WARNINGS
May be habit forming. Hydrocodone can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of HYCOTUSS Expectorant Syrup and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (See DRUG ABUSE AND DEPENDENCE).
Respiratory Depression: HYCOTUSS Expectorant Syrup produces dose-related respiratory depression by directly acting on the brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of NARCAN® (naloxone hydrochloride) and other supportive measures when indicated. Head Injury and Increased Intracranial Pressure: The respiratory depressant properties of opioids 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 HYCOTUSS Expectorant Syrup or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
PRECAUTIONS
Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided. Usage in Ambulatory Patients: Hydrocodone, like all opioids, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, and patients should be warned accordingly. Drug Interactions: Patients receiving other opioids, analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced (see WARNINGS).
Laboratory Interactions: The metabolite of guaifenesin has been found to produce an apparent increase in urinary 5-hydroxyindoleacetic acid, and guaifenesin therefore may interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. Guaifenesin administration should be discontinued 24 hours prior to the collection of urine specimens for the determination of 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity and reproduction studies have not been conducted with HYCOTUSS (hydrocodone bitartrate and guaifenesin) Expectorant Syrup.
Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with HYCOTUSS Expectorant Syrup. It is also not known whether HYCOTUSS Expectorant Syrup can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HYCOTUSS Expectorant Syrup should be given to a pregnant woman only if clearly needed. 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. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7-1.0 mg/kg q 6 h, phenobarbital 2 mg/kg q 6 h, and paregoric 2-4 drops/kg q 4 h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from HYCOTUSS Expectorant Syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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