If this SPL consists of inactivated NDCs outlined with the FDA initiated compliance action, they will be specified as a result.
Read through the Medication Guidebook supplied by your pharmacist Before you begin taking codeine/promethazine and each time you receive a refill. When you have any queries, check with your health practitioner or pharmacist.
Codeine has reduced plasma protein binding with about 7 to 25% of codeine bound to plasma proteins. Codeine passes the blood Mind barrier and the placental barrier. Little amounts of codeine and its metabolite, morphine, are transferred to human breast milk.
The chance of toddler exposure to codeine and morphine as a result of breast milk must be weighed against some great benefits of breastfeeding for both of those the mom and infant. Caution needs to be exercised when codeine is administered to your nursing female. If a codeine-containing solution is chosen, the lowest dose should be prescribed for your shortest period of time to attain the desired scientific impact. Moms using codeine need to be educated about when to seek immediate medical treatment and the way to establish the indicators and indicators of neonatal toxicity, like drowsiness or sedation, problem breastfeeding, respiration difficulties, and lowered tone, inside their newborn.
Youngsters may very well be significantly sensitive to the additive respiratory depressant consequences when promethazine is put together with other respiratory depressants, which includes codeine.
The causal role of opioids within the clinical syndrome of hypogonadism is not known since the a variety of healthcare, Actual physical, Life-style, and psychological stressors which could influence gonadal more info hormone degrees have not been sufficiently managed for in studies done to date [see ADVERSE REACTIONS (6)].
Codeine in oral therapeutic dosage doesn't generally exert significant outcomes about the cardiovascular program.
Promethazine and codeine need to be made use of through pregnancy only if the opportunity advantage justifies the likely possibility into the fetus.
To reduce your risk, your medical doctor should have you take the smallest dose that works, and choose it to the shortest feasible time. See also How to Use part To find out more about dependancy.
The day supply is predicated on the average dispensing styles for the particular drug and strength. This system, together with the charges as well as the list of protected medications, could be modified at any time without detect.
Indicators and indications of overdosage with promethazine vary from moderate depression in the central anxious system and cardiovascular program to profound hypotension, respiratory despair, unconsciousness and unexpected Dying.
Usage of promethazine and codeine mix is not suggested in kids youthful than 6 many years of age for syrup or in youngsters youthful than twelve several years of age for oral Resolution, as a result of improved threat of respiratory depression.
The dosage of Promethazine with Codeine Oral Resolution really should not be elevated if cough fails to respond; an unresponsive cough should be reevaluated for doable fundamental pathology.
Codeine is modified into a powerful opioid drug (morphine) in One's body. In a number of people, this variation takes place more rapidly and a lot more fully than normal, which raises the threat of extremely serious Unwanted side effects.