Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release

Product Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form:

NDC: 63629-2304

Application: ANDA091632

Effective: 20231120

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 : • Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4 ) ]. • Contraindicated in pediatric patients less than 6 years of age [ see Contraindications (4) ]. • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made. Hydrocodone Polistirex and Chlorpheniramine Polistirex is a combination of hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H1) receptor antagonist, 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. ( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

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 Precautions (5.1) ]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy [ see Warnings and Precautions (5.2 ) ]. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions (5.4) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions (5.1) ]. Do not abruptly discontinue Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension in a physically-dependent patient [ see Drug Abuse and Dependence (9.3 ) ]. When a patient who has been taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension regularly and may bephysically dependent no longer requires therapy with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, taper the dose gradually, by25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patientdevelops these signs or symptoms, raise the dose to the previous level and taper more slowly, either byincreasing the interval between decreases, decreasing the amount of change in dose, or both.

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 )

Not available.

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, abuse, and misuse [ see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] • Life-threatening respiratory depression [ see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.8 ), Overdosage (10) ] • Accidental overdose and death due to medication errors [ see Warnings and Precautions (5.5) ] • Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.6) ] • Interactions with benzodiazepines and other CNS depressants [ see Warnings and Precautions (5.8) , Drug Interactions (7.1 , 7.5 ) ] • Paralytic ileus, gastrointestinal adverse reactions [ see Warnings and Precautions (5.9) ] • Increased intracranial pressure [ see Warnings and Precautions (5.10 ) ] • Obscured clinical course in patients with head injuries [ see Warnings and Precautions (5.10) ] • Seizures [ see Warnings and Precautions (5.11) ] • Severe hypotension [ see Warnings and Precautions (5.12) ] • Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.13) ] • Adrenal insufficiency [ see Warnings and Precautions (5.14) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or chlorpheniramine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to Hydrocodone Polistirex and Chlorpheniramine Polistirex include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis : Anaphylaxis has been reported with hydrocodone, one of the ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Body as a whole : Coma, death, fatigue, falling injuries, lethargy. Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System : Ataxia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor, tinnitus, vertigo. Dermatologic : Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [ see Clinical Pharmacology (12.2) ]. Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi). Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Hematologic : Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported. Laboratory : Increases in serum amylase. Musculoskeletal : Arthralgia, backache, muscle spasm. Ophthalmic : Blurred vision, diplopia, miosis (constricted pupils), visual disturbances. Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations. Reproductive : Hypogonadism, infertility. Respiratory : Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection, thickening of bronchial secretions, tightness of chest and wheezing, dry nose, dry throat. Other : Drug abuse, drug dependence, opioid withdrawal syndrome. Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation (6) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .