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ZIPSOR
Nonnarcotic analgesics
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Drug Name:

ZIPSOR Rx

Generic Name and Formulations:
Diclofenac potassium 25mg; liq-filled caps; contains gelatin.

Company:
Depomed, Inc.

Therapeutic Use:

Indications for ZIPSOR:

Mild-to-moderate acute pain.

Adult:

≥18yrs: Use lowest effective dose for shortest duration. 25mg 4 times daily. Hepatic impairment: may require reduced doses.

Children:

<18yrs: not established.

Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Bovine protein sensitivity.

Warnings/Precautions:

Not interchangeable with other forms of 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: not recommended.

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. 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:

GI upset, abdominal pain, constipation, dyspepsia, dizziness, headache, somnolence, pruritus, increased sweating; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, anemia.

How Supplied:

Caps—120

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