Classes
DEA Class; OTC
Common Brand Names; Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength, Premsyn PMS
- Analgesics, Other Combos
Description
Acetaminophen: Inhibitis prostaglandin sythesis in CNS and may block peripheral pain impulse generation; acts on hypothalamus to antipyresis
Pamabrom: Weak diuretic action
Pyrilamine: Antihistamine used for sedative properties
Indications
Indicated for Analgesia/Menstrual Cramps
Contraindications
Hypersensitivity
Hepatitis or severe hepatic/renal impairment
Administration within 14 days of MAO inhibitors
Adverse Effects
Acetaminophen
Angioedema, laryngeal edema
Pruritic maculopapular rash, urticaria
Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
Hepatotoxicity
Anaphylactoid reaction
May increase uric acid, chloride, glucose
May decrease sodium, calcium, bicarbonate
Pyrilamine
Sedation
Xerostomia
Blurred vision
Pamabrom
Discolored urine (golden tinted)
Warnings
Risk of hepatotoxicity; higher in alcoholics, or with use of more than one acetaminophen-containing product
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
Caution in G6PD deficiency
May cause CNS depression and impair ability to operate heavy machinery
Use caution in cardiovascular disease, diabetes mellitus, increased intraocular pressure or glaucoma, thyroid dysfunction, and prostatic hyperplasia
Patients should drink 6-8 glasses of water daily while taking the medication
Pregnancy and Lactation
Pregnancy category: C
Lactation: Excreted in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
1-2 capsule/tablet/gelcap PO q4-6hr PRN
Pediatric
Safety and efficacy not established
How supplied
acetaminophen/pamabrom/pyrilamine
capsule
- 500mg/25mg/15mg
gelcap
- 500mg/25mg/15mg
tablet
- 500mg/25mg/15mg
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%