Hydrocodone Polistirex and Chlorpheniramine Polistirex

As with all narcotics, hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Hydrocodone affects the center that controls respiratory rhythm and may produce irregular and periodic breathing. Caution should be exercised when hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated (see OVERDOSAGE).

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.

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.

The use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS).

In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).

Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.

As with any narcotic agent, hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension 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.

As with all narcotics, hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension must not be diluted with fluids or mixed with other drugs as this may alter the resin-binding and change the absorption rate, possibly increasing the toxicity.

Patients should be advised to measure hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

Shake well before using.

Keep out of the reach of children.

Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is used postoperatively, and in patients with pulmonary disease.

Patients receiving narcotics, antihistaminics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension 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.

The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension.

As with all narcotics, administration of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

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 hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS and ADVERSE REACTIONS, Respiratory, Thoracic and Mediastinal Disorders).

Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension should be used with caution in pediatric patients 6 years of age and older (see WARNINGS, Pediatric Use).

Clinical studies of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension may produce constipation.

Death

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

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

Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (see CONTRAINDICATIONS).

Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Rash, pruritus.

Serious overdosage with hydrocodone is characterized by 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 and clammy skin, and sometimes bradycardia and hypotension. Although miosis is characteristic of narcotic overdose, mydriasis may occur in terminal narcosis or severe hypoxia. In severe overdosage apnea, circulatory collapse, cardiac arrest and death may occur. The manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation.

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone in this formulation may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

5 mL (1 teaspoonful) every 12 hours; do not exceed 10 mL (2 teaspoonfuls) in 24 hours.

2.5 mL (½ teaspoonful) every 12 hours; do not exceed 5 mL (1 teaspoonful) in 24 hours.

This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).

Shake well. Dispense in a well-closed container.

Store at 20 to 25°C (68 to 77°F); excursions permitted from 15 to 30°C (59 to 86°F)

[see USP Controlled Room Temperature].

Distributed by:

Par Pharmaceutical Companies, Inc.

Spring, Valley, NY 10977

LB8072

Rev 00 OS235-01-72-01

I 04/10

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK       74146