Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for: Diclofenac Potassium

Osteoarthritis. Rheumatoid arthritis.

Adult Dosage:

Use lowest effective dose for shortest duration. Osteoarthritis: 50mg 2–3 times daily. Rheumatoid arthritis: 50mg 3–4 times daily.

Children Dosage:

Not established.

Diclofenac Potassium Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Diclofenac Potassium 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 (≥30 weeks gestation; avoid). Nursing mothers.

Diclofenac Potassium Classification:

NSAID (benzeneacetic acid deriv.).

Diclofenac Potassium 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).

Adverse Reactions:

GI disturbances, anemia, dizziness, edema, headaches, pruritus, rash (may be serious), tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions.

Note:

Formerly known under the brand name Cataflam.

Metabolism:

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-diclofenac. The formation of 4’-hydroxy-diclofenac is primarily mediated by CYP2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3’-hydroxy-diclofenac.

Drug Elimination:

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. The terminal half-life of unchanged diclofenac is approximately 2 hours.

How Supplied:

Contact supplier.

Dysmenorrhea:

Indications for: Diclofenac Potassium

Dysmenorrhea.

Adult Dosage:

Use lowest effective dose for shortest duration. 50mg 3 times daily; may give 100mg initially.

Children Dosage:

Not established.

Diclofenac Potassium Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Diclofenac Potassium 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 (≥30 weeks gestation; avoid). Nursing mothers.

Diclofenac Potassium Classification:

NSAID (benzeneacetic acid deriv.).

Diclofenac Potassium 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).

Adverse Reactions:

GI disturbances, anemia, dizziness, edema, headaches, pruritus, rash (may be serious), tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions.

Note:

Formerly known under the brand name Cataflam.

Metabolism:

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-diclofenac. The formation of 4’-hydroxy-diclofenac is primarily mediated by CYP2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3’-hydroxy-diclofenac.

Drug Elimination:

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. The terminal half-life of unchanged diclofenac is approximately 2 hours.

How Supplied:

Contact supplier.

Nonnarcotic analgesics:

Indications for: Diclofenac Potassium

Mild to moderate pain.

Adult Dosage:

Use lowest effective dose for shortest duration. 50mg 3 times daily; may give 100mg initially.

Children Dosage:

Not established.

Diclofenac Potassium Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Diclofenac Potassium 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 (≥30 weeks gestation; avoid). Nursing mothers.

Diclofenac Potassium Classification:

NSAID (benzeneacetic acid deriv.).

Diclofenac Potassium 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).

Adverse Reactions:

GI disturbances, anemia, dizziness, edema, headaches, pruritus, rash (may be serious), tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions.

Note:

Formerly known under the brand name Cataflam.

Metabolism:

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-diclofenac. The formation of 4’-hydroxy-diclofenac is primarily mediated by CYP2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3’-hydroxy-diclofenac.

Drug Elimination:

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. The terminal half-life of unchanged diclofenac is approximately 2 hours.

How Supplied:

Contact supplier.