumatic bruises, sprains of ligaments, muscles and tendons;
• inflammatory swelling of soft tissues, soreness of muscles and joints caused by heavy physical exertion.

Use during pregnancy and lactation

Contraindicated (especially in the third trimester of pregnancy).

During the treatment period, nursing mothers should stop breastfeeding.

Contraindications

Hypersensitivity, including to other NSAIDs; peptic ulcer of the stomach and duodenum in the acute phase; allergic asthma, rhinitis, urticaria, children under 6 years of age.

Side effects

Epigastric pain, belching, nausea, vomiting, diarrhea, dizziness, headache, allergic skin reactions, increased blood pressure.

Interaction

When antihypertensive drugs are used simultaneously with Orthophen, their effect may be weakened.

There have been isolated reports of seizures in patients taking concomitant NSAIDs and quinolone-type antibacterial drugs.

When used concomitantly with glucocorticosteroids (corticosteroids), the risk of side effects from the digestive system increases.

Concomitant use of diuretics may reduce the diuretic effect. When used concomitantly with potassium-sparing diuretics, it is possible to increase the concentration of potassium in the blood.

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

Hypoglycaemia or hyperglycaemia have been reported in diabetic patients treated with Orthophen concomitantly with hypoglycaemic drugs.

When used concomitantly 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 action of anticoagulants, isolated cases of bleeding with simultaneous use of diclofenac and warfarin have been described.

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

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.

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

When used concomitantly with pentazocin, a case of a large convulsive seizure has been described; with rifampicin, the concentration of diclofenac in blood plasma may decrease; with ceftriaxone, the excretion of ceftriaxone with bile increases; with cyclosporine, the nephrotoxicity of cyclosporine may increase.

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.

Form of production

ointment

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Children over 12 years of age, For adults, Pregnant women in the first and second trimester as prescribed by a doctor

Indications

Sciatica, Myositis, Periarthritis, Osteoarthritis, Lumbago, Arthritis, Tendon Inflammation, Osteoarthritis, Rheumatoid Arthritis, Sciatica, Bursitis, Swelling after injuries and operations