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Morphine Sulfate (Morphine Sulfate)

Trade Name : Morphine Sulfate

Pharmaceutical Associates, Inc.

SOLUTION

Strength 100 mg/5mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Morphine Sulfate (Morphine Sulfate) which is also known as Morphine Sulfate and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 100 mg/5mL per ml. Read more

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.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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
  • See full prescribing information for complete boxed warning.
  • 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. (n n n , n n n )n n n
  • Morphine Sulfate Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (n n n )n n n
  • 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. (n n n )n n n
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (n n n )n n n
  • Accidental ingestion of Morphine Sulfate Oral Solution, especially by children, can result in a fatal overdose of morphine. (n n n )n n n
  • 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. (n n n )n n n
  • 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. (n n n , n n n )n n n
  • No data
  • Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid 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 [n n n , reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:n nn
  • 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. (n n n )n nn
  • Limitations of Use (n n n ):n n n
  • 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. (n n n )n n n
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (n n n )n n n
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (n n n )n n n
  • Initiate treatment with Morphine Sulfate Oral Solution: 10 to 20 mg every 4 hours as needed. (n n n )n n n
  • Do not abruptly discontinue Morphine Sulfate Oral Solution in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. (n n n )n n n
  • 100 mg per 5 mL (20 mg/mL) strength Oral Solution: Each 5 mL of clear, colorless oral solution contains 100 mg of morphine sulfate USP.
  • Oral Solution:
  • 100 mg per 5 mL (20 mg/mL) (n n n )n n n
  • Morphine Sulfate Oral Solution is contraindicated in patients with:
  • Significant respiratory depression. (n n n )n n n
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (n n n )n n n
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. (n n n )n n n
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. (n n n )n n n
  • Hypersensitivity to morphine. (n n n )n n n
  • 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.
  • The 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 patient's level of opioid tolerance, and host factors specific to the individual.
  • Other less frequently observed adverse reactions from opioid analgesics, including morphine sulfate included:
  • Body as a Whole
  • Cardiovascular System
  • Digestive System
  • Endocrine
  • Hemic and Lymphatic System
  • Metabolic and Nutritional Disorders
  • Musculoskeletal
  • Nervous System
  • Respiratory System
  • Skin and Appendages
  • Special Senses
  • Urogenital System
  • Serotonin Syndrome
  • Adrenal Insufficiency
  • Anaphylaxis
  • Androgen Deficiencyn- [see n n n ]n n n
  • Most common adverse reactions are constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, sweating. (n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or n n n n
  • Table 1 includes clinically significant drug interactions with Morphine Sulfate Oral Solution.
  • Serotonergic Drugs
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • Pregnancy
  • 8.1
  • No data
  • No data
  • Morphine Sulfate Oral Solution is an opioid agonist, available in 100 mg per 5 mL (20 mg/mL) strength for oral administration. The chemical name is 7,8-didehydro-4,5 alpha- epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83 . Its molecular formula is(Cn n n Hn n n NOn n n )n n n u2022Hn n n SOn n n u20225Hn n n O, and it has the following chemical structure.n nn
  • Morphine sulfate USP is a white to off-white crystalline powder or a fine white to light yellow 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).
  • For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate USP and the following inactive ingredients: citric acid, edetate disodium, glycerin, sodium benzoate, sorbitol solution, and purified water. May contain sodium citrate for pH adjustment.
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instruction for Use).
  • Revised October 2019
  • Morphine (mor-pheen) Sulfate Oral Solution, CII
  • MORPHINE SULFATE ORAL SOLUTION, CIIn n n 100 mg per 5 mL (20 mg/mL)n n n
  • Oral Syringe
  • Important information about measuring Morphine Sulfate Oral Solution
  • u2022 Always use the oral syringe provided with your Morphine Sulfate Oral Solution to make sure you measure the right amount.
  • u2022 Measure the dose of medicine from the widest part of the plunger. Do not measure from the narrow tip. See n n n . tttttttn n n
  • Figure 1
  • Distr by: Pharmaceutical Associates, Inc.n n n Greenville, SC 29605n nn
  • For more information, please call 1-800-845-8210.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Revised October 2019
  • NDC 0121-0825-01
  • Morphine Sulfaten n n Oral Solutionn n n CIIn n n
  • 100 mg per 5 mLn n n (20 mg/mL)n nn
  • ONLY FOR USE IN PATIENTSn n n WHO ARE OPIOID TOLERANTn nn
  • PHARMACIST:
  • Sugar and Alcohol Free.n- Rx Only
  • 1 fl oz (30 mL)
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n

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