acetaminophen/pamabrom/pyridoxine (OTC)

Brand and Other Names:Vitelle Lurline PMS
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/pamabrom/pyridoxine

capsule

  • 500mg/25mg/50mg
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Analgesia/Menstrual Cramps

1 capsule PO q4-6hr PRN

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Angioedema

Laryngeal edema

Pruritic maculopapular rash

Urticaria

Agranulocytosis

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Hepatotoxicity

Anaphylactoid reaction

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Warnings

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Repeated administration in patients with anemia, cardia, pulmonary, or renal disease

Cautions

Risk of hepatotoxicity; higher in alcoholics, or with use of more than 1 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

G6PD deficiency

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Pregnancy & Lactation

Pregnancy category: C

Lactation: excreted in breast milk

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

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Acetaminophen: Acts on hypothalamus to produce antipyresis

Pamabrom: Weak diuretic action

Pyridoxine: Vitamin B6 supplement

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Images

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