"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(hydromorphone hydrochloride) Injection
(hydromorphone hydrochloride) Injection
For intravenous, intramuscular and subcutaneous use
RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
DILAUDID-HP INJECTION IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
DILAUDID-HP INJECTION is a more concentrated solution of hydromorphone than DILAUDID INJECTION, and is for use in opioid-tolerant patients only. Do not confuse DILAUDID-HP INJECTION with standard parenteral formulations of DILAUDID INJECTION or other opioids, as overdose and death could result.
DILAUDID INJECTION and DILAUDID-HP INJECTION contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. DILAUDID INJECTION and DILAUDID-HP INJECTION can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing DILAUDID INJECTION and DILAUDID-HP INJECTION in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.
DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17- methylmorphinan-6-one hydochloride. The structural formula is:
DILAUDID INJECTION is available as a sterile, aqueous solution in COLORLESS ampules for parenteral administration. Each 1 mL ampule contains 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.
DILAUDID-HP INJECTION is available as a sterile, aqueous solution in AMBER ampules and in AMBER, single-dose vials for intravenous, subcutaneous, or intramuscular administration. Each ampule and single-dose vial contains 10 mg/mL of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH of between 3.5 and 5.5. The single dose vials are capped with stoppers containing natural rubber latex.
DILAUDID-HP INJECTION is also available as sterile, lyophilized powder in an AMBER, single-dose vial for reconstitution for intravenous, subcutaneous, or intramuscular administration. Each single dose vial contains 250 mg sterile, lyophilized hydromorphone HCl with either hydrochloric acid or sodium hydroxide added to adjust the pH. Each vial is to be reconstituted with 25 mL of Sterile Water for Injection USP to provide a solution containing 10 mg/mL with a pH between 4.5 and 6.5. The single dose vials are capped with stoppers containing natural rubber latex.
What are the possible side effects of hydromorphone injection (Dilaudid, Dilaudid-HP)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- warmth, tingling,...
What are the precautions when taking hydromorphone hydrochloride injection (Dilaudid-HP)?
Before using hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (such as chronic constipation, ileus), brain disorders (such as brain injury, tumor, increased intracranial pressure, seizures), diarrhea due to infection (such as Clostridium difficile), breathing problems (such as emphysema, chronic bronchitis, asthma, sleep apnea), heart problems (such as irregular heartbeat, heart failure, low blood pressure),...
Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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