Drug Database - Balacet

Generic Name: acetaminophen & propoxyphene
(a-see-tah-MIH-no-fen/ proe-POX-ih-feen)

Brand Names: Balacet®, Darvocet A500®, Darvocet-N100®, Darvocet-N50®, Propacet 100®, Wygesic®

Classification: Narcotic Analgesics

Issue Date: 1995

Propoxyphene (related to codeine) is in a class of drugs called narcotic analgesics. It works by changing the way the body feels pain.

Acetaminophen is a less potent pain reliever that increases the effects of propoxyphene. Together, acetaminophen and propoxyphene are called Balacet and are used to relieve pain. Balacet may also be used for purposes other than those listed here.

Take Balacet exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take Balacet with food or milk if it upsets your stomach. Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking Balacet suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

Constipation may be a side effect of treatment with Balacet. Increasing the amount of fiber and water (six to eight full glasses) in the diet may reduce constipation.

Do not share this medication with anyone else. Store Balacet at room temperature away from moisture and heat.

Do not take Balacet if you suffer from depression or have suicidal thoughts. Before taking this medication, tell your doctor if you have:

• History of drug or alcohol addiction
• Drink 3 or more alcoholic beverages per day
• Kidney disease
• Liver disease
• Asthma
• Urinary retention
• An enlarged prostate
• Hypothyroidism
• Seizures or epilepsy
• Gallbladder disease
• Head injury
• Addison's disease

You may not be able to take Balacet, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Propoxyphene may cause addiction and withdrawal symptoms as well as other harmful effects in an unborn baby. Do not take Balacet without first talking to your doctor if you are pregnant or could become pregnant during treatment. Propoxyphene may cause addiction and withdrawal symptoms in a nursing baby. Do not take Balacet without first talking to your doctor if you are breast-feeding a baby.

If you are younger than 18 years of age or older than 60 years of age, you may be more likely to experience side effects from Balacet therapy. Your doctor may prescribe a lower dose.

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

Seek emergency medical attention if an overdose is suspected. Symptoms of a Balacet overdose include:

• slow breathing
• seizures
• dizziness
• weakness
• loss of consciousness
• coma
• confusion
• tiredness
• cold and clammy skin
• small pupils
• nausea
• vomiting
• sweating

Avoid alcohol while taking Balacet. Alcohol can increase drowsiness and dizziness caused by the medication which could be dangerous. Also, alcohol may increase the risk of liver problems when taking acetaminophen.

Use caution when driving, operating machinery, or performing other hazardous activities. Balacet may cause drowsiness. If you experience drowsiness, avoid these activities.

Do not take other over-the-counter and prescription products that contain acetaminophen. Too much acetaminophen could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

Drowsiness or dizziness caused by Balacet may be increased by other drugs such as:

• antidepressants
• alcohol
• antihistamines
• sedatives (used to treat insomnia)
• other pain relievers
• anxiety medicines
• and muscle relaxants

Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Side Effects

If you experience any of the following serious side effects, stop taking Balacet and seek emergency medical attention:

• An allergic reaction:
  • difficulty breathing
  • closing of the throat
  • swelling of the lips, tongue, or face
  • hives
• Slow, weak breathing
• Seizures
• Cold, clammy skin
• Severe weakness or dizziness
• Unconsciousness
• Yellowing of the skin or eyes
• Unusual fatigue, bleeding, or bruising

Other, less serious side effects may be more likely to occur. Continue to take Balacet and talk to your doctor if you experience:

• Constipation
• Dry mouth, nausea, vomiting, or decreased appetite
• Dizziness, tiredness, or lightheadedness
• Sweating
• Decreased urination
• Decreased sex drive

Propoxyphene may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment. Do not stop taking Balacet suddenly without first talking to your doctor if you have been taking it continuously for more than 5 to 7 days. Your doctor may want to gradually reduce the dose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not take Balacet if you have taken a monoamine oxidase inhibitor (MAOI) such as:

• Isocarboxazid (Marplan®)
• Phenelzine (Nardil®)
• Tranylcypromine (Parnate®)

Dangerous side effects could result.

Propoxyphene may increase the effects of oral anticoagulants such as warfarin (Coumadin®) which could lead to bleeding. It may also increase the effects of carbamazepine (Tegretol®) leading to toxicity. Be sure your doctor is aware if you are taking either of these medications.

Drowsiness or dizziness caused by Balacet may be increased by other drugs such as:

• antidepressants
• alcohol
• antihistamines
• sedatives (used to treat insomnia)
• other pain relievers
• anxiety medicines
• muscle relaxants

Together, these medicines may cause dangerous sedation, possibly resulting in unconsciousness or death. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Drugs other than those listed here may also interact with Balacet. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.