Drug ID: 1d00000016
Drug Name: Acetaminophen and Hydrocodone bitartarate
Generic Names: Lorcet-HD | Lortab | Vicodin | Zydone | Anexsia | Co-Gesic | Hycet | Liquicet | Lorcet 10/650 | Lorcet Plus | Lortab Elixir | Maxidone | Norco | Polygesic | Stagesic | Vicodin ES | Vicodin HP | Xodol | Zamicet | Zolvit
Legal Status: Opioid Prescription only drug
Indication for Mother: Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Adult: 1 to 2 tablets or capsules every 4 to 6 hours or 5 to 10 mL (elixir, solution 15 mL) every 4 to 6 hours as needed. Max 6 doses/day.
Children (younger than 12 yr of age): 10 to 15 mg acetaminophen/kg/dose every 4 hour to max 2.6 g per 24 hour.
Children (2 to 13 years of age and at least 12 kg) - 0.2 mL/kg. Max, 6 doses/day.
Recommended In: This is a combination of the narcotic hydrocodone and non-narcotic pain reliever acetaminophen. It is prescribed for moderate to severe pain. Acetaminophen increases the effects of hydrocodone, which is an opioid pain medication.
Directions For Use: This medication comes in the form of tablet, capsule and oral solution to take by mouth, with or without food.
Storage: Store it at controlled room temperature (25°C) and in an airtight container. Keep this medication out of reach of children. Do not refrigerate.
Dosage Forms: Tablet | Capsule | Solution | Elixir
Side Effects: Most Common - Lightheadedness, dizziness, sedation, convulsions, nausea and vomiting.
Central Nervous System - Drowsiness, headache, fainting, mental clouding, fear, impairment of mental and physical performance, anxiety, psychic dependence, mood changes, somnolence progressing to stupor or coma, malaise and lethargy.
Gastrointestinal - Constipation, upper stomach pain, loss of appetite.
Genitourinary - Urethral spasm, urinary retention, decreased urination, renal toxicity; spasm of vesical sphincters.
Heart- Hypotension, bradycardia and circulatory collapse.
Respiratory - Respiratory depression, irregular breathing and acute airway obstruction.
Special Senses - Hearing impairment or permanent loss of hearing, ringing in the ears, blurred vision.
Skin - Cold and clammy skin, sweating profusely, rash and itching.
Miscellaneous - Allergic reactions.
In Case of Overdose: Hydrocodone: Serious overdose with hydro codone is 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.
Acetaminophen: In acetaminophen overdosage: dose-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.
In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams.
Treatment: A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.
Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.
Naloxone, an opioid antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. An opioid antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.
Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.
The toxic dose for adults for acetaminophen is 10 g.
Avoid If: Caution should be exercised in patients with history of liver or kidney failure, when under active treatment for thyroid disorders, Addison's disease, asthma, drug abuse or addiction, enlargement of prostate, urethral stricture (narrowing of urethra), lung disease, elderly, children, during pregnancy and breastfeeding.
Patient may develop with increased risk of respiratory depression; monitor them carefully while taking this medication.
It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.
Avoid taking sleeping pills during the treatment.
Avoid excess dosage and long-term use of this medication, because mental and physical dependence can occur.
Drug Interaction: 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.
Other adverse reactions include:
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 VICODIN (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 center.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.