Propoxyphene Napsylate and Acetaminophen (Page 5 of 5)

Symptoms of Propoxyphene Overdosage

The manifestations of acute overdosage with propoxyphene are those of opioid overdosage. The patient is usually somnolent but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and/or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated as hypoxia increases. Cheyne-Stokes respiration and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pulmonary edema and circulatory collapse, unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO2 (hypercapnia) and to lactic acid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur.

Treatment of Propoxyphene Overdosage

Attention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or without oxygen, may be required, and positive pressure respiration may be desirable if pulmonary edema is present. The opioid antagonist naloxone will markedly reduce the degree of respiratory depression, and should be administered promptly, preferably intravenously. The duration of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of propoxyphene toxicity should be questioned.

In addition to the use of an opioid antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Activated charcoal can adsorb a significant amount of ingested propoxyphene. Dialysis is of little value in poisoning due to propoxyphene. Efforts should be made to determine whether other agents, such as alcohol, barbiturates, tranquilizers, or other CNS depressants, were also ingested, since these increase CNS depression as well as cause specific toxic effects or death.

Acetaminophen Overdosage

Symptoms of Acetaminophen Overdosage

Overdose of acetaminophen may cause dose-dependent potentially fatal hepatic toxicity. Early symptoms within 24 hours after the overdose may include anorexia, nausea, vomiting, diaphoresis, general malaise, and abdominal pain. The patient may then present no symptoms, but evidence of liver dysfunction may become apparent up to 72 hours after ingestion, with elevated serum transaminase and lactic dehydrogenase levels, an increase in serum bilirubin concentrations, and a prolonged prothrombin time. Death from hepatic failure may result 3 to 7 days after overdosage.

Because clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion, liver function studies should be obtained initially and repeated at 24 hour intervals.

Acute renal failure may accompany the hepatic dysfunction and has been noted in patients who do not exhibit signs of fulminant hepatic failure. Typically, renal impairment is more apparent 6 to 9 days after ingestion of the overdose.

Treatment of Acetaminophen Overdosage

In all cases of suspected overdose, immediately call the Rocky Mountain Poison Center’s toll-free number (800-525-6115) for assistance in diagnosis and for directions in the use of N-acetylcysteine as an antidote.

Patients’ estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than 4 hours following ingestion. The antidote, N-acetylcysteine, should be administered as early as possible, and within 16 hours of the overdose ingestion for optimal results.

DOSAGE AND ADMINISTRATION

Proproxyphene napsylate and acetaminophen tablets USP are intended for the management of mild to moderate pain. The dose should be individually adjusted according to severity of pain, patient response and patient size.

Propoxyphene napsylate and acetaminophen tablets USP (100 mg propoxyphene napsylate and 650 mg acetaminophen)

The usual dosage is one tablet every 4 hours orally as needed for pain. The maximum dose of propoxyphene napsylate and acetaminophen tablets USP is 6 tablets per day. Do not exceed the maximum daily dose.

Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.

Consideration should be given to a reduced total daily dosage in elderly patients and in patients with hepatic or renal impairment.

Cessation of Therapy

For patients who used propoxyphene napsylate and acetaminophen tablets USP on a regular basis for a period of time, when therapy with propoxyphene napsylate and acetaminophen tablets USP is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the propoxyphene napsylate and acetaminophen tablets USP over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see DRUG ABUSE AND DEPENDENCE for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

HOW SUPPLIED

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) are available as film-coated, oblong, pink tablets debossed either “93”-“890” or “TEVA”-“890”, in bottles of 8, 12, 15, 15, 16, 20, 28, 30, 60, 90.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inform patients of the availability of a Medication Guide for propoxyphene napsylate and acetaminophen tablets USP that accompanies each prescription dispensed. Instruct patients to read the propoxyphene napsylate and acetaminophen Medication Guide prior to using propoxyphene napsylate and acetaminophen tablets USP.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. W 10/2009


Repackaged by:

REBEL DISTRIBUTORS CORP.

Thousand Oaks, CA 91320

MEDICATION GUIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP CIV

Rx only

Read this Medication Guide before you start taking propoxyphene napsylate and acetaminophen tablets USP and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?

Propoxyphene napsylate and acetaminophen tablets USP and other medicines that contain propoxyphene can cause serious side effects, including:

Overdoses by accident or on purpose (intentional overdose). Overdoses with propoxyphene napsylate and acetaminophen tablets USP may happen when they are taken by themselves, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.

  • Death can happen within 1 hour of taking an overdose of propoxyphene napsylate and acetaminophen tablets USP. Many of the deaths that happen in people who take propoxyphene napsylate and acetaminophen tablets USP happen in those who:
    • have emotional problems
    • have thoughts of suicide or attempted suicide, or
    • also take antidepressants, sedatives, tranquilizers, muscle relaxants, or other medicines that affect your breathing and make you very sleepy. You should not use any of these medicines with propoxyphene napsylate and acetaminophen tablets USP without talking to your doctor.
  • Before taking propoxyphene napsylate and acetaminophen tablets USP tell your doctor if you:
    • have a lung problem, such as COPD or cor pulmonale
    • have liver or kidney problems
    • have problems with your pancreas or gallbladder
    • have a history of head injury
    • are over age 65
    • have a history of drug or alcohol abuse or addiction

Take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed. Do not change your dose or stop taking propoxyphene napsylate and acetaminophen tablets USP without first talking to your doctor.

    • If you take propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg do not take more than 6 tablets in one day.
  • Before taking propoxyphene napsylate and acetaminophen tablets USP, tell your doctor about all the medicines you take. Propoxyphene napsylate and acetaminophen tablets USP and many other medicines may interact with each other and may cause serious side effects. Certain medicines can affect how your liver breaks down other medicines. See “What should I tell my doctor before taking propoxyphene napsylate and acetaminophen tablets USP?”
  • Do not drink grapefruit juice or eat grapefruit while you are taking propoxyphene napsylate and acetaminophen tablets USP. Grapefruit juice may interact with propoxyphene napsylate and acetaminophen tablets USP.
  • Do not drink alcohol while using propoxyphene napsylate and acetaminophen tablets USP. Using alcohol with propoxyphene napsylate and acetaminophen tablets USP may increase your risk of having dangerous side effects.

What are propoxyphene napsylate and acetaminophen tablets USP?

  • Propoxyphene napsylate and acetaminophen tablets USP are a prescription medicine that contains two medicines: propoxyphene and acetaminophen. Propoxyphene napsylate and acetaminophen tablets USP are used to relieve mild to moderate pain.
  • Propoxyphene napsylate and acetaminophen tablets USP are a federally controlled substance (C-IV) because they are a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
  • Prevent theft, misuse or abuse. Keep propoxyphene napsylate and acetaminophen tablets USP in a safe place to protect it from being stolen. Propoxyphene napsylate and acetaminophen tablets USP can be a target for people who misuse or abuse prescription medicines or street drugs.
  • Never give propoxyphene napsylate and acetaminophen tablets USP to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

It is not known if propoxyphene napsylate and acetaminophen tablets USP are safe and effective in children under age 18.

Who should not take propoxyphene napsylate and acetaminophen tablets USP?

Do not take propoxyphene napsylate and acetaminophen tablets USP if you:

  • are allergic to propoxyphene or acetaminophen. Ask your doctor if you are not sure. See the end of this Medication Guide for a list of the ingredients in propoxyphene napsylate and acetaminophen tablets USP.
  • are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
  • have a bowel blockage called paralytic ileus.

What should I tell my doctor before taking propoxyphene napsylate and acetaminophen tablets USP?

Before taking propoxyphen napsylate and acetaminophen tablets USP, tell your doctor:

  • if you have any of the conditions listed in the section “What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?”
  • if you are allergic to propoxyphene or acetaminophen
  • if you plan to have surgery with general anesthesia
  • if you are pregnant or plan to become pregnant.
  • if you take propoxyphene napsylate and acetaminophen tablets USP regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:
    • irritability
    • shaking (tremors)
    • jitteriness
    • breathing faster than normal
    • crying more than usual
    • diarrhea or more stools than normal
    • vomiting
    • fever
  • if you take propoxyphene napsylate and acetaminophen tablets USP right before your baby is born, your baby could have breathing problems.
  • if you are breast-feeding or plan to breast-feed. Some propoxyphene napsylate and acetaminophen passes into breast milk.

Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal supplements. Propoxyphene napsylate and acetaminophen tablets USP interact with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed.

Especially tell your doctor if you take:

See “What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?”

  • certain medicines that can affect how your liver breaks down other medicines.
  • a monoamine oxidase inhibitor (MAOI) medicine
  • other medicines that make you sleepy, such as: other medicines for pain, including other opioid medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, muscle relaxants, anti-nausea medicines, or tranquilizers
  • an anticholinergic medicine
  • a water pill (diuretic)
  • a medicine for high blood pressure or irregular heart beat
  • birth control pills taken by mouth
  • lamotrigine (Lamictal® , Lamictal® CD , Lamictal® XR , Lamictal® ODT)
  • probenecid (Probalan®)
  • a blood-thinner medicine. You may have an increased risk of bleeding while also taking propoxyphene napsylate and acetaminophen tablets USP.
  • zidovudine (Trizivir® , Combivir® , Retrovir®)

Do not take other medicines that contain acetaminophen while taking propoxyphene napsylate and acetaminophen tablets USP. See “What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?”

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take propoxyphene napsylate and acetaminophen tablets USP?

See “What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?”

  • Take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed.
  • If you take too many propoxyphene napsylate and acetaminophen tablets USP, or take it with alcohol or other medicines, you may overdose. See “What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?”. You will need medical help right away if you think you have taken an overdose of propoxyphene napsylate and acetaminophen tablets USP. A large overdose can cause you to become unconscious and die.

Signs and symptoms of an overdose of propoxyphene napsylate and acetaminophen tablets USP include:

  • you are very sleepy or do not respond to others
  • confusion
  • have trouble breathing or stop breathing
  • changes in blood pressure and heart rate
  • nausea
  • vomiting
  • loss of appetite
  • stomach-area (abdominal pain)

What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?

Propoxyphene napsylate and acetaminophen tablets USP can cause serious side effects, including:

See “What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?”

  • Serious breathing problems that can become life-threatening. This is especially true if you already have a serious lung or breathing problem, or your body is not used to opioid pain medicines. This can happen even if you take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed by your doctor. Call your doctor or get medical help right away if:
    • your breathing slows down
    • you have shallow breathing (little chest movement with breathing)
    • you feel faint, dizzy, confused, or
    • you have any other unusual symptoms
  • Propoxyphene napsylate and acetaminophen tablets USP can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
  • Liver problems. Propoxyphene napsylate and acetaminophen tablets USP contain acetaminophen. Acetaminophen can cause serious liver problems if you take more than the recommended dose. Do not take more propoxyphene napsylate and acetaminophen tablets USP than prescribed. See “How should I take propoxyphene napsylate and acetaminophen tablets USP?” Do not take any other medicines that contain acetaminophen while also taking propoxyphene napsylate and acetaminophen tablets USP. Many products contain acetaminophen. Ask your doctor or pharmacist if you are not sure. Liver damage may happen even after symptoms go away. You can die from liver failure days later. Tell your doctor if you have any of these symptoms of a liver problem while taking propoxyphene napsylate and acetaminophen tablets USP:
    • nausea
    • vomiting
    • loss of appetite
    • stomach area (abdominal pain)
  • Sleepiness. Propoxyphene napsylate and acetaminophen tablets USP can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how propoxyphene napsylate and acetaminophen tablets USP affect you.
  • Propoxyphene napsylate and acetaminophen tablets USP can cause physical dependence if you take them for more than a few weeks. Do not stop taking propoxyphene napsylate and acetaminophen tablets USP all of a sudden. You could become sick with uncomfortable withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering) because your body has become used to the medicine. Talk to your doctor about slowly stopping propoxyphene napsylate and acetaminophen tablets USP to avoid getting sick with withdrawal symptoms. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.

    Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking propoxyphene napsylate and acetaminophen tablets USP. You may need to stop propoxyphene napsylate and acetaminophen tablets USP more slowly.

Common side effects of propoxyphene napsylate and acetaminophen tablets USP include:

    • dizziness
    • feeling sleepy
    • nausea and vomiting
    • constipation
    • stomach area (abdominal) pain
    • skin rashes
    • lightheadedness
    • headache
    • weakness
    • feeling of excitement (elation) or discomfort
    • seeing, hearing, or sensing things that are not really there (hallucinations)
    • blurred vision

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

You may also report side effects to TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351.

How should I store propoxyphene napsylate and acetaminophen tablets USP?

  • Store propoxyphene napsylate and acetaminophen tablets USP at 20° to 25°C (68° to 77°F).

Keep propoxyphene napsylate and acetaminophen tablets USP and all medicines out of the reach of children.

General information about propoxyphene napsylate and acetaminophen tablets USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use propoxyphene napsylate and acetaminophen tablets USP for a purpose for which they were not prescribed. Do not give propoxyphene napsylate and acetaminophen tablets USP to others even if they have the same symptoms you have. It may harm them and is against the law. This Medication Guide summarizes the most important information about propoxyphene napsylate and acetaminophen tablets USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about propoxyphene napsylate and acetaminophen tablets USP that is written for health professionals. For more information, call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in propoxyphene napsylate and acetaminophen tablets USP?

Active ingredients: propoxyphene napsylate and acetaminophen

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 27 aluminum lake, D&C Yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Iss. 10/2009

Package Label
(click image for full-size original)

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
propoxyphene napsylate and acetaminophen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-280(NDC:0093-0890)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOXYPHENE NAPSYLATE (PROPOXYPHENE) PROPOXYPHENE NAPSYLATE 100 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
D&C RED NO. 27
D&C YELLOW NO. 10
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
CROSPOVIDONE
Product Characteristics
Color PINK Score no score
Shape OVAL (oblong) Size 20mm
Flavor Imprint Code 93;890;or;TEVA;890
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-280-08 8 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:21695-280-12 12 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:21695-280-15 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:21695-280-16 16 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:21695-280-20 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:21695-280-28 28 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
7 NDC:21695-280-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
8 NDC:21695-280-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
9 NDC:21695-280-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074119 12/01/2009
Labeler — Rebel Distributors Corp. (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 relabel, repack

Revised: 12/2009 Rebel Distributors Corp.

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