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INFUMORPH 200
Overview
What is INFUMORPH 200?
INFUMORPH (preservative-free morphine sulfate sterile solution) is an opioid agonist, available as a sterile, nonpyrogenic, isobaric, high potency solution of morphine sulfate in strengths of 10 mg or 25 mg morphine sulfate per mL, free of antioxidants, preservatives or other potentially neurotoxic additives. INFUMORPH is intended for use in continuous microinfusion devices for intraspinal administration in the management of pain. 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 INFUMORPH 200 contains morphine sulfate, USP 10 mg (200 mg/20 mL) and sodium chloride 8 mg in Water for Injection, USP. Each mL of INFUMORPH 500 contains morphine sulfate, USP 25 mg (500 mg/20 mL) and sodium chloride 6.25 mg in Water for Injection, USP. If needed, sodium hydroxide and/or sulfuric acid are added for pH adjustment to 4.5. Contains no preservative. Each 20 mL ampul of INFUMORPH is intended for SINGLE USE ONLY.
What does INFUMORPH 200 look like?
What are the available doses of INFUMORPH 200?
Injection: 200 mg/20 mL (10 mg/mL) Preservative-free amber glass ampulsInjection: 500 mg/20 mL (25 mg/mL) Preservative-free amber glass ampuls
What should I talk to my health care provider before I take INFUMORPH 200?
How should I use INFUMORPH 200?
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 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.
Candidates for neuraxial administration of INFUMORPH in a continuous microinfusion device should be hospitalized to provide for adequate patient monitoring during assessment of response to single doses of intrathecal or epidural morphine. Hospitalization should be maintained for several days after surgery involving the infusion device for additional monitoring and adjustment of daily dosage. The facility must be equipped with resuscitative equipment, oxygen, naloxone injection and other resuscitative drugs.
A period of observation appropriate to the clinical situation should follow each refill or manipulation of the drug reservoir. Before discharge, the patient and attendant(s) should receive instruction in the proper home care of the device and insertion site and in the recognition and practical treatment of an overdose of neuraxial morphine.
Familiarization with the continuous microinfusion device is essential. The desired amount of morphine should be withdrawn from the ampul through a microfilter. To minimize risk from glass or other particles, the product must be filtered through a 5 µ (or smaller) microfilter before injecting into the microinfusion device.If dilution is required, 0.9% Sodium Chloride Injection is recommended.
Reservoir filling must be performed by fully trained and qualified personnel, following the directions provided by the device manufacturer. Care should be taken in selecting the proper refill frequency to prevent depletion of the reservoir, which would result in exacerbation of severe pain, onset of opioid withdrawal symptoms, and/or reflux of cerebrospinal fluid into some devices. Strict aseptic technique is required to avoid bacterialcontamination and serious infection. Extreme care must be taken to ensure that the needle is properly inserted into the filling port of the device before attempting to refill the reservoir. Injecting the solution into the tissue around the device or (in the case of devices that have more than one port) attempting to inject the refill dose into the direct injection port will result in a large, clinically significant, overdosage to the patient.
Safety and Handling Instructions:
INFUMORPH 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 before opening the amber ampul and again for color after removing contents from the ampul. Do not use if the solution in the unopened ampul contains a precipitate which does not disappear upon shaking. After removal, do not use unless the solution is colorless or pale yellow.
INFUMORPH is intended for single-use only. Protect from light, discard any unused portion. Do not heat-sterilize.
What interacts with INFUMORPH 200?
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What are the warnings of INFUMORPH 200?
Sorry No Records found
What are the precautions of INFUMORPH 200?
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What are the side effects of INFUMORPH 200?
Sorry No records found
What should I look out for while using INFUMORPH 200?
INFUMORPH is contraindicated in patients with:
Neuraxial administration of INFUMORPH is contraindicated in patients with:
The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous.
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
Because of the risk of severe adverse reactions when INFUMORPH 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 (single) test dose and, as appropriate, for the first several days after catheter implantation
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of
INFUMORPH. Monitor for respiratory depression, especially during initiation of INFUMORPH or following a dose increase
.
Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery .
Addiction, Abuse, and Misuse
INFUMORPH 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 INFUMORPH, and monitor all patients regularly for the development of these behaviors and conditions .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of INFUMORPH 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 INFUMORPH 200?
Clinical Presentation
Acute overdose with INFUMORPH 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 INFUMORPH, particularly with epidural or intrathecal morphine, carefully monitor the patient until spontaneous respiration is reliably re-established. 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 begun with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle INFUMORPH 200?
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 92807INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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.INFUMORPH (preservative-free morphine sulfate sterile solution), is, a preservative-free solution, supplied in amber ampuls for epidural or intrathecal administration via a continuous microinfusion device as follows:NDC 0641-6039-01 INFUMORPH 200 200 mg/20 mL (10 m/mL) amber ampuls packaged individuallyNDC 0641-6040-01 INFUMORPH 500 500 mg/20 mL (25 mg/mL) amber ampuls packaged individuallyINFUMORPH 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 INFUMORPH contains no preservative or antioxidant. Each 20 mL ampul of INFUMORPH 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
INFUMORPH is contraindicated in patients with:Neuraxial administration of INFUMORPH is contraindicated in patients with:
The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous.
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
Because of the risk of severe adverse reactions when INFUMORPH 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 (single) test dose and, as appropriate, for the first several days after catheter implantation
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of
INFUMORPH. Monitor for respiratory depression, especially during initiation of INFUMORPH or following a dose increase
.
Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery .
Addiction, Abuse, and Misuse
INFUMORPH 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 INFUMORPH, and monitor all patients regularly for the development of these behaviors and conditions .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of INFUMORPH 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 opiate delivery, using a continuous microinfusion device, is always accompanied by considerable risk to the patients 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.
INFUMORPH 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. 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 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 opioid overdosage, and the personnel must be familiar with the use and limitations of specific narcotic antagonists (naloxone, naltrexone) in such cases.
For safety reasons, it is recommended that administration of INFUMORPH 200 and 500 (10 and 25 mg/mL, respectively) by the intrathecal route be limited to the lumbar area.
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 continuous intrathecal or epidural infusion of INFUMORPH were respiratory depression, myoclonus, and formation of inflammatory masses.
Cardiovascular System
Central Nervous System
Gastrointestinal System
Skin
Genito-Urinary System
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/"
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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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