Morphine Sulfate (Morphine Sulfate)

Trade Name : Morphine Sulfate

Amneal Pharmaceuticals of New York LLC

CAPSULE, EXTENDED RELEASE

Strength 20 mg/1

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

Delivery Process

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Disclaimer

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 Amneal Pharmaceuticals of New York LLC. It is available in strength of 20 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

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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About GNH

No data

Arrayn- Addiction, Abuse, and Misuse
Morphine sulfate extended-release capsules 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 extended-release capsules, and monitor all patients regularly for the development of these behaviors and conditions .
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 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 extended-release capsules. Monitor for respiratory depression, especially during initiation of morphine sulfate extended-release capsules or following a dose increase. Instruct patients to swallow morphine sulfate extended-release capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving the pellets in morphine sulfate extended-release capsules can cause rapid release and absorption of a potentially fatal dose of morphine .
Arrayn- Accidental Ingestion
Accidental ingestion of even one dose of morphine sulfate extended-release capsules, especially by children, can result in a fatal overdose of morphine .
Arrayn- Neonatal Opioid Withdrawal Syndrome
Prolonged use of morphine sulfate extended-release capsules 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- Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking morphine sulfate extended-release capsules. The co-ingestion of alcohol with morphine sulfate extended-release capsules may result in increased plasma levels and a potentially fatal overdose of morphine .
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
See full prescribing information for complete boxed warning.

Morphine sulfate extended-release capsules expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's 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. Instruct patients to swallow morphine sulfate extended-release capsules whole to avoid exposure to a potentially fatal dose of morphine. ()
Accidental ingestion of morphine sulfate extended-release capsules, especiallyu00a0by children, can result in fatal overdose of morphine. ()
Prolonged use of morphine sulfate extended-release capsules 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 availablen- ()
Instruct patients not to consume alcohol or any products containing alcohol while taking morphine sulfate extended-release capsules because co-ingestion can result in fatal plasma morphine levels. ()
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. (, )

Dosage and Administration () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2019
Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 09/2018

Morphine sulfate extended-release capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Morphine sulfate extended-release capsules are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.u00a0u00a0
Limitations of Use:

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations (5.1), reserve morphine sulfate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.

No data

To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. ()
Morphine sulfate extended-release 100 mg capsules, a single dose greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. ()
Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg of oral oxycodone per day, 8 mg of oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. ()
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. ()
Instruct patients to swallow morphine sulfate extended-release capsules intact, or to sprinkle the capsule contents on applesauce and immediately swallow without chewing. (, )
Instruct patients not to cut, break, chew, crush, or dissolve the pellets in morphine sulfate extended-release capsules to avoid the risk of release and absorption of potentially fatal dose of morphine. (, , )
For opioid-nau00efve patients, initiate treatment using an immediate-release morphine formulation and then convert patients to morphine sulfate extended-release capsules. For opioid non-tolerant patients, initiate with a 30 mg capsule orally every 24 hours. Dosage adjustments may be made every one to two days. (, )
Do not abruptly discontinue morphine sulfate extended-release capsules in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. (, )

Morphine sulfate extended-release capsules, USP contains white to off-white polymer-coated extended-release pellets of morphine sulfate, USP, have an outer opaque capsule with colors and imprints as identified below, and are available in seven dose strengths.
Morphine Sulfate Extended-Release Capsules USP, 20 mg, has a yellow opaque body and cap, imprinted with u201cJ62u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsules USP, 30 mg, has a violet opaque body and cap, imprinted with u201cJ63u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsules USP, 40 mg, has a blue violet opaque body and rich yellow opaque cap, imprinted with u201cJ69u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsules USP, 50 mg, has a light blue opaque body and cap, imprinted with u201cJ64u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsulesu00a0 USP, 60 mg, has a red opaque body and cap, imprinted with u201cJ65u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsules USP, 80 mg, has an orange opaque body and cap, imprinted with u201cJ66u201d in black ink on cap.
Morphine Sulfate Extended-Release Capsules USP, 100 mg, has a light green opaque body and cap, imprinted with u201cJ67u201d in black ink on cap.
Extended-release capsules: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg and 100 mg. ()

Morphine sulfate extended-release capsules are contraindicated in patients with:

Significant respiratory depression. ()
Acute or severe bronchial asthma in an unmonitored setting or in the absenceu00a0of resuscitative equipment. ()
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ()
Known or suspected gastrointestinal obstruction, includingu00a0paralytic 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:
Most common adverse reactions (> 10%): constipation, nausea, and somnolence. ()
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 1 includes clinically significant drug interactions with morphine sulfate extended-release capsules.
Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Extended-Release Capsules

Serotonergic Drugs:
Monoamine Oxidase Inhibitors (MAOIs):
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:

No data

Pregnancy
Lactation

No data

No data

Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate.
Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose.
The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&C Blue No. 1 and FD&C Red No. 3; the 50 mg capsule shell contains FD&C Blue No. 1; the 60 mg capsule shell contains FD&C Red No. 40; the 80 mg capsule shell contains D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40; and the 100 mg capsule shell contains D&C Yellow No. 10 and FD&C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
The chemical name of morphine sulfate is 7,8-didehydro-4,5u03b1-epoxy-17-methylmorphinan-3,6u03b1-diol sulfate (2:1) (salt) pentahydrate. Theu00a0molecular formula is (CHNO)2u2219HSOu22195HO and its molecular weight is 758.85.
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 pKis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:

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 .
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 pseudo pregnancies 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 extended-release capsules, USP contain white to off-white polymer-coated extended-release pellets of morphine sulfate and are available in seven dose strengths.
Morphine Sulfate Extended-Release Capsules USP, are size 4 capsule, yellow opaque body and cap, imprinted with u201cJ62u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1277-08Bottles of 60:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1277-13Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1277-01Bottles of 1000:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1277-03
Morphine Sulfate Extended-Release Capsules USP, are size 4 capsule, violet opaque body and cap, imprinted with u201cJ63u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1278-08Bottles of 60:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1278-13Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1278-01Bottles of 1000:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1278-03
Morphine Sulfate Extended-Release Capsules USP, are size 2 capsule, blue violet opaque body and rich yellow opaque cap, imprinted with u201cJ69u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1479-01
Morphine Sulfate Extended-Release Capsules USP, are size 2 capsule, light blue opaque body and cap, imprinted with u201cJ64u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1279-08Bottles of 60:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1279-13Bottles of 100:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 u00a0u00a0 NDC 0115-1279-01Bottles of 1000:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1279-03
Morphine Sulfate Extended-Release Capsules USP, are size 1 capsule, red opaque body and cap, imprinted with u201cJ65u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1280-08Bottles of 60: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1280-13Bottles of 100: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1280-01Bottles of 1000: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1280-03
Morphine Sulfate Extended-Release Capsules USP, are size 0 capsule, orange opaque body and cap, imprinted with u201cJ66u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0NDC 0115-1281-08Bottles of 60: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0NDC 0115-1281-13Bottles of 100: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0NDC 0115-1281-01Bottles of 1000: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0NDC 0115-1281-03
Morphine Sulfate Extended-Release Capsules USP, are size 0 capsule, light green opaque body and cap, imprinted with u201cJ67u201d in black ink on cap.Capsules are supplied as follows:
Bottles of 30: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1282-08Bottles of 60: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1282-13Bottles of 100: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1282-01Bottles of 1000: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1282-03
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Store morphine sulfate extended-release capsules securely and dispose of properly [n n

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Storage and Disposal
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store morphine sulfate extended-release capsules securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home n Inform patients that leaving morphine sulfate extended-release capsules unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused morphine sulfate extended-release capsules should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse
Inform patients that the use of morphine sulfate extended-release capsules, 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 extended-release capsules with others and to take steps to protect morphine sulfate extended-release capsules 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 extended-release capsules or when the dosage is increased, and that it can occur even at recommended doses . 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 .
Interactions with Alcohol
Instruct patients not to consume alcoholic beverages, or prescription and non-prescription products that contain alcohol, during treatment with morphine sulfate extended-release capsules. The co-ingestion of alcohol with morphine sulfate extended-release capsules may result in increased plasma levels and a potentially fatal overdose of morphine .
Interactions with Benzodiazepines and Other CNS Depressants
Instruct patients not to consume alcoholic beverages, as well as prescription and over-the counter products that contain alcohol, during treatment with morphine sulfate extended-release capsules. The co-ingestion of alcohol with morphine sulfate extended-release capsules may result in increased plasma levels and a potentially fatal overdose of (active opioid) .
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 extended-release capsules while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking morphine sulfate extended-release capsules n
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 extended-release capsules, including the following:
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue morphine sulfate extended-release capsules without first discussing a tapering plan with the prescriber .
Hypotension
Inform patients that morphine sulfate extended-release capsules 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 has been reported with morphine sulfate extended-release capsules. Advise patients how to recognize such a reaction and when to seek medical attention .
Pregnancy
Neonatal Opioid Withdrawal Syndrome n- Arrayn- [see Warnings and Precautions (), Use in Specific Populations ()]
Embryo-Fetal Toxicity n n- Array
Lactation
Advise patients that breastfeeding is not recommended during treatment with morphine sulfate extended-release capsules .
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 extended-release capsules 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 n
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n

Manufactured by:n Brookhaven, NY 11719
Distributed by:n Bridgewater, NJ 08807
Rev. 11-2019-01

Morphinen- Sulfate n- Extended-Release Capsules, USP, CII
Morphine sulfate extended-release capsules are:
Important information about morphine sulfate extended-release capsules:
Do not take morphine sulfate extended-release capsules if you have:
Before taking morphine sulfate extended-release capsules, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
When taking morphine sulfate extended-release capsules:
While taking morphine sulfate extended-release capsules DO NOT:
The possible side effects of morphine sulfate extended-release capsules are:
Get emergency medical help if you have:
These are not all the possible side effects of morphine sulfate extended-release capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:n Brookhaven, NY 11719
Distributed by:n Bridgewater, NJ 08807
Rev. 11-2019-01

Morphine Sulfate n- Extended-Release Capsules, USP, CII
If you cannot swallow morphine sulfate extended-release capsules, tell your healthcare provider. There may be another way to take morphine sulfate extended-release capsules that may be right for you. If your healthcare provider tells you that you can take morphine sulfate extended-release capsules using this other way, follow these steps:
Morphine sulfate extended-release capsules can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows:
You should not receive morphine sulfate extended-release capsules through a nasogastric tube.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:n Brookhaven, NY 11719
Distributed by:n Bridgewater, NJ 08807
Rev. 11-2019-01

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Morphine Sulfate (Morphine Sulfate)

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Morphine Sulfate (Morphine Sulfate)

Trade Name : Morphine Sulfate

CAPSULE, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

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Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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