Darvocet-N

DRUG DESCRIPTION

Darvocet-N contains 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 (?S,1R)-?-[2-(Dimethylamino)-1-methylethyl]-? phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72.

Propoxyphene Napsylate Structural Formula Illustration

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 Ámol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 Ámol) of propoxyphene hydrochloride.

Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula:

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

Each tablet of Darvocet-N (propoxyphene napsylate and acetaminophen) 100 contains 100 mg (176.8 Ámol) propoxyphene napsylate and 650 mg (4,300 Ámol) acetaminophen.

Each tablet also contains amberlite, cellulose, F D & C Yellow No. 6, magnesium stearate, stearic acid, titanium dioxide, and other inactive ingredients.

What are the possible side effects of propoxyphene (Darvon, Darvon-N)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, hallucinations, unusual thoughts or behavior;
  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects...

Read All Potential Side Effects and See Pictures of Darvocet-N

What are the precautions when taking propoxyphene napsylate and acetaminophen (Darvocet-N)?

Before taking propoxyphene with acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to...

Read All Potential Precautions of Darvocet-N


Darvocet-N Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting, seizure, slow/shallow breathing, change in amount of urine, unusual drowsiness/difficulty waking up.

Taking more than the recommended dose of acetaminophen may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking propoxyphene with acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using this medication, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG, heart block), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, urinary problems.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This medication passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Darvocet-N Patient Information Including Side Effects

Brand Names: Balacet, Darvocet A500, Darvocet-N 100, Darvocet-N 50, Propacet 100

Generic Name: acetaminophen and propoxyphene (Pronunciation: a SEET a MIN oh fen and proe POX i feen)

  • What is acetaminophen and propoxyphene (Darvocet-N)?
  • What are the possible side effects of acetaminophen and propoxyphene (Darvocet-N)?
  • What is the most important information I should know about acetaminophen and propoxyphene (Darvocet-N)?
  • What should I discuss with my healthcare provider before taking acetaminophen and propoxyphene (Darvocet-N)?
  • How should I take acetaminophen and propoxyphene (Darvocet-N)?
  • What happens if I miss a dose (Darvocet-N)?
  • What happens if I overdose (Darvocet-N)?
  • What should I avoid while taking acetaminophen and propoxyphene (Darvocet-N)?
  • What other drugs will affect acetaminophen and propoxyphene (Darvocet-N)?
  • Where can I get more information?

What is acetaminophen and propoxyphene (Darvocet-N)?

Propoxyphene is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever and a fever reducer that increases the effects of propoxyphene.

The combination of acetaminophen and propoxyphene is used to relieve mild to moderate pain with or without fever.

Acetaminophen and propoxyphene may also be used for other purposes not listed in this medication guide.

What are the possible side effects of acetaminophen and propoxyphene (Darvocet-N)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • chest pain, feeling short of breath;
  • feeling like you might pass out;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions); or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling dizzy or drowsy;
  • mild nausea, vomiting, upset stomach, constipation;
  • headache;
  • blurred vision; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acetaminophen and propoxyphene (Darvocet-N)?

Avoid drinking alcohol while taking acetaminophen and propoxyphene. Alcohol may increase your risk of liver damage while taking acetaminophen.

Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not use acetaminophen and propoxyphene if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use acetaminophen and propoxyphene before the MAO inhibitor has cleared from your body.

Do not take this medication in larger amounts, or use it for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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