Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate Breastfeeding
Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate is safe in breast-feeding or not.

What is Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate used for?


Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Is Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate safe to use while breastfeeding? Can it interfere with growth and development of my kid?

Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate high risk while breastfeeding
There are total 3 active ingredients in Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate which makes it a complicated task to assess the effect of Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate on breastfeeding. Here on drlact after analyzing all 3 ingredients we have reached on conclusion that Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate is unsafe in breastfeeding. Below is our summarized analysis of Promethazine hydrochloride, Codeine phosphate, Phenylephrine hydrochloride.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine excreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine’s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. ( WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine ). It is not known whether phenylephrine or promethazine are excreted in human milk.

Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate Breastfeeding Analsys


Promethazine hydrochloride while Breastfeeding

Low Risk

CAS Number: 60-87-7

1st-generation-antihistamine and phenothiazine-type drug with a strong sedative effect. At latest update relevant published data on excretion into breast milk were not found. It may decrease prolactin levels and interfere with milk production during the first few weeks after birth (Pontiroli 1981, Messinis 1985).Pharmacokinetic data (high volume of distribution and high plasma protein-binding capacity) would render it unlikely a significant passage into the breastmilk.In addition, a low oral bioavailability would hinder a further passage to infant’s plasma through the ingested breastmilk, except on premature infants and immediate neonatal period when there may be an increased intestinal permeability.There are doubts about any association with Sudden Infant Death Syndrome (SIDS) (Kahn 1982, Stanton 1983). It may be considered compatible with breastfeeding on isolated doses such as those used for pre-surgical medication or traveler's dizziness (WHO 2002). Avoid a repeated use as it may cause drowsiness in the infant.Avoid using it in the immediate neonatal period (first 4 to 6 weeks after birth) and in case of prematurity. If used, follow-up the infant for drowsiness and feeding issues. It is not recommended bed-sharing when taking this medication (UNICEF 2006, ABM 2008, Landa 2012, UNICEF 2013).

Codeine phosphate while Breastfeeding

Unsafe

CAS Number: 76-57-3

Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate and breastfeeding

Compound of cough and pain medication. The cytochrome P450-CYP2D6 enzyme catalyzes morphine. It is excreted in breast milk in small amounts, much lower than the dose used for newborns and infants. The plasma levels of infants whose mothers take them are very low, less than usual therapeutic levels and assuming an insignificant relative dose, less than 1.5% (Meny 1993, Naumburg 1988, Findlay 1981), so it was considered safe for use during breastfeeding (Bar-Oz 2003, WHO 2002, AAP 2001, Moretti 2000, Spigset 2000, Mitchell 1999, Meny 1993). However, excessive sedation in the mother or infant may occur if they are rapid metabolizers of codeine to morphine due to an excess of the gene linked to the P450-2D6 enzyme: this occurs in <1% of Chinese, Japanese and Hispanic people; 3% African Americans; 1-10% of Caucasians and 16-29% of North Africans, Ethiopians and Saudis (Halder 2015, Sachs 2013). The genetic diagnosis of this characteristic is not available in usual clinical practice (Madadi, 2011). Codeine through breast milk has been linked to the appearance of neonatal apnea (Naumburg, 1988), drowsiness (Ito, 1993), neurological depression (Madadi, 2008) and, above all, a fatal outcome: a newborn whose mother had this genetic abnormality died at 13 days; the mother was taking 60 mg of codeine twice daily, morphine levels were normal in breast milk, but very high in the child's plasma (Madadi 2007, Koren 2006). Subsequently, the causality of codeine in this case has been called into question (Bateman 2008, Ferner RE 2008, Young 2007). A link has been found between the use of codeine during pregnancy and breastfeeding and the risk of developing neuroblastoma in the infant (Cook, 2004). Because of all this, and with newborns having a limited capacity for opioid elimination (Willmann, 2009) and the existence of more effective alternatives, many authors and institutions advocate completely discouraging its use in infants and breastfeeding mothers (FDA 2017, Al-Adhami 2016, Lazaryan 2015, AEMPS 2015, Sachs 2013, EMA 2013). Other authors advocate cautious use (some even in the case of rapid metabolizers), using the lowest possible effective dose and for no more than 4 days and monitoring for signs of sedation in mother and infant (Royal Berkshire-NHS 2016, Halder 2015, Reece-Stremtan-ABM Protocol#21 2015, Chow 2015, Kelly 2013, UKMi NHS 2013, Rowe 2013, Montgomery-ABM protocol#15 2012, Amir 2011, Madadi 2009, Madadi 2007, FDA 2007). The use of non-steroidal anti-inflammatory drugs (NSAIDs) better controls pain and with fewer side effects than codeine alone or in combination with paracetamol (Palanisamy 2014, Hendrickson 2012, van den Anker 2012, Madadi 2009, Nauta 2009, Willmann 2009), and codeine is not included either in international consensus on the treatment of migraines (Bordini 2016, Worthington 2013). Follow WHO standards for childbirth attendance, reduce cesarean sections and episiotomies, and therefore the need for analgesics in the first few days.

Phenylephrine hydrochloride while Breastfeeding

Low Risk

CAS Number: 59-42-7

Used on topical decongestant solutions for nose drops at low concentration. 10% midriatic eye drops are available. Because low concentration is used on nose and ophtalmic drops a significant excretion into breast milk is unlikely. Low oral biodisponibility minimizes any risk of harmful effect in the infant. Authorized for nasal or ophtalmic use on children aged younger than 1 year. Although on latest update relevant data on breastfeeding was not found it is considered to be safe when minimal dose is used. Avoid excessive or long term use. A related drug Pseudoephedrine can inhibit milk production. It would be advisable to press on the lachrimal sac to minimize absorption.


Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate Breastfeeding Analsys - 2


Promethazine hydrochloride while Breastfeeding

CAS Number: 60-87-7

Based on minimal excretion of other phenothiazine derivatives, it appears that occasional short-term use of promethazine for the treatment of nausea and vomiting poses little risk to the breastfed infant. With repeated doses, observe infants for excess sedation. Because promethazine can lower basal prolactin secretion, promethazine might interfere with the establishment of lactation if given during labor, before lactation is well established or with a sympathomimetic such as pseudoephedrine. An antiemetic without potent histamine blocking action is preferred in nursing mothers.

Codeine phosphate while Breastfeeding

CAS Number: 76-57-3

Is Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate safe while breastfeeding

Maternal use of codeine during breastfeeding can cause infant drowsiness, central nervous system depression and even death, with pharmacogenetics possibly playing a role.[1][2] Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral codeine to 2-4 days at a low dosage with close infant monitoring, especially in the outpatient setting.[2][3][4][5] If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.[6] Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. Following these precautions can lower the risk of neonatal sedation.[7] Numerous professional organizations and regulatory agencies recommend that other agents are preferred over codeine or to avoid codeine completely during breastfeeding;[8][9][10][11][12] however, other opioid alternatives have been studied less and may not be safer.[13]

Phenylephrine hydrochloride while Breastfeeding

CAS Number: 59-42-7

The oral bioavailability of phenylephrine is only about 40%,[1] so the drug is unlikely to reach the infant in large amounts. However, intravenous or oral administration of phenylephrine might decrease milk production. Because no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.Phenylephrine nasal spray or ophthalmic drops are less likely to decrease lactation. To substantially diminish the effect of the drug after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.


Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate safe for breastfeeding

I am nursing mother and I have already used Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate, what should I do?

If you observer abnormal behavior or any other health issue in infant then you should immediately call 911 or contact other contact other emergency service provider in your area otherwise closely monitor the baby and inform your doctor about your Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate usage and time interval of breastfeeding.


My health care provider has asked me to use Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate, what to do?

If your doctor knows that you are breastfeeding mother and still prescribes Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate then there must be good reason for that as Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate is considered unsafe, It usually happens when doctor finds that overall advantage of taking outweighs the overall risk.


If I am using Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate, will my baby need extra monitoring?

Yes, Extra monitoring is required if mother is using Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate and breastfeeding as it is considered unsafe for baby.


Who can I talk to if I have questions about usage of Promethazine Hcl, Phenylephrine Hcl And Codeine Phosphate in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week