It is affected by light. It has the following structural formula:. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle.
The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined.
Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Pharmacokinetics — The behavior of the individual components is described below.
Hydrocodone — Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was Maximum serum levels were achieved at 1. Acetaminophen — Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1. Elimination of acetaminophen is principally by liver metabolism conjugation and subsequent renal excretion of metabolites.
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Respiratory Depression — At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center.
Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Head Injury and Increased Intracranial Pressure — The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions — The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Special Risk Patients — As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture.
The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex — Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen tablets are used post-operatively and in patients with pulmonary disease. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Drug Interactions — 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. Carcinogenesis, Mutagenesis, Impairment of Fertility — No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Teratogenic Effects. Pregnancy Category C — There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects — Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever.
The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. A cough is a symptom of many different medical conditions, some of which are serious.
In most instances, a cough will resolve by itself. Facebook Twitter Email Print. Severe toothache pain: 9 Natural home remedies and OTC options Natural home remedies and over-the-counter OTC products can be used to temporarily relieve toothache pain until you can visit your dentist. How to relieve urinary tract infection UTI pain Certain over-the-counter pain medications can be used alongside antibiotics and other self care options to help alleviate the pain caused by a UTI.
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