Drug Catalog - Product Detail
FENOPROFEN CALCIUM CP 400MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42195-0100-90 | XSPIRE PHARMA | 90 | 400MG | CAPSULE |
PACKAGE FILES
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11. DESCRIPTION Fenoprofen Calcium Capsules is a nonsteroidal, anti-inflammatory drug available in 400 mg capsule form for oral administration. The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg" on the cap and “EP 123” on the body. The chemical name is Benzenaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C 30 H 26 CaO 6 •2H 2 O, and it has the following chemical structure. Fenoprofen Calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in fenoprofen capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and red iron oxide, and the 400 mg capsules contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, and titanium dioxide. Chemical Structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Fenoprofen calcium is available in capsule form for oral administration, and is supplied as following: The 400 mg capsule has an opaque green cap and an opaque blue body, imprinted with "NALFON 400 mg" on the cap and "EP 123" on the body. NDC 42195-100-60 Bottles of 60. NDC 42195-100-90 Bottles of 90. 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]. Preserve in well-closed containers.
Indications & Usage
1. INDICATIONS AND USAGE Fenoprofen is indicated for: Relief of mild to moderate pain in adults. Relief of the signs and symptoms of rheumatoid arthrites. Relief of the signs and symptoms of osteoarthritis. Fenoprofen is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid arthritis. ( 1 ) Relief of the signs and symptoms of osteoarthritis. ( 1 )
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) Analgesia: For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed ( 2.1 ) Rheumatoid Arthritis and Osteoarthritis: For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of fenoprofen and other treatment options before deciding to use fenoprofen. Use lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. Fenoprofen may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished. Patients with rheumatoid arthritis generally seem to require larger doses of fenoprofen than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed. Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy. 2.2 Analgesia For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed. 2.3 Rheumatoid Arthritis and Osteoarthritis For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.