acetaminophen/pamabrom

Acetaminophen/pamabrom is a combination medication available over the counter (OTC), used for the temporary relief of menstrual symptoms.

Acetaminophen is a pain reliever (analgesic), and pamabrom is a weak diuretic. The combination works together to relieve various symptoms associated with menstrual periods including cramps, backache, headache, bloating, swelling, water-weight gain, minor aches and pains, muscular aches, and feeling full.

The two drugs in the combo analgesic work in the following ways:

• Acetaminophen relieves menstrual cramps, backache, headache, and other minor pains and aches by blocking pain impulse generation and inhibiting the synthesis of prostaglandin in the central nervous system (CNS). Prostaglandin is a natural substance in the body that initiates inflammation. Acetaminophen also reduces fever by acting on the hypothalamus region of the brain which regulates temperature.
• Pamabrom is a diuretic medication that increases urine output, reducing water retention and bloating that occurs during menstruation.

Who should not take acetaminophen/pamabrom?

• Do not use acetaminophen/pamabrom in patients with known hypersensitivity to acetaminophen, pamabrom or any of the components in the formulation.
• Do not take concurrently with any other drug containing acetaminophen.
• Acetaminophen can damage the liver, especially with prolonged use with high doses. The risk of liver damage is higher in people who drink 3 or more alcoholic drinks and patients with alcoholic liver disease.
• Use acetaminophen/pamabrom with caution in patients with G6PD enzyme deficiency, a genetic disorder.
• There have been rare reports of serious life-threatening skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) with symptoms such as skin redness, rash and blisters. Discontinue use if you develop such symptoms and contact your healthcare provider immediately.

Common side effects of acetaminophen/pamabrom include:

• Skin reactions that include:
  • Hives (urticaria)
  • Itchy rash with flat and raised lesions (pruritic maculopapular rash)
• Hypersensitivity reactions including:
  • Swelling of the voice box (laryngeal edema)
  • Swelling under the skin and mucous membranes (angioedema)
  • Severe anaphylaxis-like allergic reaction (anaphylactoid reaction)
• Toxicity to the liver (hepatotoxicity)
• Blood disorders including:
  • Severely low count of granulocyte immune cells (agranulocytosis)
  • Low count of neutrophil immune cells (neutropenia)
  • Low count of leukocyte immune cells (leukopenia)
  • Low count of all types of blood cells (pancytopenia)
  • Low platelet count (thrombocytopenia)
  • Easy bruising due to thrombocytopenia (thrombocytopenic purpura)
• Increase in blood levels of:
  • Glucose
  • Uric acid
  • Chloride
• Decrease in blood levels of:
  • Calcium
  • Sodium
  • Bicarbonate

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Acetaminophen/pamabrom

Caplet

• 500 mg/25 mg

Tablet

• 325 mg/25 mg

Analgesia/Menstrual Cramps

Adult:

• 1-2 caplets or tablets orally every 4-6 hours as needed; not to exceed 8 caplets/tablets for 24 hours

Pediatric:

• Children below 12 years: Safety and efficacy not established
• Children 12 years and above: 1-2 caplets or tablets orally every 4-6 hours as needed; not to exceed 8 caplets/tablets per 24 hours

Overdose

• Overdose of acetaminophen/pamabrom can result in liver damage from acetaminophen.
• Overdose treatment may include administration of N-acetylcysteine, an antidote to acetaminophen, and other symptomatic and supportive measures as needed.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of acetaminophen/pamabrom include:
  • metyrapone
• Acetaminophen/pamabrom has no listed serious interactions with other drugs.
  • dasatinib
  • probenecid
  • sorafenib
  • vaccines
• Acetaminophen/pamabrom has moderate interactions with at least 22 other drugs.
• Acetaminophen/pamabrom has no listed mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• Acetaminophen/pamabrom should be used by pregnant women only if clearly needed.
• Acetaminophen/pamabrom is excreted in breast milk, use with caution.
• If you are pregnant or breastfeeding, do not take any OTC drug, including acetaminophen/pamabrom, without first checking with your healthcare provider.

• Take acetaminophen/pamabrom exactly as prescribed or as per label instructions if taking OTC medication.
• Do not take higher or more frequent doses, do not exceed the daily recommended dosage and do not take for prolonged periods.
• Avoid acetaminophen overdose by checking product labels carefully. Acetaminophen is found in many dosage forms and many combination products.
• Discontinue immediately if you develop hypersensitivity reactions.
• Discontinue use and contact your health care provider if:
  • New symptoms occur
  • Redness or swelling occurs
  • Fever lasts longer than 3 days
  • Pain lasts longer than 10 days
• Avoid or limit intake of alcohol while on treatment.
• Store safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.