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).
Contains an analgesic (acetaminophen) for relief of pain, a barbiturate (butalbital) for its sedative effect, and caffeine, which may be of benefit in tension headaches.
Therapeutic Effect(s):
Decreased severity of headache pain with some sedation.
Metabolism and Excretion: Butalbital primarily eliminated by kidneys as unchanged drug or metabolites (59–88% of dose); acetaminophen and caffeine primarily metabolized by liver.
Pedi: Children <12 yr (safety and effectiveness not established);
Geri: Butalbital appears on Beers list. Older adults may have ↑ risk of physical dependence, tolerance to sleep benefits, and overdose. Avoid use in older adults.
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.
Assess frequency of use. Frequent, chronic use may lead to daily headaches in headache-prone individuals because of physical dependence on caffeine and other components. Chronic headaches from overmedication are difficult to treat and may require hospitalization for treatment and prophylaxis.
Instruct patient to take medication exactly as directed. Do not increase dose because of the habit-forming potential of butalbital. If medication appears less effective after a few wk, consult health care professional. Dose of acetaminophen should not exceed 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. Discontinue gradually to prevent withdrawal symptoms (anxiety, diaphoresis, disturbed sleep, nausea/vomiting, restlessness, seizures, worsened headache).
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.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Caution patient to avoid concurrent use of alcohol or other CNS depressants, may cause overdose.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. Advise patient to use an additional nonhormonal method of contraception while taking butalbital compound.