Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release (Page 4 of 11)

5.9 Risks of Use in Patients with Gastrointestinal Conditions

Hydrocodone Polistirex and Chlorpheniramine Polistirex is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications (4)]. The use of hydrocodone in Hydrocodone Polistirex and Chlorpheniramine Polistirex may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

The concurrent use of anticholinergics with Hydrocodone Polistirex and Chlorpheniramine Polistirex may produce paralytic ileus [see Drug Interactions (7.10)].

The hydrocodone in Hydrocodone Polistirex and Chlorpheniramine Polistirex may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders. Use with caution in patients with underlying intestinal motility disorders.

The hydrocodone in Hydrocodone Polistirex and Chlorpheniramine Polistirex may cause spasm of the sphincter of Oddi, resulting in an increase in biliary tract pressure. Opioids may cause increases in serum amylase [see Warnings and Precautions (5.15)]. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms.

5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors

Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Hydrocodone Polistirex and Chlorpheniramine Polistirex may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries.

5.11 Increased Risk of Seizures in Patients with Seizure Disorders

The hydrocodone and chlorpheniramine in Hydrocodone Polistirex and Chlorpheniramine Polistirex may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Hydrocodone Polistirex and Chlorpheniramine Polistirex therapy.

5.12 Severe Hypotension

Hydrocodone Polistirex and Chlorpheniramine Polistirex may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7.5)]. Monitor these patients for signs of hypotension after initiating Hydrocodone Polistirex and Chlorpheniramine Polistirex.

In patients with circulatory shock, Hydrocodone Polistirex and Chlorpheniramine Polistirex may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex in patients with circulatory shock.

5.13 Neonatal Opioid Withdrawal Syndrome

Hydrocodone Polistirex and Chlorpheniramine Polistirex is not recommended for use in pregnant women. Prolonged use of Hydrocodone Polistirex and Chlorpheniramine Polistirex during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations (8.1), Patient Counseling Information (17)].

5.14 Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

5.15 Drug/Laboratory Test Interactions

Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of Hydrocodone Polistirex and Chlorpheniramine Polistirex.

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.

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