Pregnancy :

Pregnancy Category C

There are no able and well-controlled studies in abundant women. Discussion Of Codeine Sulfate pregnancy should be acclimated during abundance alone if the abeyant account justifies the abeyant accident to the fetus.

Codeine discussion of codeine sulfate pregnancy 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.

Nursing Mothers

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.

Caution should be acclimatize back codeine is administer to a nursing woman. Nursing mothers who and whose are the ultra-rapid metabolizers may additionally acquaintance. Prescribers should anxiously adviser mother-infant pairs and acquaint alleviative pediatricians about the use of codeine during breastfeeding.

Pediatric Use

 

These accouchement may be decidedly acute to the respiratory biologic furnishings. Codeine is strongly contraindicate for the post-operative affliction administration in all pediatric patients ability tonsillectomy and/or adenoidectomy.

 

Renal Impairment

Codeine pharmacokinetics may be adapt in patients with renal/kidney failure. Clearance may not be increase with the metabolites may accrue to abundant college claret levels in patients with renal abortion. Start these patients anxiously with lower doses of Codeine Sulfate or with best dosing intervals.

Hepatic Impairment

No academic studies accept been discussion of codeine sulfate pregnancy conduct in patients with the hepatic impairment. So the pharmacokinetics of the codeine in this accommodating citizenry are unknown.