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 and a barbiturate (butalbital) for its sedative effect.
Decreased severity of pain with some sedation.
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.
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).
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.
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).
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.
Explain therapeutic value of medication before administration to enhance the analgesic effect.
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.
Advise patient to use an additional nonhormonal method of contraception while taking butalbital compound.
Decrease in severity of pain without a significant alteration in level of consciousness.
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.