Hydromorphone Hydrochloride .5 mg/.5mL
HYDROMORPHONE HYDROCHLORIDE · INJECTION, SOLUTION · Hospira, Inc.
Hydromorphone Hydrochloride is a injection, solution containing hydromorphone hydrochloride at .5 mg/.5mL, taken intramuscular. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- Hydromorphone Hydrochloride
- Generic Name
- HYDROMORPHONE HYDROCHLORIDE
- NDC Code (Product)
0409-4264- Manufacturer
- Hospira, Inc.
- Strength
- .5 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA200403
- Marketing Start
- 05/27/2022
Recall History
Hospira Inc.
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
HOSPIRA INC, LAKE FOREST
Presence of Particulate Matter: Silicone oil
Pfizer Inc.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
HOSPIRA INC, LAKE FOREST
Presence of Particulate Matter: Silicone oil
OurPharma LLC
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Pfizer Inc.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
HOSPIRA INC, LAKE FOREST
Presence of Particulate Matter: Silicone oil
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.2 ) , reserve hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of hydromorphone hydrochloride for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.2 ) Respiratory depression can occur at any time during opioid the…
Contraindications
4 CONTRAINDICATIONS Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications (e.g., anaphylaxis) [see Warnings and Precautions (5.16) , Adverse Reactions (6.1) ] Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Known hypersensitivity to hydromorphone, hydromorphone salts, or sulfite-containing medications ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with hydromorphone hydrochloride. Table 1: Clinically Significant Drug Interactions with HYDROMORPHONE HYDROCHLORIDE Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.4) ]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2) , Warnings and Precautions (5.2 , 5.3 , 5.4) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, an…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals at 1-888-827-0616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying …
Frequently Asked Questions
What is Hydromorphone Hydrochloride used for?
Hydromorphone Hydrochloride contains HYDROMORPHONE HYDROCHLORIDE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Hydromorphone Hydrochloride a controlled substance?
Yes, Hydromorphone Hydrochloride is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Hydromorphone Hydrochloride?
The generic name for Hydromorphone Hydrochloride is HYDROMORPHONE HYDROCHLORIDE. There are 4 other brand versions of HYDROMORPHONE HYDROCHLORIDE.
What is the NDC code for Hydromorphone Hydrochloride .5 mg/.5mL?
The NDC (National Drug Code) for Hydromorphone Hydrochloride .5 mg/.5mL is 0409-4264, listed by Hospira, Inc..
Other Hydromorphone Hydrochloride Dosages
- Hydromorphone Hydrochloride2 mg/mL0641-2341
- Hydromorphone Hydrochloride.2 mg/mL0641-6259
- Hydromorphone Hydrochloride2 mg/187063-037
- Hydromorphone Hydrochloride2 mg/160687-579
- Hydromorphone Hydrochloride.25 mg/.5mL0409-1805
- Hydromorphone Hydrochloride1 mg/mL0641-6169
- Hydromorphone Hydrochloride2 mg/mL0641-6170
- Hydromorphone Hydrochloride4 mg/187063-038
Other Hydromorphone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)