MORPHINE SULFATE solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Hikma Pharmaceuticals USA Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) : Morphine Sulfate Oral Solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Morphine Sulfate Oral Solution is contraindicated in patients with: Risk Summary Use of opioid analgesics for an extended period of time during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)] . There are no available data with Morphine Sulfate Oral Solution 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 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 (5.5)]. 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 Oral Solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Morphine Sulfate Oral Solution, 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 Morphine Sulfate Oral Solution and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Morphine Sulfate Oral Solution and any potential adverse effects on the breastfed infant from Morphine Sulfate Oral Solution or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to Morphine Sulfate Oral Solution 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) and 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 effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have been established for the management of pediatric patients 2 to 17 years of age with acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate. Use of Morphine Sulfate Oral Solution in this age group is supported by clinical evidence in adults and supportive data from an open-label, safety and pharmacokinetic study in pediatric patients 2 through 17 years of age with post-operative acute pain. Patients were excluded if they had used opioids for more than 7 days within the previous 30 days prior to surgery or had received opioids in any form in the previous 7 days prior to surgery.  Initial dosing was approximately 0.15 mg/kg to 0.3 mg/kg. Pharmacokinetic modeling and simulation indicate that an initial dose of 0.3 mg/kg in pediatric patients 2 years of age and older is expected to produce a maximum systemic exposure (Cmax ) similar to that achieved after single dose administration of 10 mg Morphine Sulfate Oral Solution to adults [see Clinical Pharmacology (12.3)] . Safety data were available in 81 patients who received single and multiple doses (63 patients aged 2 to 17 years received Morphine Sulfate Oral Solution; 18 patients aged 12 to 17 years received Morphine Sulfate Tablets).  The median duration of treatment was 20 hours (range 4 hours to 36 hours). Opioid and non-opioid rescue analgesics were allowed. The safety profile in pediatric patients consisted primarily of opioid-related adverse reactions and is similar to that observed in adults [see Adverse Reactions (6)]. The safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have not been established for the management of pediatric patients 2 to 17 years of age with chronic pain severe enough to require an opioid analgesic when alternative treatments are inadequate. The safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) have not been established in pediatric patients less than 2 years of age. The safety and effectiveness of Morphine Sulfate Oral Solution 20 mg/mL have not been established in pediatric patients. Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. In general, use caution when selecting a dose 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 Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.8)]. Morphine 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 Oral Solution and titrate slowly while regularly evaluating 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 Oral Solution and titrate slowly while regularly evaluating for signs of respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)] . Morphine Sulfate Oral Solution contains morphine, a Schedule II controlled substance. Morphine Sulfate Oral Solution contains morphine, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.2)]. 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 Oral Solution 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 Oral Solution with alcohol and/or 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 Oral Solution abuse include those with a history of prolonged use of any opioids, including products containing morphine, those with a history of drug or alcohol abuse, or those who use Morphine Sulfate Oral Solution 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 Oral Solution, 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 Oral Solution Abuse of Morphine Sulfate Oral Solution poses a risk of overdose and death. The risk is increased with concurrent use of Morphine Sulfate Oral Solution with alcohol and/or other CNS depressants. Morphine Sulfate Oral Solution is approved for oral use only. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during chronic 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 Oral Solution in a patient physically dependent on opioids. Rapid tapering of Morphine Sulfate Oral Solution 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 Oral Solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Morphine Sulfate Oral Solution 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 a long duration 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 (2.6) 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)]. Instructions For Use Morphine Sulfate Oral Solution, CII 20 mg/mL Important Information You Need to Know Before Using Morphine Sulfate Oral Solution: Each Morphine Sulfate Oral Solution carton contains: Step 1: Remove the Morphine Sulfate Oral Solution bottle and oral syringe from the carton. Place all items on a flat surface. Open the bottle by pressing downward firmly on the child-resistant cap and twisting it in the direction of the arrow (counter-clockwise). See Figure A. Do not throw away the child-resistant cap. Figure A Step 2: Check the dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the oral syringe. See Figure B. Figure B Step 3: Push the oral syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air. See Figure C. Figure C Step 4: On the flat surface, use one hand to hold the bottle and use your other hand to insert the oral syringe into the bottle opening. See Figure D. Figure D Step 5: With the oral syringe in the bottle, pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of oral solution in Step 2). See Figure E. Note: Measure the dose of medicine from the widest part of the plunger. Do not measure from the narrow tip. If you see air bubbles in the syringe, fully push in the plunger so that the oral solution flows back into the bottle. Then withdraw your prescribed dose of oral solution. Figure E Step 6: Remove the oral syringe from the bottle. See Figure F. Figure F Step 7: Check that the correct dose was drawn up into the oral syringe. See Figure G. If the dose is not correct, insert the oral syringe tip into the bottle. Fully push in the plunger so that the oral solution flows back into the bottle. Repeat Steps 4 through 6. Figure G Steps 8 : Take the dose of Morphine Sulfate Oral Solution. See Figure H. Figure H Step 9 : Put the child-resistant cap back on the bottle. See Figure I. Figure I Step 10 : Rinse the oral syringe with tap water after each use. See Figure J. Do not throw away the oral syringe. Figure J How should I store Morphine Sulfate Oral Solution? Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 For more information, please call 1-800-962-8364. This Instructions for Use has been approved by the U.S. Food and Drug Administration C50001154/02 Revised December 2023

Proizvod sažetak:

Morphine Sulfate Oral Solution: 20 mg per 5 mL (4 mg/ mL) Oral Solution is supplied as a clear, blue-green solution. Each 1 mL of clear, blue-green oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine). 100 mg per 5 mL (20 mg/mL) Oral Solution (colorless) (only for opioid-tolerant adults) is supplied as a clear, colorless solution. Each 1 mL of clear, colorless oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). 100 mg per 5 mL (20 mg/mL) Oral Solution (color added) (only for opioid-tolerant adults) is supplied as a clear, pink solution. Each 1 mL of clear, pink oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store Morphine Sulfate Oral Solution securely and dispose of properly.

Status autorizacije:

New Drug Application

Uputa o lijeku

Hikma Pharmaceuticals USA Inc.
Reference Label Set Id: 19a17354-8ae9-48cf-ad52-cc774ca801be
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MEDICATION GUIDE
Medication Guide
Morphine (mor-pheen) Sulfate Oral Solution, CII
Morphine Sulfate Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short
term (acute) and long term (chronic) pain severe enough to require an
opioid pain medicine, when
other pain treatments such as non-opioid pain medicines do not treat
your pain well enough or you
cannot tolerate them.
•
An 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.
Important information about Morphine Sulfate Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Morphine Sulfate Oral Solution
(overdose). When you first start taking Morphine Sulfate Oral
Solution, 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 Oral Solution 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 Oral Solution. They could
die from taking it.
Selling or giving away Morphine Sulfate Oral Solution is against the
law.
•
Store Morphine Sulfate Oral Solution 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 Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
an allergy to morphine.
Before taking

Svojstava lijeka

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
REFERENCE LABEL SET ID: 19A17354-8AE9-48CF-AD52-CC774CA801BE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE
ORAL SOLUTION.
MORPHINE SULFATE ORAL SOLUTION, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1941
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE
SULFATE
ORAL SOLUTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning
12/2023
Indications and Usage (1)
12/2023
Dosage and Administration (2.2, 2.4, 2.5)
12/2023
Warnings and Precautions (5.7)
12/2023
INDICATIONS AND USAGE
Morphine Sulfate Oral Solution is an opioid agonist.
Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management
of:
•
•
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
MORPHINE
SULFATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND
ML, AND
OTHER MORPHINE SULFATE ORAL SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN
RESULT IN
ACCIDENTAL OVERDOSE AND DEATH. (2.1, 5.1)
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 REASSESS REGULARLY FOR THESE BEHAVIORS AND CONDITIONS.
(5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
ESPECIALLY
DURING INITIATION AND FOLLOWING DOSAGE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF MORPHINE SULFATE ORAL
SOLUTION ARE
ESSENTIAL. (5.3)
ACCIDENTAL INGESTION OF MORPHINE SULFATE ORAL SOLUTION, ESPECIALLY BY
CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF MORPHINE. (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 CON