butalbital, acetaminophen

butalbital, acetaminophen†

(byoo-tal-bi-tal & a-seet-a-min-oh-fen) ,

Butapap

(trade name),

Phrenilin

(trade name),

Phrenilin Forte

(trade name)

Classification

Therapeutic: nonopioid analgesics
Pharmacologic: barbiturates
Pregnancy Category: C
† For information on acetaminophen component in formulation, see acetaminophen monograph

Indications

Relief of the symptom complex of tension (or muscle contraction) headaches (use should be short-term only as the butalbital component may be habit-forming).

Action

Contains an analgesic (acetaminophen) for relief of pain and a barbiturate (butalbital) for its sedative effect.

Therapeutic effects

Decreased severity of pain with some sedation.

Pharmacokinetics

Absorption: Well absorbed.
Distribution: Widely distributed; crosses the placenta and enters breast milk.
Metabolism and Excretion: Butalbital primarily eliminated by kidneys as unchanged drug or metabolites (59–88% of dose); acetaminophen primarily metabolized by liver.
Half-life: Butalbital = 35 hr; acetaminophen = 1–3 hr.

Time/action profile

ROUTEONSETPEAKDURATION
PO15–30 min1–2 hr30 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to individual components; Lactation: Lactation; Porphyria.
Use Cautiously in: History of suicide attempt or drug addiction; Chronic alcohol use; Severe hepatic or renal disease; Patients concomitantly receiving other CNS depressants; Geriatric: Appears on Beers list. Geriatric patients are at ↑ risk for side effects (dose ↓ recommended); Pediatric: Children <12 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness (most frequent)
  • confusion
  • delirium
  • depression
  • dizziness
  • excitation
  • headache (with chronic use)
  • irritability
  • lethargy
  • nervousness
  • numbness
  • tingling

Ear, Eye, Nose, Throat

  • earache
  • nasal congestion
  • tinnitus

Respiratory

  • respiratory depression

Cardiovascular

  • tachycardia

Gastrointestinal

  • constipation
  • dry mouth
  • dysphagia
  • flatulence
  • heartburn

Dermatologic

  • dermatitis
  • pruritis
  • rash
  • sweating

Musculoskeletal

  • leg pain
  • muscle weakness

Miscellaneous

  • fever
  • physical dependence
  • psychological dependence
  • tolerance

Interactions

Drug-Drug interaction

Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and sedative/hypnotics.May ↑ the metabolism and ↓ the effectiveness of other drugs including amiodarone, benzodiazepines, bupropion, calcium channel blockers, carbamazepine, citalopram, clarithromycin, cyclosporine, erythromycin, fluoxetine, fluvoxamine, glipizide, hormonal contraceptives, losartan, methadone, mirtazapine, nateglinide, nefazodone, nevirapine, phenytoin, pioglitazone, promethazine, propranolol, protease inhibitors, proton pump inhibitors, rifampin, ropinirole, rosiglitazone, selegiline, sertraline, tacrolimus, theophylline, venlafaxine, voriconazole, warfarin, and zafirlukast.MAO inhibitors, felbamate, primidone, and valproic acid may ↓ metabolism and ↑ the effecta of butalbital.St. John’s wort may ↓ barbiturate effect.Concurrent use of kava kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

Route/Dosage

Oral (Adults) 1–2 capsules or tablets (50–100 mg butalbital) every 4 hr as needed for pain (should not exceed 6 tablets or capsules/24 hr).

Availability (generic available)

Tablets: 50 mg butalbital/325 mg acetaminophen, 50 mg butalbital/650 mg acetaminophen
Capsules: 50 mg butalbital/650 mg acetaminophen

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain before and 60 min following administration.
  • Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Most patients who receive butalbital compound for pain do not develop psychological dependence.

Potential Nursing Diagnoses

Acute pain (Indications)
Risk for injury (Side Effects)

Implementation

  • Explain therapeutic value of medication before administration to enhance the analgesic effect.
  • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
  • Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms.

Patient/Family Teaching

  • Instruct patient to take medication as directed. Do not increase dose because of the habit-forming potential of butalbital. If medication appears less effective after a few weeks, consult health care professional. The dose of acetaminophen should not exceed the maximum recommended daily dose of 4 g/day. Chronic excessive use of >4 g/day (2 g in chronic alcoholism) may lead to hepatotoxicity, renal or cardiac damage.
  • Advise patients with tension headaches to take medication at first sign of headache. Lying down in a quiet, dark room may also be helpful. Medications taken for prophylaxis should be continued.
  • May cause drowsiness or dizziness. Advise patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants.
  • Advise patient to use an additional nonhormonal method of contraception while taking butalbital compound.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness.
References in periodicals archive ?
Zebutal, a product containing butalbital, acetaminophen and caffeine, had sales of $5 million in the 12 months ended December 2013.
ZEBUTAL[TM], a product containing butalbital, acetaminophen and caffeine, had sales of $5 million in the 12 months ending December 2013.
Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg.
Sales of Butalbital, Acetaminophen and Caffeine Tablets have been climbing five percent annually over the past three years," said Arthur P.
M2 EQUITYBITES-September 17, 2012-Lannett Company Inc awarded FDA approval for Butalbital, Acetaminophen and Caffeine Tablets USP, 50mg/325mg/40mg(C)2012 M2 COMMUNICATIONS http://www.
Pharmaceutical company Lannett Company Inc (NYSE MKT:LCI) reported on Friday the receipt of approval for its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg.
For the year ended July 2012, the total sales of Butalbital, Acetaminophen and Caffeine Tablets at Average Wholesale Price were approximately USD30m, according to IMS.
5 mg (generic version of Activella); oxcarbazepine tablets (generic version of Trileptal); meloxicam tablets (generic version of Mobic); Ascomp w/ codeine (generic version of Fiorinal with codeine); butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with codeine); cyclobenzaprine (generic version of Flexeril); methylprednisolone (generic version of Medrol); polyethylene glycol powder (generic version of Miralax); folic acid tablets; and Vitamin D capsules (generic of Drisdol).
5 mg (generic version of Activella); oxcarbazepine tablets (generic version of Trileptal); meloxicam tablets (generic version of Mobic); Ascomp with codeine (generic version of Fiorinal with codeine); butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with codeine); cyclobenzaprine (generic version of Flexerfl); methylprednisolone (generic version of Medrol); polyethylene glycol powder (generic version of Miralax); folic acid tablets; and prednisone 1-mg tablets.
Breckenridge also currently markets Ascomp with codeine (Fiorinal with codeine), butalbital, acetaminophen, caffeine and codeine phosphate (Fioricet with codeine), cyclobenzaprine (Flexeril), folic acid 1 mg, methylprednisolone (Medrol), polyethylene glycol powder (Miralax), prednisone 1-mg tablets, and prochlorperazine (Compazine).
The company has introduced several products after their abbreviated new drug applications (ANDAs) won approval from the Food and Drug Administration, including meloxicam tablets (a generic version of Mobic), ascomp with codeine (generic version of Fiorinal with codeine), methylprednisolone (generic version of Medrol), prochlorperazine (generic version of Compazine), butalbital, acetaminophen, caffeine and codeine phosphate (generic version of Fioricet with Codeine), and folic acid, 1 mg.
s pain reliever Fiorinal with codeine; methylprednisolone, a generic equivalent to Pharmacia's antiinflammatory drug Medrol; prochlorperazine, the generic version of GlaxoSmithKline PLC's Compazine; butalbital, acetaminophen, caffeine and codeine phosphate, the generic version of Novartis' Fioricet with codeine; and folic acid, 1 mg.