HYDROmorphone HCl 8 MG Oral Tablet

Brand Name: Hydromorphone Hydrochloride
  • Substance Name(s):


Respiratory Depression Respiratory depression is the chief hazard of hydromorphone hydrochloride tablets and oral solution. Respiratory depression is more likely to occur in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation. Hydromorphone hydrochloride tablets and oral solution should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or in patients with preexisting respiratory depression. In such patients even usual therapeutic doses of opioid analgesics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Hydromorphone hydrochloride tablets and oral solution contain hydromorphone, which is a potent Schedule II controlled opioid agonist. Schedule II opioid agonists, including morphine, oxymorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids and central nervous system depressants (sedative-hypnotics) potentiate the respiratory depressant effects of hydromorphone, increasing the risk of respiratory depression that might result in death. Misuse, Abuse, and Diversion of Opioids Hydromorphone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Hydromorphone hydrochloride tablets and oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydromorphone hydrochloride in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Prescribers should monitor all patients receiving opioids for signs of abuse, misuse, and addiction. Furthermore, patients should be assessed for their potential for opioid abuse prior to being prescribed opioid therapy. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness (e.g., depression). Opioids may still be appropriate for use in these patients, however, they will require intensive monitoring for signs of abuse. Hydromorphone hydrochloride tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices pose a significant risk to the abuser that could result in overdose or death (see and DRUG ABUSE AND DEPENDENCE). Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Interactions with Alcohol and Drugs of Abuse Hydromorphone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Neonatal Withdrawal Syndrome Infants born to mothers physically dependent on hydromorphone hydrochloride will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms (see DRUG ABUSE AND DEPENDENCE). Head Injury and Increased Intracranial Pressure The respiratory depressant effects of hydromorphone hydrochloride tablets and oral solution with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure. Opioid analgesics including hydromorphone hydrochloride tablets and oral solution may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in intracranial pressure in patients with head injuries. Hypotensive Effect Opioid analgesics, including hydromorphone hydrochloride tablets and oral solution, may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics (see PRECAUTIONS: Drug Interactions). Therefore, hydromorphone hydrochloride tablets and oral solution should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.


Drug Interactions Drug Interactions with Other CNS Depressants The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Hydromorphone hydrochloride should not be taken with alcohol. Opioid analgesics, including hydromorphone hydrochloride tablets and oral solution may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression. Interactions with Mixed Agonist/Antagonist Opioid Analgesics Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as hydromorphone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and/or may precipitate withdrawal symptoms in these patients.


Serious overdosage with hydromorphone hydrochloride tablets and oral solution is characterized by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia and hypotension. In serious overdosage, particularly following intravenous injection, apnea, circulatory collapse, cardiac arrest and death may occur. In the treatment of overdosage, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. A potentially serious oral ingestion, if recent, should be managed with gut decontamination. In unconscious patients with a secure airway, instill activated charcoal (30 to 100 g in adults, 1 to 2 g/kg in infants) via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal. Supportive measures (including oxygen, 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, is a specific antidote against respiratory depression which may result from overdosage, or unusual sensitivity to hydromorphone hydrochloride. Therefore, an appropriate dose of this antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression. Naloxone should be administered cautiously to persons who are known, or suspected to be physically dependent on hydromorphone hydrochloride. In such cases, an abrupt or complete reversal of narcotic effects may precipitate an acute withdrawal syndrome. Since the duration of action of hydromorphone hydrochloride may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. Apply other supportive measures when indicated.


Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of hydromorphone hydrochloride is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is: C17H19NO3 ●HCl M.W. 321.81 Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution.


Hydromorphone Hydrochloride Tablets, USP, are supplied as white to off-white, round tablets. The 4 mg tablet is debossed with “4” on one side and “54 196” on the other side. The 8 mg tablet is scored on one side and debossed with product identification “54 425” on the other side. NDC 0054-0264-24 4 mg, 4 x 25 Reverse Numbered Unit Dose NDC 0054-0264-25 4 mg, bottle of 100 NDC 0054-0265-25 8 mg, bottle of 100 Hydromorphone Hydrochloride Oral Solution, USP is supplied as a clear, red solution. NDC 0054-0386-63 1 mg/mL, 473 mL bottle Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Protect from light. A schedule CS-II Narcotic. DEA Order Form is Required. 10007362/01 Revised March 2012 © RLI, 2012


Geriatric Use Clinical studies of hydromorphone hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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 (see INDIVIDUALIZATION OF DOSAGE and PRECAUTIONS).


Hydromorphone Hydrochloride Tablets, USP and Hydromorphone Hydrochloride Oral Solution, USP are indicated for the management of pain in patients where an opioid analgesic is appropriate.


Pediatric Use Safety and effectiveness in children have not been established.


Pregnancy Pregnancy Category C No effects on teratogenicity or embryotoxicity were observed in female rats given oral doses up to 7 mg/kg/day, which is approximately equivalent to the human dose of 2.5 to 10 mg every 3 to 6 hours for oral solution, and 3-fold higher than the human dose of 2 to 4 mg every 4 to 6 hours for the tablet on a body surface area basis. Hydromorphone produced skull malformations (exencephaly and cranioschisis) in Syrian hamsters given oral doses up to 20 mg/kg during the peak of organogenesis (gestation days 8 to 9). The skull malformations were observed at doses approximately 2-fold higher than the human dose of 2.5 to 10 mg every 3 to 6 hours for oral solution, and 7-fold higher than the human dose of 2 to 4 mg every 4 to 6 hours for the tablet on a body surface area basis. There are no adequate and well-controlled studies of hydromorphone hydrochloride in pregnant women. Hydromorphone crosses the placenta, resulting in fetal exposure. Hydromorphone hydrochloride should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus (see PRECAUTIONS: Labor and Delivery and DRUG ABUSE AND DEPENDENCE). Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Approaches to the treatment of this syndrome have included supportive care and, when indicated, drugs such as paregoric or phenobarbital.


Nursing Mothers Low levels of opioid analgesics have been detected in human milk. As a general rule, nursing should not be undertaken while a patient is receiving hydromorphone hydrochloride tablets or oral solution since it, and other drugs in this class, may be excreted in the milk.




The usual starting dose for Hydromorphone Hydrochloride Tablets, USP is 2 mg to 4 mg, orally, every 4 to 6 hours. Appropriate use of the Hydromorphone Hydrochloride Tablets, USP must be decided by careful evaluation of each clinical situation. The usual adult oral dosage of Hydromorphone Hydrochloride Oral Solution, USP is one-half (2.5 mL) to two teaspoonfuls (10 mL) (2.5 mg to 10 mg) every 3 to 6 hours as directed by the clinical situation. Oral dosages higher than the usual may be required in some patients. A gradual increase in dose may be required if analgesia is inadequate, as tolerance develops, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. Patients with hepatic and renal impairment should be started on a lower starting dose (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism).