MEPERIDINE HYDROCHLORIDE tablet MEPERIDINE HYDROCHLORIDE solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)

Verfügbar ab:

Hikma Pharmaceuticals USA Inc.

INN (Internationale Bezeichnung):

MEPERIDINE HYDROCHLORIDE

Zusammensetzung:

MEPERIDINE HYDROCHLORIDE 50 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute 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, which can occur at any dosage or duration [see Warnings and Precautions (5.2)] , reserve Meperidine Hydrochloride Tablets and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products] : Meperidine Hydrochloride Tablets or 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. Meperidine Hydrochloride Tablets or Oral Solution should not be used for the treatment of chronic pain. Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine . Meperidine Hydrochloride Tablets and Oral Solution are contraindicated in patients with: Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)]. Available data with meperidine is insufficient to inform a drug-associated risk for major birth defects and miscarriage. Formal animal reproduction studies have not been conducted with meperidine. Neural tube defects (exencephaly and cranioschisis) have been reported in hamsters administered a single bolus dose of meperidine during a critical period of organogenesis at 0.85 and 1.5 times the total human daily dose of 1,200 mg [see Data]. Adverse outcomes in pregnancy can occur regardless of the health of the mother or the use of medications. 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 and Delivery : Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Resuscitation may be required [see Overdose (10)]. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Meperidine is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including meperidine, 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 Animal Data : Formal reproductive and developmental toxicology studies for meperidine have not been completed. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of meperidine hydrochloride (127 and 218 mg/kg, respectively) on Gestation Day 8 to pregnant hamsters (0.85 and 1.5 times the total daily dose of 1,200 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity. Risk Summary Meperidine appears in the milk of nursing mothers receiving the drug. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meperidine and any potential adverse effects on the breastfed infant from Meperidine Hydrochloride Tablets or Oral Solution or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to meperidine through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding 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), Clinical Pharmacology (12.2)], Nonclinical Toxicology (13.1)]. The safety and effectiveness of meperidine in pediatric patients has not been established. Literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient. Clinical studies of meperidine during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. Reducing the total daily dose of meperidine is recommended in elderly patients, and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient. 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 Meperidine Hydrochloride Tablets or Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.4, 5.11)]. Meperidine 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. Accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Elevated serum levels have been reported to cause central nervous system excitatory effects. Meperidine should therefore be used with caution in patients with hepatic impairment. Titrate the dosage of Meperidine Hydrochloride Tablets or Oral Solution slowly in patients with hepatic impairment and regularly evaluate for signs of central nervous system and respiratory depression. Accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment. Titrate the dosage of Meperidine Hydrochloride Tablets or Oral Solution slowly in patients with renal impairment and regularly evaluate for signs of central nervous system and respiratory depression. Meperidine Hydrochloride Tablets and Oral Solution contain meperidine, a Schedule II controlled substance. Meperidine Hydrochloride Tablets and Oral Solution contain meperidine, 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 (5.2)]. 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 Meperidine Hydrochloride Tablets and 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 Meperidine Hydrochloride Tablets and/or Oral Solution 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 Meperidine Hydrochloride Tablets and Oral Solution abuse include those with a history of prolonged use of any opioid, including products containing meperidine, those with a history of drug or alcohol abuse, or those who use Meperidine Hydrochloride Tablets and 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. Meperidine Hydrochloride Tablets and 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 Meperidine Hydrochloride Tablets and Oral Solution Abuse of Meperidine Hydrochloride Tablets and Oral Solution poses a risk of overdose and death. The risk is increased with concurrent use of Meperidine Hydrochloride Tablets and Oral Solution with alcohol and/or other CNS depressants. Meperidine Hydrochloride Tablets and Oral Solution are approved for oral use only. Meperidine Hydrochloride Tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. Inappropriate intravenous, intramuscular, or subcutaneous use of Meperidine Hydrochloride Tablets and Oral Solution 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 Meperidine Hydrochloride Tablets and Oral Solution in a patient physically dependent on opioids. Rapid tapering of Meperidine Hydrochloride Tablets and 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, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Meperidine Hydrochloride Tablets and 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 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 (2.6), and Warnings and Precautions (5.17)]. 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)].

Produktbesonderheiten:

Meperidine Hydrochloride Tablets, USP 50 mg tablet is supplied as a white, round tablet, scored on one side with “54 879” debossed on the other side. NDC 0054-8595-11: 1 x 25 Unit-Dose (Reverse Numbered) Tablets NDC 0054-4595-25: Bottle of 100 Tablets 100 mg tablet is supplied as a white, round tablet, scored on one side with “54 163” debossed on the other side. NDC 0054-4596-25: Bottle of 100 Tablets Meperidine Hydrochloride Oral Solution, USP 50 mg per 5 mL oral solution is supplied as a clear, colorless, slightly viscous (unflavored) solution. NDC 0054-3545-63: Bottle of 500 mL Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store Meperidine Hydrochloride Tablets and Oral Solution securely and dispose of properly [see Patient Counseling Information (17)] .

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE SOLUTION
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Meperidine Hydrochloride Tablets, USP CII
and
Meperidine Hydrochloride Oral Solution, USP CII
(me per’ i deen hye” droe klor’ ide)
Rx only
Meperidine Hydrochloride Tablets and Oral Solution are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage the
relief short-term (acute) pain, 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 Meperidine Hydrochloride Tablets and Oral
Solution:
•
Get emergency help or call 911 right away if you take too much
(overdose) Meperidine
Hydrochloride Tablets or Oral Solution. When you first start taking
Meperidine Hydrochloride
Tablets or 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 treatment of opioid
overdose.
•
Taking Meperidine Hydrochloride Tablets and 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 Meperidine Hydrochloride Tablets and Oral
Solution. They could die
from taking it. Selling or giving away Meperidine Hydrochloride
Tablets and Oral Solution is
against the law.
•
Store Meperidine Hydrochloride Tablets and Oral Solution away from
children and in a safe
location not accessible to others, including visitors to the home.
Do not take Meperidine Hydrochloride Tablets and Oral Solution if you
have:
•
severe a

Fachinformation

MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE TABLET
MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEPERIDINE
HYDROCHLORIDE TABLETS AND MEPERIDINE HYDROCHLORIDE ORAL SOLUTION
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MEPERIDINE
HYDROCHLORIDE TABLETS AND
MEPERIDINE HYDROCHLORIDE ORAL SOLUTION.
MEPERIDINE HYDROCHLORIDE TABLETS, FOR ORAL USE CII
MEPERIDINE HYDROCHLORIDE ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 1942
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE
HYDROCHLORIDE TABLETS AND 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 (2.1, 2.3, 2.5)
12/2023
Warnings and Precautions (5.9)
12/2023
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
MEPERIDINE
HYDROCHLORIDE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG
AND ML,
AND OTHER MEPERIDINE HYDROCHLORIDE ORAL SOLUTIONS OF DIFFERENT
CONCENTRATIONS CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.1,5.1)
MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION EXPOSE USERS TO
RISKS OF
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS
PATIENT’S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE
BEHAVIORS AND
CONDITIONS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSAGE INCREASE.
(5.3)
ACCIDENTAL INGESTION OF MEPERIDINE HYDROCHLORIDE TABLETS OR ORAL
SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF MEPERIDINE.
(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