Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule Breastfeeding
American Academy of Pediatrics and other medical experts exclusively recommend to breastfeed the baby for first 6 months. Once you introduce baby to other foods it is recommended to breastfeed for at least first year of babys life. Taking medication while breastfeeding could be tricky as most drugs pass in breast milk. In this article we will evaluate Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule for its safety in breastfeeding.

What is Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule ?


Fiorinal with Codeine is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of Fiorinal with Codeine is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: Fiorinal with Codeine, codeine, Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP), and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Fiorinal with Codeine proved statistically significantly superior to each of its components (Fiorinal, codeine) and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of Fiorinal with Codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

Can I use Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule while breastfeeding?

Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule high risk while breastfeeding
There are total 4 active ingredients in Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule which makes it a complicated task to assess the effect of Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule on breastfeeding. Here on drlact after analyzing all 4 ingredients we have reached on conclusion that Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule is unsafe in breastfeeding. Below is our summarized analysis of Codeine phosphate, Butalbital, Caffeine, Aspirin.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Aspirin, caffeine, barbiturates and codeine are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Fiorinal with Codeine, a decision should be made whether to discontinue nursing or 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 )

Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule Breastfeeding Analsys


Codeine phosphate while Breastfeeding

Unsafe

CAS Number: 76-57-3

Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule 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.

Butalbital while Breastfeeding

Low Risk

CAS Number: 77-26-9

Commercialized in association with other drugs for migraine treatment. Multiple drug compounds are not advisable. Caffeine may be a part of it (100 mg each tablet) and may be a cause of irritability to the infant. (See Caffeine)

Caffeine while Breastfeeding

Low Risk

CAS Number: 58-08-2

Trimethylxanthine component which is present in many compounds like decongestant or pain relief drugs (50 to 100 mg per unit) . It is also present in many infusion beverages (coffee, tea, mate, guarana) and other drinks with allegedly energizing properties. See also Coffee, Caffeine (beverages). At a dose higher than 300 mg a-day may induce nervousness and irritability in the infant. Intravenous high doses used to treat post-epidural anesthesia headache within 2-3 days after delivery, before mature breast milk comes, are compatible with breastfeeding. High doses used Intravenously to treat headache related to epidural should be regarded as compatible with breastfeeding only in the 2-3 days before milk comes in. Elimination period may last from few hours in adults, to 3-4 days in the newborn infant. American Academy of Pediatrics: Maternal Medication Usually Compatible With Breastfeeding.

Aspirin while Breastfeeding

Low Risk

CAS Number: 50-78-2

Is Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule safe while breastfeeding

Excreted in non-significant amount into breast milk. Reye’s Syndrome has never been reported due to ASA through breast milk. It is thought to be highly unlikely to occur after isolated or small doses like those used for treatment of thrombosis or anti-abortion therapy. At high maternal dose, one case (dubious) of salicylic intoxication in the neonatal period and another case of thrombocytopenia in an infant have been reported. Likelihood of hemolysis should be considered in those patients with G6PD-deficiency. WHO Model List of Essential Medication: compatible while breastfeeding when used occasionally or small dose for antithrombotic prophylaxis management.


Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule 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]

Butalbital while Breastfeeding

CAS Number: 77-26-9

Because there is no published experience with butalbital or combination products containing butalbital during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

Caffeine while Breastfeeding

CAS Number: 58-08-2

Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule safe for breastfeeding

Caffeine appears in breastmilk rapidly after maternal ingestion. Insufficient high-quality data are available to make good evidence-based recommendations on safe maternal caffeine consumption.[1] Fussiness, jitteriness and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes equivalent to about 10 or more cups of coffee daily. Studies in mothers taking 5 cups of coffee daily found no stimulation in breastfed infants 3 weeks of age and older. Some experts feel that a maternal intake limit of 300 mg daily might be a safe level of intake.[2] However, preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers' levels,[2][3][4] so a lower intake level preferable in the mothers of these infants. Other sources of caffeine, such as cola and energy drinks, yerba mate or guarana, will have similar dose-related effects on the breastfed infant. Coffee intake of more than 450 mL daily may decrease breastmilk iron concentrations and result in mild iron deficiency anemia in some breastfed infants.[5]

Aspirin while Breastfeeding

CAS Number: 50-78-2

After aspirin ingestion, salicylic acid is excreted into breastmilk, with higher doses resulting in disproportionately higher milk levels. Long-term, high-dose maternal aspirin ingestion probably caused metabolic acidosis in one breastfed infant. Reye's syndrome is associated with aspirin administration to infants with viral infections, but the risk of Reye's syndrome from salicylate in breastmilk is unknown. An alternate drug is preferred over continuous high-dose, aspirin therapy. After daily low-dose aspiring (75 to 325 mg daily), no aspirin is excreted into breastmilk and salicylate levels are low. Daily low-dose aspirin therapy may be considered as an antiplatelet drug for use in breastfeeding women.[1][2][3].


Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule for breastfeeding

I already used Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule and meanwhile I breastfed my baby should I be concerned?

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 Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule usage and time interval of breastfeeding.


My doctor has prescribed me Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule, what should I do?

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


If I am using Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule, will my baby need extra monitoring?

Yes, Extra monitoring is required if mother is using Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule and breastfeeding as it is considered unsafe for baby.


Who can I talk to if I have questions about usage of Fiorinal With Codeine | Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsule 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