ould be advised not to adjust the dose of Coldcough™ PD without consulting the prescribing professional. Patients should not combine Coldcough™ PD with alcohol or other central nervous system stimulants.
Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child.
Patients should be advised that Coldcough™ PD is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with Coldcough™ PD. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to pregnant women only if clearly needed, especially during the first trimester.
Non-Teratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal, Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 2-4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.
Labor and Delivery
Coldcough™ PD is not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.
Geriatric Use
Coldcough™ PD should be given with caution to the elderly.
Hepatic Impairment
Coldcough™ PD should be given with caution to patients with hepatic insufficiency. Since dihydrocodeine is metabolized by the liver, the effects of this combination product should be monitored closely in such patients.
Renal Impairment
Coldcough™ PD should be used with caution and at reduced dosage in the presence of impaired renal function.
Pancreatic/Biliary Tract Disease
Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease including pancreatitis.
ADVERSE REACTIONS
The most frequently observed adverse reactions with hydrocodeine 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 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 pyschological dependence are possibilities. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, s
