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Lortab Elixir (Hydrocodone Bitartrate / Acetaminophen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Potential effects of high dosage are also listed in the OVERDOSAGE section.

Cardio-renal:    Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.

Central Nervous System/Psychiatric:    Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.

Endocrine:    Hypoglycemic coma.

Gastrointestinal System:    Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.

Genitourinary System:    Spasm of vesical sphincters, ureteral spasm, and urinary retention.

Hematologic:    Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.

Hypersensitivity:    Allergic reactions.

Musculoskeletal:    Skeletal muscle flaccidity.

Respiratory Depression:    Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE), shortness of breath.

Special Senses:    Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Skin:    Cold and clammy skin, diaphoresis, pruritus, rash.

DRUG ABUSE AND DEPENDENCE

CONTROLLED SUBSTANCE

Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is classified as a Schedule III controlled substance.

ABUSE AND DEPENDENCE

Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. However, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment of pain.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

POSSIBLE SIDE EFFECTS

Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.

Call your doctor if these effects continue or are bothersome.

Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor.

STORAGE

  • Keep out of the reach of children.
  • Store at room temperature (protect from heat, do not refrigerate).
  • Keep in original labeled bottle.
  • Discard medicines that are old or no longer needed.
  • Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use if for another condition or give the drug to others.
  • This leaflet provides a summary of information about Lortab Elixir. If you have any questions or concerns, or want more information about Lortab Elixir, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Lortab Elixir that is written for health professionals that you can ask to read.

Prepared by UCB Pharma, Inc.Rev. 6E 03/2004

Drug label data at the top of this Page last updated: 2006-03-11

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