ACETAMINOPHEN AND CODEINE PHOSPHATE liquid

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Mikart, LLC

INN (Nama Antarabangsa):

ACETAMINOPHEN

Komposisi:

ACETAMINOPHEN 120 mg in 5 mL

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Acetaminophen and codeine phosphate oral solution is 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 oral solution 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 oral solution is contraindicated for: - All children younger than 12 years of age [see WARNINGS ]. - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS ]. Acetaminophen and codeine phosphate oral solution is contraindicated in patients with: - Significant respirat

Ringkasan produk:

Acetaminophen and Codeine Phosphate Oral Solution USP, each 5 mL (teaspoonful) of which contains acetaminophen 120 mg, codeine phosphate 12 mg ( WARNING: May be habit forming) and alcohol 7%, is supplied as an orange-colored, cherry-flavored liquid, in 16 fluid ounce (473 mL) bottles, NDC 46672-561-16. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Store acetaminophen and codeine phosphate oral solution securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Manufactured by: MIKART, LLC Atlanta, GA 30318 Rev. 07/2020 Code 378Z00

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Mikart, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Acetaminophen (a seet"
a min' oh fen) and
Codeine Phosphate (koe'
deen fos' fate) Oral
Solution USP, CV
Acetaminophen and
Codeine Phosphate Oral
Solution is:
•
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 Codeine Phosphate
Oral Solution:
•
Get emergency
help or call 911
right away if you
take too much
Acetaminophen
and Codeine
Phosphate Oral
Solution
(overdose).
When you first
start taking
Acetaminophen
and Codeine
Phosphate 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
Acetaminophen
and Codeine
Phosphate 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
Acetaminophen
and Codeine
Phosphate Oral
Solution. They
could die from
taking it. Selling
or giving away
Acetaminophen
and Codeine
Phosphate Oral
Solution is
against the law.
•
Store
Acetaminophen
and Codeine
Phosphate Oral
Solution
securely, out of
sight and reach
of children, and
in a location not
accessible by
others, including
visitors to the
home.
Important Information
Guiding Use in
Pediatric Patients:
Do not give
Acetaminophen and
Codeine Phosphate Oral
Solution to a child
younger than 12 years
of age.
Do not give
Acet

Ciri produk

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE LIQUID
MIKART, LLC
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP
DESCRIPTION
Acetaminophen and codeine phosphate oral solution is pharmacologically
classified as an analgesic.
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opioid, non-salicylate analgesic and antipyretic. It has the following
structural formula:
Codeine phosphate, 7,8-didehydro-4,
5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)
(salt) hemihydrate, a white crystalline powder, is an opioid agonist.
It has the following structural
formula:
Each 5 mL (teaspoonful) of acetaminophen and codeine phosphate oral
solution contains:
Acetaminophen …………… 120 mg
Codeine Phosphate ………... 12 mg
Alcohol ……………………. 7%
INACTIVE INGREDIENTS: citric acid (anhydrous), glycerin,
methylparaben, propylene glycol,
propylparaben, purified water, saccharin sodium, sorbitol solution,
sucrose, with natural and artificial
cherry flavor. Contains FD&C Yellow No. 6 as a color additive.
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
RISK EVALUATION AND MITIGATION STRATEGY (REMS) LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID
METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-
THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
ACETAMINOPHEN AND
CODEINE PHOSPHATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION
BETWEEN MG AND ML, AND
OTHER CODEINE CONTAINING ORAL PRODUCTS OF DIFFERENT CONCENTRATIONS CAN
RESULT IN ACCIDENTAL
OVERDOSE AND DEATH [SEE WARNINGS, DOSAGE AND ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION EXPOSES