Overview
11 DESCRIPTION Fenoprofen calcium capsules, USP 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 “SUVEN” on the cap and “400 mg” on the body. The chemical name is Benzeneaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Fenoprofen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of fenoprofen calcium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Fenoprofen is a potent inhibitor of prostaglandin synthesis in vitro . Fenoprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because fenoprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. 12.
Indications
- 1 INDICATIONS AND USAGE Fenoprofen calcium is indicated for: • Relief of mild to moderate pain in adults • Relief of the signs and symptoms of rheumatoid arthritis • Relief of the signs and symptoms of osteoarthritis Fenoprofen calcium 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 )
Common Doses
- 200 mg
- 600 mg
Dosage
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.
Black Box Warning
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombic Events • Non-Steroidal Anti-Inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions ( 5.1 ) ]. • Fenoprofen calcium is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ) and Warnings and precautions (5.1) ].
Contraindications
- 4 CONTRAINDICATIONS Fenoprofen calcium is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.
Side Effects
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: •Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] •GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] •Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] •Hypertension [ see Warnings and Precautions ( 5.4 ) ] •Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] •Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] •Anaphylactic Reactions [ see Warnings and Precautions ( 5.
Interactions
- 7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with fenoprofen. Table 1: Clinically Significant Drug Interactions with Fenoprofen Drugs That Interfere with Hemostasis Clinical Impact: • Fenoprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of fenoprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis.