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Propoxyphene
Overview
What is Propoxyphene?
Propoxyphene hydrochloride, USP is an odorless, white crystalline
powder with a bitter taste. It is freely soluble in water. Chemically, it is
(2,3)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol
propionate (ester) hydrochloride, which can be represented by the accompanying
structural formula. Its molecular formula is CHNO∙HCl and its molecular weight is
375.93.
What does Propoxyphene look like?
What are the available doses of Propoxyphene?
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What should I talk to my health care provider before I take Propoxyphene?
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How should I use Propoxyphene?
Propoxyphene hydrochloride capsules are indicated for the relief
of mild to moderate pain.
Propoxyphene hydrochloride capsules 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 hydrochloride capsules are given orally. The usual dosage is one
65 mg propoxyphene hydrochloride capsule every 4 hours as needed for pain. The
maximum dose of propoxyphene hydrochloride capsules is 6 capsules per day.
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 propoxyphene hydrochloride capsules on a
regular basis for a period of time, when therapy with propoxyphene hydrochloride
capsules is no longer needed for the treatment of their pain, it may be useful
to gradually discontinue the propoxyphene hydrochloride capsules 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 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.
What interacts with Propoxyphene?
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What are the warnings of Propoxyphene?
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What are the precautions of Propoxyphene?
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What are the side effects of Propoxyphene?
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What should I look out for while using Propoxyphene?
Propoxyphene hydrochloride capsules are contraindicated in
patients with known hypersensitivity to propoxyphene.
Propoxyphene hydrochloride capsules 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 hydrochloride capsules are contraindicated in any patient who
has or is suspected of having paralytic ileus.
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. Propoxyphene 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 preexisting respiratory depression. In such patients,
even usual therapeutic doses of propoxyphene 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.
Propoxyphene, 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 may produce orthostatic hypotension in ambulatory patients.
Propoxyphene, 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 preexisting
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.
What might happen if I take too much Propoxyphene?
Overdose of propoxyphene 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 CO (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.
How should I store and handle Propoxyphene?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP.The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with over in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows:NDC 0378-7065-01bottles of 100 capsulesNDC 0378-7065-05bottles of 500 capsulesStore at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Propoxyphene is a centrally acting opiate analgesic. 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 hours. After a 65 mg oral dose of propoxyphene hydrochloride, peak plasma
levels of 0.05 to 0.1 mcg/mL for propoxyphene and 0.1 to 0.2 mcg /mL for
norpropoxyphene (major metabolite) are achieved. Repeated doses of propoxyphene
at 6 hour intervals lead to increasing plasma concentrations, with a plateau
after the ninth dose at 48 hours. Propoxyphene has a half-life of 6 to 12 hours,
whereas that of norpropoxyphene is 30 to 36 hours.
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 hours, 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
to 78 years), much longer half-lives of propoxyphene and norpropoxyphene have
been reported (propropoxyphene 13 to 35 hours, norpropoxyphene 22 to 41 hours).
In addition, the AUC was an average of 3-fold higher and the C was an average of 2.5-fold higher in the elderly when
compared to a younger (20 to 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 to 78 years), the C 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
C 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.
Non-Clinical Toxicology
Propoxyphene hydrochloride capsules are contraindicated in patients with known hypersensitivity to propoxyphene.Propoxyphene hydrochloride capsules 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 hydrochloride capsules are contraindicated in any patient who has or is suspected of having paralytic ileus.
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. Propoxyphene 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 preexisting respiratory depression. In such patients, even usual therapeutic doses of propoxyphene 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.
Propoxyphene, 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 may produce orthostatic hypotension in ambulatory patients. Propoxyphene, 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 preexisting 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.
There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.
Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.
False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.
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 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 combined with symptomatic support (see ).
Propoxyphene 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 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 ).
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.
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 propoxyphene. 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 propoxyphene. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of propoxyphene 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 propoxyphene is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
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 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
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/mbody 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 breast-feeding infants for signs of sedation including poor feeding, somnolence or respiratory depression. Caution should be exercised when propoxyphene is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of propoxyphene did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, post-marketing 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 ).
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 post-marketing 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 post-marketing 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 propoxyphene. 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.
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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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. 315.72Tips
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Interactions
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).