DARVON®
(propoxyphene hydrochloride) Capsules, USP Pulvules®
WARNINGS
Darvon contains propoxyphene hydrochloride, USP which is an odorless, white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is (2S,3R)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride, which can be represented by the accompanying structural formula. Its molecular weight is 375.94.
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Each pulvule contains 65 mg (172.9 µmol) propoxyphene hydrochloride. It also contains D & C Red No. 33, F D & C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients.
Last updated on RxList: 10/12/2009
Darvon is 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.
Darvon is given orally. The usual dosage is one 65 mg propoxyphene hydrochloride capsule every 4 hours as needed for pain. The maximum dose of Darvon 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.
For patients who used Darvon on a regular basis for a period of time, when therapy with Darvon is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the Darvon 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.
Darvon Pulvules are available in:
65 mg capsules with opaque pink body and cap, imprinted with the script "Darvon" on the body, in edible black ink.
They are available as follows:
Bottles of 100........................NDC 66479-510-10
Storage: Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].
Inform patients of the availability of a Medication Guide for Darvon/Darvon-N that accompanies each prescription dispensed. Instruct patients to read the Darvon/Darvon-N Medication Guide prior to using Darvon.
Marketed by: X-nodyne pharmaceuticals, inc. Newport, KY 41071. REV. 09-2009.
Last updated on RxList: 10/12/2009
In hospitalized patients, the most frequently reported were dizziness, sedation, nausea, and vomiting. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, and minor visual disturbances.
The most frequently reported postmarketing adverse events have included completed suicide, accidental and intentional overdose, drug dependence, cardiac arrest, coma, drug ineffective, drug toxicity, nausea, respiratory arrest, cardio-respiratory arrest, death, vomiting, dizziness, convulsion, confusional state, and diarrhea.
Additional adverse experiences reported through postmarketing surveillance include:
Cardiac disorders: arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI)
Eye disorder: eye swelling, vision blurred
General disorder and administration site conditions: , drug interaction, drug tolerance, drug withdrawal syndrome
Gastrointestinal disorder: gastrointestinal bleed, acute pancreatitis
Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury
Immune system disorder: hypersensitivity
Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose
Investigations: blood pressure decreased, heart rate elevated/abnormal
Metabolism and nutrition disorder: metabolic acidosis
Nervous system disorder: ataxia, coma, dizziness, somnolence, syncope
Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change
Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea
Skin and subcutaneous tissue disorder: rash, itch
Liver dysfunction has been reported in association with Darvon. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice).
Subacute painful myopathy has been reported following chronic propoxyphene overdosage.
Darvon is a Schedule IV narcotic under the U.S. Controlled Substances Act. Darvon can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Darvon should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications.
Since Darvon is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing Darvon.
Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug after long term administration. Also, symptoms of withdrawal may be precipitated through the administration of drugs with mu-opioid antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine, dezocine) (see OVERDOSAGE). Physical dependence usually does not occur to a clinically significant degree, until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of an analgesic effect and subsequently, by decreases in the intensity of analgesia.
In chronic pain patients, and in opioid-tolerant cancer patients, the administration of Darvon should be guided by the degree of tolerance manifested and the doses needed to adequately relieve pain.
The severity of the Darvon abstinence syndrome may depend on the degree of physical dependence. Withdrawal is characterized by rhinitis, myalgia, abdominal cramping, and occasional diarrhea. Most observable symptoms disappear in 5 to 14 days without treatment; however, there may be a phase of secondary or chronic abstinence which may last for 2 to 6 months characterized by insomnia, irritability, and muscular aches. The patient may be detoxified by gradual reduction of the dose. Gastrointestinal disturbances or dehydration should be treated with supportive care.
Propoxyphene is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when propoxyphene is administered concurrently with agents that affect CYP3A4 activity.
The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of propoxyphene. Strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.
Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties and coadministration with drugs that rely on either of these enzymes for metabolism may result in increased pharmacologic or adverse effects of that drug. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine (metabolized by CYP3A4).
Increased risk of bleeding has been observed with warfarin-like agents when given along with propoxyphene; however, the mechanistic basis of this interaction is unknown.
Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with propoxyphene may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Darvon. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as Darvon. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Darvon and/or may precipitate withdrawal symptoms in these patients.
MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of Darvon is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
Last updated on RxList: 10/12/2009
There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.
Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Darvon should be used with extreme caution in patients with significant chronic obstructive pulmonary disease (COPD) or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Darvon may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Darvon, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Darvon may produce orthostatic hypotension in ambulatory patients. Darvon, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
The concomitant use of propoxyphene and CNS depressants, including alcohol, can result in potentially serious adverse events including death. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs.
Propoxyphene may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.
Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents that can lead to death.
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).
If Darvon is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see Drug Abuse And Dependence). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of Darvon combined with symptomatic support (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).
Darvon may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like Darvon may cause increases in the serum amylase level.
Insufficient information exists to make appropriate dosing recommendations regarding the use of either propoxyphene in patients with hepatic or renal impairment as a function of degree of impairment. Higher plasma concentrations and/or delayed elimination may occur in case of impaired hepatic function and/or impaired renal function (see CLINICAL PHARMACOLOGY).
If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of propoxyphene metabolites.
The mutagenic and carcinogenic potential of propoxyphene has not been evaluated.
In animal studies there was no effect of propoxyphene on mating behavior, fertility, duration of gestation, or parturition when rats were fed propoxyphene as a component of their daily diet at estimated daily propoxyphene intake up to eightfold greater than the maximum human equivalent dose (HED) based on body surface area comparison. At this highest dose, fetal weight and survival on postnatal day 4 was reduced
Pregnancy category C.
There are no adequate and well-controlled studies of propoxyphene in pregnant women. While there are limited data in the published literature, adequate animal reproduction studies have not been conducted with propoxyphene. Therefore, it is not known whether propoxyphene can affect reproduction or cause fetal harm when administered to a pregnant woman. Propoxyphene should be given to a pregnant woman only if clearly needed.
Propoxyphene and its major metabolite, norpropoxyphene, cross the human placenta. Neonates whose mothers have taken opiates chronically may exhibit respiratory depression or withdrawal symptoms.
In published animal reproduction studies, no teratogenic effects occurred in offspring born to pregnant rats or rabbits that received propoxyphene during organogenesis. Pregnant animals received propoxyphene doses approximately 10-fold (rats) and 4-fold (rabbits) the maximum recommended human dose (based on mg/m2 body surface area comparison).
Propoxyphene, norpropoxyphene (major metabolite), are excreted in human milk. Published studies of nursing mothers using propoxyphene detected no adverse effects in nursing infants. Based on a study of six mother-infant pairs, an exclusively breastfed infant receives approximately 2% of the maternal weight-adjusted dose. Norpropoxyphene is renally excreted, and renal clearance is lower in neonates than in adults. Therefore, it is possible that prolonged maternal propoxyphene use could result in norpropoxyphene accumulation in a breastfed infant. Watch breastfeeding infants for signs of sedation including poor feeding, somnolence, or respiratory depression. Caution should be exercised when Darvon is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Darvon did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, postmarketing reports suggest that patients over the age of 65 may be more susceptible to CNS-related side effects. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Decreased total daily dosage should be considered (see DOSAGE AND ADMINISTRATION).
Last updated on RxList: 10/12/2009
Overdose of Darvon may present with the signs and symptoms of propoxyphene overdose. Fatalities within the first hour of overdosage are not uncommon.
In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdose. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts.
Initial consideration should be given to the management of the CNS effects of propoxyphene overdosage. Resuscitative measures should be initiated promptly.
The manifestations of acute overdosage with propoxyphene are those of narcotic 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.
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.
Darvon is contraindicated in patients with known hypersensitivity to propoxyphene.
Darvon is contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia.
Darvon is contraindicated in any patient who has or is suspected of having paralytic ileus.
Last updated on RxList: 10/12/2009
Propoxyphene is a centrally acting opiate analgesic. In vitro studies demonstrated propoxyphene and the metabolite norpropoxyphene inhibit sodium channels (local anesthetic effect) with norpropoxyphene being approximately 2-fold more potent than propoxyphene and propoxyphene approximately 10-fold more potent than lidocaine. Propoxyphene and norpropoxyphene inhibit the voltage-gated potassium current carried by cardiac rapidly activating delayed rectifier (hERG) channels with approximately equal potency. It is unclear if the effects on ion channels occur within therapeutic dose range.
Peak plasma concentrations of propoxyphene are reached in 2 to 2.5 h. After a 65-mg oral dose of propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 µg/mL for propoxyphene and 0.1 to 0.2 µg/mL for norpropoxyphene (major metabolite) are achieved. Repeated doses of propoxyphene at 6 h intervals lead to increasing plasma concentrations, with a plateau after the ninth dose at 48 h. Propoxyphene has a half-life of 6 to 12 h, whereas that of norpropoxyphene is 30 to 36 h.
Propoxyphene is about 80% bound to proteins and has a large volume of distribution, 16 L/kg.
Propoxyphene undergoes extensive first-pass metabolism by intestinal and hepatic enzymes. The major route of metabolism is cytochrome CYP3A4 mediated N-demethylation to norpropoxyphene, which is excreted by the kidneys. Ring hydroxylation and glucuronide formation are minor metabolic pathways.
In 48 h, approximately 20 to 25% of the administered dose of propoxyphene is excreted via the urine, most of which is free or conjugated norpropoxyphene. The renal clearance rate of propoxyphene is 2.6 L/min.
After oral administration of propoxyphene in elderly patients (70-78 years), much longer half-lives of propoxyphene and norpropoxyphene have been reported (propropoxyphene 13 to 35 h, norpropoxyphene 22 to 41 h). In addition, the AUC was an average of 3-fold higher and the Cmax was an average of 2.5-fold higher in the elderly when compared to a younger (20-28 years) population. Longer dosage intervals may be considered in the elderly because the metabolism of propoxyphene may be reduced in this patient population. After multiple oral doses of propoxyphene in elderly patients (70-78 years), the Cmax of the metabolite (norpropoxyphene) was increased 5-fold.
Propoxyphene has not been studied in pediatric patients.
No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe hepatic impairment.
After oral administration of propoxyphene in patients with cirrhosis, plasma concentrations of propoxyphene were considerably higher and norpropoxyphene concentrations were much lower than in control patients. This is presumably because of a decreased first-pass metabolism of orally administered propoxyphene in these patients. The AUC ratio of norpropoxyphene: propoxyphene was significantly lower in patients with cirrhosis (0.5 to 0.9) than in controls (2.5 to 4).
No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe renal impairment.
After oral administration of propoxyphene in anephric patients, the AUC and Cmax values were an average of 76% and 88% greater, respectively. Dialysis removes only insignificant amounts (8%) of administered dose of propoxyphene.
The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. On the other hand, strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.
Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties. Coadministration with a drug that is a substrate of CYP3A4 or CYP2D6, may result in higher plasma concentrations and increased pharmacologic or adverse effects of that drug.
Last updated on RxList: 10/12/2009
MEDICATION GUIDE
DARVON-N®
[dar-von-N]
(propoxyphene napsylate) Tablets
DARVON® [dar-von]
(propoxyphene hydrochloride) Capsules Pulvules®
Read this Medication Guide before you start taking Darvon-N or Darvon, 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 Darvon-N and Darvon?
Darvon-N and Darvon, and other medicines that contain propoxyphene can cause serious side effects, including:
Overdoses by accident or on purpose (intentional overdose). Overdoses with Darvon-N and Darvon may happen when it is taken by itself, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.
Many of the deaths that happen in people who take Darvon-N and Darvon happen in those who:
Take Darvon-N and Darvon exactly as prescribed. Do not change your dose or stop taking Darvon-N or Darvon without first talking to your doctor.
What are Darvon-N and Darvon?
It is not known if Darvon-N and Darvon are safe and effective in children younger than age 18.
Who should not take Darvon-N or Darvon?
Do not take Darvon-N or Darvon if you:
What should I tell my doctor before taking Darvon-N or Darvon?
Before you take Darvon-N or Darvon, tell your doctor:
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Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins, and herbal supplements. Darvon-N and Darvon interacts 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 Darvon-N and Darvon?”
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 Darvon-N or Darvon?
See “What is the most important information I should know about Darvon-N and Darvon?”
Signs and symptoms of an overdose of Darvon-N or Darvon include:
What are the possible side effects of Darvon-N and Darvon?
Darvon-N and Darvon can cause serious side effects, including:
See “What is the most important information I should know about Darvon-N and Darvon?”
Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking Darvon-N or Darvon. You may need to stop Darvon-N or Darvon more slowly.
Common side effects of Darvon-N and Darvon include:
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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 Xanodyne Pharmaceuticals, Inc. at 1-877-773-7793.
How should I store Darvon-N and Darvon?
Keep Darvon-N, Darvon and all medicines out of the reach of children.
General information about Darvon-N and Darvon
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Darvon-N or Darvon for a purpose for which it was not prescribed. Do not give Darvon-N or Darvon 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 Darvon-N and Darvon. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Darvon-N and Darvon that is written for health professionals. For more information, go to www.Xanodyne.com or call 1-877-773-7793.
What are the ingredients in Darvon-N and Darvon?
Darvon-N:
Active ingredient: propoxyphene napsylate
Inactive ingredients: cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide
Darvon:
Active ingredient: propoxyphene hydrochloride
Inactive ingredients: D & C Red No. 33, FD & C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Last updated on RxList: 10/12/2009
IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
PROPOXYPHENE - ORAL
(pro-POX-ee-feen)
COMMON BRAND NAME(S): Darvon, Darvon-N
WARNING: Propoxyphene has caused death when taken in large doses, either alone or with alcohol/drugs that can cause drowsiness (e.g., antidepressants, sedatives, muscle relaxants). Do not take this medication more often or use a larger dose than prescribed. Limit alcoholic beverages. Before taking this medication, tell your doctor or pharmacist of all the medications you may use.
USES: This medication is used to treat mild-to-moderate pain. It acts on certain centers in the brain to give you pain relief. This medication is a narcotic pain reliever (opiate-type).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using propoxyphene and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually every 4 hours or as directed by your doctor. Do not take more than 6 tablets/capsules in a 24-hour period. If you have nausea, you may take this drug with food. Also, consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to therapy. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
You may also take long-acting narcotic medications or use narcotic patches for ongoing pain if so directed by your doctor. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Also follow your doctor's or pharmacist's instructions for safely using non-narcotic pain relievers (e.g., naproxen, ibuprofen). Ask your doctor or pharmacist if you have any questions.
This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., restlessness, watery eyes, runny nose) may occur if you suddenly stop this drug. To prevent withdrawal reactions when stopping extended, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Inform your doctor if your pain persists or worsens.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).
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: slow/shallow breathing, mental/mood changes, vision changes, dark urine, yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, 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.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking propoxyphene, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., methadone, morphine) or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: personal or family history of regular use/abuse of drugs/alcohol, thoughts of suicide or history of suicide attempt, intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives), infectious diarrhea.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia, hypercapnia), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis, depression), a certain spinal problem (kyphoscoliosis), gallbladder disease, kidney disease, liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), intestinal diseases (e.g., colitis), recent bowel/abdominal surgery.
This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. Limit alcoholic beverages because they may increase the risk of this drug's side effects.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.
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 possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants 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. Tell your doctor immediately if you notice any of these symptoms in your newborn.
This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
This drug should not be used with the following medication because a very serious interaction may occur: naltrexone.
If you are currently using this medication listed above, tell your doctor or pharmacist before starting propoxyphene.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), carbamazepine, cimetidine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), other medications for pain (e.g., pentazocine, nalbuphine), ritonavir, tipranavir, tricyclic antidepressants (e.g., doxepin).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow/irregular heartbeat, loss of consciousness, muscle pain, seizures.
NOTES: Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
MISSED DOSE: If you take this medication regularly and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
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