DrugBuyers.Com: Darvocet N-100

Propoxyphene Napsylate and Acetaminophen

Propoxyphene napsylate, USP is an odorless, white, crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (aS,1R)-a-[2-(Dimethylamino)-1-methylethyl]-a-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate. Its molecular weight is 565.72.

Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 mcmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 mcmol) of propoxyphene hydrochloride.

Each Darvocet-N 50 tablet contains 50 mg (88.4 mcmol) propoxyphene napsylate and 325 mg (2,150 mcmol) acetaminophen.

Each Darvocet-N 100 tablet contains 100 mg (176.8 mcmol) propoxyphene napsylate and 650 mg (4,300 mcmol) acetaminophen.
These products are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.

PATIENT INFORMATION

PATIENT PACKAGE INSERT
YOUR PRESCRIPTION FOR A PROPOXYPHENE PRODUCT

Summary: Products containing propoxyphene are used to relieve pain.

LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING THIS DRUG. Make sure your doctor knows if you are taking tranquilizers, sleep aids, antidepressants, antihistamines, or any other drugs that make you sleepy. Combining propoxyphene with alcohol or these drugs in excessive doses is dangerous.

Use care while driving a car or using machines until you see how the drug affects you because propoxyphene can make you sleepy. Do not take more of the drug than your doctor prescribed. Dependence has occurred when patients have taken propoxyphene for a long period of time at doses greater than recommended.

The rest of this leaflet gives you more information about propoxyphene. Please read it and keep it for future use.

Uses of Propoxyphene: Products containing propoxyphene are used for the relief of mild to moderate pain. Products that contain propoxyphene plus aspirin or acetaminophen are prescribed for the relief of pain or pain associated with fever.

Before Taking Propoxyphene: Make sure your doctor knows if you have ever had an allergic reaction to propoxyphene, aspirin, or acetaminophen. Some forms of propoxyphene products contain aspirin to help relieve the pain. Your doctor should be advised if you have a history of ulcers or if you are taking an anticoagulant ("blood thinner"). The aspirin may irritate the stomach lining and may cause bleeding, particularly if an ulcer is present. Also, bleeding may occur if you are taking an anticoagulant. In a small group of people, aspirin may cause an asthma attack. If you are one of these people, be sure your drug does not contain aspirin.

The effect of propoxyphene in children under 12 has not been studied. Therefore, use of the drug in this age group is not recommended.

Also, due to the possible association between aspirin and Reye Syndrome, those propoxyphene products containing aspirin should not be given to children, including teenagers, with chicken pox or flu unless prescribed by a physician. The following propoxyphene product contains aspirin: propoxyphene hydrochloride, aspirin, and caffeine, USP.

How to Take Propoxyphene: Follow your doctor's directions exactly. Do not increase the amount you take without your doctor's approval. If you miss a dose of the drug, do not take twice as much the next time.

Pregnancy: Do no take propoxyphene during pregnancy unless your doctor knows you are pregnant and specifically recommends its use. Cases of temporary dependence in the newborn have occurred when the mother has taken propoxyphene consistently in the weeks before delivery. As a general principle, no drug should be taken during pregnancy unless it is clearly necessary.

General Cautions: Heavy use of alcohol with propoxyphene is hazardous and may lead to overdosage symptoms (see OVERDOSAGE.) THEREFORE, LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING PROPOXYPHENE.

Combinations of excessive doses of propoxyphene, alcohol, and tranquilizers are dangerous. Make sure your doctor knows if you are taking tranquilizers, sleep aids, antidepressant drugs, antihistamines, or any other drugs that make you sleepy. The use of these drugs with propoxyphene increases their sedative effects and may lead to overdosage symptoms including death (see OVERDOSAGE).

Propoxyphene may cause drowsiness or impair your mental and/or physical abilities; therefore, use caution when driving a vehicle or operating dangerous machinery. DO NOT perform any hazardous task until you have seen your response to this drug.

Propoxyphene may increase the concentration in the body of medications, such as anticoagulants ("blood thinners"), antidepressants, or drugs used for epilepsy. The result may be excessive or adverse effects of these medications. Make sure your doctor knows if you are taking any of these medications.

Dependence: You can become dependent on propoxyphene if you take it in higher than recommended doses over a long period of time. Dependence is a feeling of need for the drug and a feeling that you cannot perform normally without it.

Overdose: An overdose of propoxyphene, alone or in combination with other drugs, including alcohol, may cause weakness, difficulty in breathing, confusion, anxiety, and more severe drowsiness and dizziness. Extreme overdosage may lead to unconsciousness and death.

If the propoxyphene product contains acetaminophen, the overdosage symptoms include nausea, vomiting, lack of appetite, and abdominal pain. Liver damage may occur even after symptoms disappear. Death can occur days later.

When the propoxyphene product contains aspirin, symptoms of taking too much of the drug are headache, dizziness, ringing in the ears, difficulty in hearing, dim vision, confusion, drowsiness, sweating, thirst, rapid breathing, nausea, vomiting, and, occasionally, diarrhea.

In any suspected overdosage situation, contact your doctor or nearest hospital emergency room. GET EMERGENCY HELP IMMEDIATELY. KEEP THIS DRUG AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Possible Side Effects: When propoxyphene is taken as directed, side effects are infrequent. Among those reported are drowsiness, dizziness, nausea, and vomiting. If these effects occur, it may help if you lie down and rest.

Less frequently reported side effects are constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, hallucinations, minor visual disturbances, and feelings of elation or discomfort.

If side effects occur and concern you, contact your doctor.

Other Information: The safe and effective use of propoxyphene depends on your taking it exactly as directed. This drug has been prescribed specifically for you and your present condition. Do not give this drug to others who may have similar symptoms. Do not use it for any other reason.