HYDROCODONE BITARTRATE AND IBUPROFEN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Amneal Pharmaceuticals of New York LLC

INN (Kansainvälinen yleisnimi):

HYDROCODONE BITARTRATE

Koostumus:

HYDROCODONE BITARTRATE 2.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Hydrocodone bitartrate and ibuprofen 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. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. 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 hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (see WARNINGS ) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia Hydrocodone bitartrate and ibuprofen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with: - Significant respiratory depression (see WARNINGS: Life-Threatening Respiratory Depression ) . - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS: Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients ) . - Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS: Risks of Use in Patients with Gastrointestinal Conditions ) . - Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product (see WARNINGS: Anaphylactic Reactions, Serious Skin Reactions ) . Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic Reactions, Exacerbation of Asthma Related to Aspirin Sensitivity ) . - In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS: Cardiovascular Thrombotic Events ) . Controlled Substance Hydrocodone bitartrate and ibuprofen contains hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone bitartrate and ibuprofen contains hydrocodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see WARNINGS ) . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of hydrocodone bitartrate and ibuprofen increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of hydrocodone bitartrate and ibuprofen with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of hydrocodone bitartrate and ibuprofen abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and ibuprofen in combination with other abused drugs. “Drug seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Hydrocodone bitartrate and ibuprofen, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Hydrocodone Bitartrate and Ibuprofen Abuse of hydrocodone bitartrate and ibuprofen poses a risk of overdose and death. The risk is increased with concurrent use of hydrocodone bitartrate and ibuprofen with alcohol and/or other CNS depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue hydrocodone bitartrate and ibuprofen in a patient physically dependent on opioids. Rapid tapering of hydrocodone bitartrate and ibuprofen in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing hydrocodone bitartrate and ibuprofen, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and ibuprofen the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper (see DOSAGE AND ADMINISTRATION, and   WARNINGS ) . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see Pregnancy ) .

Tuoteyhteenveto:

Hydrocodone bitartrate and ibuprofen tablets, 2.5 mg/200 mg , are supplied as white, capsule-shaped, film-coated tablets, debossed “IP 116” on obverse and plain on reverse. They are available as follows: Bottles of 100:             NDC 53746-116-01 Hydrocodone bitartrate and ibuprofen tablets, 5 mg/200 mg , are supplied as white, oval-shaped, film-coated tablets, debossed “IP 146” on obverse and plain on reverse. They are available as follows: Bottles of 100:             NDC 53746-146-01 Hydrocodone bitartrate and ibuprofen tablets, 7.5 mg/200 mg , are supplied as white, round, film-coated, biconvex tablets, debossed with “IP” over “145” on one side and plain on the other side. They are available as follows: Bottles of 100:             NDC 53746-145-01 Bottles of 500:             NDC 53746-145-05 Hydrocodone bitartrate and ibuprofen tablets, 10 mg/200 mg , are supplied as yellow, round-shaped, film-coated tablets, debossed “IP 117” on obverse and plain on reverse. They are available as follows: Bottles of 100:             NDC 53746-117-01 Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Store hydrocodone bitartrate and ibuprofen tablets securely and dispose of properly (see PRECAUTIONS: Information for Patients ) . Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 01-2024-13 Dispense with Medication Guide available at: documents.amneal.com/mg/hydro-ibu.pdf

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
Hydrocodone Bitartrate (hye" droe koe' done bye tar' trate) and
Ibuprofen (eye" bue proe' fen) tablets, CII
Hydrocodone bitartrate and ibuprofen tablets are:
•
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 hydrocodone bitartrate and ibuprofen
tablets:
•
Get emergency help or call 911 right away if you take too much
hydrocodone bitartrate and
ibuprofen tablets (overdose). When you first start taking hydrocodone
bitartrate and ibuprofen
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. Talk to your
healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
Taking hydrocodone bitartrate and ibuprofen 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 hydrocodone bitartrate and ibuprofen
tablets. They could die from
taking it. Selling or giving away hydrocodone bitartrate and ibuprofen
tablets is against the law.
•
Store hydrocodone bitartrate and ibuprofen tablets securely, out of
sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Hydrocodone bitartrate and ibuprofen tablets contain an NSAID. NSAIDs
can cause

Valmisteyhteenveto

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS CII
(2.5 MG/200 MG, 5 MG/200 MG, 7.5 MG/200 MG & 10 MG/200 MG)
RX ONLY
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF HYDROCODONE BITARTRATE AND IBUPROFEN 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 AND REASSESS 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 HYDROCODONE BITARTRATE AND IBUPROFEN, ESPECIALLY DURING
INITIATION
OR FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF HYDROCODONE BITARTRATE AND
IBUPROFEN ARE ESSENTIAL _(SEE WARNINGS)_.
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF HYDROCODONE BITARTRATE AND
IBUPROFEN, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
HYDROCODONE _(SEE WARNINGS)_.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF HYDROCODONE BITARTRATE AND IBUPROFEN AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE (_SEE WARNINGS)_.
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE-
THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY _(SEE