Hydrocodone Polistirex and Chlorpheniramine Polistirex

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX — hydrocodone bitartrate and chlorpheniramine maleate suspension
Physicians Total Care, Inc.

DESCRIPTION

Each teaspoonful (5 mL) of hydrocodone polistirex and chlorpheniramine polistirex extended release (ER) oral suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension provides up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is for oral use only.

Hydrocodone Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one.

This is the hydrocodone formula
(click image for full-size original)

Chlorpheniramine Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.

This is the chlorpherniramine formula
(click image for full-size original)

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.

CLINICAL PHARMACOLOGY

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, and physical and psychological dependence.

Chlorpheniramine is an antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Hydrocodone release from hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is controlled by an extended-release drug delivery system, which combines an ion-exchange polymer matrix with a diffusion rate-limiting permeable coating. Chlorpheniramine release is prolonged by use of an ion-exchange polymer system.

Following multiple dosing with hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension, hydrocodone mean (S.D.) peak plasma concentrations of 22.8 (5.9) ng/mL occurred at 3.4 hours. Chlorpheniramine mean (S.D.) peak plasma concentrations of 58.4 (14.7) ng/mL occurred at 6.3 hours following multiple dosing. Peak plasma levels obtained with an immediate-release syrup occurred at approximately 1.5 hours for hydrocodone and 2.8 hours for chlorpheniramine. The plasma half-lives of hydrocodone and chlorpheniramine have been reported to be approximately 4 and 16 hours, respectively.

INDICATIONS AND USAGE

Hydrocodone polistirex and chlorpheniramine polistirex ER 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.

CONTRAINDICATIONS

Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.

The use of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.

WARNINGS

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Respiratory Depression

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).

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 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).

PRECAUTIONS

General

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

Special Risk Patients

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.

Information for Patients

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.

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