Trade Name: Morphine Sulfate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/5mL

Storage and handling

MORPHINE SULFATE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Arrayn- Risk of Medication Errors
  • Ensure accuracy when prescribing, dispensing, and administering Morphine Sulfate Oral Solution. Dosing errors due to confusion between mg and mL, and other morphine solutions of different concentrations can result in accidental overdose and death [].
  • Arrayn- Addiction, Abuse, and Misuse
  • Morphine Sulfate Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing Morphine Sulfate Oral Solution, and monitor all patients regularly for the development of these behaviors and conditions [n n ].
  • Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions ()]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Oral Solution. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Oral Solution or following a dose increase [].
  • Arrayn- Accidental Ingestion
  • Accidental ingestion of even one dose of Morphine Sulfate Oral Solution, especially by children, can result in a fatal overdose of morphine [].
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of Morphine Sulfate Oral Solution 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 [].
  • Arrayn- 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 [n ].
  • WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • Seen
  • Ensure accuracy when prescribing, dispensing, and administering Morphine Sulfate Oral Solution. Dosing errors due to confusion between mg and mL, and other morphine solutions of different concentrations can result in accidental overdose and death. (, )u00a0
  • Morphine Sulfate Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. ()
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. ()
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ()
  • Accidental ingestion of Morphine Sulfate Oral Solution, especially by children, can result in a fatal overdose of morphine. ()
  • Prolonged use of Morphine Sulfate Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
  • u00a0n- 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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (, )
  • No data
  • Morphine Sulfate Oral Solution is indicated for the management ofu00a0acute and chronic painu00a0severe enough to require anu00a0opioid analgesic and for which alternative treatments are inadequate.
  • Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients.
  • Limitations of Use
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Morphine Sulfate Oral Solution is an opioid agonist indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ()
  • Limitations of Use
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia
  • No data
  • Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is for opioid-tolerant patients only. ()
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ()
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
  • Initiate treatment with Morphine Sulfate Oral Solution: 10 to 20 mg every 4 hours as needed. ()
  • Do not stop Morphine Sulfate Oral Solution abruptly in a physically dependent patient. ()
  • 10 mg per 5 mL (2 mg/mL) strength Oral Solution: Each 5 mL of clear, red oral solution contains 10 mg of morphine sulfate USP.
  • 20 mg per 5 mL (4 mg/mL) strength Oral Solution: Each 5 mL of clear, red oral solution contains 20 mg of morphine sulfate USP.
  • Oral solution:
  • 10 mg per 5 mL (2 mg/mL)
  • 20 mg per 5 mL (4 mg/mL)
  • Morphine Sulfate Oral Solution is contraindicated in patients with:
  • Significant respiratory depression. ()
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ().
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days ()
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. ()
  • Hypersensitivity to morphine. ()
  • No data
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients:
  • Adrenal Insufficiency:
  • Severe Hypotension:
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness:
  • 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.
  • Serious adverse reactions associated with morphine use included: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
  • u00a0The common adverse reactions seen on initiation of therapy with morphine were dose-dependent and were typical opioid-related adverse reactions. The most frequent of these included constipation, nausea, and somnolence. Other commonly observed adverse reactions included: lightheadedness, dizziness, sedation, vomiting, and sweating. The frequency of these events depended upon several factors including clinical setting, the patientu2019s level of opioid tolerance, and host factors specific to the individual.
  • u00a0Other less frequently observed adverse reactions from opioid analgesics, including morphine sulfate included:
  • u00a0: malaise, withdrawal syndrome
  • u00a0: bradycardia, hypertension, hypotension, palpitations, syncope, tachycardia
  • u00a0: anorexia, biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectal disorder, thirst
  • u00a0: hypogonadism
  • u00a0: anemia, thrombocytopenia
  • u00a0: edema, weight loss
  • u00a0: skeletal muscle rigidity, decreased bone mineral density
  • u00a0: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, depression, dry mouth, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo, headache
  • u00a0: hiccup, hypoventilation, voice alteration
  • u00a0: dry skin, urticaria, pruritus
  • u00a0: amblyopia, eye pain, taste perversion
  • u00a0: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention or hesitancy, anti-diuretic effect, amenorrhea
  • u00a0: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
  • u00a0: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
  • u00a0: Anaphylaxis has been reported with ingredients contained in Morphine Sulfate Oral Solution.u00a0
  • u00a0: Cases of androgen deficiency have occurred with chronic use of opioids []n
  • Most common adverse reactions are constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, sweating. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc. at 1-888-655-1505 or FDA at 1-800-FDA-1088 or .
  • Table 1 includes clinically significant drug interactions with Morphine Sulfate Oral Solution.
  • Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Oral Solution
  • No data
  • Pregnancy
  • 8.1
  • No data
  • Clinical Presentation
  • Acute overdose with Morphine Sulfate Oral Solution 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.
  • Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Oral Solution, 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 productu2019s 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.
  • Morphine Sulfate Oral Solution is an opioid agonist, available in 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL) strengths for oral administration. The chemical name is 7,8-didehydro-4,5 alphaepoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (CHNO)u2022HSOu20225u0397u039f, and it has the following chemical structure.
  • Morphine sulfate USP is a white to off-white crystalline powder. It is soluble in water and slightly soluble in 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).n
  • For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate USP and the following inactive ingredients: anhydrous citric acid, edetate disodium, FD&C Red No. 40, wild cherry flavor, glycerin, purified water, sodium benzoate, sorbitol solution.n
  • For the 20 mg per 5 mL (4 mg/mL) strength: Each 5 mL of oral solution contains 20 mg of morphine sulfate USP and the following inactive ingredients: anhydrous citric acid, edetate disodium, FD&C Red No. 40, wild cherry flavor, glycerin, methylparaben, propylparaben, purified water, sodium benzoate, sorbitol solution.n
  • No data
  • Carcinogenesis
  • Long-term studies in animals to evaluate the carcinogenic potential of morphine have not been conducted.
  • Mutagenesis
  • No formal studies to assess the mutagenic potential of morphine have been conducted. In the published literature, morphine was found to be mutagenic increasing DNA fragmentation in human T-cells. Morphine was reported to be mutagenic in the mouse micronucleus assay and positive for the induction of chromosomal aberrations in mouse spermatids and murine lymphocytes. Mechanistic studies suggest that the clastogenic effects reported with morphine in mice may be related to increases in glucocorticoid levels produced by morphine in this species. In contrast to the above positive findings, studies in the literature have also shown that morphine did not induce chromosomal aberrations in human leukocytes or translocations or lethal mutations in Drosophila.
  • Impairment of Fertility
  • No formal nonclinical studies to assess the potential of morphine to impair fertility have been conducted.
  • Several nonclinical studies from the literature have demonstrated adverse effects on male fertility in the rat from exposure to morphine. One study in which male rats were administered morphine sulfate subcutaneously prior to mating (up to 30 mg/kg twice daily) and during mating (20 mg/kg twice daily) with untreated females, a number of adverse reproductive effects including reduction in total pregnancies and higher incidence of pseudopregnancies at 20 mg/kg/day (3.2 times the HDD) were reported.
  • Studies from the literature have also reported changes in hormonal levels in male rats (i.e., testosterone, luteinizing hormone) following treatment with morphine at 10 mg/kg/day or greater (1.6 times the HDD).
  • Female rats that were administered morphine sulfate intraperitoneally prior to mating exhibited prolonged estrous cycles at 10 mg/kg/day (1.6 times the HDD).n
  • Exposure of adolescent male rats to morphine has been associated with delayed sexual maturation and following mating to untreated females, smaller litters, increased pup mortality, and/or changes in reproductive endocrine status in adult male offspring have been reported (estimated 5 times the plasma levels at the HDD).
  • Morphine Sulfate Oral Solution
  • 10 mg per 5 mL (2 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution.
  • NDC 66689-032-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-032-01), packaged in 5 trays of 10 unit dose cups each.
  • NDC 66689-032-04: Bottles of 100 mL; supplied with calibrated measuring cup
  • NDC 66689-032-16: Bottles of 500 mL; supplied with calibrated measuring cup
  • 20 mg per 5 mL (4 mg/mL) Oral Solution is supplied as a clear, red, cherry flavor solution.
  • NDC 66689-033-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-033-01), packaged in 5 trays of 10 unit dose cups each.
  • NDC 66689-033-04: Bottles of 100 mL; supplied with calibrated measuring cup
  • NDC 66689-033-16: Bottles of 500 mL; supplied with calibrated measuring cup
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Protect from moisture.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Medication Errors
  • Advise patients that Morphine Sulfate Oral Solution is available in three concentrations: 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL). Inform patients about which concentration they have been prescribed and provide detailed instruction on how to measure and take the correct dose of Morphine Sulfate Oral Solution, and to always use the enclosed measuring device when administering Morphine Sulfate Oral Solution to ensure that the dose is measured and administered accurately [].
  • If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of Morphine Sulfate Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death []. Instruct patients not to share Morphine Sulfate Oral Solution with others and to take steps to protect Morphine Sulfate Oral Solution from theft or misuse.
  • Life-Threatening Respiratory Depression
  • Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Morphine Sulfate Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages []. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
  • Accidental Ingestion
  • Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death []. Instruct patients to take steps to store Morphine Sulfate Oral Solution securely and to dispose of unused Morphine Sulfate Oral Solution by flushing the unused oral solution down the toilet.
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if Morphine Sulfate Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [].
  • Serotonin Syndrome
  • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [].
  • MAOI Interaction
  • Inform patients not to take Morphine Sulfate Oral Solution while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Morphine Sulfate Oral Solution [].
  • Adrenal Insufficiency
  • Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [].
  • Important Administration Instructions
  • Instruct patients how to properly take Morphine Sulfate Oral Solution.
  • Hypotension
  • Inform patients that Morphine Sulfate Oral Solution may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [].
  • Anaphylaxis
  • Inform patients that anaphylaxis have been reported with ingredients contained in Morphine Sulfate Oral Solution. Advise patients how to recognize such a reaction and when to seek medical attention [].
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndromen- see Warnings and Precautions (), Use in Specific Populations (n
  • Embryo-Fetal Toxicityn- see Use in Specific Populations ()
  • Lactation
  • Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [].
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [].
  • Driving or Operating Heavy Machinery
  • Inform patients that Morphine Sulfate Oral Solution may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [].
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [].
  • Disposal of Unused Morphine Sulfate Oral Solution
  • Advise patients to dispose of unused morphine oral solution by flushing down the toilet.
  • Manufactured by:
  • VP2064R3Rev.12/18
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Largo, FL 33771, USA
  • VP2088R3 Rev. 12/18
  • NDC 66689-032-04
  • MORPHINE SULFATE ORAL SOLUTION CII
  • 10 mg per 5 mL
  • PHARMACIST: Dispense the enclosed Medication Guide to each patient.
  • SUGAR AND ALCOHOL FREE
  • 100 mL
  • USUAL DOSAGE:
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [See USP Controlled Room Temperature]
  • Rx Only VP2058
  • VistaPharm Inc., Largo, FL 33771
  • Arrayn- VistaPharm
  • NDC 66689-033-04
  • MORPHINE SULFATE ORAL SOLUTION CII
  • 20 mg per 5 mL
  • PHARMACIST: Dispense the enclosed Medication Guide to each patient.
  • SUGAR AND ALCOHOL FREE
  • 100 mL
  • USUAL DOSAGE:
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [See USP Controlled Room Temperature]
  • Rx Only VP2062
  • VistaPharm Inc., Largo, FL 33771
  • Arrayn- VistaPharm

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Morphine Sulfate (Morphine Sulfate) which is also known as Morphine Sulfate and Manufactured by VistaPharm, Inc.. It is available in strength of 10 mg/5mL.

Morphine Sulfate (Morphine Sulfate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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