Indometacin-Akri^® (Ointment) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

M02AA23 (Indometacin)

Active Substance

Indometacin (Rec.INN registered by WHO)

Dosage Form

Indometacin-Akri®

Ointment for external use 10%: tube 40 g or jar 50 g

Dosage Form, Packaging, and Composition

40 g – aluminum tubes (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID, a derivative of indoleacetic acid. It has anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action is associated with the inhibition of the COX enzyme, which leads to the suppression of prostaglandin synthesis from arachidonic acid.

When applied externally, it helps to alleviate pain, especially joint pain at rest and during movement, reduce morning stiffness and joint swelling, and increase the range of motion.

Pharmacokinetics

It is absorbed through the skin; with repeated application, it accumulates in the underlying tissues, muscles, joints, and synovial fluid.

When applied externally, a clinically insignificant amount of indometacin may enter the systemic circulation, from where it is excreted by the kidneys as metabolites and in small amounts unchanged, and also partially through the gastrointestinal tract.

Indications

Back pain in inflammatory and degenerative diseases of the spine (radiculitis, osteoarthrosis, lumbago, sciatica); joint pain in osteoarthrosis; muscle pain (due to sprains, overexertion, bruises, injuries); inflammation and swelling of soft tissues and joints due to injuries and in rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues, carpal tunnel syndrome).

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use; it does not affect the progression of the disease.

ICD codes

Dosage Regimen

Apply the ointment externally to the affected skin area.

Use a thin layer of ointment on the painful or inflamed joints or body areas.

Apply the ointment 2 to 4 times per day.

Gently rub the ointment into the skin until fully absorbed.

The maximum duration of treatment is 7 to 10 days.

Do not exceed the recommended application frequency or treatment duration.

Avoid applying the ointment to skin with open wounds, abrasions, or infections.

Wash hands thoroughly with soap and water after each application.

Do not use occlusive dressings or bandages over the applied ointment.

Consult a physician if symptoms persist or worsen after the 10-day treatment course.

Adverse Reactions

Local reactions are possible – itching and redness of the skin, burning, rash, peeling, dry skin; rarely – local edema and vesicular rash.

Allergic reactions in some cases – angioedema, shortness of breath.

Systemic reactions when applied to a large skin surface area are possible – gastrointestinal disorders (loss of appetite, nausea, vomiting, diarrhea, abdominal pain, bleeding and ulcerations); in isolated cases – exacerbation of psoriasis.

Contraindications

Hypersensitivity to indometacin, other NSAIDs; complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in history); impaired skin integrity at the intended site of indometacin application; III trimester of pregnancy, period of breastfeeding; children under 6 years of age.

With caution

Simultaneous use with other NSAIDs, hepatic porphyria (exacerbation), erosive-ulcerative diseases of the gastrointestinal tract in the acute phase (including ulcerative colitis, Crohn’s disease), severe liver and kidney dysfunction (creatinine clearance less than 30 ml/min), blood clotting disorders (including hemophilia, prolonged bleeding time, tendency to bleed, hemorrhagic diathesis); chronic heart failure, elderly age, condition after coronary artery bypass surgery, confirmed hyperkalemia, children aged 6 to 12 years, I-II trimesters of pregnancy.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Indometacin is excreted in small amounts in breast milk.

Use in Hepatic Impairment

Use with caution in patients with severe liver dysfunction.

Use in Renal Impairment

Use with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated in children under 6 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

The preparation for external use should be applied only to intact skin areas; avoid contact with eyes and mucous membranes.

With prolonged therapy (more than 10 days), a doctor’s consultation is necessary, as well as monitoring of blood counts (determination of the number of leukocytes and platelets).

Do not use with occlusive dressings.

Drug Interactions

The effect of indometacin is enhanced when combined with glucocorticosteroids and pyrazolone derivatives.

Simultaneous use with glucocorticosteroids leads to an increase in their ulcerogenic effect.

It may enhance the effect of drugs that cause photosensitization.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.