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 HYCOMINE Compound 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: HYCOMINE Compound produces dose-related respiratory depression by directly acting on 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions: The administration ofHYCOMINE Compound or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Phenylephrine: Hypertensive crises can occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta-blockers and methyldopa.
If a hypertensive crisis occurs these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling. Chlorpheniramine: Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients.
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, and antihistamines such as chlorpheniramine maleate, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; phenylephrine may produce a rapid pulse, dizziness or palpitations; patients should be cautioned accordingly. Drug Interactions: Patients receiving other opioid 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. The use of phenylephrine with other sympathomimetic amines and MAO inhibitors may produce an additive elevation of blood pressure. MAO inhibitors may prolong the anticholinergic effects of antihistamines. (See WARNINGS).
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with HYCOMINE Compound.
Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted withHYCOMINE Compound. It is also not known whetherHYCOMINE Compound can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HYCOMINE Compound 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. 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 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 HYCOMINE Compound, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
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