FDA label 21b3efbe-a447-4c90-b981-61c7a14b482f

WARNINGS Respiratory Depression Codeprex is not recommended for use in pediatric patients under 6 years of age. Pediatric patients under 2 years of age may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death (see PRECAUTIONS, Pediatric Use ). As with other opioids, codeine produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Codeine affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Caution should be exercised when Codeprex is used postoperatively, in patients with pulmonary disease or shortness of breath, 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 Respiratory depressant effects of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions Administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Obstructive Bowel Disease Chronic use of opioids may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder. Respiratory Conditions Codeprex should be used with caution in patients with persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or with cough accompanied by excessive phlegm. In patients with asthma or pulmonary emphysema, the indiscriminate use of antitussives may precipitate respiratory insufficiency due to increased viscosity of bronchial secretions and suppression of the cough reflex. In addition, the anticholinergic activity of antihistamines might reduce the volume and cause thickening of bronchial secretions and thus result in obstruction of the respiratory passages. Benefit to risk ratio should be carefully considered especially in pediatric patients with respiratory embarrassment (e.g., croup). (See PRECAUTIONS .)

ADVERSE REACTIONS Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with Codeprex. Also included are events which occurred during clinical pharmacokinetic studies (in a total of 147 healthy adult volunteers with either single or multiple dose exposure) with Codeprex and judged by the investigator to be related to study treatment. There are insufficient data to support a statement regarding distribution of adverse events by gender, race and age (see PRECAUTIONS: Pediatric Use and PRECAUTIONS: Geriatric Use ). Body as a Whole Asthenia, feeling of relaxation, redness or flushing of the face, unusual tiredness or weakness. Allergic Allergic laryngospasm, atelectasis, bronchospastic allergic reaction, hives, itching, swelling of face. Cardiovascular Fast, slow, or pounding heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope. Dermatologic System Dermatitis, excessive perspiration, urticaria, erythema, pruritus, rash. Endocrine Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation. Gastrointestinal Abdominal distension, abdominal pain, acute pancreatitis, constipation, diarrhea, dry mouth, dyspepsia, epigastric distress, loss of appetite, nausea, vomiting; also observed with opioids: decreased gastric motility with increased likelihood of esophageal reflux. Genitourinary Dysuria, irritative bladder symptoms, urinary frequency, urinary hesitancy, urinary retention, ureteral spasm. Nervous System Blurred, double, or other visual disturbances; confusion; dizziness; depression; drowsiness and sedation; headache; euphoria; facial dyskinesia; false sense of well-being; feeling faint, lightheadedness, general feeling of discomfort or illness; may cause excitability, especially in children; nervousness, agitation and restlessness; minimal sedation; somnolence; also observed with antihistamine agents: insomnia, dyskinesia, irritability, tremor. Respiratory System Dryness of pharynx and respiratory passages, laryngismus, nasal stuffiness, wheezing or troubled breathing, respiratory depression. Special Senses Ears: labyrinthitis, tinnitus, vertigo; eyes: blurred vision, diplopia, hypermetropia, lacrimation increased, mydriasis, photophobia. Other Drug fever.