Diclofenac + misoprostol - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

NSAIDs - Derivatives of acetic acid and related compounds

Included in the formulation

АТХ:

M.01.A.B.55 Diclofenac in combination with other drugs

Pharmacodynamics:

Has analgesic, antipyretic, anti-inflammatory action.

Diclofenac inhibits cyclooxygenase and reduces the formation of prostaglandins. Misoprostol (synthetic analogue of prostaglandin E₁) prevents the negative effects of diclofenac on the mucosa and the development of non-steroid gastropathy.

Pharmacokinetics:Misoprostol is rapidly absorbed and metabolized to the active metabolite - misoprostol acid, the latter has a decay period of about 30 minutes. 70% of the administered dose of misoprostol is excreted in the urine as inactive metabolites. Diclofenac sodium is also rapidly and almost completely absorbed, reversibly binds to plasma proteins; from 40 to 60% is excreted in the urine, the rest - with bile and feces.

Indications:Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, pain syndrome of various etiologies, rheumatic diseases.

ICD-10

XIII.M05-M14.M06.9 Rheumatoid arthritis, unspecified

XIII.M15-M19 Osteoarthritis

XIII.M45-M49.M45 Ankylosing spondylitis

XVIII.R50-R69.R52.2 Another constant pain

Contraindications:Hypersensitivity, bleeding (including gastrointestinal).

Carefully:Caution is prescribed for patients with congestive heart failure, impaired renal function, predisposition to fluid retention in the body.

Pregnancy and lactation:The drug is contraindicated for use in pregnancy and lactation.

Dosing and Administration:Inside, without chewing, while eating, 1 tablet 2-3 times a day.

Side effects:Gastrointestinal disorders (abdominal pain, nausea, dyspepsia, flatulence, diarrhea); decreased platelet aggregation, prolonged bleeding time, fluid retention and edema (especially in predisposed patients), menorrhagia and metrorrhagia in pre- and post-menopausal women, headache, dizziness, skin rash.

Overdose:Treatment is symptomatic.

Interaction:

With simultaneous use with diclofenac antihypertensive drugs may weaken their effect.

There are isolated reports of the occurrence of seizures in patients taking both non-steroidal anti-inflammatory drugs and antibacterial drugs of the quinolone series.

When used simultaneously with glucocorticosteroids, the risk of side effects from the digestive system is increased.

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

When used simultaneously with other non-steroidal anti-inflammatory drugs, there may be an increased risk of side effects.

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

With simultaneous use with acetylsalicylic acid, a decrease in the concentration of diclofenac in the blood plasma is possible.

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

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

Absorption of diclofenac from the digestive tract decreases with simultaneous application with colestyramine, to a lesser extent - with colestipol.

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

With simultaneous application 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 the morphine metabolite, including the risk of respiratory depression.

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

Special instructions:

With the history of allergic reactions to non-steroidal anti-inflammatory drugs and sulfites diclofenac apply only in urgent cases. In the process of treatment, systematic monitoring of liver and kidney function, and peripheral blood patterns are necessary.

Rectal use in patients with anorectal disease or anorectal hemorrhage in the anamnesis is not recommended. Outer should be used only on intact skin areas.

Avoid contact with diclofenac in the eyes (with the exception of eye drops) or mucous membranes. Patients using contact lenses should use eye drops not earlier than 5 minutes after removing the lenses.

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.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, the speed of psychomotor reactions may decrease. If vision deteriorates after application of eye drops, do not drive and engage in other potentially hazardous activities.

Instructions

Diclofenac + Misoprostol (Diclophenacum + Misoprostolum)