openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS General: Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic, heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions. Usage in Ambulatory Patients: Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. 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. WellTuss EXP may product 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).
6 ADVERSE REACTIONS The most frequently observed adverse reaction with dihydrocodeine include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration. Other reactions observed with the ingredients in WellTuss EXP inclue lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).