ZORVOLEX Capsule (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Zyla Life Sciences US Inc.

Λέξεις κλειδιά

69344-203 69344-204

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1. Indications and Usage

ZORVOLEX is indicated for: Management of mild to moderate acute pain Management of osteoarthritis pain

2. Dosage and Administration

2.1 General Dosing Instructions Carefully consider the potential benefits and risks of ZORVOLEX and other treatment options before deciding to use ZORVOLEX. Use the lowest effective dosage for the shortest ...

3. Dosage Forms and Strengths

ZORVOLEX (diclofenac) capsules: 18 mg blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink). ZORVOLEX (diclofenac) capsules: 35 mg blue body and ...

4. Contraindications

ZORVOLEX is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

See Table 4 for clinically significant drug interactions with diclofenac. Table 4. Clinically Significant Drug Interactions with Diclofenac: Drugs That Interfere with Hemostasis Clinical ...

8.1. Pregnancy

Risk Summary Use of NSAIDs, including ZORVOLEX, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. ...

8.2. Lactation

Risk Summary Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for ZORVOLEX ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including ZORVOLEX, may delay or prevent rupture of ovarian follicles, which has been associated with reversible ...

8.4. Pediatric Use

The safety and effectiveness of ZORVOLEX in pediatric patients has not been established.

8.5. Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly ...

10. Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal ...

11. Description

ZORVOLEX (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] ...

12.1. Mechanism of Action

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of ZORVOLEX, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase ...

12.3. Pharmacokinetics

The relative bioavailability of ZORVOLEX 35 mg capsules was compared to diclofenac potassium immediate-release (IR) tablets 50 mg in 39 healthy subjects under fasted and fed conditions in a single-dose ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (approximately 0.2 times the maximum recommended human dose [MRHD] of ZORVOLEX based on body surface area ...

14. Clinical Studies

Acute Pain The efficacy of ZORVOLEX in the management of acute pain was demonstrated in a single multicenter, randomized, double-blind, placebo-controlled, parallel arm study comparing ZORVOLEX 18 mg and ...

16.1. How Supplied

ZORVOLEX (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 (69344-203-29), Bottles of 90 capsules 35 mg ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information ...