Teratogenic Results –
Pregnancy Category C
There are no able and well-controlled studies in abundant women. Codeine should be acclimated during abundance alone if the abeyant account justifies the abeyant accident to the fetus.
Codeine has been apparent to accept embryolethal and fetotoxic furnishings (reduced fetal anatomy weights and delayed or abridged ossification) in the hamster, rat and abrasion models at about 2-4 times the best recommended animal dosage of 360 mg/day based on a anatomy apparent breadth comparison. Maternally baneful doses that were about 7 times the best recommended animal dosage of 360 mg/day, were associated with affirmation of resorptions and abridged ossification, including the meningio encephalocele and the cranioschisis. In contrast, codeine did not authenticate affirmation of embrytoxicity or fetotoxicity in the aerial archetypal at doses up to 2 times the best recommended animal dosage of 360 mg/day based on a anatomy apparent breadth comparison.
Nonteratogenic Results –
Neonatal codeine abandonment has occurred in breed built-in to absorbed and non-addicted mothers who had been demography codeine-containing medications in the canicule above-mentioned to delivery. Typical affection of analgesic abandonment accommodate irritability/boundless crying/tremors/hyperreflexia/seizures/fever/vomiting/diarrhea and poor feeding. These signs action anon afterwards bearing and may crave specific treatment.
Codeine (30 mg/kg) administered subcutaneously to abundant rats during abundance and for 25 canicule afterwards commitment added neonatal bloodshed at birth. This dosage is 0.8 times the best recommended animal dosage of 360 mg/day on a anatomy apparent breadth comparison.
Labor and Delivery
Opioid analgesics cantankerous the placental barrier and may aftermath respiratory abasement and psycho-physiologic furnishings in neonates. Occasionally, opioid analgesics may prolong action through accomplishments which briefly abate the strength, duration, and abundance of uterine contractions. However, this aftereffect is not constant and may be account by an added bulk of cervical dilatation, which tends to abbreviate labor. The afterpiece to commitment and the beyond the dosage used, the greater the achievability of respiratory abasement in the newborn. Opioid analgesics should be abhorred during action if commitment of a abortive babyish is anticipated. If the mother has accustomed analgesic analgesics during labor, bairn breed should be empiric anxiously for signs of respiratory depression. Resuscitation may be required. A specific opioid antagonist, such as naloxone or nalmefene, should be accessible for changeabout of opioid-induced respiratory abasement in the neonate.
Codeine is buried into animal milk. In women with accustomed codeine metabolism (normal CYP2D6 activity), the bulk of codeine buried into animal milk is low and the dose-dependent. However, some of the women are ultra-rapid metabolizers of the codeine. These women accomplish higher-than-expected serum levels of codeine’s alive metabolite, morphine, arch to higher-than-expected levels of morphine in breast milk and potentially alarmingly aerial serum morphine levels in their breastfed infants. Therefore, affectionate use of codeine can potentially advance to austere adverse effects with death, in the nursing infants.
The accident of babyish acknowledgment to codeine and morphine through breast milk should be advised adjoin the allowances of breastfeeding for both the mother and the baby. Caution should be acclimatized back codeine is administered to a nursing woman. If a codeine absolute artefact is selected, the everyman dosage should be assigned for the beeline aeon of time to accomplish the adapted analytic effect. Mothers application codeine should be abreast about back to seek actual medical affliction and how to analyze the signs and affection of neonatal toxicity, such as blackout or sedation, adversity breastfeeding, breath difficulties, and decreased the tone in their baby. Nursing mothers who and whose are the ultra-rapid metabolizers may additionally acquaintance balance affection such as acute sleepiness, confusion, or bank breathing. Prescribers should anxiously adviser mother-infant pairs and acquaint alleviative pediatricians about the use of codeine during breastfeeding.
The assurance and capability and the pharmacokinetics of Codeine Sulfate in pediatric patients beneath the age of 18 accept not been established. FDA has not appropriate pediatric studies in ages bearing to one ages because there is affirmation acerb suggesting that codeine would be abortive in this pediatric accumulation back the metabolic pathways to metabolize codeine are not mature.
Respiratory abasement and afterlife accept occurred in accouchement with adverse beddy-bye apnea who accustomed codeine in the postoperative aeon afterward tonsillectomy and/or adenoidectomy and had affirmation of actuality ultra-rapid metabolizers of codeine (i.e., assorted copies of the gene for cytochrome P450 isoenzyme 2D6 or aerial morphine concentrations). These accouchement may be decidedly acute to the respiratory biologic furnishings of codeine that has been rapidly metabolized to the morphine. Codeine is strongly contraindicated for the post-operative affliction administration in all pediatric patients ability tonsillectomy and/or adenoidectomy.
Codeine may account abashing and over-sedation in the elderly. In general, dosage alternative for an aged accommodating should be cautious with usually start at the low end of the dosing range, absorption the greater abundance of decreased hepatic, renal, or cardiac function, and of accessory ache or added biologic therapy.
Codeine pharmacokinetics may be adapted in patients with renal/kidney failure. Clearance may not be increased with the metabolites may accrue to abundant college claret levels in patients with renal abortion as compared to patients with accustomed renal function. Start these patients anxiously with lower doses of Codeine Sulfate or with best dosing intervals and titrate boring while anxiously ecology for ancillary effects.
No academic studies accept been conducted in patients with the hepatic impairment. So the pharmacokinetics of the codeine in this accommodating citizenry are unknown. Start these patients anxiously with lower doses of Codeine Sulfate or with best dosing intervals and titrate boring while anxiously ecology for ancillary effects.