HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Hydrocodone Bitartrate (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Commercializzato da:

Upsher-Smith Laboratories, LLC

INN (Nome Internazionale):

Hydrocodone Bitartrate

Composizione:

Hydrocodone Bitartrate 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen 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. Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial a

Dettagli prodotto:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP (5 mg/325 mg) are available as white, capsule-shaped tablets with score on both sides, debossed "U4 10" on one side and no debossing on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Tablets are supplied in bottles of 100 (NDC 0245-0410-11), bottles of 500 (NDC 0245-0410-50), and unit-dose cartons of 100 (NDC 0245-0410-01). Hydrocodone Bitartrate and Acetaminophen Tablets, USP (7.5 mg/325 mg) are available as light orange, capsule-shaped tablets with score on both sides, debossed "U4 11" on one side and no debossing on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Tablets are supplied in bottles of 100 (NDC 0245-0411-11), bottles of 500 (NDC 0245-0411-50), and unit-dose cartons of 100 (NDC 0245-0411-01). Hydrocodone Bitartrate and Acetaminophen Tablets, USP (10 mg/325 mg) are available as yellow, capsule-shaped tablets with score on both sides, debossed "U4 12" on one side and no debossing on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Tablets are supplied in bottles of 100 (NDC 0245-0412-11), bottles of 500 (NDC 0245-0412-50), and unit-dose cartons of 100 (NDC 0245-0412-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients/Caregivers ].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ACETAMINOPHEN TABLET
Upsher-Smith Laboratories, LLC
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Medication Guide
Hydrocodone Bitartrate (hye" droe koe' done bye tar' trate) and
Acetaminophen (a seet" a min' oh fen) Tablets CII
Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone Bitartrate and Acetaminophen
Tablets:
•
Get emergency help or call 911 right away if you take too much
Hydrocodone Bitartrate and
Acetaminophen Tablets (overdose). When you first start taking
Hydrocodone Bitartrate and
Acetaminophen 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 emergency treatment of an
opioid overdose.
•
Taking Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone Bitartrate and Acetaminophen
Tablets. They could die
from taking it. Selling or giving away Hydrocodone Bitartrate and
Acetaminophen Tablets is
against the law.
•
Store Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone Bitartrate and Acetaminophen Tablets if you
have:
•
severe asthma, trouble breathing, or other l

Scheda tecnica

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
UPSHER-SMITH LABORATORIES, LLC
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
CII
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS,
EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION,
ABUSE,
AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH, ASSESS EACH
PATIENT'S RISK PRIOR TO PRESCRIBING AND REASSESS ALL PATIENTS
REGULARLY FOR
THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, ESPECIALLY
DURING INITIATION OR FOLLOWING A DOSE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF HYDROCODONE
BITARTRATE AND ACETAMINOPHEN TABLETS ARE ESSENTIAL [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF HYDROCODONE AND ACETAMINOPHEN [SEE WARNINGS].
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLETS AND BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN
PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE [SEE
WARNINGS, PRECAUTIONS; DRUG LNTERACTIONS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE­
THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT BY
NEONATOLOGY EXPE