Classes
DEA Class; Rx
Common Brand Names; Ansaid, Flurprofen, Froben, Froben SR
NSAIDs
Description
Propionic acid NSAID; longer half-life allows for twice daily dosing; oral formulation used for RA, OA, dysmenorrhea; ophthalmic form used for inhibition of intraoperative miosis. Oral administration causes an increased risk of serious gastrointestinal adverse effects and may cause an increased risk of serious cardiovascular events; use lowest effective dose for the shortest possible duration.
Indications
For the treatment of mild pain and moderate pain.
For the treatment of osteoarthritis or rheumatoid arthritis.
For intraoperative miosis inhibition.
For the treatment of ankylosing spondylitis
For the acute treatment of migraine
Contraindications
Absolute: hypersensitivity to flurbiprofen, ASA allergy, history of aspirin triad, CABG
Relative: Bleeding disorders, duodenal/gastric/peptic ulcer, stomatitis, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)
Adverse Effects
Edema
Fluid retention
UTI
Abdominal pain with cramps
Diarrhea
Headache
Hypersecretory conditions
Nausea
Amnesia
Bloody stools/vomit
Blurred vision
Depression
Diplopia
Gastritis
Gastrointestinal hemorrhage
Mental/mood changes
Rhinitis
Skin rash
Tinnitus
Anorexia
Anxiety
Constipation
Dizziness
Drowsiness
Flatulence
Flushing
Insomnia
Irritability
Nervousness
Tachycardia
Warnings
Use caution in asthma (bronchial), cardiac disease, CHF, hepatic/renal impairment, HTN, SLE
Potential risk of adverse cardiovascular events
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs
Heart Failure (HF) risk
Pregnancy and Lactation
Pregnancy Category: C; avoid in late pregnancy
Lactation: excreted in breast milk; not recommended
Maximum Dosage
300 mg/day PO; not to exceed 100 mg/dose PO.
300 mg/day PO; not to exceed 100 mg/dose PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tablet
- 50mg
- 100mg
Classes
DEA Class; Rx
Common Brand Names; Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, Zorvolex
Diclofenac topical (Rx, OTC)
NSAIDs
Description
NSAID available in intravenous, oral, topical, and ophthalmic formulations
Analgesic and antipyretic properties
Increases risk of serious GI events and may increase risk of serious CV events; use lowest dose for shortest time
Indications
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Dysmenorrhea
Acute Pain
Indicated for treatment of mild to moderate acute pain in adults
Acute Migraine
Indicated for acute treatment of migraine attacks with or without aura, Not for prophylaxis. Use lowest effective dose for shortest duration consistent with individual patient treatment goals
Contraindications
Hypersensitivity (eg, anaphylaxis, serious skin reactions) to diclofenac or any components of the product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
In the setting of coronary artery bypass graft (CABG) surgery
Zipsor capsules are contraindicated in patients with history of hypersensitivity to bovine protein
Adverse Effects
>10%
Zorvolex
Edema (33%)
Nausea (27%)
Headache (13%)
Zipsor
Nausea (16.5%)
Headache (12.5%)
1-10%
Cambia
Nausea (3%)
Dizziness (1%)
Diclofenac potassium tablets
Abdominal pain
Constipation
Diarrhea
Dyspepsia
Flatulence
Gross bleeding/perforation
Heartburn
Nausea
GI ulcers (gastric/duodenal)
Vomiting
Abnormal renal function
Anemia
Dizziness
Ophthalmic Solution (Voltaren Ophthalmic)
Mild ocular stinging, irritation
May slow corneal wound healing
Lacrimation
Increased IOP
Keratitis
Dizziness
Insomnia
Pain
Fever
Chills
Warnings
Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus
Platelet aggregation and adhesion may be decreased; may prolong bleeding time
Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
Increase risk of hyperkalemia may occur, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely
Pregnancy and Lactation
Pregnancy; There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
Lactation; The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
Maximum Dosage
Adults
Rheumatoid Arthritis
Diclofenac potassium: 50 mg PO q8-12hr
Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr
Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr
Osteoarthritis
Diclofenac potassium: 50 mg PO q8-12hr
Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr
Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr
Zorvolex: 35 mg PO TID
Ankylosing Spondylitis
Diclofenac sodium: 25 mg PO 4 or 5 times daily
Diclofenac potassium: 50 mg PO q12hr
Dysmenorrhea
Immediate-release: 100 mg PO once, then 50 mg PO q8hr PRN
Acute Pain
Indicated for treatment of mild to moderate acute pain in adults
Immediate-release tablets: 100 mg PO once, then 50 mg PO q8hr PRN
Extended-release tablets
Zipsor: 25 mg PO QID PRN
Zorvolex: 18 mg or 35 mg PO TID
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goal
Acute Migraine
Indicated for acute treatment of migraine attacks with or without aura
Cambia: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately
Not for prophylaxis
Use lowest effective dose for shortest duration consistent with individual patient treatment goals
Pediatric
Acute Pain
Zipsor only
Indicated for relief of mild-to-moderate pain in adult and pediatric patients aged ≥12 years
<12 years: Safety and efficacy not established
≥12 years: 25 mg PO QID PRN
How supplied
Diclofenac potassium
Packet
50mg/single-dose packet (generic, Cambia)
Delivers 50-mg dose when mixed in water
Tablet
50mg (generic)
capsule
25mg (Zipsor)
Diclofenac sodium
Tablet, delayed release
25mg (generic)
50mg (generic)
75mg (generic)
Tablet, extended-release
100mg (generic)
capsule
18mg (Zorvolex)
35mg (Zorvolex)
Ophthalmic solution
- 0.1%
Classes
DEA Class; Rx
Common Brand Names; Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, Zorvolex
Diclofenac topical (Rx, OTC)
NSAIDs
Description
NSAID available in intravenous, oral, topical, and ophthalmic formulations
Analgesic and antipyretic properties
Increases risk of serious GI events and may increase risk of serious CV events; use lowest dose for shortest time
Indications
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Dysmenorrhea
Acute Pain
Indicated for treatment of mild to moderate acute pain in adults
Acute Migraine
Indicated for acute treatment of migraine attacks with or without aura, Not for prophylaxis. Use lowest effective dose for shortest duration consistent with individual patient treatment goals
Contraindications
Hypersensitivity (eg, anaphylaxis, serious skin reactions) to diclofenac or any components of the product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
In the setting of coronary artery bypass graft (CABG) surgery
Zipsor capsules are contraindicated in patients with history of hypersensitivity to bovine protein
Adverse Effects
>10%
Zorvolex
Edema (33%)
Nausea (27%)
Headache (13%)
Zipsor
Nausea (16.5%)
Headache (12.5%)
1-10%
Cambia
Nausea (3%)
Dizziness (1%)
Diclofenac potassium tablets
Abdominal pain
Constipation
Diarrhea
Dyspepsia
Flatulence
Gross bleeding/perforation
Heartburn
Nausea
GI ulcers (gastric/duodenal)
Vomiting
Abnormal renal function
Anemia
Dizziness
Ophthalmic Solution (Voltaren Ophthalmic)
Mild ocular stinging, irritation
May slow corneal wound healing
Lacrimation
Increased IOP
Keratitis
Dizziness
Insomnia
Pain
Fever
Chills
Warnings
Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus
Platelet aggregation and adhesion may be decreased; may prolong bleeding time
Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
Increase risk of hyperkalemia may occur, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely
Pregnancy and Lactation
Pregnancy; There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
Lactation; The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
Maximum Dosage
Adults
Rheumatoid Arthritis
Diclofenac potassium: 50 mg PO q8-12hr
Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr
Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr
Osteoarthritis
Diclofenac potassium: 50 mg PO q8-12hr
Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr
Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr
Zorvolex: 35 mg PO TID
Ankylosing Spondylitis
Diclofenac sodium: 25 mg PO 4 or 5 times daily
Diclofenac potassium: 50 mg PO q12hr
Dysmenorrhea
Immediate-release: 100 mg PO once, then 50 mg PO q8hr PRN
Acute Pain
Indicated for treatment of mild to moderate acute pain in adults
Immediate-release tablets: 100 mg PO once, then 50 mg PO q8hr PRN
Extended-release tablets
Zipsor: 25 mg PO QID PRN
Zorvolex: 18 mg or 35 mg PO TID
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goal
Acute Migraine
Indicated for acute treatment of migraine attacks with or without aura
Cambia: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately
Not for prophylaxis
Use lowest effective dose for shortest duration consistent with individual patient treatment goals
Pediatric
Acute Pain
Zipsor only
Indicated for relief of mild-to-moderate pain in adult and pediatric patients aged ≥12 years
<12 years: Safety and efficacy not established
≥12 years: 25 mg PO QID PRN
How supplied
Diclofenac potassium
Packet
50mg/single-dose packet (generic, Cambia)
Delivers 50-mg dose when mixed in water
Tablet
50mg (generic)
capsule
25mg (Zipsor)
Diclofenac sodium
Tablet, delayed release
25mg (generic)
50mg (generic)
75mg (generic)
Tablet, extended-release
100mg (generic)
capsule
18mg (Zorvolex)
35mg (Zorvolex)
Ophthalmic solution
- 0.1%