Classes
DEA Class; OTC
Common Brand Names; Pamprin Cramp
- Analgesics, Other Combos
Description
Acetaminophen: Acts on hypothalamus to produce antipyresis
Magnesium salicylate: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2
Pamabrom: Weak diuretic action
Indications
Indicated for relief of symptoms associated with menstrual periods including cramps, headaches, backaches, water-weight gain, bloating, muscular aches
Contraindications
Hypersensitivity/allergy to salicylates or other ingredients
Adverse Effects
Angioedema
Laryngeal edema
Pruritic maculopapular rash
Urticaria
Anaphylactoid reaction
Agranulocytosis
Leukopenia
Neutropenia
Pancytopenia
Thrombocytopenia
Thrombocytopenic purpura
Hepatotoxicity
Tinnitus (high or chronic dose)
Dyspepsia
Heartburn
Nausea
Vomiting
Stomach pain
Warnings
Contains aspirin; children and adolescents should not use for symptoms of viral infections (eg, chickenpox, influenza) due to risk for Reye syndrome
Hepatic impairment or consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen) or GI bleeding (associated with magnesium salicylate)
Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose
Avoid with active peptic ulcer disease
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
Pregnancy and Lactation
Pregnancy Category: D; avoid aspiring (NSAIDs) during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus
Lactation: excreted in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
2 caplets PO q4-6hr prn; not to exceed 8 caplets/24 hr
Pediatric
<12 years: Safety and efficacy not established
≥12 years: 2 caplets PO q4-6hr prn; not to exceed 8 caplets/24 hr
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%