"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other Adverse reactions include:
Gastrointestinal System: Prolonged administration of Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets may produce constipation.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Potential effects of high dosage are listed in the OVERDOSAGE section.
DRUG ABUSE AND DEPENDENCE:
Controlled Substance: Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 2.5 mg/500 mg) are classified as a Schedule III controlled substance.
Abuse and Dependence: Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets 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.
Read the Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) Side Effects Center for a complete guide to possible side effects
Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2008
Additional Lortab 2.5 Information
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