INFUMORPH 500 25 mg/mL

morphine sulfate · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.

No Recall HistoryCurrently in Shortage

Plain English

INFUMORPH 500 is a injection, solution containing morphine sulfate at 25 mg/mL, taken epidural. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name: INFUMORPH 500
Generic Name: morphine sulfate
NDC Code (Product): 0641-6040
Manufacturer: Hikma Pharmaceuticals USA Inc.
Strength: 25 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: EPIDURAL, INTRATHECAL
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 dependence10,436 reports

drug hypersensitivity10,093 reports

pain9,093 reports

overdose7,698 reports

emotional distress5,159 reports

dependence4,672 reports

nausea4,513 reports

drug ineffective4,284 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 INFUMORPH is for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of Use Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because INFUMORPH is too concentrated for accurate delivery of the smaller doses used in this setting. INFUMORPH is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because INFUMORPH is too concentrated for accurate delivery of the smaller doses used in this setting. ( 1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION INFUMORPH 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 ) Patients should be observed in a fully equipped and staffed environmentforatleast24hoursaftereachtestdoseand,as indicated, for the first several days after surgery. (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 INFUMORPH 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 ) 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…

Contraindications

4 CONTRAINDICATIONS INFUMORPH 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 (5.10) , 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 INFUMORPH 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. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting in abse…

Drug Interactions

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with INFUMORPH. Table 1. Clinically Significant Drug Interactions with INFUMORPH 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 patients 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, gaba…

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 CNS Benzodiazepines or Other Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Inflammatory Masses [see Warnings and Precautions (5.6) ] Myoclonic Activity [see Warnings and Precautions (5.7) ] 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 (5.18) ] Orthostatic Hypotension [see Warnings and Precautions (5.19) ] The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these …

Frequently Asked Questions

What is INFUMORPH 500 used for?

INFUMORPH 500 contains morphine sulfate. It is a injection, solution taken epidural. Consult your doctor for specific uses.

Is INFUMORPH 500 a controlled substance?

Yes, INFUMORPH 500 is classified as CII under the DEA Controlled Substances Act.

What is the generic name for INFUMORPH 500?

The generic name for INFUMORPH 500 is morphine sulfate. There are 12 other brand versions of morphine sulfate.

What is the NDC code for INFUMORPH 500 25 mg/mL?

The NDC (National Drug Code) for INFUMORPH 500 25 mg/mL is 0641-6040, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0641-6040

Package NDC

0641-6040-01

Other Morphine Brands

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

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