Darvocet-N 100: Warnings

Warning: Excessive doses of propoxyphene products, either alone or in combination with other CNS depressants (including alcohol), are a major cause of drug-related deaths. Do not use propoxyphene formulations in patients with depression or suicidal ideation. Propoxyphene formulations should be used with caution if you are taking tranquilizers or antidepressants, or if you consume alcohol in excess. You should inform your physician if you take these drugs or consume excessive amount of alcohol. Limit your alcohol intake while taking this drug, and never exceed the recommended doses.

Precautions

• If you normally drink alcohol, limit your intake while you are on this drug due to the additive depressant effects of this drug with alcohol.

Infants and Children
The safety and efficacy of this drug have not been established in this age group.

Adults Over 60
Use with caution in this age group, as older patients are more likely to experience the drug's adverse reactions.

Drug Dependency
Propoxyphene has an abuse potential similar to that of codeine. Its dependency is characterized mostly by psychological dependency, and much less often, physical dependency and tolerance. Dependency will most likely occur with repeated or prolonged use of high doses. Use caution and avoid doses higher than which is recommended by your physician.

Pregnancy Risk Category: C; D if used for prolonged periods.



Pregnancy Warnings
There are no adequate studies of fetal harm in pregnant women. This drug should be used only if the benefits to the mother clearly outweigh the potential risks to the fetus. Note: Instances of withdrawal in neonates have been reported following prolonged usage during pregnancy.

Nursing Mothers
Although low levels of the drug were detected in breast milk, postpartum studies showed no adverse effects in the breastfeeding infants. The American Academy of Pediatrics considers propoxyphene napsylate with acetaminophen to be compatible with breastfeeding.

Prolonged Use
Chronic daily dosing in adults of 5 to 8 g acetaminophen a day for several weeks or 3 to 4 g a day for 1 year has resulted in liver damage. Prolonged use of propoxyphene can cause tolerance and addiction.
Do not use longer than 10 days for adolescents and adults without continued supervision of your physician. Consult your physician about regular checkups.

Discontinuing Therapy
It is taken on as needed basis. Discontinue when pain no longer exists.

Operating a Vehicle or Heavy Machinery
This drug may produce side effects that impair your mental alertness, such as drowsiness, dizziness, lightheadedness, sedation, or confusion. Avoid such activities if you feel these symptoms. Avoid consuming alcohol or other CNS depressants while taking this drug. They may intensify these side effects.

Sun Exposure
No problems expected.

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