ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)

Available from:

Xspire Pharma, Llc

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 320.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are indicated for the management of 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, Caffeine, and Dihydrocodeine Bitartrate 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, Caffeine, and Dihydrocodeine Bitartrate is contraindicated for: - All children younger than 12 years of age [see WARNINGS and PRECAUTIONS] - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS and PRECAUTIONS]. Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate is also contraindicated in pati

Product summary:

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing Acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 capsules (NDC # 42195-840-10) and 30 capsules (NDC # 42195-840-30). Capsules are imprinted “TREZIX” on the red cap in white ink. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture. Rx Only Manufactured for: Xspire Pharma LLC Ridgeland, MS 39157 13001 Rev. 7/2017 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN,
CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE
XSPIRE PHARMA, LLC
----------
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE CIII
320.5 MG / 30 MG / 16 MG CAPSULES
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; 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 ISOENZYME; HEPATOTOXICITY AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE 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,
CAFFEINE, AND
DIHYDROCODEINE BITARTRATE 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, CAFFEINE, AND DIHYDROCODEINE BITARTRATE MONITOR FOR
RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIATION OF ACETAMINOPHEN, CAFFEINE,
AND DIHYDROCODEINE
BITARTRATE OR FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE
BITARTRATE, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN,
CAFFEINE, AND DIHYDROCODEINE
BITARTRATE [SEE WARNINGS].
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED
CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY
AND/OR
ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN
ULTRA-RAPID METABOLIZER
OF CODEINE DUE TO CYP2D6 POLYMORPHISM [SEE