DVORAH- acetaminophen, caffeine and dihydrocodeine bitartrate tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Phlight Pharma, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

DVORAH is 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 DVORAH 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 DVORAH 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 ]. DVORAH is also contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in

Sommarju tal-prodott:

DVORAH (acetaminophen, caffeine, and dihydrocodeine bitartrate tablets), containing acetaminophen 325 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 tablets (NDC 70569-152-01) and 30 tablets (NDC 70569-152-30). Tablets are white, capsule-shaped tablets debossed “LL 720” on one side and plain on the other side. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container with a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Rx Only Manufactured for: Phlight Pharma, LLC. Ocean Springs, MS 39564 500508-01 Rev. 11/2018

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

DVORAH- ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
Phlight Pharma, LLC
----------
MEDICATION GUIDE
DVORAH (DŬH-VOR′-ŬH)
(ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE
BITARTRATE TABLETS), CIII
DVORAH is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage moderate
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 DVORAH:
•
Get emergency help right away if you take too much DVORAH (overdose).
When you first start
taking DVORAH, 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 DVORAH 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 DVORAH. They could die from taking it.
Store DVORAH away from
children and in a safe place to prevent stealing or abuse. Selling or
giving away DVORAH is against
the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give DVORAH to a child younger than 12 years of age.
•
Do not give DVORAH to a child younger than 18 years of age after
surgery to remove the tonsils and/
or adenoids.
•
Avoid giving DVORAH to children between 12 to 18 years of age who have
risk factors for breathing
problems such as obstructive sleep apnea, obesity, or underlying lung
problems.
Do not take DVORAH if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
previously had an allergic reaction to dihydroco

Karatteristiċi tal-prodott

DVORAH- ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
PHLIGHT PHARMA, LLC
----------
DVORAH (ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLETS)
C-III
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
DVORAH EXPOSES 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 DVORAH, 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
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF DVORAH.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
DVORAH OR FOLLOWING A