Indometacin (Tablets, Ointment, Gel, Suppositories) Instructions for Use

Instructions
Dosage forms

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. C_max 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.

T_1/2 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

Open the list of 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 T_1/2 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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Indometacin [Actavis LLC (Russia)]
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.

Indometacin [Atoll LLC (Russia)]
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.

Indometacin [Atoll LLC (Russia)]
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.

Indometacin [Balkanpharma-Troyan, AD (Bulgaria)]
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.

Indometacin [Biosintez, PJSC (Russia)]
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.

Indometacin [Biosintez, PJSC (Russia)]
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.

Indometacin [Biosintez, PJSC (Russia)]
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.

Indometacin [Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)]
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.

Indometacin [Ivanovo Pharmaceutical Factory PJSC (Russia)]
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.

Indometacin [Murom Instrument-Making Plant, JSC (Russia)]
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.

Indometacin [Tula Pharmaceutical Factory, LLC (Russia)]
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.

Indometacin [Tula Pharmaceutical Factory, LLC (Russia)]
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.

Indometacin [Pharmaprim, LLC (Republic of Moldova)]
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.

Indometacin [YUGPHARM, LLC (Russia)]
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.