Hydrocodone Bitartrate and Acetaminophen
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Hepatotoxicity:Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN DESCRIPTION
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg
CLINICAL PHARMACOLOGY
Pharmacokinetics:
Hydrocodone:
OVERDOSAGE for toxicity information.
Acetaminophen:
OVERDOSAGE for toxicity information.
INDICATIONS & USAGE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN CONTRAINDICATIONS
WARNINGS
Hepatotoxicity:Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Hypersensitivity/anaphylaxis:
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets, USP for patients with acetaminophen allergy.
Respiratory Depression:
Head Injury and Increased Intracranial Pressure:
Acute Abdominal Conditions:
Misuse, Abuse, and Diversion of Opioids:
DRUG ABUSE AND DEPENDENCE).
PRECAUTIONS
General:Special Risk Patients:
Cough Reflex:
Information for Patients/Caregivers:
Laboratory Tests:
Drug Interactions:
Drug/Laboratory Test Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy:
Teratogenic Effects:
Nonteratogenic Effects:
Labor and Delivery:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ADVERSE REACTIONS
Central Nervous System:Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
Gastrointestinal System:Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation.
Genitourinary System:Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression:Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers (seeOVERDOSAGE).
Special Senses:Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological:Skin rash, pruritus.
OVERDOSAGE section.
DRUG ABUSE AND DEPENDENCE
Misuse, Abuse, and Diversion of Opioids:OVERDOSAGE
Signs and Symptoms:
Hydrocodone:
Acetaminophen:
Treatment:
DOSAGE & ADMINISTRATION
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg
HOW SUPPLIED
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mgHydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
