Duramorph 1 mg/mL

morphine sulfate · INJECTION · Hikma Pharmaceuticals USA Inc.

No Recall HistoryCurrently in Shortage

Plain English

Duramorph is a injection containing morphine sulfate at 1 mg/mL, taken epidural. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name: Duramorph
Generic Name: morphine sulfate
NDC Code (Product): 0641-6019
Manufacturer: Hikma Pharmaceuticals USA Inc.
Strength: 1 mg/mL
Dosage Form: INJECTION
Route: EPIDURAL, INTRATHECAL, INTRAVENOUS
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA018565
Marketing Start: 09/18/1984

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence10,437 reports

drug hypersensitivity10,102 reports

pain9,108 reports

overdose7,698 reports

emotional distress5,162 reports

dependence4,672 reports

nausea4,519 reports

drug ineffective4,312 reports

death4,159 reports

drug withdrawal syndrome3,346 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DURAMORPH is indicated for: the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for which alternative treatments are not expected to be adequate. the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Limitation of Use DURAMORPH is not for use in continuous microinfusion devices. 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 [see Warnings and Precautions (5.2) ] , reserve opioid analgesiscs, including DURAMORPH for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain. DURAMORPH is an opioid agonist, indicated for: the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate. the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. ( 1) Limitation of Use DURAMORPH is n…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION DURAMORPH should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration. ( 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 DURAMORPH 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. ( 2.2 , 5 ) 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 following dosage increases with DURAMORPH. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2 , 5.3 ) Dosage for Intravenous Administration: 2 mg to 1…

Contraindications

4 CONTRAINDICATIONS DURAMORPH is 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 (5.9) ] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.10) , Drug Interactions (7) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.14) ] Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions (6) ] Neuraxial administration of DURAMORPH is contraindicated in patients with: Infection at the injection microinfusion site [see Warnings and Precautions (5.1) ] Concomitant anticoagulant therapy [see Warnings and Precautions (5.1) ] Uncontrolled bleeding diathesis [see Warnings and Precautions (5.1) ] The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous. DURAMORPH is contraindicated in patients with: Significant respiratory depression (4) Acute or severe bron…

Drug Interactions

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with DURAMORPH. Table 1 Clinically Significant Drug Interactions with DURAMORPH 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. The depressant effects of morphine are potentiated by the presence of other CNS depressants. Use of neuroleptics in conjunction with neuraxial morphine may increase the risk of respiratory depression [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. Monitor closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.4) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, psychotropic drugs, antihistamines, neuroleptics, gabapentinoids…

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) ] Myoclonic Activity [see Warnings and Precautions (5.6) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.11) ] Severe Hypotension [see Warnings and Precautions (5.12)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14) ] Seizures [see Warnings and Precautions (5.15) ] Withdrawal [see Warnings and Precautions (5.16) ] Urinary Retention [see Warnings and Precautions (5.17) ] Orthostatic Hypotension [see Warnings and Precautions (5.18)] The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of unce…

Frequently Asked Questions

What is Duramorph used for?

Duramorph contains morphine sulfate. It is a injection taken epidural. Consult your doctor for specific uses.

Is Duramorph a controlled substance?

Yes, Duramorph is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Duramorph?

The generic name for Duramorph is morphine sulfate. There are 12 other brand versions of morphine sulfate.

What is the NDC code for Duramorph 1 mg/mL?

The NDC (National Drug Code) for Duramorph 1 mg/mL is 0641-6019, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0641-6019

Package NDC

0641-6019-10

Other Morphine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)