Dosing and uses of Vitelle Lurline PMS (acetaminophen/pamabrom/pyridoxine)
Adult dosage forms and strengths
acetaminophen/pamabrom/pyridoxine
capsule
- 500mg/25mg/50mg
Analgesia/Menstrual Cramps
1 capsule PO q4-6hr PRn
Pediatric dosage forms and strengths
Safety and efficacy not established
Vitelle Lurline PMS (acetaminophen/pamabrom/pyridoxine) adverse (side) effects
Frequency not defined
Angioedema
Laryngeal edema
Pruritic maculopapular rash
Urticaria
Agranulocytosis
Leukopenia
Neutropenia
Pancytopenia
Thrombocytopenia
Thrombocytopenic purpura
Hepatotoxicity
Anaphylactoid reaction
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
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
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.
Pharmacology of Vitelle Lurline PMS (acetaminophen/pamabrom/pyridoxine)
Mechanism of action
Acetaminophen: Acts on hypothalamus to produce antipyresis
Pamabrom: Weak diuretic action
Pyridoxine: Vitamin B6 supplement
