FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Each 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 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.
Chlorpheniramine Polistirex
Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-α-[2-(dimethylamino)ethyl]-benzyl]pyridine.
Sources
Ceo-two Manufacturers
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Beutlich Pharmaceuticals, Llc
Ceo-two | Tris Pharma Inc
It is important that hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension is measured with an accurate measuring device (see PRECAUTIONS, Information for Patients).
A dosing cup is provided with the 4 fl. oz. (115 mL) packaged product. The dosing cup fills for a 2.5 mL and for a 5 mL dose. Instruct the patient to fill to the line for the dose that has been prescribed. Do not fill over the dose prescribed. Rinse with water after each use.
For prescriptions where a dosing device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. A household teaspoon is not an accurate measuring device and could lead to overdosage.
Each 5 mL of hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate, and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. Shake well before using. Rinse the measuring device with water after each use.
Shake well before using.
Adults and Children 12 Years and Older
5 mL every 12 hours; do not exceed 10 mL in 24 hours.
Children 6 to 11 Years of Age
2.5 mL every 12 hours; do not exceed 5 mL in 24 hours.
This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).
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