Due to challenges of habit, abuse, and misuse with opioids, even at advisable doses [see Warnings and Safeguards (5.one)], reserve promethazine HCl and codeine phosphate oral Resolution to be used in adult sufferers for whom the main advantages of cough suppression are anticipated to outweigh the risks, and in whom an satisfactory evaluation of your etiology of your cough has actually been produced.
Absorption Codeine is absorbed in the gastrointestinal tract with most plasma focus happening sixty minutes publish administration. The existence of a superior-Body fat, substantial-calorie meal didn't substantially effects the PK of codeine.
The estimated background possibility of key beginning defects and miscarriage for your indicated populace is unfamiliar. All pregnancies Possess a background threat of start defect, loss, or other adverse results.
All individuals addressed with opioids involve very careful checking for signs of abuse and habit, since usage of opioid analgesic and antitussive goods carries the risk of dependancy even below ideal clinical use.
are breastfeeding or plan to breastfeed. Codeine Phosphate passes into your breast milk and should hurt your little one. Both you and your healthcare provider should really examine whether you must choose Promethazine with Codeine Oral Answer or breastfeed. You should not do both equally.
Mainly because these reactions could be described voluntarily from the population of uncertain dimensions, It's not always doable to reliably estimate their frequency or establish a causal relationship to drug exposure.
INDICATIONS AND USAGE Promethazine HCl and codeine phosphate oral Option is a combination of codeine, an opioid agonist, and promethazine, a phenothiazine, indicated for the temporary aid of cough and higher respiratory signs connected to allergy or perhaps the popular chilly in people eighteen several years of age and more mature. (one) (one)
Fetal/Neonatal Adverse Reactions Prolonged utilization of opioid analgesics during pregnancy for health care or nonmedical purposes may result in Actual physical dependence within the neonate and neonatal opioid withdrawal syndrome shortly following beginning.
Treatment method of Overdose Therapy of overdosage is pushed by the general scientific presentation, and contains discontinuation of promethazine HCl and codeine phosphate oral Answer together with institution of proper therapy. Give Most important attention for the reestablishment of enough respiratory exchange via provision of the patent and protected airway as well as the establishment of assisted or controlled ventilation.
In animal reproduction studies, codeine administered through the oral path to pregnant rats through the period of organogenesis improved resorptions and decreased fetal weights at a dose around 25 instances the maximum encouraged human dose (MRHD) inside the presence of maternal toxicity (see Details).
Postmarketing circumstances of respiratory depression, which includes fatalities have already been described with usage of promethazine in pediatric clients.
If any of one's drugs are recalled, gurus advise speaking to your pharmacist to see if there are actually alternate products or suppliers. If there isn't a similar generic alternative, it is best get more info to Get in touch with your Health care provider to discuss other medication alternatives.
Serotonin Syndrome Inform patients that promethazine HCl and codeine phosphate oral Remedy could lead to a rare but potentially everyday living-threatening condition resulting from concomitant administration of serotonergic medicines.
Make sure that clients have an oral dosing dispenser that actions the suitable volume in milliliters. Counsel people regarding how to make the most of an oral dosing dispenser and correctly measure the oral suspension as prescribed.