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Duramorph
Overview
What is Duramorph?
DURAMORPH (morphine sulfate injection) is an opioid agonist, available as a sterile, nonpyrogenic isobaric solution of morphine sulfate in strengths of 0.5 mg or 1 mg morphine sulfate per mL, free of antioxidants, preservatives or other potentially neurotoxic additives, and is intended for intravenous, epidural, or intrathecal administration. Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, chemically identified as 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate, with the following structural formula:
(CHNO) • HSO • 5HO Molecular Weight is 758.83
Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol,, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).
Each mL of DURAMORPH contains morphine sulfate, USP 0.5 mg (5 mg/10 mL) or 1 mg (10 mg/ 10 mL) and sodium chloride 9 mg in Water for Injection. The pH range is 2.5 – 6.5. Contains no preservative. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY.
What does Duramorph look like?
What are the available doses of Duramorph?
Injection: 5 mg/10 mL (0.5 mg/mL) Preservative-free amber glass ampulsInjection: 10 mg/10 mL (1 mg/mL) Preservative-free amber glass ampuls
What should I talk to my health care provider before I take Duramorph?
How should I use Duramorph?
DURAMORPH is indicated for:
Limitation of Use
DURAMORPH is not for use in continuous microinfusion devices.
Do Not Use DURAMORPH in Continuous Microinfusion Devices.
DURAMORPH should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration and familiar with the patient management problems associated with epidural or intrathecal drug administration and the labeling, and should take place only in settings where adequate patient monitoring is possible.
Epidural Administration
Verify proper placement of a needle or catheter in the epidural space before DURAMORPH is injected.
Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has been made).
Safety and Handling Instructions:
DURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.
Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate
DURAMORPH is intended for single use only. Protect from light, discard any unused portion. Do not heat-sterilize.
What interacts with Duramorph?
Sorry No Records found
What are the warnings of Duramorph?
Sorry No Records found
What are the precautions of Duramorph?
Sorry No Records found
What are the side effects of Duramorph?
Sorry No records found
What should I look out for while using Duramorph?
DURAMORPH is contraindicated in patients with:
Neuraxial administration of DURAMORPH is contraindicated in patients with:
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risks with Neuraxial Administration
Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when DURAMORPH is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of
DURAMORPH. Monitor for respiratory depression, especially during initiation of DURAMORPH or following a dose increase. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid IV administration may result in overdosing .
Addiction, Abuse, and Misuse
DURAMORPH exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DURAMORPH, and monitor all patients regularly for the development of these behaviors and conditions .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of DURAMORPH during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death see
What might happen if I take too much Duramorph?
Clinical Presentation
Acute overdose with DURAMORPH can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to morphine overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose.
As the duration of effect of naloxone is considerably shorter than that of epidural or intrathecal morphine, repeated administration may be necessary. Patients should be closely observed for evidence of renarcotization.
Because the duration of opioid reversal is expected to be less than the duration of action of morphine in DURAMORPH, particularly with epidural or intrathecal morphine, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Duramorph?
Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.DURAMORPH (morphine sulfate injection, USP) is a preservative-free solution, available as 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1mg/mL), in amber ampuls, for single use administration. NDC 0641-6020-10 5 mg/10 mL (0.5 mg/mL) amber ampuls packaged in 10sNDC 0641-6019-10 10 mg/10 mL (1 mg/mL) amber ampuls packaged in 10sDURAMORPH is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rinsing the affected area with water.PROTECT FROM LIGHT. Keep stored in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. DO NOT FREEZE.DURAMORPH contains no preservative or antioxidant. Each 10 mL ampul of DURAMORPH is intended for SINGLE USE ONLY. Discard any unused portion. Do not heat-sterilize. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
Non-Clinical Toxicology
DURAMORPH is contraindicated in patients with:Neuraxial administration of DURAMORPH is contraindicated in patients with:
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risks with Neuraxial Administration
Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when DURAMORPH is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of
DURAMORPH. Monitor for respiratory depression, especially during initiation of DURAMORPH or following a dose increase. Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid IV administration may result in overdosing .
Addiction, Abuse, and Misuse
DURAMORPH exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DURAMORPH, and monitor all patients regularly for the development of these behaviors and conditions .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of DURAMORPH during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death see
Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.
Control of pain by neuraxial opioid delivery is always accompanied by considerable risk to the patient and requires a high level of skill to be successfully accomplished. The task of treating these patients must be undertaken by experienced clinical teams, well-versed in patient selection, evolving technology and emerging standards of care.
In the case of epidural or intrathecal administration, DURAMORPH should be administered by or under the direction of a physician experienced in the techniques and familiar with the patient management problems associated with epidural or intrathecal drug administration. The physician should be familiar with patient conditions (such as infection at the injection site, bleeding diathesis, anticoagulant therapy, etc.) which call for special evaluation of the benefit versus risk potential.
Because epidural administration has been associated with less potential for immediate or late adverse effects than intrathecal administration, the epidural route should be used whenever possible.
For safety reasons, it is recommended that administration of DURAMORPH by the epidural or intrathecal routes be limited to the lumbar area. Thoracic epidural administration has been shown to dramatically increase the incidence of early and late respiratory depression even with doses of 1 to 2 mg.
Because of the risk of severe adverse effects when the epidural or intrathecal route of administration is employed, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose.
The facility must be equipped to resuscitate patients with severe opiate overdosage, and the personnel must be familiar with the use and limitations of specific narcotic antagonists (naloxone, naltrexone) in such cases.
Parenteral administration of narcotics in patients receiving epidural or intrathecal morphine may result in overdosage.
The following serious adverse reactions are described, or described in greater detail, in other sections:
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 uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most serious adverse reactions encountered during administration of DURAMORPH were respiratory depression and/or respiratory arrest.
Cardiovascular System
Central Nervous System
Gastrointestinal System
Skin
Urinary System
Peripheral edema:
Other
Serotonin syndrome
Adrenal insufficiency
Anaphylaxis
Androgen deficiency
[see ]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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