ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

RedPharm Drug, Inc.

INN（国際名）:

ACETAMINOPHEN

構図:

ACETAMINOPHEN 300 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Acetaminophen and codeine phosphate 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, 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 provided adequate analgesia, or are not expected to provide adequate analgesia Have not been tolerated, or are not expected to be tolerated Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Patients with significant respiratory depression [see WARNINGS]. Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]. Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNI

製品概要:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/15 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U35” on one side and plain on the other side. Bottles of 30 NDC 13107-058-30 Bottles of 100 NDC 13107-058-01 Bottles of 500 NDC 13107-058-05 Bottles of 1000 NDC 13107-058-99 300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. Bottles of 30 NDC 13107-059-30 Bottles of 100 NDC 13107-059-01 Bottles of 500 NDC 13107-059-05 Bottles of 1000 NDC 13107-059-99 300 mg/60 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U37” on one side and plain on the other side. Bottles of 30 NDC 13107-060-30 Bottles of 100 NDC 13107-060-01 Bottles of 500 NDC 13107-060-05 Bottles of 1000 NDC 13107-060-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 12/2016 LM 2126

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

ACETAMINOPHEN AND CODEINE PHOSPHATE- acetaminophen and codeine
phosphate tablet
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
Acetaminophenand Codeine Phosphate Tablets, USP CIII
ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate
Acetaminophen and Codeine PhosphateTablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage mild to
moderate 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 codeinephosphate
tablets:
Get emergency help right away if you take too much 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 much (overdose), serious or
life-threatening breathing problems that can lead to
death may occur.
Acetaminophen and Codeine Phosphate Tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that depress
consciousness.
Never give anyone else your acetaminophen and codeine phosphate
tablets. They could die from taking it.
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 are against the law.
Do not take Acetaminophen and Codeine Phosphate Tablets ifyou have:
•severe asthma, trouble breathing, or other lung problems.
•a bowel blockage or narrowing of the stomach or intestines.
•previously had an allergic reaction to codeine or acetaminophen.
Before taking acetaminophen and codeine phosphatetablets, tell your
healthcare providerif you have a history
of:
head injury, seizu

製品の特徴

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; and RISKS
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 and 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].
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in child