Drug Catalog - Product Detail
DICLOFENAC 35MG CAP 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 73480-0242-90 | TRIVUE PHARMACEUTICAL | 90 | 35MG | CAPSULE |
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Description
11 DESCRIPTION Diclofenac Capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C 14 H 1 1Cl 2 NO 2 , and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in Diclofenac Capsules include a combination of 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, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac Capsules are supplied as: 18 mg – blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink) NDC (73480-240-90), Bottles of 90 capsules 35 mg – blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink) NDC (73480-242-90), Bottles of 90 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. Dispense in a tight container if package is subdivided.
Indications & Usage
1 INDICATIONS AND USAGE Diclofenac Capsules is indicated for: Management of mild to moderate acute pain Management of osteoarthritis pain Diclofenac Capsules is a nonsteroidal anti-inflammatory drug indicated for management of mild to moderate acute pain ( 1 ) management of osteoarthritis pain.( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2 ) The dosage for acute pain is 18 mg or 35 mg orally three times a day. ( 2 ) The dosage for osteoarthritis pain is 35 mg orally three times a day. ( 2 ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of Diclofenac Capsules and other treatment options before deciding to use Diclofenac Capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. The effectiveness of Diclofenac Capsules when taken with food has not been studied in clinical studies. Taking Diclofenac Capsules with food may cause a reduction in effectiveness compared to taking Diclofenac Capsules on an empty stomach [ see Clinical Pharmacology (12) ]. Acute Pain For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily. Osteoarthritis Pain For management of osteoarthritis pain, the dosage is 35 mg orally three times daily. 2.2 Dosage Adjustments in Patients with Hepatic Impairment Patients with hepatic disease may require reduced doses of Diclofenac Capsules compared to patients with normal hepatic function [ see Clinical Pharmacology (12) ]. As with other diclofenac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use. 2.3 Non-Interchangeability with Other Formulations of Diclofenac Diclofenac Capsules are not interchangeable with other formulations of oral diclofenac even if the milligram strength is the same. Diclofenac Capsules contain diclofenac free acid whereas other diclofenac products contain a salt of diclofenac, i.e., diclofenac potassium or sodium. A 35 mg dose of Diclofenac Capsules is approximately equal to 37.6 mg of sodium diclofenac or 39.5 mg of potassium diclofenac. Therefore, do not substitute similar dosing strengths of other diclofenac products without taking this into consideration.