acetaminophen/pamabrom/pyrilamine

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

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

The three 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.
• Pyrilamine is an antihistamine drug that works by blocking H1 histamine receptors, inhibiting the activity of histamine. Histamine is a substance that is released by immune cells in inflammation and in the brain, it promotes wakefulness. Pyrilamine is a first-generation antihistamine that crosses the blood-brain barrier rapidly and produces sedative and calming effects.

• Do not use in patients with known hypersensitivity to acetaminophen, pamabrom, pyrilamine, or any of the components in the formulation.
• Do not take concurrently with any other drug containing acetaminophen.
• Do not take concurrently or within 14 days after treatment with monoamine oxidase inhibitor (MAOI) type of antidepressant medications.
• Acetaminophen can damage the liver, especially with prolonged use with high doses.
• Use acetaminophen/pamabrom/pyrilamine with caution in patients with G6PD enzyme deficiency, a genetic disorder.
• Use with caution in patients with any of the following conditions:
  • Cardiovascular disease
  • Diabetes mellitus
  • Active liver disease or liver function impairment
  • Increased intraocular pressure or glaucoma, a condition that damages the optic nerve
  • Prostate enlargement
  • Thyroid dysfunction
• 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 treatment if the patient develops such symptoms.

Common side effects of acetaminophen/pamabrom/pyrilamine include:

Acetaminophen

• Hives (urticaria)
• Itchy rash with flat and raised lesions (pruritic maculopapular rash)
• Swelling under the skin and mucous membranes (angioedema)
• Swelling of the voice box (laryngeal edema)
• Severe anaphylaxis-like allergic reaction (anaphylactoid reaction)
• 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)
• Toxicity to the liver (hepatotoxicity)
• Decrease in blood levels of:
  • Sodium
  • Calcium
  • Bicarbonate
• Increase in blood levels of:
  • Uric acid
  • Chloride
  • Glucose

Pamabrom

• Discolored urine (golden tinted)

Pyrilamine

• Blurred vision
• Sleepiness (sedation)
• Dry mouth (xerostomia)

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/pyrilamine

Capsule

• 500 mg/25 mg/15 mg

Gel cap

• 500 mg/25 mg/15 mg

Tablet

• 500 mg/25 mg/15 mg

Adult:

Analgesia/Menstrual Cramps

• 1-2 capsule/tablet/gel cap orally every 4-6 hours as needed

Pediatric:

• Safety and efficacy not established

Overdose

• Overdose of acetaminophen/pamabrom/pyrilamine can result in liver damage from acetaminophen with severe adverse effects that include symptoms such as nausea, vomiting, loss of appetite, sweating, abdominal pain, extreme tiredness, yellowing eyes and skin, dark urine, agitation, confusion, hallucinations, and seizures.
• Overdose treatment may include administration of N-acetylcysteine, 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/pyrilamine include:
  • metyrapone
• Acetaminophen/pamabrom/pyrilamine has no listed serious interactions with other drugs.
  • dasatinib
  • probenecid
  • vaccines
• Acetaminophen/pamabrom/pyrilamine has moderate interactions with at least 22 other drugs.
• Acetaminophen/pamabrom/pyrilamine 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/pyrilamine should be used by pregnant women only if clearly needed.
• Acetaminophen/pamabrom/pyrilamine is likely safe to take while breastfeeding, use with caution.
• If you are pregnant or breastfeeding, do not take any OTC drug, including acetaminophen/pamabrom/pyrilamine, without first checking with your healthcare provider.

• Take acetaminophen/pamabrom/pyrilamine exactly as prescribed or as per label instructions if taking OTC medication.
• Drink 6-8 glasses of water daily while taking this medication.
• 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.
• Avoid or limit intake of alcohol while on treatment.
• This medication may cause drowsiness, avoid hazardous activities such as driving and operating heavy machinery while taking this drug.
• Store safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.