Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit Breastfeeding

It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit is safe for baby while breastfed.

What is Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit ?


Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
INDICATIONS FOR USE Theramine is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions.

Can I use Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit while breastfeeding?

Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit Contains 3 active ingredients that are Codeine phosphate, Acetaminophen, .gamma.-aminobutyric acid. We do have breastfeeding analysis and safety rating of some of the active ingredients but unfortunately we do not have any information of some of active ingredients used. Below we have provided whatever information we do have. But please do not take any decision based on below provided information and contact your health care provider as this information is incomplete.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted 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 prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. 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 (see PRECAUTIONS - General - Ultra-Rapid Metabolizers of Codeine).

Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit Breastfeeding Analsys


Codeine phosphate while Breastfeeding

Unsafe

CAS Number: 76-57-3

Is Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit safe while 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.

Acetaminophen while Breastfeeding

Safe

CAS Number: 103-90-2

Excreted in very low amount into breast milk. Infant intake may be lower than 4% of usual pediatric dose. The American Academy of Pediatrics rates it as compatible with Breastfeeding.


Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit Breastfeeding Analsys - 2


Codeine phosphate while Breastfeeding

CAS Number: 76-57-3

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]

Acetaminophen while Breastfeeding

CAS Number: 103-90-2

Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.


Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit safe for breastfeeding

What should I do if already breastfed my kid after using Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit?

Not much study has been done on safety of Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit in breastfeeding and its ingredients. Even we do not have complete information about usage of Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit in breastfeeding so at this point a trained medical professional could be your best bet. If you observe anything abnormal with your baby please contact 911.


My doctor has prescribed me Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit, what should I do?

If your doctor considers Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit safe enough to prescribe for you that means its benefits should outweigh its known risks for you.


If I am using Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit, will my baby need extra monitoring?

We are not Sure, Please check with your healthcare provider or doctor.


Who can I talk to if I have questions about usage of Theracodeine-300 | Acetaminophen, Codeine Phosphate, .gamma.-aminobutyric Acid Kit 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