apy is 4 to 28 days, with the dosages decreased as tolerated. Labor and Delivery Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use This product is not recommended for use in children under 6 years of age. Children under two years may be more susceptible to respiratory arrest, coma and death. Use of antihistamines is not recommended in infants. This age group may be at a higher risk than other age groups because of an increased susceptibility to anticholinergic effects, such as CNS excitation, and an increased tendency toward convulsions. In older children taking antihistamines, a paradoxical reaction characterized by hyper excitability may occur. Very young children may be more sensitive to the effects, especially the vasopressor effects of sympathomimetic amines. Geriatric Use Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid should be given with caution to elderly patients as they are more likely to exhibit adverse reactions.
Most Frequently Observed The most frequently observed adverse reactions 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 Other reactions that have been observed with dihydrocodeine or other 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 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 adverse reactions observed with the ingredients in Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid include, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children). To report ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Misuse, Abuse, and Diversion of Opioids Under the provisions of the Controlled Substance Act this product has been placed in Schedule V. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety and p
