Indomethacin Sofarma - Instructions For Use, Tablets, Ointment, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Indomethacin Sopharma

Indomethacin sofarma: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Drug interactions
10. 10. Analogs
11. 11. Terms and conditions of storage
12. 12. Terms of dispensing from pharmacies
13. 13. Reviews
14. 14. Price in pharmacies

Latin name: Indometacin sopharma

ATX code: M02AA23

Active ingredient: indomethacin (indometacin)

Manufacturer: Sopharma (Bulgaria)

Description and photo updated: 20.11.2018

Prices in pharmacies: from 31 rubles.

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Indomethacin Sopharma is a non-steroidal anti-inflammatory drug (NSAID).

Release form and composition

Dosage forms of Indomethacin Sopharma:

• enteric-coated tablets: round, biconvex, light brown on the outside and light yellow at the break [30 tablets in a blister, 1 or 45 blisters in a cardboard box (for hospitals)];
• rectal suppositories: torpedo-shaped, with a smooth surface, from white to yellowish, odorless, smooth and uniform on the cut (6 suppositories in a blister strip, 1 package in a cardboard box);
• ointment for external use: homogeneous, yellow, has a specific smell (40 g in a tube, 1 tube in a cardboard box).

Composition of 1 enteric-coated tablet:

• active substance: indomethacin - 25 mg;
• auxiliary components: lactose monohydrate, wheat starch, microcrystalline cellulose, povidone, anhydrous colloidal silicon dioxide, talc, magnesium stearate;
• shell: solution of methacrylic acid and methyl methacrylate copolymer (1: 1) - eudragit L-12.5 (dry), solution of methacrylic acid and methyl methacrylate copolymer (1: 2) - eudragit S-12.5 (dry), dibutyl phthalate, diethyl phthalate, macrogol-400, macrogol-6000, castor bean seed oil, talc, titanium dioxide, dyes.

Composition of 1 suppository:

• active substance: indomethacin - 50/100 mg;
• auxiliary components: hard fat Estaram 8770 N ₁₅ (witepsol N ₁₅), hard fat Estaram 8780 W ₃₅ (witepsol W ₃₅).

Composition of 100 mg ointment:

• active substance: indomethacin - 10 mg;
• auxiliary components: petroleum jelly, lanolin, dimethyl sulfoxide, yellow beeswax, colloidal silicon dioxide, lavender oil.

Pharmacological properties

Pharmacodynamics

Indomethacin is a derivative of indoleacetic acid, has anti-inflammatory, antipyretic, analgesic and antiaggregatory effects. Able to suppress the activity of pro-inflammatory factors, reduce platelet aggregation.

Indomethacin, inhibiting cyclooxygenase I and II, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins in the focus of inflammation and healthy tissues, and suppresses the exudative and proliferative phases of inflammation. Effective for rheumatic and non-rheumatic pains.

Pharmacokinetics

When taken orally, absorption occurs mainly through the mucous membrane of the small intestine and, to a lesser extent, through the mucous membrane of the stomach. The bioavailability of indomethacin when taken orally and rectally is 80–90%. The time to reach the maximum plasma concentration is 1–2 hours. The connection with plasma proteins is 90–98% when taken orally and 90% when administered rectally. The substance is distributed in all organs and tissues of the body. Penetrates the blood-brain and placental barriers. Through the synovial membrane it enters the joints, while the concentration of indomethacin in the synovial fluid increases. The half-life of the substance when using the tablet form of the drug is 2.6–11.2 hours, suppositories - 4.5 hours. The metabolism of indomethacin occurs mainly in the liver. It is excreted by the kidneys (70%) and intestines (30%). Found in breast milk.

Ointment Indomethacin Sopharma is absorbed through the skin, accumulating in the underlying tissues, joints, synovial fluid. Excretion also occurs mainly through the kidneys and partially through the intestines.

Indications for use

According to the instructions, Indomethacin Sopharma is indicated for symptomatic therapy in order to reduce inflammation and pain in the following conditions:

• pain in inflammatory diseases of the musculoskeletal system [arthritis (rheumatoid, juvenile chronic, ankylosing, gouty, psoriatic), spondyloarthritis (ankylosing spondylitis), Reiter's disease];
• diseases of the periarticular tissues (bursitis, tendinitis, tendovaginitis, tendobursitis);
• injuries in athletes;
• neuritis, discopathy, plexitis, radiculoneuritis;
• dysmenorrhea.

Additionally for the ointment: osteoarthritis, ligament injuries, bruises, post-traumatic lesions of the musculoskeletal system.

Contraindications

Rectal tablets and suppositories

Absolute contraindications:

• ulcerative lesions of the stomach and duodenum;
• inflammatory bowel disease (Crohn's disease, ulcerative colitis);
• bleeding from the organs of the gastrointestinal tract (GIT), as well as intracranial bleeding;
• congenital heart disease (severe tetrad of Fallot, severe coarctation of the aorta, pulmonary atresia);
• condition after recently undergone coronary artery bypass grafting;
• severe heart failure;
• renal failure with creatinine clearance (CC) ˂ 30 ml / min;
• active liver disease, liver failure;
• bleeding disorders (hemophilia, prolonged bleeding time, bleeding tendency;
• anemia, leukopenia;
• hyperkalemia (confirmed);
• age up to 14 years (for tablets), up to 15 years (for suppositories);
• pregnancy and lactation;
• hypersensitivity to any of the components of the drug, acetylsalicylic acid or other NSAIDs.

Relative contraindications:

• ischemic heart disease, chronic heart failure;
• cerebrovascular diseases;
• hyperlipidemia, dyslipidemia;
• diabetes;
• thrombocytopenia;
• peripheral arterial disease;
• arterial hypertension;
• smoking;
• kidney disease with CC ˂ 60 ml / min;
• hyperbilirubinemia;
• cirrhosis of the liver with portal hypertension;
• history of gastrointestinal ulcers;
• presence of Helicobacter pylori infection;
• long-term use of NSAIDs;
• severe somatic diseases;
• mental disorders;
• depression;
• epilepsy;
• parkinsonism;
• elderly age;
• alcohol abuse.

Ointment for external use

Absolute contraindications:

• damage to the skin at the site of application of the drug;
• pregnancy and lactation;
• age up to 14 years;
• hypersensitivity to any of the components of the drug, as well as rhinitis, urticaria, bronchial asthma and angioedema, which developed against the background of the use of NSAIDs.

Relative contraindications:

• allergic reactions;
• dysfunction of the kidneys and liver (in the case of using the ointment on large areas of the skin);
• erosive and ulcerative diseases of the gastrointestinal tract;
• blood clotting disorders;
• exacerbation of hepatic porphyria;
• a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs;
• elderly age.

Instructions for the use of Indomethacin Sopharma: method and dosage

Pills

Indomethacin Sopharma tablets are taken orally after meals with plenty of water.

The recommended starting dose of the drug is 25 mg 2–3 times a day. If necessary, it is increased to 50 mg 3 times a day. The maximum daily dose is 200 mg. With long-term use of the drug, its dose should not exceed 75 mg per day.

For the relief of an acute attack of gout, a single dose of 100 mg of the drug is recommended, then the treatment is continued, taking 50 mg 3 times a day until the pain disappears.

Indomethacin Sopharma should be taken in the minimum effective dose for the minimum possible course.

Rectal suppositories

Suppositories are used rectally (injected into the rectum), 50 mg 2 times a day, or 100 mg 1 time a day. The maximum daily dose is 200 mg. The duration of the drug should not exceed 7 days.

To reduce undesirable effects, it is recommended to use Indomethacin Sopharma in the lowest effective dose, as long as possible.

Ointment for external use

Ointment Indomethacin Sopharma is used externally. Adults apply the drug in a thin layer (a strip of ointment 4–5 cm), rubbing with light movements into the skin, 3-4 times a day; children over 14 years old - with a thin layer (strip of ointment 2–2.5 cm) 2-3 times a day.

The interval between applications should be at least 6 hours. Duration of use is 7-10 days.

The total daily amount of ointment squeezed out of the tube should not exceed 15 cm for adults and 7.5 cm for children.

Side effects

Rectal tablets and suppositories

• digestive system: abdominal pain, NSAID gastropathy, nausea, vomiting, diarrhea, anorexia, heartburn, bleeding, liver dysfunction, toxic hepatitis, fulminant hepatitis; with prolonged use of large doses of the drug - ulcerative stomatitis, ulceration of the gastrointestinal mucosa;
• central nervous system: dizziness, headache, agitation, drowsiness, fatigue, peripheral neuropathy, sensory disturbances, including paresthesia, disorientation, insomnia, depression, irritability, anxiety, memory disorder, psychotic reactions;
• cardiovascular system: development or worsening of chronic heart failure, tachyarrhythmia, edema syndrome, increased blood pressure;
• sense organs: tinnitus, hearing loss, taste disturbance, diplopia, blurred vision, corneal opacity, conjunctivitis;
• urinary system: edema, proteinuria, hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis;
• hematopoietic and hemostatic system: bleeding, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura;
• allergic reactions: skin rash, itching, urticaria, angioedema, bronchospasm, photosensitivity, Lyell's syndrome, Stevens-Johnson syndrome, erythema nodosum, anaphylactic shock;
• laboratory parameters: leukopenia, agranulocytosis, thrombocytopenia, glucosuria, hyperglycemia, hyperkalemia;
• local reactions (when using rectal suppositories): itching, burning, heaviness in the anorectal region, exacerbation of hemorrhoids;
• other: increased sweating, aseptic meningitis (more common in patients with autoimmune diseases), aplastic anemia, autoimmune hemolytic anemia.

Ointment for external use

Itching, burning, rash, peeling, dryness and flushing of the skin, irritation, contact dermatitis, exacerbation of psoriasis, local edema, vesicular rash, shortness of breath, angioedema are possible.

When applied to large areas of the skin, systemic side effects may develop.

Overdose

Symptoms of an overdose of Indomethacin Sopharma: nausea, vomiting, dizziness, severe headache, disorientation, memory impairment. In case of severe overdose - paresthesia, numbness of the extremities, convulsions.

Symptomatic therapy is recommended. Hemodialysis is ineffective.

In case of unintentional ingestion of the drug in the form of an ointment, burning sensation, salivation, nausea, vomiting are possible. Lavage of the oral cavity and stomach and symptomatic treatment are indicated.

special instructions

Rectal tablets and suppositories

During the period of drug therapy, the picture of peripheral blood and the functional state of the liver and kidneys should be monitored.

If it is necessary to determine 17-ketosteroids, Indomethacin Sopharma should be canceled 48 hours before the study in order to avoid distortion of its results.

If signs of hypersensitivity appear, the drug should be discontinued.

Due to the fact that indomethacin can mask the symptoms of acute inflammation, it is recommended to exclude bacterial infection before starting therapy. The risk of developing hyperkalemia is higher with renal failure, age over 65 years, concomitant use of β-blockers, ACE inhibitors, potassium-sparing diuretics. In such patients, it is recommended to keep the serum potassium level under control.

Women of reproductive age are at risk of reversible suppression of fertility when taking Indomethacin Sopharma.

Ointment for external use

Do not apply Indomethacin Sopharma ointment to damaged or infected skin.

It is recommended to avoid getting the ointment in the eyes, mouth, mucous membranes and open wounds. In case of accidental contact, it is advisable to rinse the affected area abundantly with water or 0.9% sodium chloride solution until the complaints decrease or disappear (redness, burning, tearing, pain).

Interrupt drug treatment if a rash occurs. When used for more than 10 days, it is recommended to control the content of leukocytes and platelets.

Influence on the ability to drive vehicles and complex mechanisms

At the time of using rectal suppositories and Indomethacin Sopharma tablets, you should refrain from driving vehicles and other complex mechanisms that require the speed of psychomotor reactions.

Drug interactions

• other NSAIDs, acetylsalicylic acid, glucocorticosteroids, alcohol, colchicine, corticotropin: the risk of bleeding from the gastrointestinal tract increases;
• diuretics: their effectiveness decreases;
• potassium-sparing diuretics: increased risk of hyperkalemia;
• uricosuric and antihypertensive drugs: their effectiveness decreases;
• indirect anticoagulants, antiplatelet agents, thrombolytics (alteplase, streptokinase, urokinase): their effect is enhanced;
• glucocorticosteroids, NSAIDs, estrogens, acetylsalicylic acid: side effects of these drugs increase;
• sulfonylurea derivatives: their hypoglycemic effect is enhanced;
• paracetamol, cyclosporine, gold preparations: the risk of nephrotoxic effects increases;
• methotrexate, lithium preparations, digoxin: their toxicity increases due to an increase in plasma concentration;
• cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: the risk of hypoprothrombinemia and bleeding increases;
• zidovudine: its toxic effect increases;
• antacids, cholestyramine: reduce the absorption of indomethacin;
• myelotoxic drugs: increase the manifestation of indomethacin hematotoxicity;
• quinolones: the risk of seizures increases;
• insulin, oral hypoglycemic drugs: their hypoglycemic effect is enhanced.

No interactions were observed with local application of the drug.

Analogs

Indomethacin Sopharma analogs are Indocollir, Metindol retard.

Terms and conditions of storage

Store in a dry place, away from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life - 5 years (for tablets), 3 years (for suppositories and ointments).

After the first opening of the tube, the shelf life of the ointment is 30 days.

Terms of dispensing from pharmacies

Tablets and suppositories are available with a prescription, ointment is available without a prescription.

Reviews of Indomethacin Sopharma

Reviews of Indomethacin Sopharma are contradictory. With regard to tablets and suppositories, patients mainly note the relief of pain and inflammation. Some patients, on the contrary, claim that the drug did not help them. The advantages of the drug include the small size of the tablets, the low cost. Among the disadvantages are side effects.

Reviews of the ointment are positive, it effectively relieves inflammation and relieves pain. The downside is its oily and sticky consistency, as well as a specific smell.

Price for Indomethacin Sopharma in pharmacies

Indicative prices for Indomethacin Sopharma:

• tablets (30 pcs in the package) - 52 rubles;
• rectal suppositories (pack of 6) - 84 rubles;
• ointment (tube 40 g) - 72 rubles.

Indomethacin sofarma: prices in online pharmacies

Drug name Price Pharmacy

Indomethacin Sopharma 25 mg enteric-coated tablets 30 pcs. RUB 31 Buy

Indomethacin sofarma tab. p.o ksh / solution 25mg n30 52 RUB Buy

Indomethacin Sopharma (suppositories) 50 mg rectal suppositories 6 pcs. RUB 64 Buy

Indomethacin Sopharma (ointment) 10% ointment for external use 40 g 1 pc. RUB 69 Buy

Reviews Indomethacin Sopharma (ointment) RUB 69 Buy

Indomethacin Sopharma (suppositories) 100 mg rectal suppositories 6 pcs. 79 RUB Buy

Indomethacin Sopharma rectal suppositories. 100mg 6 pcs. RUB 88 Buy

Indomethacin Sopharma ointment 10% 40g 93 rbl. Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!