Hycodan (Hydrocodone Bitartrate)


DuPont Pharma

Hydrocodone Bitartrate


Action And Clinical Pharmacology: Clinical trials have proven hydrocodone bitartrate to be an effective antitussive agent which is pharmacologically 2 to 8 times as potent as codeine. At equi-effective doses, its sedative action is greater than that of codeine. The precise mechanisms of action of hydrocodone and other opiates are not known; however, hydrocodone is believed to act by directly depressing the cough centre. In excessive doses, hydrocodone, like other opium derivatives, can depress respiration. The effects of therapeutic doses of hydrocodone on the cardiovascular system are insignificant. The constipating effects of hydrocodone are much weaker than those of morphine and no stronger than those of codeine. Hydrocodone can produce miosis, euphoria, physical and psychological dependence. At therapeutic antitussive doses, it does exert analgesic effects. Following a 10 mg oral dose of hydrocodone administered to 5 male human subjects, the mean peak serum concentration was 23.6±5.2 ng/mL. Maximum serum levels were achieved at approximately 1.3±0.3 hours and the half-life was determined to be approximately 3.8±0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-a- and 6-b-hydroxymetabolites.

Indications And Clinical Uses: The control of exhausting, nonproductive cough.

Contra-Indications: Hypersensitivity to any component of the drug. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure, and whenever ventilatory function is depressed.

Manufacturers’ Warnings In Clinical States: Hydrocodone can produce drug dependence and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Prescribe and administer with the same degree of caution appropriate to the use of other narcotic drugs (see Drug Abuse and Dependence).

Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory centres. If respiratory depression occurs, it may be antagonized by the use of naloxone HCl and other supportive measures when indicated.

Occupational Hazards: Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Caution patients accordingly.

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 elevated intracranial pressure. Furthermore, narcotics may produce adverse reactions which can obscure the clinical course of patients with head injuries.

The administration of hydrocodone or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines or other tranquilizers, tricyclic antidepressants, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit an additive CNS depression. When such combined therapy is contemplated, reduce the dose of one or both agents.

Precautions: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.

In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit to risk ratio should be carefully considered, especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child’s age and weight is of great importance.

As hydrocodone may inhibit peristalsis, patients with chronic constipation should be given the drug only after weighing the potential therapeutic benefit against the hazards involved.

In patients with asthma or pulmonary emphysema, indiscriminate use may precipitate respiratory insufficiency resulting from increased viscosity of bronchial secretions and suppression of the cough reflex.

Use with caution in sedated or debilitated patients, in patients who have undergone thoracotomies or laparotomies, since suppression of the cough reflex may lead to retention of secretions postoperatively in these patients.

The CNS-depressant effect of hydrocodone may be additive with that of other drugs which depress the CNS (see Warnings).

Carcinogenicity, mutagenicity and reproduction studies have not been conducted.

Pregnancy: Animal reproduction studies have not been conducted. It is not known if hydrocodone can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Hydrocodone crosses the placental barrier. Give to pregnant women only if clearly needed.

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Withdrawal signs include: irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. Intensity of the syndrome does not always correlate with the duration of maternal opioids use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine (0.7 to 1.0 mg/kg q6h), phenobarbital (2 mg/kg q6h), and paregoric (2 to 4 drops/kg q4h) have been used to treat withdrawal symptoms in infants. Duration of therapy is 4 to 28 days, with dosages decreased as tolerated.

Lactation: It is not known if this drug is excreted in human milk. Because many drugs are excreted in human milk and because there is potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug. Take into account the importance of the drug to the mother.

Drug Interactions: The CNS depressant effect of hydrocodone may be additive with that of other CNS depressants (see Warnings).

Adverse Reactions: Respiratory: Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centres.

Cardiovascular: Hypertension, postural hypotension and palpitations.

Genitourinary: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

CNS: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision.

Gastrointestinal: Nausea and vomiting occur more frequently in ambulatory than in recumbent patients. Constipation may also occur.

Drug Abuse and Dependence: Exercise special care in prescribing hydrocodone for emotionally unstable patients and for those with a history of drug misuse. Supervise such patients closely when long-term therapy is contemplated.

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; prescribe and administer hydrocodone with caution. Physical dependence is the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome.

Patients physically dependent on opioids will develop an abstinence syndrome upon abrupt discontinuation of the opioid or following administration of a narcotic antagonist. The character and severity of the withdrawal symptoms are related to the degree of physical dependence. Manifestations of opioid withdrawal are similar to, but milder than that of morphine and include: lacrimation, rhinorrhea, yawning, sweating, restlessness, dilated pupils, anorexia, gooseflesh, irritability, and tremor. In more severe forms, nausea, vomiting, intestinal spasm and diarrhea, increased heart rate and blood pressure, chills, and pains in bones and muscles of the back and extremities may occur. Peak effects will usually be apparent at 48 to 72 hours.

Treatment of withdrawal is usually managed by providing sufficient quantities of an opioid to suppress severe withdrawal symptoms and then gradually reducing the dose of opioid over a period of several days.

Symptoms And Treatment Of Overdose: Symptoms: Respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold, clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment: Give primary attention to the re-establishment of adequate respiratory exchange by providing a patent airway and instituting assisted or controlled ventilation. The narcotic antagonist naloxone HCl is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Administer an appropriate dose of naloxone, preferably by the i.v. route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the antagonist, keep the patient under continued surveillance and administer repeated doses of the antagonist as needed to maintain adequate respiration. Observe carefully the manufacturer’s package insert instructions. Employ oxygen, i.v. fluids, vasopressors, and other supportive measures as indicated.

Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may be of benefit.

Dosage And Administration: Adults: 5 mg (1 tablet or 5 mL) not less than 4 hours apart, after meals and at bedtime with food or a glass of milk, not to exceed 30 mg (6 tablets or 30 mL) in a 24-hour period. Maximum single dose 15 mg (3 tablets or 15 mL).

Children over 12 yrs: 5 mg (1 tablet or 5 mL) not less than 4 hours apart, after meals and at bedtime with food or a glass of milk, not to exceed 30 mg (6 tablets or 30 mL) in a 24-hour period. Maximum single dose 10 mg (2 tablets or 10 mL).

Age 2 to 12 yrs: 2.5 mg (one half tablet or 2.5 mL) not less than 4 hours apart, after meals and at bedtime with food or a glass of milk, not to exceed a total of 15 mg (3 tablets or 15 mL) in a 24-hour period. Maximum single dose 5 mg (1 tablet or 5 mL).

Age less than 2 yrs: 1.25 mg (one quarter tablet or 1.25 mL) not less than 4 hours apart, after meals and at bedtime with food or a glass of milk, not to exceed a total of 7.5 mg (1.5 tablets or 7.5 mL) in a 24-hour period. Maximum single dose 1.25 mg (one quarter tablet or 1.25 mL).

Availability And Storage: Syrup: Each 5 mL of red, wild-cherry-flavored syrup contains: hydrocodone bitartrate 5 mg. Nonmedicinal ingredients: artificial cherry flavor, caramel syrup, FD&C RED No. 2, hydrochloric acid, methylparaben, propylparaben, purified water, sorbitol solution 70% and sucrose. Alcohol-, lactose-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500 mL.

Tablets: Each white, scored tablet contains: hydrocodone bitartrate 5 mg. Nonmedicinal ingredients: cornstarch, lactose, pregelatinized tapioca starch, stearic acid, talc and zinc stearate. Sodium- and tartrazine-free. Bottles of 100.

Store at room temperature (15 to 30°C) in a tightly closed container. Protect from light. Dispense syrup in a tight, light resistant container. (Shown in Product Recognition Section)

HYCODAN® DuPont Pharma Hydrocodone Bitartrate Antitussive

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