ACETAMINOPHEN AND CODEINE PHOSPHATE- acetaminophen and codeine phosphate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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] Acetaminophen and codeine phosphate tablets are contraindicated for: Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, a Schedule III controlled substance. Acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and c

Product summary:

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]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from moisture. PROTECT FROM LIGHT KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. AP 7/2018 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate (a seet' a min' oh fen and koe'
deen fos' fate) Tablets USP, CIII
Acetaminophen and Codeine Phosphate Tablets 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 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
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 acetaminophen and codeine 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 acetaminophen and codeine phosphate
tablets. They could die
from taking them. Store acetaminophen and codeine 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.
Important Information Guiding Use in Pediatric Patients:
•
Do not give acetaminophen and codeine phosphate tablets to a child
younger than 12 years of age.
•
Do not give acetaminophen and codeine phosphate tablets to a child
younger than 18 years of age
after surgery to remove the tonsils and/or adenoids.
•
Avoid giving acetaminophen and code

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
RX ONLY
WARNING: 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
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].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
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 REMS FOR
THESE PRODUCTS
_[SEE WARNINGS]_. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
•
•
•
•
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 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS [SE