OXAPROZIN

OXAPROZIN- oxaprozin tablet, film coated
California Pharmaceuticals LLC

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
2.2 Osteoarthritis
2.3 Rheumatoid Arthritis
2.4 Juvenile Rheumatoid Arthritis
2.5 Individualization of Dosage

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events
5.2 Gastrointestinal Bleeding, Ulceration, and Perforation
5.3 Hepatotoxicity
5.4 Hypertension
5.5 Heart Failure and Edema
5.6 Renal Toxicity and Hyperkalemia
5.7 Anaphylactic Reactions
5.8 Exacerbation of Asthma Related to Aspirin Sensitivity
5.9 Serious Skin Reactions
5.10 Premature Closure of Fetal Ductus Arteriosus
5.11 Hematologic Toxicity
5.12 Masking of Inflammation and Fever
5.13 Laboratory Monitoring
5.14 Photosensitivity

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

14 CLINICAL STUDIES
14.1 Osteoarthritis
14.2 Rheumatoid Arthritis

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

Oxaprozin tablets is a non-steroidal anti-inflammatory drug indicated for:

• Relief of signs and symptoms of Osteoarthritis (OA) (1)
• Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1)
• Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)

2 DOSAGE AND ADMINISTRATION

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1)
• OA: 1200 mg (two 600 mg tablets) given orally once a day (2.2, 2.5, 14.1)
• RA: 1200 mg (two 600 mg tablets) given orally once a day (2.3, 2.5, 14.2)
• JRA: 600 mg once daily in patients 22 to 31 kg. 900 mg once daily in patients 32 to 54 kg. 1200 mg once daily in patients ≥ 55 kg (2.4, 2.5)

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

2.2 Osteoarthritis

For OA, the dosage is 1200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)].

2.3 Rheumatoid Arthritis

For RA, the dosage is 1200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)].

2.4 Juvenile Rheumatoid Arthritis

For JRA, in patients 6 to 16 years of age, the recommended dosage given orally once per day should be based on body weight of the patient as given in Table 1 [see Dosage and Administration (2.5)].

Table 1. Recommended Daily Dose of Oxaprozin by Body Weight in Pediatric Patients

Body Weight Range (kg) Dose (mg)
22 to 31 600
32 to 54 900
≥55 1200

2.5 Individualization of Dosage

After observing the response to initial therapy with oxaprozin tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin tablets to minimize adverse effects. The maximum recommended total daily dose of oxaprozin tablets in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.

Patients with low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring [see Clinical Pharmacology (12.3)].

In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allows therapy to be started with a one-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with oxaprozin tablets, although divided doses may be tried in patients unable to tolerate single doses.