Vicodin

INDICATIONS AND USAGE

Vicodin (Hydrocodone bitartrate and acetaminophen) tablets are indicated for the relief of moderate to moderately severe pain.

WARNINGS AND PRECAUTIONS

Misuse, Abuse, and Diversion of Opioids

VICODIN tablets contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion. VICODIN tablets can be abused in a manner similar to other opioid agonists, legal or illicit.

ADVERSE REACTIONS

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down

OVERDOSE

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms:

Serious overdose with hydrocodone is Hydrocodone characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

In acetaminophen overdosage: dose- Acetaminophen dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/088058s027lbl.pdf