OXYCODONE HYDROCHLORIDE solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570)

MAH:

Genus Lifesciences Inc.

INN:

Oxycodone Hydrochloride

composition:

Oxycodone Hydrochloride 100 mg in 5 mL

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. 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 Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated or are not expected to be tolerated - Have not provided adequate analgesia or are not expected to provide adequate analgesia Oxycodone Hydrochloride 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. Oxycodone Hydrochloride Oral Solution is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.3)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.9)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13)] - Hypersensitivity to oxycodone (e.g., angioedema) [see Adverse Reactions (6)] 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 Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see 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. Oxycodone Hydrochloride 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 Oxycodone Hydrochloride 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 Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 25 mg/kg/day, respectively. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis). Risk Summary Available data from lactation studies indicate that oxycodone is present in breastmilk and that doses of less than 60 mg/day of the immediate-release formulation are unlikely to result in clinically relevant exposures in breastfed infants. A pharmacokinetics study utilizing opportunistic sampling of 76 lactating women receiving oxycodone immediate-release products for postpartum pain management showed that oxycodone concentrates in breastmilk with an average milk to plasma ratio of 3.2. The relative infant dose was low, approximately 1.3% of a weight-adjusted maternal dose (see Data) . In the same study, among the 70 infants exposed to oxycodone in breastmilk, no adverse events were attributed to oxycodone. However, based on known adverse effects in adults, infants should be monitored for signs of excess sedation and respiratory depression (see Clinical Considerations) . There are no data on the effects of the oxycodone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oxycodone Hydrochloride Oral Solution and any potential adverse effects on the breastfed infant from Oxycodone Hydrochloride Oral Solution or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to Oxycodone Hydrochloride Oral Solution 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. Data Oxycodone concentration data from 76 lactating women receiving immediate-release oxycodone products for postpartum pain management, and 28 infants exposed to oxycodone in breastmilk showed that following a median (range) dose of oxycodone in mothers of 9.2 (5-10) mg/dose or 33.0 (5.4-59.3) mg/day, oxycodone concentrated in breastmilk with a median (range) milk to plasma ratio of 3.2 (1.2-5.3). However, when using maternal breastmilk data to estimate the daily and relative infant dose, the infant dose was 0.006 mg/kg/day, which is 1.3% of a weight-adjusted maternal dose of 10 mg every 6 hours. These estimates based on maternal breastmilk concentrations were corroborated by the observed infant concentrations, of which over 75% (19/25) were below the limit of quantification. Among the 6 infants with quantifiable concentration, the median (range) concentration was 0.2 ng/mL (0.1-0.7). These concentrations are 100 to 1000 times lower than concentrations observed in other studies after infants received oxycodone at 0.1 mg/kg/dose (~20-200 ng/mL). 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)]. The safety and effectiveness of Oxycodone Hydrochloride Oral Solution have not been established in pediatric patients. The safety and pharmacokinetics of a single-dose of an Oxycodone Hydrochloride Oral Solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain. However definitive conclusions were not possible because of insufficient information. Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. 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 Oxycodone Hydrochloride Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.9)]. Oxycodone 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. Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Initiate therapy in these patients with a lower than usual dosage of Oxycodone Hydrochloride Oral Solution and titrate carefully. Regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)]. Information from oxycodone tablets indicate that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. Initiate therapy with a lower than usual dosage of Oxycodone Hydrochloride Oral Solution and titrate carefully. Regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)]. Oxycodone Hydrochloride Oral Solution contains oxycodone, a Schedule II controlled substance. Oxycodone Hydrochloride Oral Solution contains oxycodone, 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 Oxycodone Hydrochloride 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 Oxycodone Hydrochloride 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 Oxycodone Hydrochloride Oral Solution abuse include those with a history of prolonged use of any opioid, including products containing oxycodone, those with a history of drug or alcohol abuse, or those who use Oxycodone Hydrochloride 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. Oxycodone Hydrochloride 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 Oxycodone Hydrochloride Oral Solution Abuse of Oxycodone Hydrochloride oral Solution poses a risk of overdose and death. The risk is increased with concurrent use of Oxycodone Hydrochloride Oral Solution with alcohol and/or other CNS depressants. Oxycodone Hydrochloride 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 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), missed 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 Oxycodone Hydrochloride Oral Solution in a patient physically dependent on opioids. Rapid tapering of Oxycodone Hydrochloride 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 Oxycodone Hydrochloride Oral Solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Oxycodone Hydrochloride 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 (2.5), 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)]. - Always use the oral syringe provided with your Oxycodone Hydrochloride Oral Solution to make sure you measure the right amount. - Measure the dose of medicine from the widest part of the plunger. Do not measure from the narrow tip. See Figure 1.

leaflet_short:

Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL), is a red solution, supplied as: NDC# 64950-354-10: Bottle of 100 mL supplied with a calibrated measuring cup NDC# 64950-354-50: Bottle of 500 mL supplied with a calibrated measuring cup NDC# 64950-354-05: 5 mL unit dose cup NDC# 64950-354-45: Case contains 40 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 4 trays of 10 unit dose cups each NDC# 64950-354-55: Case contains 50 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 5 trays of 10 unit dose cups each Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL), is a yellow solution, supplied as: NDC# 64950-353-03: Bottle of 30 mL supplied with a calibrated oral syringe NDC# 64950-353-01: Prefilled Oral Dispenser, 10 mg per 0.5 mL NDC# 64950-353-02: Prefilled Oral Dispenser, 20 mg per mL NDC# 64950-353-51: Case contains 50 prefilled oral dispensers of 10 mg/0.5 mL (NDC # 64950-353-01), packaged in 10 pouches of 5 prefilled oral dispensers each (NDC# 64950-353-91) NDC# 64950-353-52: Case contains 50 prefilled oral dispensers of 20 mg/mL (NDC# 64950-353-02), packaged in 10 pouches of 5 prefilled oral dispensers each (NDC# 64950-353-92) Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly.

authorization_status:

New Drug Application

PIL

Genus Lifesciences Inc.
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MEDICATION GUIDE
OXYCODONE HYDROCHLORIDE (OX-EE-CO-DOHN) ORAL SOLUTION, CII
Oxycodone Hydrochloride Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage 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 Oxycodone Hydrochloride Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Oxycodone Hydrochloride Oral
Solution (overdose). When you first start taking Oxycodone
Hydrochloride 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 Oxycodone Hydrochloride 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 Oxycodone Hydrochloride Oral Solution.
They could die from
taking it. Selling or giving away Oxycodone Hydrochloride Oral
Solution is against the law.
•
Store Oxycodone Hydrochloride 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 Oxycodone Hydrochloride 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 oxycodone or any of the ingredients in Oxycodone
Hydrochloride Oral Solution.

SPC

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE SOLUTION
GENUS LIFESCIENCES INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE
HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR OXYCODONE HYDROCHLORIDE ORAL SOLUTION.
OXYCODONE HYDROCHLORIDE ORAL SOLUTION CII
INITIAL U.S. APPROVAL: 1950
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE
HYDROCHLORIDE SOLUTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE
HYDROCHLORIDE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG
AND ML,
AND OTHER OXYCODONE HYDROCHLORIDE ORAL SOLUTIONS OF DIFFERENT
CONCENTRATIONS CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH (2.1, 5.1).
OXYCODONE HYDROCHLORIDE 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 OR FOLLOWING A DOSAGE INCREASE. TO REDUCE RISK OF
RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF OXYCODONE HYDROCHLORIDE
ORAL SOLUTION
ARE ESSENTIAL. (5.3)
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. (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. (5.4, 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 WIL