Propoxyphene and Acetaminophen

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Overview

What is Propoxyphene 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 (α,1)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-napthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula.

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 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) 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 CHNO and the molecular weight is 151.16. It may be represented by the following structural formula.

Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg

Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg

What does Propoxyphene and Acetaminophen look like?

What are the available doses of Propoxyphene and Acetaminophen?

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What should I talk to my health care provider before I take Propoxyphene and Acetaminophen?

How should I use Propoxyphene and Acetaminophen?

Propoxyphene napsylate and acetaminophen tablets, USP are indicated for the relief of mild to moderate pain.

Propoxyphene napsylate and acetaminophen tablets 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 100 mg/650 mg

Do not exceed the maximum daily dose.

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.

What interacts with Propoxyphene and Acetaminophen?

Propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen.

Propoxyphene napsylate and acetaminophen tablets are 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.

Propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

What are the warnings of Propoxyphene and Acetaminophen?

Risk of Overdose

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

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. Propoxyphene napsylate and acetaminophen should be used with extreme caution in patients with significant chronic obstructive pulmonary disease 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 propoxyphene napsylate and acetaminophen 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.

Hypotensive Effect

Propoxyphene napsylate and acetaminophen, 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. Propoxyphene napsylate and acetaminophen may produce orthostatic hypotension in ambulatory patients. Propoxyphene napsylate and acetaminophen, 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.

Head Injury and Increased Intracranial 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.

Drug Interactions

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.

Usage in Ambulatory Patients

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.

Use with Other Acetaminophen-Containing Agents

Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, propoxyphene napsylate and acetaminophen should not be used concomitantly with other acetaminophen-containing products.

Use with Alcohol

Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses of acetaminophen. 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.

What are the precautions of Propoxyphene and Acetaminophen?

Tolerance and Physical Dependence

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 ).

If propoxyphene napsylate and acetaminophen is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see ). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of propoxyphene napsylate and acetaminophen combined with symptomatic support (see ).

Use in Pancreatic/Biliary Tract Disease

Propoxyphene napsylate and acetaminophen 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 propoxyphene napsylate and acetaminophen may cause increases in the serum amylase level.

Hepatic or Renal Impairment

Insufficient information exists to make appropriate dosing recommendations regarding the use of either propoxyphene alone or in combination with acetaminophen 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 ). If the drug is used in these patients, it should be used with caution because of the hepatic metabolism of propoxyphene and acetaminophen and renal excretion of their metabolites.

Information for Patients/Caregivers

Drug Interactions with Propoxyphene

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.

CNS Depressants

Mixed Agonist/Antagonist Opioid Analgesics

Monoamine Oxidase Inhibitors (MAOIs)

Drug Interactions with Acetaminophen

Alcohol

Anticholinergics

Oral Contraceptives

Beta Blockers (Propranolol)

Loop Diuretics

Lamotrigine

Probenecid

Zidovudine

Carcinogenesis, Mutagenesis, Impairment of Fertility

The mutagenic and carcinogenic potential of propoxyphene and acetaminophen alone and in combination have 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 8-fold 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. Acetaminophen has not been studied in animals for effects on fertility and the effects on human fertility are unknown.

Pregnancy

Risk summary

Clinical considerations

Data

Nursing Mothers

Propoxyphene, norpropoxyphene (major metabolite), and acetaminophen 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 propoxyphene napsylate and acetaminophen is administered to a nursing woman.

Pediatric Patients

Safety and effectiveness in pediatric patients have not been established.

Elderly Patients

Clinical studies of propoxyphene napsylate and acetaminophen 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 ).

What are the side effects of Propoxyphene and Acetaminophen?

During clinical trials, the most frequently reported adverse reactions 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:

Eye disorder:

General disorder and administration site conditions:

Gastrointestinal disorder:

Hepatobiliary disorder:

Immune system disorder:

Injury poisoning and procedural complications:

Investigations:

Metabolism and nutrition disorder:

Nervous system disorder:

Psychiatric:

Respiratory, thoracic, and mediastinal disorders:

Skin and subcutaneous tissue disorder:

Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophen tablets. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see ). In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred.

There have also been postmarketing reports of renal papillary necrosis associated with chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin. Subacute painful myopathy has been reported following chronic propoxyphene overdosage.

What should I look out for while using Propoxyphene and Acetaminophen?

Propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen.

Propoxyphene napsylate and acetaminophen tablets are 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.

Propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

What might happen if I take too much Propoxyphene and Acetaminophen?

Propoxyphene napsylate and acetaminophen is a combination product containing propoxyphene and acetaminophen. Overdose of propoxyphene napsylate and acetaminophen may present with the signs and symptoms of propoxyphene overdose, acetaminophen overdose or both. 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.

How should I store and handle Propoxyphene and Acetaminophen?

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyStore at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from excessive light and humidity.Dispense in a tight, light-resistant container according to USP/NF.*AN69 is a registered trademark of Hospal Ltd.WockhardtThis Product was Repackaged By:State of Florida DOH Central PharmacyPropoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side.Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows:Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side.White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side.Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side.They are supplied by as follows:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pharmacology

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.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is mediated through activity in the hypothalamic heat-regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Non-Clinical Toxicology

Propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen.

Propoxyphene napsylate and acetaminophen tablets are 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.

Propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

Alcohol

Anticholinergics

Oral Contraceptives

Beta Blockers (Propranolol)

Loop Diuretics

Lamotrigine

Probenecid

Zidovudine

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 ).

If propoxyphene napsylate and acetaminophen is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see ). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of propoxyphene napsylate and acetaminophen combined with symptomatic support (see ).

During clinical trials, the most frequently reported adverse reactions 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:

Eye disorder:

General disorder and administration site conditions:

Gastrointestinal disorder:

Hepatobiliary disorder:

Immune system disorder:

Injury poisoning and procedural complications:

Investigations:

Metabolism and nutrition disorder:

Nervous system disorder:

Psychiatric:

Respiratory, thoracic, and mediastinal disorders:

Skin and subcutaneous tissue disorder:

Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophen tablets. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see ). In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred.

There have also been postmarketing reports of renal papillary necrosis associated with chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin. Subacute painful myopathy has been reported following chronic propoxyphene overdosage.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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