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ZORVOLEX
Arthritis/rheumatic disorders
Nonnarcotic analgesics
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Drug Name:

ZORVOLEX Rx

Generic Name and Formulations:
Diclofenac 18mg, 35mg; hard gelatin caps.

Company:
Iroko Pharmaceuticals, LLC

Therapeutic Use:

Indications for ZORVOLEX:

Osteoarthritis pain.

Adult:

Use lowest effective dose for shortest duration. Take on empty stomach. ≥18yrs: 35mg three times daily. Hepatic impairment: may require reduced doses.

Children:

<18yrs: not established.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Not interchangeable with other forms of oral diclofenac. Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP2C9 inhibitors (eg, voriconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need dose adjustments. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).

Pharmacological Class:

NSAID (benzeneacetic acid deriv.).

Adverse Reactions:

Edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, ALT/creatinine increase, hypertension, dyspepsia; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

Generic Availability:

NO

How Supplied:

Caps—30, 90

Indications for ZORVOLEX:

Mild-to-moderate acute pain.

Adult:

Use lowest effective dose for shortest duration. Take on empty stomach. ≥18yrs: 18mg or 35mg three times daily. Hepatic impairment: may require reduced doses.

Children:

<18yrs: not established.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Not interchangeable with other forms of oral diclofenac. Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP2C9 inhibitors (eg, voriconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need dose adjustments. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).

Pharmacological Class:

NSAID (benzeneacetic acid deriv.).

Adverse Reactions:

Edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, ALT/creatinine increase, hypertension, dyspepsia; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.

Generic Availability:

NO

How Supplied:

Caps—30, 90

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