Drug Catalog - Product Detail
INDOMETHACIN 20MG CAPS 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 73308-0350-30 | AYURAX | 30 | 20MG | CAPSULE |
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Description
11 DESCRIPTION Indomethacin Capsules is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Indomethacin Capsules are supplied as: 20 mg, dark blue body and light blue cap (imprinted IP-201 on the body and 20 mg on the cap in white ink); NDC 73308-350-30, Bottles of 30 capsules 40 mg, dark blue body and blue cap (imprinted IP-202 on the body and 40 mg on the cap in white ink); NDC 73308-349-30, Bottles of 30 capsules Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture and light. Dispense in a tight container if package is subdivided.
Indications & Usage
1 INDICATIONS AND USAGE Indomethacin Capsules is indicated for treatment of mild to moderate acute pain in adults. Indomethacin Capsules is a nonsteroidal anti-inflammatory drug indicated for treatment of mild to moderate acute pain in adults ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) The dosage is 20 mg orally three times daily or 40 mg orally two or three times daily. ( 2.1 ) Indomethacin Capsules capsules are not interchangeable with other formulations of oral indomethacin ( 2.2 ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of Indomethacin Capsules and other treatment options before deciding to use Indomethacin Capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. For treatment of mild to moderate acute pain, the dosage is 20 mg three times daily or 40 mg two or three times daily. 2.2 Non-Interchangeability with Other Formulations of Indomethacin Different dose strengths and formulations of oral indomethacin are not interchangeable. This difference should be taken into consideration when changing strengths or formulations.