DEMEROL 75 mg/mL
MEPERIDINE HYDROCHLORIDE · INJECTION, SOLUTION · Hospira, Inc.
DEMEROL is a injection, solution containing meperidine hydrochloride at 75 mg/mL, taken intramuscular. Manufactured by Hospira, Inc..
Key Facts
- Brand Name
- DEMEROL
- Generic Name
- MEPERIDINE HYDROCHLORIDE
- NDC Code (Product)
0409-1179- Manufacturer
- Hospira, Inc.
- Strength
- 75 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA021171
- Marketing Start
- 10/12/2005
Recall History
Hospira Inc.
Labeling; Missing label; ampoules are missing the immediate container label
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 DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DEMEROL Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including DEMEROL Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Use of DEMEROL Injection for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine. ( 1 , 5.1 ) Limitations of Use: Because of the risks of addiction, abuse, misuse , overdose, …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • DEMEROL Injection 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 DEMEROL Injection 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 therapy, especially when initiating and follow…
Contraindications
4 CONTRAINDICATIONS DEMEROL Injection is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.2) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.9) ] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.6) , Drug Interactions (7) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13) ] • Hypersensitivity to meperidine (e.g., anaphylaxis) [see Adverse Reactions (6) ] • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ( 7 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Hypersensitivity to meperidine or to any other ingredients of the product. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with DEMEROL Injection. Table 1: Clinically Significant Drug Interactions with DEMEROL Injection Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute opioid overdose. Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors, and impaired consciousness may also occur. In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension [see Warnings and Precautions (5.6) ] . Intervention: Do not use DEMEROL Injection in patients taking MAOIs or within 14 d…
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 (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] • Serotonin Syndrome with Concomitant Use of Serotonergic Drugs [see Warnings and Precautions (5.8) ] • Adrenal Insufficiency [see Warnings and Precautions (5.10) ] • Severe Hypotension [see Warnings and Precautions (5.11) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13) ] • Seizures [see Warnings and Precautions (5.14) ] • Withdrawal [see Warnings and Precautions (5.15) ] The following adverse reactions associated with the use of meperidine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably…
Frequently Asked Questions
What is DEMEROL used for?
DEMEROL contains MEPERIDINE HYDROCHLORIDE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is DEMEROL a controlled substance?
Yes, DEMEROL is classified as CII under the DEA Controlled Substances Act.
What is the generic name for DEMEROL?
The generic name for DEMEROL is MEPERIDINE HYDROCHLORIDE. There are 7 other brand versions of MEPERIDINE HYDROCHLORIDE.
What is the NDC code for DEMEROL 75 mg/mL?
The NDC (National Drug Code) for DEMEROL 75 mg/mL is 0409-1179, listed by Hospira, Inc..