Hydrocodone Polistirex And Chlorpheniramine Polistirex

Description

11 DESCRIPTION Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension contains hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist. Each 5 mL of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release (ER) 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 ER Suspension is for oral use only. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension also contains the following inactive ingredients: Ascorbic acid, D&C Yellow No. 10, flavors, high fructose corn syrup, modified food starch, methylparaben, polysorbate 80, polyvinyl acetate, propylene glycol, propylparaben, purified water, sodium ascorbate, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, xanthan gum. Hydrocodone Polistirex The chemical name for hydrocodone, a centrally-acting narcotic antitussive, is 4,5α-epoxy-3-methoxy-17- methylmorphinan-6-one. Hydrocodone polistirex is a complex of sulfonated styrene-divinylbenzene copolymer. The molecular weight for hydrocodone and the polistirex resin is 298.364 g/mol and n x 315 g/mol- 1, respectively. The molecular formula for hydrocodone and the polistirex resin is C 18 H 21 NO 3 and (C 18 SO 3 H 19 )n, respectively. It has the following structural formula: Structure 1 Chlorpheniramine Polistirex The chemical name for chlorpheniramine, an antihistamine, is 2-[p-chloro-α-[2-(dimethylamino)ethyl]- benzyl]pyridine. Chlorpheniramine polistirex is a complex of sulfonated styrene-divinylbenzene copolymer. The molecular weight for chlorpheniramine and the polistirex resin is 274.79 g/mol and n x 315 g/mol-1, respectively. The molecular formula for chlorpheniramine and the...

What Is Hydrocodone Polistirex And Chlorpheniramine Polistirex Used For?

1 INDICATIONS AND USAGE Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use :

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : 5 mL every 12 hours as needed, not to exceed 2 doses (10 mL) in 24 hours. ( 2.2 ) Measure Hydrocodone Polistirex and Chlorpheniramine Polistirex with an accurate milliliter measuring device. ( 2.1 , 5.5 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. (2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Administer Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension by the oral route only. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension can be taken with or without food. Shake well before using. Do not mix Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with other liquids or medicines. Mixing may change how Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension works. Always use an accurate milliliter measuring device when administering Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Warnings and Precautions (5.5) ]. The dosing cup is provided with the 3 oz (70 mL) and 4 oz (115 mL) packaged product. The dosing cup fills for 2.5 mL dose and for 5 mL dose. Instruct the patient to fill to the line that the dose has been prescribed. Do not fill over the dose prescribed. Rinse the measuring cup with water after each use. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use. Advise patients not to increase the dose or dosing frequency of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2 ) and Overdosage (10 ) ]. The dosage of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration (2.3 ) and Warnings and Precautions (5.4) ] . 2.2 Recommended Dosage Adults 18 years of age and older : 5 mL every 12 hours as needed, not to exceed 2 doses (10 mL) in 24 hours 2.3 Monitoring, Maintenance, and Discontinuation of Therapy Prescribe Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections:

Drug Interactions

7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with Hydrocodone Polistirex and Chlorpheniramine Polistirex. Phenytoin : Avoid concomitant use; may increase phenytoin levels. ( 7.4 ) Serotonergic drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. ( 7.6 ) Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. ( 7.7 ) Muscle relaxants : Avoid concomitant use. ( 7.8 ) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. ( 7.9 ) Anticholinergic drugs : Concomitant use may cause paralytic ileus. ( 5.9 , 7.10 ) 7.1 Alcohol Concomitant use of alcohol with Hydrocodone Polistirex and Chlorpheniramine Polistirex can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on Hydrocodone Polistirex and Chlorpheniramine Polistirex therapy [ see Warnings and Precautions (5.8) , Clinical Pharmacology (12.3) ]. 7.2 Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Polistirex and Chlorpheniramine Polistirex is achieved [ see Warnings and Precautions (5.7 ) ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [ see Clinical Pharmacology (12.3 ) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex while taking a CYP3A4 or CYP2D6 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. 7.3 CYP3A4 Inducers The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [ see Warnings and Precautions (5.7) ]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [ see...

Contraindications

4 CONTRAINDICATIONS Hydrocodone Polistirex and Chlorpheniramine Polistirex is contraindicated for: All children younger than 6 years of age [ see Warnings and Precautions (5.2 , 5.3 ), Use in Specific Populations (8.4) ]. Hydrocodone Polistirex and Chlorpheniramine Polistirex is also contraindicated in patients with: Significant respiratory depression [ see Warnings and Precautions (5.2) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment[ see Warnings and Precautions (5.4) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.9) ]. Hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex [ see Adverse Reactions (6) ]. Children younger than 6 years of age. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus.( 4 ) Hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [ see Warnings and Precautions (5.13) , Clinical Considerations ]. There are no available data with Hydrocodone Polistirex and Chlorpheniramine Polistirex use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations ( see Data ). Reproductive toxicity studies have not been conducted with Hydrocodone Polistirex and Chlorpheniramine Polistirex; however, studies are available with individual active ingredients or related active ingredients ( see Data ). In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 70 times the maximum recommended human dose (MRHD) ( see Data ). Chlorpheniramine administered by the oral route to mice throughout pregnancy was embryo lethal at a dose approximately 9 times the MRHD and decreased postnatal survival when dosing was continued after parturition. Chlorpheniramine administered by the oral route to male and female rats prior to mating produced embryolethality at a dose approximately 9 times the MRHD ( see Data ). Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations...

8.3 Females and Males of Reproductive Potential Infertility Chronic use of opioids, such as hydrocodone, a component of Hydrocodone Polistirex and Chlorpheniramine Polistirex, may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [ see Adverse Reactions (6) , Clinical Pharmacology (12.2) ].

Overdosage

10 OVERDOSAGE Clinical Presentation Hydrocodone Acute overdose 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, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Hydrocodone may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see Clinical Pharmacology (12.2) ]. Chlorpheniramine Signs and symptoms of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucinations, gastrointestinal symptoms, convulsions, urinary retention, cardiac arrhythmias and coma) may be observed. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Hydrocodone Polistirex and Chlorpheniramine Polistirex together with...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL, is a yellow viscous suspension, available as: NDC 63629-2303-1 4 fl. oz. bottle containing 115 mL suspension. Each bottle is supplied with a dosing cup calibrated for measuring 2.5 mL and 5 mL doses. Shake well. Dispense entire bottle as one unit. Light Sensitive: Protect from light. Store away from direct sunlight. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature.] Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize the oral dosing dispenser and correctly measure the oral suspension as prescribed. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504