Drug Catalog - Product Detail
LOFENA 60ct
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 15370-0180-60 | CARWIN ASSOCIATES | 60 | 25MG | TABS |
PACKAGE FILES
Generic Name
DICLOFENAC POTASSIUM
Substance Name
DICLOFENAC POTASSIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA076561
Description
DESCRIPTION LOFENA ™ (diclofenac potassium tablets, USP) are a benzeneacetic acid derivative. LOFENA , are available as tablets of 25 mg (white to off-white) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14 H 10 C l2 NKO 2 , and it has the following structural formula: Each 25mg LOFENA intended for oral administration, contains 25 mg diclofenac potassium for oral administration. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, iron oxide red, magnesium stearate, methanol, polyethylene glycol, povidone, sodium bicarbonate, titanium dioxide and yellow iron oxide. Chemical Structure
How Supplied
HOW SUPPLIED LOFENA ™ (diclofenac potassium tablets, USP) 25 mg are available for oral administration as white to off-white, round shaped, unscored, film coated tablets, imprinted "A" on one side and "25" on the other side. They are supplied as follows: NDC 15370-180-60 Bottles of 60 NDC 15370-180-10 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Keep container tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of LOFENA ™ ( diclofenac potassium tablets, USP) and other treatment options before deciding to use LOFENA. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). LOFENA is indicated: For treatment of primary dysmenorrhea For relief of mild to moderate pain For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of LOFENA and other treatment options before deciding to use LOFENA . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). After observing the response to initial therapy with diclofenac potassium tablets, the dose and frequency should be adjusted to suit an individual patient's needs. For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg three times a day. With experience, physicians may find that in some patients an initial dose of 100 mg of LOFENA , followed by 50 mg doses, will provide better relief. For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses, 50 mg twice a day or three times a day. For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses, 50 mg three times a day or four times a day. Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.