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OXYMORPHONE HYDROCHLORIDE
Overview
What is Opana ER?
11 DESCRIPTION
OPANA ER (oxymorphone hydrochloride) extended-release is a semi-synthetic opioid analgesic supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: hypromellose, methylparaben, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx-N, titanium dioxide, and triacetin. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets also contain macrogol, and polysorbate 80. In addition, the 5 mg, 7.5 mg and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FDandC yellow No. 6. The 20 mg tablets contain FDandC blue No. 1, FDandC yellow No. 6, and DandC yellow No. 10. The 40 mg tablets contain FDandC yellow No. 6, DandC yellow No. 10, and lactose monohydrate.
Chemically, oxymorphone hydrochloride is 4, 5-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98.
The structural formula for oxymorphone hydrochloride is as follows:
What does Opana ER look like?
What are the available doses of Opana ER?
3 DOSAGE FORMS AND STRENGTHS
The 5 mg dosage form is a pink, octagon shape, film coated, convex extended-release tablets debossed with “5” on one side and plain on the other.
The 7.5 mg dosage form is a gray, octagon shape, film coated, convex extended-release tablets debossed with “7 ½” on one side and plain on the other.
The 10 mg dosage form is a light orange, octagon shape, film coated, convex extended-release tablets debossed with “10” on one side and plain on the other.
The 15 mg dosage form is a white, octagon shape, film coated, convex extended-release tablets debossed with “15” on one side and plain on the other.
The 20 mg dosage form is a light green, octagon shape, film coated, convex extended-release tablets debossed with “20” on one side and plain on the other.
The 30 mg dosage form is a red, octagon shape, film coated, convex extended-release tablets debossed with “30” on one side and plain on the other.
The 40 mg dosage form is a yellow, octagon shape, film coated, convex extended-release tablets debossed with “40” on one side and plain on the other.
What should I talk to my health care provider before I take Opana ER?
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
The safety of using oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of OPANA ER in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.
Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence.
Teratogenic EffectsPregnancy Category CThere are no adequate and well-controlled studies of oxymorphone in pregnant women. OPANA ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see ].
Oxymorphone hydrochloride administration did not cause malformations at any doses evaluated during developmental toxicity studies in rats (less than or equal to 25 mg/kg/day) or rabbits (less than or equal to 50 mg/kg/day). These doses are 3-fold and 12-fold the human dose of 40 mg every 12 hours, based on body surface area. There were no developmental effects in rats treated with 5 mg/kg/day or rabbits treated with 25 mg/kg/day. Fetal weights were reduced in rats and rabbits given doses of greater than or equal to 10 mg/kg/day and 50 mg/kg/day, respectively. These doses are 1.2-fold and 12-fold the human dose of 40 mg every 12 hours based on body surface area, respectively. There were no effects of oxymorphone hydrochloride on intrauterine survival in rats at doses less than or equal to 25 mg/kg/day, or rabbits at less than or equal to 50 mg/kg/day in these studies (see Non-teratogenic Effects, below). In a study that was conducted prior to the establishment of Good Laboratory Practices (GLP) and not according to current recommended methodology, a single subcutaneous injection of oxymorphone hydrochloride on gestation day 8 was reported to produce malformations in offspring of hamsters that received 15.5-fold the human dose of 40 mg every 12 hours based on body surface area. This dose also produced 20% maternal lethality.
Non-teratogenic EffectsOxymorphone hydrochloride administration to female rats during gestation in a pre- and postnatal developmental toxicity study reduced mean litter size (18%) at a dose of 25 mg/kg/day, attributed to an increased incidence of stillborn pups. An increase in neonatal death occurred at greater than or equal to 5 mg/kg/day. Post-natal survival of the pups was reduced throughout weaning following treatment of the dams with 25 mg/kg/day. Low pup birth weight and decreased postnatal weight gain occurred in pups born to oxymorphone-treated pregnant rats given a dose of 25 mg/kg/day. This dose is ~ 3-fold higher than the human dose of 40 mg every 12 hours on a body surface area basis.
How should I use Opana ER?
1 INDICATIONS AND USAGE
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
Limitations of UsageOPANA ER is not intended for use as an as needed analgesic.
OPANA ER is not indicated for pain in the immediate post-operative period if the pain is mild, or not expected to persist for an extended period of time.
OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines).
2 DOSAGE AND ADMINISTRATION
2.1 Safe Administration Instructions
OPANA ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
While symmetric (same dose AM and PM), around-the-clock, every 12 hours dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one extended-release opioid for around-the-clock therapy.
Selection of patients for treatment with OPANA ER should be governed by the same principles that apply to the use of other extended-release opioid analgesics [see ]. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring [see ].
2.2 Initiating Therapy with OPANA ER It is necessary to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of OPANA ER, attention should be given to the following:
- total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;- relative potency estimate used to calculate the equivalent oxymorphone dose needed;- patient’s degree of opioid tolerance;- age, general condition, and medical status of the patient;- concurrent non-opioid analgesics and other medications;- type and severity of the patient’s pain;- balance between pain control and adverse experiences;- risk factors for abuse or addiction, including a prior history of abuse or addiction.
Once therapy is initiated, frequently assess pain relief and other opioid effects. Base the titration of the total daily OPANA ER dose upon the amount of supplemental opioid utilization, severity of the patient’s pain, and the patient’s ability to tolerate the opioid. Titrate dose to generally mild or no pain with the regular use of no more than two doses of supplemental analgesia, i.e. “rescue,” per 24 hours. Patients who experience breakthrough pain may require dosage adjustment.
If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of an immediate-release opioid, or a non-opioid analgesic may be administered. Adjust dosing to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are adequately managed, continue upward titration to an acceptable level of pain control.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family. Advise patients and caregivers/family members of the potential adverse reactions.
The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Titrate dose to adequate pain relief (generally mild or no pain).
Administer OPANA ER on an empty stomach, at least one hour prior to or two hours after eating [see ].
Opioid-Naïve PatientsThe initial dose for patients who are not opioid-experienced and who are being initiated on chronic around-the-clock opioid therapy with OPANA ER is 5 mg every 12 hours. Thereafter, titrate the dose individually at increments of 5-10 mg every 12 hours every 3-7 days, to a level that provides adequate analgesia and minimizes side effects under the close supervision of the prescribing physician.
Opioid-Experienced PatientsConversion from OPANA to OPANA ERPatients receiving OPANA may be converted to OPANA ER by administering half the patient's total daily oral OPANA dose as OPANA ER, every 12 hours.
Conversion from Parenteral Oxymorphone to OPANA ERGiven OPANA ER’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA ER by administering 10 times the patient's total daily parenteral oxymorphone dose as OPANA ER in two equally divided doses (e.g., [IV dose x 10] divided by 2). Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side effects.
Conversion from Other Oral Opioids to OPANA ERFor conversion from other opioids to OPANA ER, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start the OPANA ER therapy by administering half of the calculated total daily dose of OPANA ER (see conversion ratio table below) in 2 divided doses, every 12 hours. Gradually adjust the initial dose of OPANA ER until adequate pain relief and acceptable side effects have been achieved.
The following table provides approximate equivalent doses, which may be used as a guideline for conversion. The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to OPANA ER. In a Phase 3 clinical trial with an open-label titration period, patients were converted from their current opioid to OPANA ER using the following table as a guide. There is substantial patient variation in the relative potency of different opioid drugs and formulations.
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What should I look out for while using Opana ER?
4 CONTRAINDICATIONS
OPANA ER is contraindicated in patients who have:
- significant respiratory depression- or are suspected of having paralytic ileus- acute or severe bronchial asthma or hypercarbia- moderate and severe hepatic impairment [see , ,].- known hypersensitivity to any of its components or the active ingredient, oxymorphone or with known hypersensitivity to morphine analogs such as codeine.
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE
Potential for AbuseOPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ()Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. ()
Proper Patient SelectionOPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. ()
Limitations of UseOPANA ER is NOT intended for use as an as needed analgesic. ()OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone. ()
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone. ()
What might happen if I take too much Opana ER?
10 OVERDOSAGE
10.1 Symptoms
Acute overdosage with OPANA ER is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils and sometimes bradycardia and hypotension. In some cases, apnea, circulatory collapse, cardiac arrest and death may occur.
OPANA ER may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see ].
10.2 Treatment
In the treatment of OPANA ER overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression that may result from overdosage or unusual sensitivity to opioids including OPANA ER. Nalmefene is an alternative pure opioid antagonist, which may be administered as a specific antidote to respiratory depression resulting from opioid overdose. Since the duration of action of OPANA ER may exceed that of the antagonist, keep the patient under continued surveillance and administer repeated doses of the antagonist according to the antagonist labeling as needed to maintain adequate respiration.
In patients receiving OPANA ER, opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression. Administer opioid antagonists cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including OPANA ER. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. If respiratory depression is associated with muscular rigidity, administration of a neuromuscular blocking agent may be necessary to facilitate assisted or controlled ventilation. Muscular rigidity may also respond to opioid antagonist therapy.
How should I store and handle Opana ER?
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Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Oxymorphone, a pure opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses.
The precise mechanism of analgesia, the principal therapeutic action of oxymorphone, is unknown. Specific central nervous system (CNS) opiate receptors and endogenous compounds with morphine-like activity have been identified throughout the brain and spinal cord and are likely to play a role in the expression and perception of analgesic effects. In addition, opioid receptors have also been identified within the peripheral nervous system (PNS). The role that these receptors play in these drugs’ analgesic effects is unknown.
Non-Clinical Toxicology
4 CONTRAINDICATIONS OPANA ER is contraindicated in patients who have: - significant respiratory depression- or are suspected of having paralytic ileus- acute or severe bronchial asthma or hypercarbia- moderate and severe hepatic impairment [see , ,].- known hypersensitivity to any of its components or the active ingredient, oxymorphone or with known hypersensitivity to morphine analogs such as codeine.WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE
Potential for AbuseOPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ()Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. ()
Proper Patient SelectionOPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. ()
Limitations of UseOPANA ER is NOT intended for use as an as needed analgesic. ()OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone. ()
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone. ()
Drug Interactions
Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
5 WARNINGS AND PRECAUTIONS 5.1 Information Essential for Safe Administration OPANA ER tablets are to be swallowed whole, and are not to be broken, chewed, crushed or dissolved. Taking broken, chewed, crushed or dissolved OPANA ER tablets could lead to the rapid release and absorption of a potentially fatal dose of oxymorphone [see ]. Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see ]. Instruct patients against use by individuals other than the patient for whom OPANA ER was prescribed, as such inappropriate use may have severe medical consequences, including death. 5.2 Respiratory DepressionRespiratory depression is the chief hazard of OPANA ER. Respiratory depression is a potential problem in elderly or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Administer OPANA ER with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma. In these patients, even usual therapeutic doses of oxymorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Consider alternative non-opioid analgesics and use OPANA ER only under careful medical supervision at the lowest effective dose in such patients. 5.3 Misuse, Abuse and Diversion of OpioidsOPANA ER contains oxymorphone, a mu opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This issue should be considered when prescribing or dispensing oxymorphone in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. OPANA ER tablets may be abused by crushing, chewing, snorting or injecting the product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death [see ]. OPANA ER may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of OPANA ER. Healthcare professionals should advise patients to store OPANA ER in a secure place, preferably locked and out of the reach of children and other non-caregivers. Concerns about abuse, misuse, diversion and addiction should not prevent the proper management of pain. 5.4 Interactions with Alcohol and other CNS DepressantsPatients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with oxymorphone may experience respiratory depression, hypotension, profound sedation, coma and death [see ]. Avoid concurrent use of alcohol and OPANA ER [see ]. 5.5 Use in Patients with Head Injury and Increased Intracranial PressureIn the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of opioid analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, opioid analgesics can produce effects on papillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. Administer OPANA ER with extreme caution to patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted. 5.6 Hypotensive EffectOPANA ER may cause severe hypotension in a patient 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 that compromise vasomotor tone. Administer OPANA ER with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. 5.7 Hepatic ImpairmentA study of OPANA ER in patients with hepatic disease indicated greater plasma concentrations than those with normal hepatic function [See ]. Use OPANA ER with caution in patients with mild impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects [see ]. OPANA ER is contraindicated in patients with moderate or severe hepatic impairment. 5.8 Special Risk GroupsUse OPANA ER with caution in the following conditions: adrenocortical insufficiency (e.g., Addison's disease), prostatic hypertrophy or urethral stricture, severe impairment of pulmonary or renal function, and toxic psychosis. Opioids may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. 5.9 Gastrointestinal EffectsOPANA ER decreases bowel motility. Opioids diminish propulsive peristaltic waves in the gastrointestinal tract. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of OPANA ER may obscure the diagnosis or clinical course in patients with acute abdominal conditions. OPANA ER is contraindicated in patients with paralytic ileus. 5.10 Ambulatory Surgery and Post-Operative UseOPANA ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain). OPANA ER is only indicated for postoperative use in the patient if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines). Patients who are already receiving OPANA ER as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention. 5.11 Use in Pancreatic/Biliary Tract DiseaseOPANA ER, like other opioids, may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. 5.12 Driving and Operating MachineryOpioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: - Respiratory depression [see ]- Misuse and abuse [see and ]- CNS depressant effects [see ]
6.1 Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of OPANA ER was evaluated in a total of 2011 patients in controlled clinical trials. The clinical trials consisted of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain. Tables 1 and 2 list the most frequently occurring adverse reactions (in at least 5% of patients) from the placebo-controlled trials in patients with low back pain.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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