Indomethacin DS (Ointment) Instructions for Use

Marketing Authorization Holder

Danson-BG (Bulgaria)

ATC Code

M02AA23 (Indometacin)

Active Substance

Indometacin (Rec.INN registered by WHO)

Dosage Form

Indometacin DS

Ointment for external use 10%: tube 40 g

Dosage Form, Packaging, and Composition

Ointment for external use 10% yellow in color, homogeneous.

Excipients: dimethyl sulfoxide 150 mg, lanolin 175 mg, yellow beeswax 20 mg, petrolatum 524.5 mg, colloidal silicon dioxide (Aerosil 200) 300 mg, lavender oil 0.5 mg.

40 g – aluminum tubes (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 inhibition of the COX enzyme, which leads to 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 indomethacin 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 intact skin only. Use a thin layer, covering the affected joints or painful body areas.

Apply the ointment two to four times daily. Gently rub it into the skin until fully absorbed.

The maximum duration of treatment is 7 to 10 days. Do not exceed this period without consulting a physician.

For application to large skin surface areas, use the minimum effective amount to minimize systemic absorption.

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

Wash hands thoroughly with soap and water after each application, unless the hands are the treated area.

Avoid contact with eyes, mucous membranes, and open wounds. If accidental contact occurs, rinse immediately with plenty of water.

Discontinue use and seek medical advice if local skin reactions worsen or if systemic adverse effects occur.

Adverse Reactions

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

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

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

Contraindications

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

With caution

Concomitant use with other NSAIDs, hepatic porphyria (exacerbation), erosive and 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 coagulation 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, first and second 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 dysfunction (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 drug 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 the blood picture (determination of the number of leukocytes and platelets).

Do not use with occlusive dressings.

Drug Interactions

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

Concomitant use with glucocorticosteroids leads to an increase in the ulcerogenic effect of the latter.

May enhance the effect of drugs that cause photosensitization.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.