MORPHINE SULFATE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

MORPHINE SULFATE

Composition:

MORPHINE SULFATE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: - Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release opioid formulations/long-acting opioid formulations, [see Warnings and Precautions (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. Morphine sulfate extended-release capsules are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] -   Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7)] -   Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.8),  Drug Interactions (7)] -   Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] -   Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions (6.2)] Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with morphine sulfate extended-release capsules in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data] . In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HDD) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the HDD in the rabbit, growth retardation at 6 times the HDD in the rat, and axial skeletal fusion and cryptorchidism at 16 times the HDD in the mouse. Administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3 to 4 times the HDD; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the HDD [see Animal Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Morphine sulfate extended-release capsules are not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including morphine sulfate extended-release capsules, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Human Data The results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. Animal Data Formal reproductive and developmental toxicology studies for morphine have not been conducted. Exposure margins for the following published study reports are based on human daily dose of 60 mg morphine using a body surface area comparison (HDD). Neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35 to 322 mg/kg) on Gestation Day 8 to pregnant hamsters (4.7 to 43.5 times the HDD). A no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. Neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (SC) injection of morphine sulfate to pregnant mice (100 to 500 mg/kg) on Gestation Day 8 or 9 at 200 mg/kg or greater (16 times the HDD) and fetal resorption at 400 mg/kg or higher (32 times the HDD). No adverse effects were noted following 100 mg/kg morphine in this model (8 times the HDD). In one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the HDD), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted. The effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. The clinical significance of this report is not clear. Decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the HDD) from Gestation Day 7 to 9. There was no evidence of malformations despite maternal toxicity (10% mortality). In a second rat study, decreased fetal weight and increased incidences of growth retardation were noted at 35 mg/kg/day (5.7 times the HDD) and there was a reduced number of fetuses at 70 mg/kg/day (11.4 times the HDD) when pregnant rats were treated with 10, 35, or 70 mg/kg/day morphine sulfate via continuous infusion from Gestation Day 5 to 20. There was no evidence of fetal malformations or maternal toxicity. An increased incidence of abortion was noted in a study in which pregnant rabbits were treated with 2.5 (0.8 times the HDD) to 10 mg/kg morphine sulfate via subcutaneous injection from Gestation Day 6 to 10. In a second study, decreased fetal body weights were reported following treatment of pregnant rabbits with increasing doses of morphine (10 to 50 mg/kg/day) during the pre-mating period and 50 mg/kg/day (16 times the HDD) throughout the gestation period. No overt malformations were reported in either publication; although only limited endpoints were evaluated. In published studies in rats, exposure to morphine during gestation and/or lactation periods is associated with: decreased pup viability at 12.5 mg/kg/day or greater (2 times the HDD); decreased pup body weights at 15 mg/kg/day or greater (2.4 times the HDD); decreased litter size, decreased absolute brain and cerebellar weights, cyanosis, and hypothermia at 20 mg/kg/day (3.2 times the HDD); alteration of behavioral responses (play, social-interaction) at 1 mg/kg/day or greater (0.2 times the HDD); alteration of maternal behaviors (e.g., decreased nursing and pup retrievals) in mice at 1 mg/kg or higher (0.08 times the HDD) and rats at 1.5 mg/kg/day or higher (0.2 times the HDD); and a host of behavioral abnormalities in the offspring of rats, including altered responsiveness to opioids at 4 mg/kg/day (0.7 times the HDD) or greater. Fetal and/or postnatal exposure to morphine in mice and rats has been shown to result in morphological changes in fetal and neonatal brain and neuronal cell loss, alteration of a number of neurotransmitter and neuromodulator systems, including opioid and non-opioid systems, and impairment in various learning and memory tests that appear to persist into adulthood. These studies were conducted with morphine treatment usually in the range of 4 to 20 mg/kg/day (0.7 to 3.2 times the HDD). Additionally, delayed sexual maturation and decreased sexual behaviors in female offspring at 20 mg/kg/day (3.2 times the HDD), and decreased plasma and testicular levels of luteinizing hormone and testosterone, decreased testes weights, seminiferous tubule shrinkage, germinal cell aplasia, and decreased spermatogenesis in male offspring were also observed at 20 mg/kg/day (3.2 times the HDD). Decreased litter size and viability were observed in the offspring of male rats that were intraperitoneally administered morphine sulfate for 1 day prior to mating at 25 mg/kg/day (4.1 times the HDD) and mated to untreated females. Decreased viability and body weight and/or movement deficits in both first and second generation offspring were reported when male mice were treated for 5 days with escalating doses of 120 to 240 mg/kg/day morphine sulfate (9.7 to 19.5 times the HDD) or when female mice treated with escalating doses of 60 to 240 mg/kg/day (4.9 to 19.5 times the HDD) followed by a 5-day treatment-free recovery period prior to mating. Similar multigenerational findings were also seen in female rats pre-gestationally treated with escalating doses of 10 to 22 mg/kg/day morphine (1.6 to 3.6 times the HDD). Risk Summary Morphine is present in breast milk. Published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers in the early postpartum period with a milk-to-plasma morphine AUC ratio of 2.5:1 measured in one lactation study. However, there is insufficient information to determine the effects of morphine on the breastfed infant and the effects of morphine on milk production. Lactation studies have not been conducted with extended–release morphine, including morphine sulfate extended-release capsules. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with morphine sulfate extended-release capsules. Clinical Considerations Monitor infants exposed to morphine sulfate extended-release capsules through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of morphine is stopped, or when breastfeeding is stopped. Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Clinical Pharmacology (12.2)]. In published animal studies, morphine administration adversely effected fertility and reproductive endpoints in male rats and prolonged estrus cycle in female rats [see Nonclinical Toxicology (13)] . The safety and efficacy of morphine sulfate extended-release capsules in patients less than 18 years have not been established. Clinical studies of morphine sulfate extended-release capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of morphine sulfate extended-release capsules slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.7)] . This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. Morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. Start these patients with a lower than usual dosage of morphine sulfate extended-release capsules and titrate slowly while regularly evaluate for signs of respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)]. Morphine pharmacokinetics are altered in patients with renal failure. Start these patients with a lower than usual dosage of morphine sulfate extended-release capsules and titrate slowly while regularly evaluate for signs of respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)]. Morphine sulfate extended-release capsules contain morphine, a Schedule II controlled substance. Morphine sulfate extended-release capsules contains morphine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1)] . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of morphine sulfate extended-release capsules increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of morphine sulfate extended-release capsules with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of morphine sulfate extended-release capsules abuse include those with a history of prolonged use of any opioid, including products containing morphine, those with a history of drug or alcohol abuse, or those who use morphine sulfate extended-release capsules in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Morphine sulfate extended-release capsules, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Morphine sulfate extended-release capsules Abuse of morphine sulfate extended-release capsules poses a risk of overdose and death. This risk is increased with concurrent use of morphine sulfate extended-release capsules with alcohol and/or other CNS depressants. Taking cut, broken chewed, crushed, or dissolved morphine sulfate extended-release capsules enhances drug release and increases the risk of overdose and death. Morphine sulfate extended-release capsules are approved for oral use only. Inappropriate intravenous, intramuscular, or subcutaneous use of morphine sulfate extended-release capsules can result in death, local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, and embolism. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue morphine sulfate extended-release capsules in a patient physically dependent on opioids. Rapid tapering of morphine sulfate extended-release capsules in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing morphine sulfate extended-release capsules, gradually taper the dosage using a patient-specific plan that considers the following: the dose of morphine sulfate extended-release capsules the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see Dosage and Administration (2.5), and Warnings and Precautions (5.15)] . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)] . Morphine Sulfate (mor’ feen sul’ fate) 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: Figure 1 - Open the morphine sulfate extended-release capsule and sprinkle the pellets over about one tablespoon of applesauce. (see Figure 1) Figure 2 - Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose. (see Figure 2) Figure 3 - Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets. (see Figure 3) Figure 4 - Flush the empty capsule down the toilet right away. (see Figure 4) 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: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2021-03 Dispense with Medication Guide available at: documents.amneal.com/mg/morphine-sulfate-er-cap.pdf

Product summary:

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, 20 mg are size 4 capsule, yellow opaque body and cap, imprinted with “J62” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                      NDC 0115-1277-08 Bottles of 60:                                      NDC 0115-1277-13 Bottles of 100:                                    NDC 0115-1277-01 Bottles of 1000:                                  NDC 0115-1277-03 Morphine Sulfate Extended-Release Capsules USP, 30 mg are size 4 capsule, violet opaque body and cap, imprinted with “J63” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                      NDC 0115-1278-08 Bottles of 60:                                      NDC 0115-1278-13 Bottles of 100:                                    NDC 0115-1278-01 Bottles of 1000:                                  NDC 0115-1278-03 Morphine Sulfate Extended-Release Capsules USP, 40 mg are size 2 capsule, blue violet opaque body and rich yellow opaque cap, imprinted with “J69” in black ink on cap. Capsules are supplied as follows: Bottles of 100:                                    NDC 0115-1479-01 Morphine Sulfate Extended-Release Capsules USP, 50 mg are size 2 capsule, light blue opaque body and cap, imprinted with “J64” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                      NDC 0115-1279-08 Bottles of 60:                                      NDC 0115-1279-13 Bottles of 100:                                    NDC 0115-1279-01 Bottles of 1000:                                  NDC 0115-1279-03 Morphine Sulfate Extended-Release Capsules USP, 60 mg are size 1 capsule, red opaque body and cap, imprinted with “J65” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                      NDC 0115-1280-08 Bottles of 60:                                      NDC 0115-1280-13 Bottles of 100:                                    NDC 0115-1280-01 Bottles of 1000:                                  NDC 0115-1280-03 Morphine Sulfate Extended-Release Capsules USP, 80 mg are size 0 capsule, orange opaque body and cap, imprinted with “J66” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                       NDC 0115-1281-08 Bottles of 60:                                       NDC 0115-1281-13 Bottles of 100:                                     NDC 0115-1281-01 Bottles of 1000:                                   NDC 0115-1281-03 Morphine Sulfate Extended-Release Capsules USP, 100 mg are size 0 capsule, light green opaque body and cap, imprinted with “J67” in black ink on cap. Capsules are supplied as follows: Bottles of 30:                                      NDC 0115-1282-08 Bottles of 60:                                      NDC 0115-1282-13 Bottles of 100:                                    NDC 0115-1282-01 Bottles of 1000:                                  NDC 0115-1282-03 Store at 20° to 25°C (68° to 77°F) [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 [see Patient Counseling Information (17)] .

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
Morphine Sulfate (mor’ feen sul’ fate) Extended-Release Capsules,
USP, CII
Morphine sulfate extended-release capsules are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain that requires an extended treatment period
with a daily opioid pain
medicine when other pain medicines do not treat your pain well enough
or you cannot tolerate
them.
•
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and
death. Even if you take your dose correctly as prescribed you are at
risk for opioid addiction,
abuse, and misuse that can lead to death.
•
Not to be taken on an “as needed” basis.
Important information about morphine sulfate extended-release
capsules:
•
Get emergency help or call 911 right away if you take too much
morphine sulfate extended-
release capsules (overdose). When you first start taking morphine
sulfate extended-release
capsules, when your dose is changed, or if you take too much
(overdose), serious or life-
threatening breathing problems that can lead to death may occur. Talk
to your healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
Taking morphine sulfate extended-release capsules with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your morphine sulfate extended-release
capsules. They could die from
taking it. Selling or giving away morphine sulfate extended-release
capsules is against the law.
•
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.
Do not take morphine sulfate extended-release capsules if you have:
•
severe asthma, trouble breathing, or other lung

Summary of Product characteristics

MORPHINE SULFATE- MORPHINE SULFATE CAPSULE, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES.
MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1941
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE
SULFATE
EXTENDED-RELEASE CAPSULES
_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.
(5.1)
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. (5.2)
ACCIDENTAL INGESTION OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES,
ESPECIALLY BY
CHILDREN, CAN RESULT IN FATAL OVERDOSE OF MORPHINE. (5.2)
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. (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. (5.3, 7)
PROLONGED USE OF MORPHINE SULFATE EXTENDED-RELEASE CAPSULES DURING
PREGNANCY CAN
RESULT IN NEONATAL OPIOID WIT