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Product Name
:
PARABROM
Chemical Name
:
Paracetamol+Pamabrom
Therapeutic Category
:
Analgesic & Anesthetic
Pharmacologic Category
:
Analgesic, Miscellaneous -Diuretic, Combination
Pharmaceutical Form
:
Tablets
Composition
:
Paracetamol 500mg+Pamabrom 25mg
Contraindications
Pregnancy
Lactation
Monitoring Parameters
Mechanism of Action
Pharmacodynamics / Kinetics
Dosing
 
Dosing: Adult
Menstrual symptoms: Oral: Acetaminophen 650-1000 mg and pamabrom 50 mg every 4-6 hours as needed (maximum: 8 caplets/tablets/24 hours)

Dosing: Pediatric

Children ≥12 years: Refer to adult dosing.
Use
 
Temporary relief of symptoms associated with premenstrual and menstrual symptoms (eg, cramps, bloating, water-weight gain, headache, backache, muscle aches)
Adverse Reactions
 
Dermatologic: Rash
Endocrine & metabolic: May increase chloride, uric acid, glucose; may decrease sodium, bicarbonate, calcium
Hematologic: Anemia, blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Hepatic: Bilirubin increased, alkaline phosphatase increased
Renal: Ammonia increased, nephrotoxicity with chronic overdose, analgesic nephropathy
Miscellaneous: Hypersensitivity reactions (rare)
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Hepatotoxicity: Acetaminophen may cause hepatic toxicity with acute overdose; in addition chronic daily dosing has resulted in liver damage in some adults.
• Hypersensitivity: Discontinue use if hypersensitivity occurs.
Disease-related concerns:
• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.
Special populations:
• Pediatrics: Not for use in children <12 years of age.
Other warnings/precautions:
• Dosage limit: Limit acetaminophen dose to <4 g/day in adults.
• Self-medication (OTC use): Should not be used with other products containing acetaminophen. Patients should be instructed to contact healthcare provider if new symptoms occur, if redness or swelling occurs, or pain lasting >10 days.
Interactions
 
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Conivaptan: May increase the serum concentration of CYP3A4 Substrates (Low risk). Risk C: Monitor therapy
Cyproterone: May decrease the serum concentration of CYP1A2 Substrates. Risk C: Monitor therapy
Cyproterone: May decrease the serum concentration of CYP2E1 Substrates. Risk C: Monitor therapy
Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Imatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib. Imatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Metyrapone: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Risk D: Consider therapy modification
SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
 
   
 
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