ACETAMINOPHEN AND CODEINE PHOSPHATE- acetaminophen and codeine phosphate tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Disponível em:

NCS HealthCare of KY, Inc dba Vangard Labs

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe 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 ], reserve acetaminophen and codeine phosphate 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 Acetaminophen and codeine phosphate tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or aden

Resumo do produto:

Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed "2" on one side and "TV"-"50" on the other side of tablet. List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed "3" on one side and "TV"- "150" on the other side of tablet is available in blistercards of 30 (NDC 0615-7792-39) tablets. List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed "4" on one side and "93"- "350" on the other side of tablet. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. AJ 3/2016

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate (a-SEET-a-MIN-oh-fen and KOE-deen
FOSS-fate) Tablets USP,
CIII
Acetaminophen and codeine phosphate tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the relief of
mild to moderately severe 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 acetaminophen and codeine phosphate
tablets:
•
Get emergency help right away if you take too many acetaminophen and
codeine phosphate
tablets (overdose). When you first start taking acetaminophen and
codeine phosphate tablets, when
your dose is changed, or if you take too many tablets (overdose),
serious or life-threatening
breathing problems that can lead to death may occur.
•
Never give anyone else your acetaminophen and codeine phosphate
tablets. They could die from
taking them. Store acetaminophen and codeine phosphate tablets away
from children and in a safe
place to prevent stealing or abuse. Selling or giving away
acetaminophen and codeine phosphate
tablets is against the law.
Do not take acetaminophen and codeine phosphate tablets 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 any of its ingredients.
•
developed signs of allergy such as a rash or difficulty breathing.
Stop taking acetaminophen and
codeine phosphate tablets and contact your healthcare provider
immediately.
•
taken more than 4000 milligrams of acetaminophen per day. Call your
doctor if you took more
than the recommended dose.
Before taki

Características técnicas

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
0050
0150
0350
RX ONLY
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION
ADDICTION, ABUSE, AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS EXPOSE 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 ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS, AND
MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS
OR CONDITIONS [SEE
WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION,
ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLETS OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS DURING
PREGNANCY CAN
RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE
LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS
DEVELOPED BY
NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD
IN A PREGNANT WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE THAT
APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS].
CYTOCHROME P450 3A4 INTERACTION
THE CONCOMITANT USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS
WITH ALL CYTOCHROME
P450 3A4 INHIBITORS MAY RESULT IN AN INCREASE IN ACETAMINOPHEN AND