OXYCODONE HYDROCHLORIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Dostupné z:

Zydus Pharmaceuticals (USA) Inc.

INN (Medzinárodný Name):

OXYCODONE HYDROCHLORIDE

Zloženie:

OXYCODONE HYDROCHLORIDE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Oxycodone hydrochloride (HCl) tablets are indicated for the management of 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, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone HCl tablets 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 HCl 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 or hypercarbia [see Warnings and Precautions (5.7)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [s

Prehľad produktov:

Oxycodone HCl tablets, USP are available as follows: 5 mg: Orange round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "11" on the other. NDC 68382-793-01 – Bottle of 100 Tablets 10 mg: Pink round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "12" on the other. NDC 68382-794-01 – Bottle of 100 Tablets 15 mg: Yellow round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "13" on the other. NDC 68382-795-01 – Bottle of 100 Tablets 20 mg: Gray round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "14" on the other. NDC 68382-796-01 – Bottle of 100 Tablets 30 mg: White round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "15" on the other. NDC 68382-797-01 – Bottle of 100 Tablets DEA Order Form Required Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store oxycodone HCl securely and dispose of properly [see Patient Counseling Information (17)] .

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Zydus Pharmaceuticals (USA) Inc.
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SPL MEDGUIDE
Medication Guide
Oxycodone (ox-i-KOE-done) HCl Tablets USP, CII
Oxycodone HCl Tablets are:
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 HCl tablets:
Get emergency help right away if you take too many oxycodone HCl
tablets
(overdose). When you first start taking oxycodone HCl 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.
Taking oxycodone HCl 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 oxycodone HCl tablets. They could die from
taking
it. Selling or giving away oxycodone HCl tablets is against the law.
Store oxycodone HCl tablets 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 HCl tablets if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
allergy to oxycodone.
Before taking oxycodone HCl tablets, tell your healthcare provider if
you have a
history of:
head injury, seizures
problems urinating
abuse of street or prescription drugs, alcohol addiction, or mental
health
problems.
liver, kidney, thyroid problems
pancreas or gallbladder problems
Tell your healthcare provider if you are:
pregnant or planning to become pregn

Súhrn charakteristických

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HCL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE
HCL TABLETS CII
INITIAL U.S. APPROVAL: 1950
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONOTAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER
CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYCODONE HCL EXPOSES 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. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF OXYCODONE HCL, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL
OVERDOSE OF OXYCODONE. (5.3)
PROLONGED USE OF OXYCODONE HCL DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED.
IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE
RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT
APPROPRIATE TREATMENT
WILL BE AVAILABLE. (5.4)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF OXYCODONE FROM OXYCODONE HCL TABLETS
(5.5, 7, 12.3)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESUL