warnings
WARNINGS General At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Antihistamines may cause excitability, especially in children. Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution i the elderly (60 years and older), as they are more likely to exhibit adverse reactions. Special Risk Patients Use with caution in debilitated patients,or those with any of the following conditions: ischemic heart disease; increase intraocular pressure; prostatic hypertrophy; adrenocortical insufficiency (e.g.; Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; diabetes mellitus; head injury; hypotension; hypertension; increased intracranial pressure; myxedema or hypothyroidism; hyperthyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of opioids in patients taking monamine oxidase (MAO) inhibitors and in those with a history of drug abuse should be carefully considered. This combination product may aggravate convulsions in patients with convulsive disorders, and, like all opioids, may induce or aggravate seizures i some clinical settings. Ambulatory Patients Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid may produce orthostatic hypotension in ambulatory patients, and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Renal Impairment Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution and at reduced dosage in the presence of impaired renal function. Hepatic Impairment Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given with caution to patients with hepatic insufficiency. Pancreatic/Biliary Tract Disease Opioids may cause spasms of the sphincter of Oddi and should be used with caution i patients with biliary tract disease including pancreatitis. Respiratory Depression Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly more debilitated patients, usually after large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hyoxia hypercapnia, or respiratory depression. Hypotensive Effect Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone. This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Drug Dependence and Abuse Potential Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid contains dihydrocodeine, and is a Schedule V controlled substance. Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused. This product should be prescribed and administered with the appropriate degree of caution. (see DRUG ABUSE AND DEPENDENCE) Monitoring Since, dihydrocodeine is metabolized by the liver; the effects of this combination product should be monitored closely in patients with hepatic insufficiency.