Paracetamol/Pamabrom/Pyrilamine

Paracetamol/Pamabrom/Pyrilamine

DEA Class;  OTC

Common Brand Names; Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength, Premsyn PMS

  • Analgesics, Other Combos

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

Indicated for Analgesia/Menstrual Cramps

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Administration within 14 days of MAO inhibitors

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)

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 category: C

Lactation: Excreted in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Adults

1-2 capsule/tablet/gelcap PO q4-6hr PRN

Pediatric

Safety and efficacy not established

acetaminophen/pamabrom/pyrilamine

capsule

  • 500mg/25mg/15mg

gelcap

  • 500mg/25mg/15mg

tablet

  • 500mg/25mg/15mg

DEA Class; Rx


Common Brand Names; Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, Zorvolex

Diclofenac topical (Rx, OTC)

Brand and Other Names: Flector Transdermal Patch, Voltaren Gel, Pennsaid topical solution, Solaraze Gel, Licart, Voltaren Arthritis Pain

NSAIDs

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

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

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

>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

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; 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

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

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%
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