Indometacin (Tablets, Ointment, Gel, Suppositories) Instructions for Use
ATC Code
M01AB01 (Indometacin)
Active Substance
Indometacin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
NSAID
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.
It suppresses platelet aggregation.
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
After oral administration, Indometacin is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is reached within 2 hours. It is metabolized in the liver. It undergoes enterohepatic recirculation. Indometacin is detected in blood plasma as an unchanged substance and unconjugated metabolites – desmethyl, desbenzoyl, desmethyl-desbenzoyl.
T1/2 is about 4.5 hours. It is excreted in the urine – 60% as unchanged substance and metabolites, and in the feces – 33%, mainly as metabolites.
Indications
Joint syndrome (including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), spinal pain, neuralgia, myalgia, traumatic inflammation of soft tissues and joints, rheumatism, diffuse connective tissue diseases, dysmenorrhea. As an auxiliary agent in infectious and inflammatory diseases of the ENT organs, adnexitis, prostatitis, cystitis.
It is intended for symptomatic therapy, to reduce pain and inflammation at the time of use; it does not affect the progression of the disease.
ICD codes
| ICD-10 code | Indication |
| H66 | Suppurative and unspecified otitis media |
| I00 | Rheumatic fever without mention of heart involvement |
| I01 | Rheumatic fever with heart involvement |
| I09 | Other rheumatic heart diseases |
| J01 | Acute sinusitis |
| J02 | Acute pharyngitis |
| J03 | Acute tonsillitis |
| J31.2 | Chronic pharyngitis |
| J32 | Chronic sinusitis |
| J35.0 | Chronic tonsillitis |
| M05 | Seropositive rheumatoid arthritis |
| M10 | Gout |
| M15 | Polyosteoarthritis |
| M19.9 | Unspecified arthrosis |
| M25.5 | Pain in joint |
| M32 | Systemic lupus erythematosus |
| M33 | Dermatopolymyositis |
| M34 | Systemic sclerosis |
| M42 | Spinal osteochondrosis |
| M45 | Ankylosing spondylitis |
| M47 | Spondylosis |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M54.9 | Dorsalgia, unspecified |
| M70 | Soft tissue disorders related to use, overuse, and pressure |
| M71 | Other bursopathies |
| M79 | Other soft tissue disorders, not elsewhere classified |
| M79.0 | Unspecified rheumatism |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| N30 | Cystitis |
| N41 | Inflammatory diseases of prostate |
| N70 | Salpingitis and oophoritis |
| N94.4 | Primary dysmenorrhea |
| N94.5 | Secondary dysmenorrhea |
| R07.0 | Pain in throat |
| R52.0 | Acute pain |
| R52.2 | Other chronic pain |
| T14.3 | Dislocation, sprain and strain of joint and ligament of unspecified body region |
| ICD-11 code | Indication |
| 1B40.0 | Rheumatic arthritis, acute or subacute |
| 1B40.Z | Acute rheumatic fever without mention of heart involvement, unspecified |
| 1B41.Z | Acute rheumatic heart disease, unspecified |
| 4A40.0Z | Systemic lupus erythematosus, unspecified |
| 4A41.Z | Idiopathic inflammatory myopathy, unspecified |
| 4A42.0 | Systemic scleroderma in children |
| 4A42.Z | Systemic sclerosis, unspecified |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| AA9Z | Unspecified suppurative otitis media |
| BC20.Z | Chronic rheumatic heart disease, unspecified |
| CA01 | Acute rhinosinusitis |
| CA02.Z | Acute pharyngitis, unspecified |
| CA03.Z | Acute tonsillitis, unspecified |
| CA09.2 | Chronic pharyngitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0F.Y | Other specified chronic diseases of the palatine tonsils and adenoids |
| FA05 | Polyosteoarthritis |
| FA0Z | Osteoarthritis, unspecified |
| FA20.0 | Seropositive rheumatoid arthritis |
| FA25 | Gout |
| FA27.2 | Palindromic rheumatism |
| FA85.Z | Defects of vertebral end-plates, unspecified |
| FA8Z | Degenerative disease of spine, unspecified |
| FA92.0Z | Ankylosing spondylitis, unspecified |
| FB50.1 | Bursitis associated with use, overuse or pressure |
| FB50.Z | Bursitis, unspecified |
| FB51.3 | Fibroblastic rheumatism |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.2 | Myalgia |
| GA07.Z | Salpingitis and oophoritis, unspecified |
| GA34.3 | Dysmenorrhea |
| GA91.Z | Inflammatory and other diseases of prostate, unspecified |
| GC00.Z | Cystitis, unspecified |
| MD36.0 | Pain in throat |
| ME82 | Pain in joint |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
| ME84.Z | Back pain, unspecified |
| MG30.Z | Chronic pain syndrome, unspecified |
| MG31.Z | Acute pain, unspecified |
| ND56.3 | Dislocation, sprain or strain of unspecified body region |
| 1B40.Y | Other specified acute rheumatic fever without mention of heart involvement |
| CA40.08 | Pneumonia due to Beta-haemolytic streptococcus |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
The dose is set individually, taking into account the severity of the disease and the dosage form used. For adults, when taken orally, the initial dose is 25 mg 2-3 times/day. If the clinical effect is insufficient, the dose is increased to 50 mg 3 times/day. Extended-release dosage forms are used 1-2 times/day. The maximum daily dose when combining any dosage forms of indomethacin is 200 mg.
Once the effect is achieved, treatment is continued for 4 weeks at the same or a reduced dose. For long-term use, the daily dose should not exceed 75 mg.
Ointment
For external use. Apply a thin layer to the affected joints or body areas 2-4 times/day.
The duration of therapy should not exceed 7 – 10 days.
Occlusive dressings are not recommended.
Gel
The gel is rubbed in a thin layer into the skin of painful body areas: 5% – 3-4 times/day; 10% – 2-3 times/day. A single dose for adults is 4-5 cm of gel squeezed from the tube, and for children over 14 years old – 2-2.5 cm. The daily dose should not exceed 20 cm of 5% gel or 15 cm of 10% gel for adults and 10 cm of 5% gel or 7.5 cm of 10% gel for children.
Suppositories
Rectally. Prescribed 50-100 mg 1 time/day. The maximum daily dose is 200 mg. The duration of treatment is no more than 7 days.
Adverse Reactions
From the digestive system nausea, anorexia, vomiting, abdominal pain and discomfort, constipation or diarrhea, erosive and ulcerative lesions, bleeding and perforations of the gastrointestinal tract; rarely – intestinal strictures, stomatitis, gastritis, flatulence, bleeding from the sigmoid colon or from a diverticulum, jaundice, hepatitis.
From the nervous system dizziness, headache, depression, feeling of fatigue; rarely – anxiety, fainting, drowsiness, convulsions, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disorders, mental disorders (depersonalization, psychotic episodes), paresthesia, dysarthria, parkinsonism.
From the cardiovascular system edema, increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, arterial hypotension, congestive heart failure, hematuria.
Allergic reactions rarely – itching, urticaria, angiitis, erythema nodosum, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, hair loss, acute respiratory distress, sharp drop in blood pressure, anaphylactic reactions, angioedema, dyspnea, bronchial asthma, pulmonary edema.
From the hematopoietic system rarely – leukopenia, petechiae or ecchymoses, purpura, aplastic and hemolytic anemia, thrombocytopenia, DIC syndrome.
From the sensory organs rarely – impaired visual acuity, diplopia, orbital and periorbital pain, tinnitus, hearing impairment, deafness.
From the urinary system rarely – proteinuria, nephrotic syndrome, interstitial nephritis, renal function impairment, renal failure.
From the metabolic system rarely – hyperglycemia, glucosuria, hyperkalemia.
Other rarely – vaginal bleeding, hot flashes, increased sweating, nosebleed, enlargement and tension of the mammary glands, gynecomastia.
Contraindications
Hypersensitivity to indomethacin, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, hematopoiesis disorders, blood clotting disorders, severe liver and/or kidney dysfunction, confirmed hyperkalemia, severe forms of chronic heart failure, congenital heart defects, period after coronary artery bypass surgery, severe arterial hypertension, pancreatitis, pregnancy, breastfeeding; children under 14 years of age.
With caution
Coronary artery disease, cerebrovascular diseases, congestive heart failure, dyslipidemia, hyperlipidemia, diabetes mellitus, thrombocytopenia, peripheral arterial diseases, arterial hypertension, smoking, creatinine clearance 30-60 ml/min, liver cirrhosis with portal hypertension, hyperbilirubinemia, history of ulcerative gastrointestinal tract lesions, presence of Helicobacter pylori infection, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases. Concomitant therapy with the following drugs: anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (including prednisolone), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); mental disorders, epilepsy, parkinsonism, depression, elderly age.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and breastfeeding.
Indometacin is excreted in small amounts in breast milk.
Use in Hepatic Impairment
Contraindicated in severe liver dysfunction. Use with caution in liver diseases.
Use in Renal Impairment
Contraindicated in severe kidney dysfunction. Use with caution in kidney diseases.
Pediatric Use
Contraindicated for use in children and adolescents under 14 years of age.
Geriatric Use
Use with caution in elderly patients.
Special Precautions
Use with caution in elderly patients, as well as in patients with a history of liver, kidney, gastrointestinal tract diseases, with dyspeptic symptoms at the time of use, arterial hypertension, heart failure, immediately after major surgical interventions, with parkinsonism, epilepsy.
In case of a history of allergic reactions to NSAIDs, use only in emergency cases.
During treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary.
Effect on ability to drive vehicles and machinery
During treatment, one should refrain from potentially hazardous activities that require concentration and increased speed of psychomotor reactions.
Drug Interactions
Concomitant use of indomethacin with other drugs from the NSAID group, acetylsalicylic acid, glucocorticosteroids, alcohol, colchicine, and corticotropin increases the risk of gastrointestinal bleeding.
Indometacin reduces the effectiveness of diuretics; against the background of potassium-sparing diuretics, the risk of hyperkalemia increases; reduces the effectiveness of uricosuric and antihypertensive drugs; enhances the effect of indirect anticoagulants, antiplatelet agents, thrombolytics (alteplase, streptokinase and urokinase); enhances the side effects of glucocorticosteroids, NSAIDs, estrogens, acetylsalicylic acid; enhances the hypoglycemic effect of sulfonylurea derivatives.
Concomitant use with paracetamol increases the risk of nephrotoxic effects.
Cyclosporine and gold preparations increase nephrotoxicity (apparently due to suppression of prostaglandin synthesis in the kidneys).
Increases the plasma concentration of methotrexate, which can lead to increased toxicity.
With simultaneous use of indomethacin with digoxin, an increase in the plasma concentration of digoxin and an increase in the T1/2 of digoxin are possible.
Indometacin at a dose of 50 mg 3 times/day increases the plasma concentration of lithium and reduces the clearance of lithium from the body in patients with mental illnesses. When using indomethacin concomitantly with lithium preparations, the possibility of symptoms of lithium toxicity should be considered.
Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the risk of hypoprothrombinemia and the danger of bleeding.
Potentiates the toxic effect of zidovudine.
Antacids and cholestyramine reduce the absorption of indomethacin.
Myelotoxic drugs enhance the manifestation of hematotoxicity of indomethacin.
Concomitant use with quinolones may increase the threat of seizures in patients with or without a history of epilepsy or seizures.
Enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs.
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
Rx Only
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Enteric-coated tablets, 25 mg: 30 pcs.
Marketing Authorization Holder
Actavis LLC (Russia)
Manufactured By
Balkanpharma-Dupnitsa, AD (Bulgaria)
Dosage Form
 |
Indometacin | Enteric-coated tablets, 25 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Enteric-coated tablets light brown in color, round, biconvex.
| 1 tab. | |
| Indometacin | 25 mg |
Excipients : lactose, wheat starch, gelatin, talc, magnesium stearate, microcrystalline cellulose, eudragit (L-12.5% and S-12.5%), titanium dioxide, macrogol 6000, macrogol 400, sicovit lacquer (10E172, 30E172) diethyl phthalate, acetone, isopropanol, purified water.
30 pcs. – blisters (1) – cardboard packs.
Tablets, enteric-coated, 25 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Indometacin | Tablets, enteric-coated, 25 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs. |
Dosage Form, Packaging, and Composition
Enteric-coated tablets white or almost white, round, biconvex; on the break of the tablet, two layers are visible – a core of white or white with a yellowish tint and a film coating.
| 1 tab. | |
| Indometacin | 25 mg |
Excipients : lactose monohydrate 41.6 mg, potato starch 10 mg, microcrystalline cellulose 16 mg, povidone 2.5 mg, magnesium stearate 0.9 mg.
Film coating composition: cellacephate 2.2 mg, polysorbate-80 0.72 mg, titanium dioxide 1.08 mg.
10 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (8) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (10) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (8) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
Ointment for external use 10%: tube 40 g
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Indometacin | Ointment for external use 10%: tube 40 g |
Dosage Form, Packaging, and Composition
Ointment for external use from light yellow to dark yellow with a greenish tint, with a characteristic odor.
| 100 g | |
| Indometacin | 10 g |
Excipients: macrogol 400 – 44.9 g, macrogol 1500 – 35 g, dimethyl sulfoxide – 10 g, butylated hydroxytoluene – 0.1 g.
40 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5%: tube 40 g
Gel for external use 10%: tube 40 g
Marketing Authorization Holder
Balkanpharma-Troyan, AD (Bulgaria)
Dosage Forms
|
Indometacin | Gel for external use 5%: tube 40 g |
| Gel for external use 10%: tube 40 g |
Dosage Form, Packaging, and Composition
Gel for external use 10% homogeneous, yellow in color, with a faint alcohol odor.
| 1 g | |
| Indometacin | 100 mg |
Excipients: macrogol 400, carbomer, propylene glycol, sodium benzoate, ethanol 96%.
40 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5% homogeneous, yellow in color, with a faint alcohol odor.
| 1 g | |
| Indometacin | 50 mg |
Excipients: macrogol 400, carbomer, propylene glycol, sodium benzoate, ethanol 96%.
40 g – aluminum tubes (1) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Indometacin | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories white with a yellowish or creamy tint, torpedo-shaped, with a faint specific odor.
| 1 supp. | |
| Indometacin | 50 mg |
5 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories 100 mg: 10 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Indometacin | Rectal suppositories 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories white with a yellowish or creamy tint, torpedo-shaped, with a faint specific odor.
| 1 supp. | |
| Indometacin | 100 mg |
5 pcs. – contour cell packs (2) – cardboard packs.
Ointment for external use 10%: tube 30 g
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Indometacin | Ointment for external use 10%: tube 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use homogeneous, from light yellow to dark yellow in color, with a faint specific odor.
| 100 g | |
| Indometacin | 10 g |
30 g – aluminum tubes (1) – cardboard packs.
30 g – polymer tubes (1) – cardboard packs.
Ointment for external use 10%: tube 40 g
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Indometacin | Ointment for external use 10%: tube 40 g |
Dosage Form, Packaging, and Composition
| Ointment for external use 10% | 1 g |
| Indometacin | 100 mg |
40 g – aluminum tubes (1) – cardboard packs.
Ointment for external use 10%: jars or tubes 15 g, 30 g, 40 g, or 50 g
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Indometacin | Ointment for external use 10%: jars or tubes 15 g, 30 g, 40 g, or 50 g |
Dosage Form, Packaging, and Composition
Ointment for external use yellow homogeneous with a specific odor.
| 100 g | |
| Indometacin | 10 g |
Excipients: anhydrous lanolin, petrolatum, dimethyl sulfoxide, yellow beeswax, colloidal silicon dioxide, lavender oil.
15 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
15 g – polyethylene jars (1) – cardboard packs.
30 g – polyethylene jars (1) – cardboard packs.
40 g – polyethylene jars (1) – cardboard packs.
50 g – polyethylene jars (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
Ointment for external use 10%: 15 g or 30 g tubes
Marketing Authorization Holder
Murom Instrument-Making Plant, JSC (Russia)
Dosage Form
|
Indometacin | Ointment for external use 10%: 15 g or 30 g tubes |
Dosage Form, Packaging, and Composition
Ointment for external use from light yellow to dark yellow with a greenish tint, with the odor of dimethyl sulfoxide.
| 100 g | |
| Indometacin | 10 g |
Excipients: dimethyl sulfoxide 10 g, macrogol 1500 25 g, macrogol 400 45 g, glycerol 10 g.
15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
Rectal suppositories 50 mg: from 1 to 100 pcs.
Rectal suppositories 100 mg: from 1 to 100 pcs.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Forms
|
Indometacin | Rectal suppositories 50 mg: from 1 to 100 pcs. |
| Rectal suppositories 100 mg: from 1 to 100 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories from white to light yellow in color, torpedo-shaped, with a smooth surface, odorless; the cut surface must be smooth and uniform.
| 1 supp. | |
| Indometacin | 50 mg |
Excipients: hard fat (Witepsol H15) – 1.3 g, hard fat (Witepsol W35) – 0.65 g.
From 1 to 10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
Rectal suppositories from white to light yellow in color, torpedo-shaped, with a smooth surface, odorless; the cut surface must be smooth and uniform.
| 1 supp. | |
| Indometacin | 100 mg |
Excipients: hard fat (Witepsol H15) – 1.3 g, hard fat (Witepsol W35) – 0.6 g.
From 1 to 10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
Ointment for external use 10%: tubes from 10 g to 200 g
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Indometacin | Ointment for external use 10%: tubes from 10 g to 200 g |
Dosage Form, Packaging, and Composition
Ointment for external use yellow in color, homogeneous, with a specific odor.
| 100 g | |
| Indometacin | 10 g |
Excipients: lanolin – 17.5 g, petrolatum (white soft paraffin) – 52.45 g, dimethyl sulfoxide – 15 g, yellow beeswax – 2 g, colloidal silicon dioxide – 3 g, lavender oil – 0.05 g.
10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
45 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
55 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
65 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
75 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
85 g – aluminum tubes (1) – cardboard packs.
90 g – aluminum tubes (1) – cardboard packs.
95 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
110 g – aluminum tubes (1) – cardboard packs.
120 g – aluminum tubes (1) – cardboard packs.
130 g – aluminum tubes (1) – cardboard packs.
140 g – aluminum tubes (1) – cardboard packs.
150 g – aluminum tubes (1) – cardboard packs.
160 g – aluminum tubes (1) – cardboard packs.
170 g – aluminum tubes (1) – cardboard packs.
180 g – aluminum tubes (1) – cardboard packs.
190 g – aluminum tubes (1) – cardboard packs.
200 g – aluminum tubes (1) – cardboard packs.
Rectal suppositories 50 mg: 6 pcs.
Marketing Authorization Holder
Pharmaprim, LLC (Republic of Moldova)
Dosage Form
|
Indometacin | Rectal suppositories 50 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Indometacin | 50 mg |
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
Rectal suppositories 50 mg: 5, 6, 10, 12, 15, 30, or 50 pcs.
Rectal suppositories 100 mg: 5, 6, 10, 12, 15, 30, or 50 pcs.
Marketing Authorization Holder
YUGPHARM, LLC (Russia)
Dosage Forms
|
Indometacin | Rectal suppositories 50 mg: 5, 6, 10, 12, 15, 30, or 50 pcs. |
| Rectal suppositories 100 mg: 5, 6, 10, 12, 15, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
Rectal suppositories from white to light yellow in color, torpedo-shaped, with a smooth surface, odorless; the presence of an air core and a funnel-shaped depression on the cut is allowed; the cut surface must be smooth and uniform.
| 1 supp. | |
| Indometacin | 50 mg |
Excipients: hard fat (Estaram W35-PA-(MV)/Witepsol W35/Suposire NAS 50) – 0.65 g, hard fat (Estaram H15-PA-(MV)/Suposire NA 15) – 1.3 g.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories from white to light yellow in color, torpedo-shaped, with a smooth surface, odorless; the presence of an air core and a funnel-shaped depression on the cut is allowed; the cut surface must be smooth and uniform.
| 1 supp. | |
| Indometacin | 100 mg |
Excipients: hard fat (Estaram W35-PA-(MV)/Witepsol W35/Suposire NAS 50) – 0.6 g, hard fat (Estaram H15-PA-(MV)/Suposire NA 15) – 1.3 g.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories 50 mg: 6 pcs.
Marketing Authorization Holder
Sopharma, JSC (Bulgaria)
Dosage Form
|
Indometacin Sopharma | Rectal suppositories 50 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Indometacin | 50 mg |
6 pcs. – PVC containers (1) – cardboard packs.
Rectal suppositories 100 mg: 6 pcs.
Marketing Authorization Holder
Sopharma, JSC (Bulgaria)
Dosage Form
|
Indometacin Sopharma | Rectal suppositories 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Indometacin | 100 mg |
6 pcs. – PVC containers (1) – cardboard packs.
Rectal suppositories 50 mg: 10 pcs.
Marketing Authorization Holder
Altpharm LLC (Russia)
Dosage Form
|
Indometacin-Altfarm | Rectal suppositories 50 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Indometacin | 50 mg |
5 pcs. – contour cell packs (2) – cardboard packs.
Rectal suppositories 100 mg: 10 pcs.
Marketing Authorization Holder
Altpharm LLC (Russia)
Dosage Form
|
Indometacin-Altpharm | Rectal suppositories 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Rectal suppositories | 1 supp. |
| Indometacin | 100 mg |
5 pcs. – contour cell packs (2) – cardboard packs.
![Indometacin [Tablets, Ointment, Gel, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Indometacin [Tablets, Ointment, Gel, Suppositories] 2")