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 tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression
occurs most frequently in elderly or debilitated patients, usually after large initial doses in
non-tolerant patients, or when opioids are given in conjunction with other agents that depress
respiration. This combination product 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, hypoxia, hypercapnia, or respiratory depression.

Hypertensive 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
received concurrent therapy with drugs such as phenothiazine or other agents which compromise
vasomotor tone. This product may produce orthostatic hypotension in ambulatory patients. This
combination product should be administered with caution to patients with circulatory shock since
vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Dependence: 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 section).

PRECAUTIONS
General: This combination product should be used with caution in elderly or debilitated patients
or those with any of the following conditions: 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, head injury; hypotension; hypertension; increased
intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral structure;
and toxic psychosis. The benefits and risks of opioids in patients taking monoamine oxidase
inhibitors and in those with a history or 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 in some clinical settings.

Drug Interactions:
General: Sympathomimetic amines may reduce the antihypertensive effects of methyldopa,
mecamylamine, reserpine, and veratrum alkaloids.

Other CNS Depressants: Patients receiving other opioid analgesics, sedatives or hypnotics,
muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other
tranquilizers, or alcohol concomitantly with this product may exhibit additive depressant
effects on the central nervous system. When such combination therapy is contemplated, the
dose of one or both agents should be reduced. Concomitant use of dihydrocodeine with alcohol
and other CNS depressants may have an additive effec