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acetaminophen/magnesium salicylate/pamabrom (Pamprin Cramp)

 

Classes: Analgesics, Other Combos

Dosing and uses of Pamprin Cramp (acetaminophen/magnesium salicylate/pamabrom)

 

Adult dosage forms and strengths

acetaminophen/magnesium salicylate/pamabrom

caplet

  • 250mg/250mg/25mg

 

Menstrual Symptoms

Indicated for relief of symptoms associated with menstrual periods including cramps, headaches, backaches, water-weight gain, bloating, muscular aches

2 caplets PO q4-6hr prn; not to exceed 8 caplets/24 hr

 

Pediatric dosage forms and strengths

acetaminophen/magnesium salicylate/pamabrom

caplet

  • 250mg/250mg/25mg

 

Menstrual Symptoms

Indicated for relief of symptoms associated with menstrual periods including cramps, headaches, backaches, water-weight gain, bloating, muscular aches

<12 years: Safety and efficacy not established

≥12 years: 2 caplets PO q4-6hr prn; not to exceed 8 caplets/24 hr

 

Pamprin Cramp (acetaminophen/magnesium salicylate/pamabrom) adverse (side) effects

Frequency not defined

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

Contraindications

Hypersensitivity/allergy to salicylates or other ingredients

 

Cautions

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

 

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 Pamprin Cramp (acetaminophen/magnesium salicylate/pamabrom)

Mechanism of action

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