CODEINE SULFATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

CODEINE SULFATE (UNII: 11QV9BS0CB) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

제공처:

Hikma Pharmaceuticals USA Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 ( 5.1)] , reserve Codeine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products] : Codeine Sulfate Tablets 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. Codeine Sulfate Tablets are contraindicated for: Codeine Sulfate Tablets are also 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 (5.4)] . Available data with Codeine Sulfate Tablets are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, codeine administration during organogenesis has been shown to produce delayed ossification in the offspring of mice at 1.4 times maximum recommended human dose (MRHD) of 360 mg/day, embryolethal and fetotoxic effects in the offspring of rats and hamsters at approximately 2 to 3 times the MRHD, and cranial malformations/cranioschisis in the offspring of hamsters between 2 and 8 times the MRHD [see Data ]. 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. Codeine Sulfate Tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Codeine Sulfate Tablets, 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: Studies on the reproductive and developmental effects of codeine have been reported in the published literature in hamsters, rats, mice and rabbits. In a study in which pregnant hamsters were administered 150 mg/kg twice daily of codeine (oral; approximately 7 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m2 basis) during organogenesis cranial malformations (i.e., meningoencephalocele) in several fetuses were reported; as well as the observation of increases in the percentage of resorptions per litter. Doses of 50 and 150 mg/kg, bid resulted in fetotoxicity as demonstrated by decreased fetal body weight. In an earlier study in hamsters, single oral doses of 73 to 360 mg/kg level on Gestation Day 8 (oral; approximately 2 to 8 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m2 basis), reportedly produced cranioschisis in all of the fetuses examined. In studies in rats, doses at the 120 mg/kg level (oral; approximately 3 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m2 basis) during organogenesis, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In pregnant mice, a single 100 mg/kg dose (subcutaneous; approximately 1.4 times the recommended daily dose of 360 mg/day for adults on a mg/mg2 basis) administered between Gestation Day 7 and 12 reportedly resulted in delayed ossification in the offspring. No teratogenic effects were observed in rabbits administered up to 30 mg/kg (approximately 2 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m2 basis) of codeine during organogenesis. Codeine (30 mg/kg) administered subcutaneously to pregnant rats during pregnancy and for 25 days after delivery increased neonatal mortality at birth. This dose is 0.8 times the maximum recommended human dose of 360 mg/day on a body surface area comparison. Risk Summary: Codeine and its active metabolite, morphine, are present in human milk. There are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk. Women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. There is no information on the effects of codeine on milk production. Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Codeine Sulfate Tablets [see Warnings and Precautions (5.4)] . Clinical Considerations: If infants are exposed to Codeine Sulfate Tablets through breast milk, they should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic 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)] . The safety and effectiveness of Codeine Sulfate Tablets in pediatric patients have not been established. Life-threatening respiratory depression and death have occurred in children who received codeine [see Warnings and Precautions (5.6)] . In most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine. Because of the risk of life-threatening respiratory depression and death: Elderly patients (aged 65 years or older) may have increased sensitivity to codeine. 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 Codeine Sulfate Tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.9)] . Codeine 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. No formal studies have been conducted in patients with hepatic impairment so the pharmacokinetics of codeine in this patient population are unknown. Start these patients with a lower than normal dosage of Codeine Sulfate Tablets or with longer dosing intervals and titrate slowly while regularly evaluating for signs of respiratory depression, sedation, and hypotension. Codeine pharmacokinetics may be altered in patients with renal failure. Clearance may be decreased and the metabolites may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function. Start these patients with a lower than normal dosage of Codeine Sulfate Tablets or with longer dosing intervals and titrate slowly while regularly evaluating for signs of respiratory depression, sedation, and hypotension. Codeine Sulfate Tablets contain codeine, a Schedule II controlled substance. Codeine Sulfate Tablets contains codeine, 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 Codeine Sulfate Tablets increases risk of overdosage, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of Codeine Sulfate Tablets 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 Codeine Sulfate Tablets abuse include those with a history of prolonged use of any opioid, including products containing codeine, those with a history of drug or alcohol abuse, or those who use Codeine Sulfate Tablets 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. Codeine Sulfate Tablets, 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 Codeine Sulfate Tablets: Abuse of Codeine Sulfate Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Codeine Sulfate Tablets with alcohol and/or other CNS depressants. Codeine Sulfate Tablets 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 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 Codeine Sulfate Tablets in a patient physically dependent on opioids. Rapid tapering of Codeine Sulfate Tablets 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 Codeine Sulfate Tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Codeine Sulfate Tablets 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), Warnings and Precautions (5.16)]. 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)] .

제품 요약:

Codeine Sulfate Tablets, USP 15 mg tablet: supplied as white to off-white biconvex tablets with “15” debossed on the scored side and “54 613” debossed on the other side. NDC 0054-0243-24: 10 x 10 Unit-Dose 30 mg tablet: supplied as white to off-white biconvex tablets with “30” debossed on the scored side and “54 783” debossed on the other side. NDC 0054-0244-24: 10 x 10 Unit-Dose NDC 0054-0244-25: Bottle of 100 Tablets 60 mg tablet: supplied as white to off-white biconvex tablets with “60” debossed on the scored side and “54 412” debossed on the other side. NDC 0054-0245-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP/NF. Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient. Store Codeine Sulfate Tablets securely and dispose of properly.

승인 상태:

New Drug Application

환자 정보 전단

Hikma Pharmaceuticals USA Inc.
Reference Label Set Id: fa3ed180-298a-4f9d-9d05-15182d7218bf
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MEDICATION GUIDE
Codeine Sulfate (koe’ deen sul’ fate) Tablets, USP CII
Codeine Sulfate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage mild
to moderate pain, where treatment with an opioid is appropriate, and
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 Codeine Sulfate Tablets:
•
Get emergency help or call 911 right away if you take too much Codeine
Sulfate Tablets
(overdose). When you first start taking Codeine Sulfate Tablets, 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 Codeine Sulfate Tablets 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 Codeine Sulfate Tablets. They could die
from taking it. Selling or
giving away Codeine Sulfate Tablets is against the law.
•
Store Codeine Sulfate Tablets securely, out of sight and reach of
children, and in a location not
accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give Codeine Sulfate Tablets to a child younger than 12 years
of age.
•
Do not give Codeine Sulfate Tablets to a child younger than 18 years
of age after surgery to
remove the tonsils and/or adenoids.
•
Avoid giving Codeine Sulfate Tablets to

제품 특성 요약

CODEINE SULFATE- CODEINE SULFATE TABLET
HIKMA PHARMACEUTICALS USA INC.
REFERENCE LABEL SET ID: FA3ED180-298A-4F9D-9D05-15182D7218BF
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CODEINE SULFATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CODEINE SULFATE
TABLETS.
CODEINE SULFATE TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1950
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE
SULFATE
TABLETS
_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, 2.4)
12/2023
CODEINE SULFATE TABLETS 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. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSAGE INCREASE. TO
REDUCE THE
RISK OF RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF CODEINE
SULFATE
TABLETS ARE ESSENTIAL. (5.2)
ACCIDENTAL INGESTION OF CODEINE SULFATE TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF CODEINE. (5.2)
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. (5.3, 7)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME,
WHICH MAY
BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT
MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY. (5.4)
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A
REMS-COMPLIANT
EDUCATION PROGRAM AND TO COU