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Respiratory Depression:
As with all narcotics, Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release 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 Extended-Release 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).
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.
Obstructive Bowel Disease:
Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
Pediatric Use:
The use of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release 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 Extended-Release Oral Suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release 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).
Respiratory Depression:
As with all narcotics, Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release 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 Extended-Release 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).
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.
Obstructive Bowel Disease:
Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
There is currently no manufacturer warning information available for this drug.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.
Each 5 mL of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension is for oral use only.
Hydrocodone Polistirex: Sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one.
Hydrocodone Polistirex
Chlorpheniramine Polistirex: Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.
Chlorpheniramine Polistirex
Purified Water, High Fructose Corn Syrup, Sucrose, Propylene Glycol, Xanthan Gum, Vegetable (Corn) Oil, Methylparaben, Polysorbate 80, Ascorbic Acid, Propylparaben, Ethylcellulose, Sorbitol, Dibutyl Sebacate, Natural Mango Flavor, D&C Yellow No. 10, FD&C Yellow No. 6, Sodium Benzoate, and Phosphoric Acid.