Balacet® 325
Each year, millions of people in the U.S. suffer from pain, and many will turn to an over-the-counter (OTC) product like acetaminophen. But since many OTC pain relievers, cold medicines and sleep aids contain acetaminophen — which, when taken in excess, has been linked to liver toxicity — it’s important for patients to know the total acetaminophen they are taking. The FDA recommends no more than 2600 mg per day if taking these medications for 10 or more days, and no more than 4000 mg per day if taking them for less than 10 days.
When OTC medication is not enough and you seek treatment from your Healthcare Provider, ask about Balacet
® 325 for your mild-to-moderate pain. With 100 mg of propoxyphene napsylate and only 325 mg of acetaminophen, you will find relief — and keep your daily acetaminophen at a safer level (when taken as your sole medication and as directed).
Balacet 325 tablets are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.
Balacet 325 is contraindicated in patients with hypersensitivity to propoxyphene or acetaminophen.
WARNINGS:
- Do not prescribe propoxyphene for patients who are suicidal or addiction-prone.
- Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
- Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.
Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes). Propoxyphene should not be taken in doses higher than those recommended by the physician. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.
For Balacet 325 full prescribing information,
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