IBUDONE- hydrocodone bitartrate and ibuprofen tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

Poly Pharmaceuticals

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IBUDONE ® tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Carefully consider the potential benefits and risks of IBUDONE ® and other treatment options before deciding to use IBUDONE ® . Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation) . Do not use IBUDONE ® for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS: Addiction, Abuse, and Misuse) , reserve IBUDONE ® 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 analges

Product summary:

IBUDONE ® (hydrocodone bitartrate and ibuprofen tablets) 5 mg/200 mg are available as: White, film-coated, oval shaped, scored tablets, debossed "3584" on one side and debossed "V" on the reverse side, in bottles of 100 (NDC 50991-578-01). IBUDONE ® (hydrocodone bitartrate and ibuprofen tablets) 10 mg/200 mg are available as: Purple, film-coated, oval shaped, scored tablets, debossed "3586" on one side and debossed "V" on the reverse side in bottles of 100 (NDC 50991-579-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-II Controlled Substance.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUDONE- HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
Poly Pharmaceuticals
----------
MEDICATION GUIDE
IBUDONE ® (eye " bue done)
(hydrocodone bitartrate and ibuprofen tablets), CII
IBUDONE ® is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
and a non-steroidal anti-
inflammatory drug (NSAID), that is used to manage short-term (acute)
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 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.
•
NSAIDs are used to treat pain, redness, swelling, and inflammation.
Important information about IBUDONE ®:
•
Get emergency help right away if you take too much IBUDONE ®
(overdose). When you first
start taking IBUDONE ®, 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 IBUDONE ® 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 IBUDONE ®. They could die from taking it.
Store IBUDONE ®
away from children and in a safe place to prevent stealing or abuse.
Selling or giving away
IBUDONE ® is against the law.
IBUDONE ® contains an NSAID. NSAIDs can cause serious side effects,
including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
◦ with increasing doses of medicine containing NSAIDs
◦ with longer use of medicine containing NSAIDs
Do not take NSAIDS right before or after a heart surgery called a
“coronary artery bypass graft
(CABG)."
Avoid taking NSAIDS after a recent heart attack, unless your
healthcare provider tells you

Summary of Product characteristics

IBUDONE- HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED
POLY PHARMACEUTICALS
----------
IBUDONE
(HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS)
5 MG/200 MG AND 10 MG/200 MG
CII
RX ONLY
®
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
ADDICTION, ABUSE, AND MISUSE
IBUDONE 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 IBUDONE
, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS _(SEE WARNINGS: ADDICTION, ABUSE, AND MISUSE)
_. LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF IBUDONE
. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
IBUDONE OR
FOLLOWING A DOSE INCREASE _(SEE WARNINGS: LIFE-THREATENING RESPIRATORY
DEPRESSION) _. ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF IBUDONE
, ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF HYDROCODONE _(SEE WARNINGS: LIFE-THREATENING
RESPIRATORY DEPRESSION) _. NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF IBUDONE 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: NEONATAL OPIOID WITHDRAWAL SYNDROME) _. CYTOCHROME P450 3A4 INTERACTION
THE CONCOMITANT USE OF IBUDONE WITH ALL CYTOCHROME P450 3A4 INHIBITORS MAY RESULT IN
AN INCREASE IN HYDROCODONE PLASMA CONCENTRATIONS, WHI