Indomethacin - instructions for use, dose, side effects, contraindications

Excipients: dimethyl sulfoxide 150 mg, lanolin 175 mg, wax bee yellow 20 mg, petrolatum 524.5 mg, silicon dioxide colloid (Aerosil 200) 30 mg, lavender oil 0.5 mg.

Description:

Homogeneous yellow ointment.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

C.01.E.B.03 Indomethacin

S.01.B.C.01 Indomethacin

M.02.A.A.23 Indomethacin

Pharmacodynamics:

Has anti-inflammatory and analgesic effect due to non-selective inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) regulating the synthesis of prostaglandins. It contributes to the weakening of the pain syndrome, especially joint pain at rest and during movement, reduction of morning stiffness and swelling of the joints, increase in the volume of movements.

Pharmacokinetics:

Indomethacin penetrates through the skin, with repeated use accumulates in the underlying tissues, muscles, joints, synovial fluid. When administered externally, clinically insignificant amounts of indomethacin can enter the systemic circulation, from which it is excreted by the kidneys in the form of metabolites and in a small amount - unchanged, and also partially through the gastrointestinal tract.

Indications:

- Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout);

- traumatic inflammation of soft tissues and musculoskeletal system;

- neuralgia;

- myalgia.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

Hypersensitivity to indomethacin, other NSAIDs, or other components of the drug (including dimexide), a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis) , violations of the integrity of the skin in the place of the intended application, pregnancy III trimester, children's age (under 14 years).

Carefully:

Simultaneous use with other non-steroidal anti-inflammatory drugs, hepatic porphyria (exacerbation), erosive and ulcerative diseases of the gastrointestinal tract in the exacerbation phase (including peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease),severe violations of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, blood clotting disorders (including hemophilia, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis); severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after aortocoronary shunting, confirmed hyperkalemia, pregnancy I-II trimester, the period of breastfeeding.

Dosing and Administration:

Outwardly.

Ointment rub with light movements, a thin layer in the skin of the painful areas of the body for 2-3 cm of ointment (1-1.5 g) 2-3 times a day.

The total amount of ointment for adults per day should not exceed 15 cm, squeezed out from the tube, for children over 14 years - 7.5 cm. The duration of treatment should not exceed 10 days.

Side effects:

Local Reactions: eczema, photosensitivity, contact dermatitis, pruritus and skin flushing, rashes at the site of application, dry skin, burning.

Systemic reactions: generalized skin rash, allergic reactions (urticaria,angioedema, bronchospasmic reactions), anaphylactic reactions. In isolated cases - exacerbation of psoriasis.

Overdose:

Symptoms overdose are possible only if the ointment is accidentally swallowed, while burning in the oral cavity, salivation, nausea, vomiting can occur.

It is necessary to wash the mouth and stomach; if necessary, prescribe symptomatic treatment. Hemodialysis is ineffective.

Interaction:

The effect of indomethacin is enhanced when it is combined with glucocorticosteroids and pyrazolone derivatives. Simultaneous use of the drug with glucocorticosteroids leads to an increase in the ulcerogenic effect of the latter.

May enhance the effect of drugs that cause photosensitivity.

Special instructions:

With a duration of treatment more than 10 days, it is necessary to check the blood picture (the number of leukocytes and platelets).

Ointment should be applied only to undamaged skin areas, avoid contact with eyes or mucous membranes.

If you get into eyes, mucous membranes or open wounds, there is local irritation - lacrimation, redness, burning, pain.In this case, the corresponding body area is washed with distilled water or saline.

Do not use in the form of occlusive dressings.

Do not administer to children under 14 years of age due to a lack of sufficient clinical experience.

Effect on the ability to drive transp. cf. and fur:

With external use of indomethacin, there is no evidence of an effect on the ability to drive or work with machinery.

Form release / dosage:

Ointment for external use, 10%.

Packaging:

For 40 grams in aluminum tubes, with an internal lacquer coating, a lithographed outer surface, a membrane and a sealing ring, with a polyethylene screw cap.

Each tube, together with instructions for use, is placed in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002705

Date of registration:13.11.2014

Expiration Date:13.11.2019

The owner of the registration certificate:VetProm ADVetProm AD Bulgaria

Manufacturer: & nbsp

VETPROM, AD Bulgaria

Representation: & nbspVETPROM ADVETPROM ADBulgaria

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Indomethacin (Indometacin)