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Morphine Sulfate (Morphine Sulfate)

Trade Name : Morphine Sulfate

Paddock Laboratories, LLC

SUPPOSITORY

Strength 5 mg/1

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 Paddock Laboratories, LLC. It is available in strength of 5 mg/1 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

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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.

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
  • Boxed Warning 11/2018
  • Indications and Usage (1) 11/2018
  • Dosage and Administration (2) 11/2018
  • Contraindications (4) 11/2018
  • Warnings and Precautions (5) 11/2018
  • Arrayn- Addiction, Abuse, and Misuse
  • Morphine sulfate suppositories expose 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 suppositories, and monitor all patients regularly for the development of these behaviors and conditions [].
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate suppositories. Monitor for respiratory depression, especially during initiation of morphine sulfate suppositories or following a dose increase [].
  • Arrayn- Accidental Exposure
  • Accidental exposure of even one dose of morphine sulfate suppositories, especially by children, can result in a fatal overdose of morphine [].
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of morphine sulfate suppositories 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 Alcohol, 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 [].
  • WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • See full prescribing information for complete boxed warning.
  • Morphine sulfate suppositories expose users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors or conditions. (5.1)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)
  • Accidental exposure of morphine sulfate suppositories, especially by children, can result in a fatal overdose of opium. (5.2)
  • Prolonged use of morphine sulfate suppositories 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. (5.3)
  • 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. (5.4, 7)
  • Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and 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 suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Morphine sulfate suppositories 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 suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • No data
  • Morphine Sulfate Suppositories are available in four strengths:
  • Suppositories:
  • Morphine sulfate suppositories are contraindicated in patients with:
  • 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 patientu2019s 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 Clinical Pharmacology (12.2)]
  • Most common adverse reactions are constipation, nausea, somnolence, lightheadedness, dizziness, sedation, vomiting, sweating. (6)
  • Table 1 includes clinically significant drug interactions with morphine sulfate suppositories.
  • Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Suppositories
  • Pregnancy
  • No data
  • Clinical Presentation
  • Acute overdose with morphine sulfate suppositories 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 suppositories, 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 suppositories are an opioid agonist, available in 5 mg, 10 mg, 20 mg, and 30 mg strengths for rectal administration. The chemical name is morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-, (5a,6a)-, sulfate (2:1) (salt), pentahydrate. The molecular weight is 758. Its molecular formula is (CHNO) u00b7 HSO u00b7 5HO, and it has the following chemical structure:
  • 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).
  • The inactive ingredients in morphine sulfate suppositories include: butylated hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide, glyceryl monostearate, hydrogenated vegetable oil, polysorbate 80.
  • 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).
  • 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 Suppositories are white to cream torpedo shaped suppositories
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of morphine sulfate suppositories, 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 suppositories with others and to take steps to protect morphine sulfate suppositories 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 suppositories 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 Exposure
  • Inform patients that accidental exposure (including ingestion), especially by children, may result in respiratory depression or death . Instruct patients to take steps to store morphine sulfate suppositories securely and to dispose of unused morphine sulfate suppositories by flushing the unused suppositories down the toilet.
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if morphine sulfate suppositories are 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 suppositories while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking morphine sulfate suppositories .
  • 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 .
  • Hypotension
  • Inform patients that morphine sulfate suppositories 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 suppositories. Advise patients how to recognize such a reaction and when to seek medical attention .
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndromen- [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)]
  • Embryo-Fetal Toxicityn- [see Use in Specific Populations (8.1)]
  • 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 suppositories 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 Suppositories
  • Advise patients to dispose of unused morphine suppositories by flushing down the toilet.
  • Morphine Sulfate (moru2019 feen sulu2019 fate) Suppositories, CII
  • Morphine Sulfate Suppositories are:
  • Important information about morphine sulfate:
  • Do not take morphine sulfate suppositories if you have:
  • Before taking morphine sulfate suppositories, tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking morphine sulfate suppositories:
  • While taking morphine sulfate suppositories DO NOT:
  • The possible side effects of morphine sulfate suppositories:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of morphine sulfate suppositories. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • For more information go to dailymed.nlm.nih.gov.
  • Manufactured by: Perrigo, Minneapolis, MN 55427, www.perrigo.com or please call 1-866-634-9120
  • Issued: 11/2018
  • Manufactured By
  • Perrigou00ae
  • Minneapolis, MN 55427
  • www.perrigo.com
  • Rev 11-18 A
  • 2203930
  • 1R600 RC J1
  • Rx Only
  • Morphine Sulfate Suppositories 5 mg
  • FOR RECTAL USE ONLY
  • Warning: May be habit forming.
  • Dispense the accompanying Medication Guide to each patient
  • 12 Suppositories
  • UNIT DOSE
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • Morphine Sulfate Suppositories 10 mg
  • FOR RECTAL USE ONLY
  • Warning: May be habit forming.
  • Dispense the accompanying Medication Guide to each patient
  • 12 Suppositories
  • UNIT DOSE
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • Morphine Sulfate Suppositories 20 mg
  • FOR RECTAL USE ONLY
  • Warning: May be habit forming.
  • Dispense the accompanying Medication Guide to each patient
  • 12 Suppositories
  • UNIT DOSE
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • Morphine Sulfate Suppositories 30 mg
  • FOR RECTAL USE ONLY
  • Warning: May be habit forming.
  • Dispense the accompanying Medication Guide to each patient
  • 12 Suppositories
  • UNIT DOSE
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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