Butalbital-Acetaminophen

Butalbital-Acetaminophen is a combination medication used for the treatment of tension headache.

• Butalbital-Acetaminophen is available under the following different brand names: Phrenilin Forte, Phrenilin, Bupap, Orbivan CF

Common side effects of Butalbital-Acetaminophen include:

• drowsiness,
• lightheadedness,
• dizziness,
• shortness of breath,
• nausea,
• vomiting,
• abdominal pain, and
• feeling intoxicated

Serious side effects of Butalbital-Acetaminophen include:

• suddenly appearing rash,
• swelling of the face, mouth or throat,
• difficulty breathing,
• vomiting,
• hives,
• itching,
• fever,
• diarrhea,
• dark-colored urine,
• yellowing of eyes and skin (jaundice),
• headache,
• nausea,
• stomach pain,
• weight loss,
• white or gray stool,
• fatigue,
• dehydration,
• abdominal upset,
• skin changes,
• sudden high blood pressure, and
• convulsions (seizures),

Rare side effects of Butalbital-Acetaminophen include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

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

Adult dosage

• FDA is asking manufacturers to limit acetaminophen in prescription products to 325 mg/dosage unit; manufacturers have until January 14, 2014 to comply

Tablet

• 50 mg/300 mg (Orbivan CF)
• 50 mg/325 mg (Phrenilin)
• 50 mg/650 mg (Bupap)

Capsule

• 50 mg/650 mg (Phrenilin Forte)

Tension Headache

Adult and geriatric dosage

• 1-2 tabs/cap orally every 4 hours; not to exceed 6 tabs/cap per day
• Not to exceed 4 g acetaminophen/24 hr

Pediatric dosage

• Below 12 years: Safety and efficacy not established
• Above 12 years: As adults; 1-2 tabs or cap orally every 4 hours; not to exceed 6 tabs or cap per day
• Not to exceed 4 g acetaminophen/24 h

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Butalbital-Acetaminophen has severe interactions with the following drugs:
  • doravirine
  • fostemsavir
  • isavuconazonium sulfate
  • lonafarnib
  • lorlatinib
  • mavacamten
• Butalbital-Acetaminophen has serious interactions with at least 72 other drugs.
• Butalbital-Acetaminophen has moderate interactions with at least 319 other drugs.
• Butalbital-Acetaminophen has minor interactions with at least 159 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Hepatitis or severe hepatic/renal impairment
• Repeated administration in patients w/ anemia, cardiovascular, pulmonary, or renal disease
• Porphyria

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Butalbital-Acetaminophen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Butalbital-Acetaminophen?”

Cautions

• Acetaminophen is associated with cases of acute liver failure, at times resulting in liver transplant and death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
• 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
• Avoid driving a car or operating machinery

Pregnancy and Lactation

• Use with caution if benefits outweigh risks during pregnancy.
• Lactation
  • Excreted in breast milk; caution advised