|Drug Name:||Hydromorphone Hydrochloride|
(HIGH POTENCY Formulation)10 mg/mLCIIRx onlyWARNING: HYDROMORPHONE HYDROCHLORIDE INJECTION (HIGH POTENCY FORMULATION) IS A HIGHLY CONCENTRATED SOLUTION OF HYDROMORPHONE, A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST, INTENDED FOR USE IN OPIOID-TOLERANT PATIENTS.
DO NOT CONFUSE HYDROMORPHONE HYDROCHLORIDE INJECTION (HIGH POTENCY FORMULATION) WITH STANDARD PARENTERAL FORMULATIONS OF HYDROMORPHONE HYDROCHLORIDE OR OTHER OPIOIDS.
OVERDOSE AND DEATH COULD RESULT.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.
Hydromorphone hydrochloride injection (high potency formulation) is indicated for the relief of moderate to severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief.
Because hydromorphone hydrochloride injection (high potency formulation) contains 10 mg of hydromorphone hydrochloride per mL, a smaller injection volume can be used than with other parenteral opioid formulations.Discomfort associated with the intramuscular or subcutaneous injection of an unusually large volume of solution can therefore be avoided.
Respiratory Depression: Respiratory depression is the chief hazard of hydromorphone hydrochloride injection (high potency formulation).
Respiratory depression occurs most frequently in the overdose situations, 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 injection (high potency formulation) 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 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 injection (high potency formulation) contains hydromorphone, which is a potent Schedule II, controlled opioid agonist.
Schedule II opioid agonists, including morphine, oxycodone, oxymorphone, fentanyl and methadone, have the highest potential for abuse and risk of fatal 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 OpioidsHydromorphone 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 injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing hydromorphone 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.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 AbuseHydromorphone 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 injection (high potency formulation) 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 injection (high potency formulation) 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 injection (high potency formulation) may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in pressure in patients with head injuries.Hypotensive Effect: Opioid analgesics, including hydromorphone hydrochloride injection (high potency formulation), may cause severe hypotension in an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics (see also PRECAUTIONS—DRUG INTERACTIONS).Hydromorphone hydrochloride injection (high potency formulation) may produce orthostatic hypotension in ambulatory patients.Hydromorphone hydrochloride injection (high potency formulation) should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.