Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir 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 Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir for its safety in breastfeeding.

What is Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir ?


Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. Final classification of the less-than-effective indications requires further investigation. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Can I use Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir while breastfeeding?

Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir low risk for breastfeeding
Task to evaluate the effect of Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir is quite difficult as it consist mainly 4 ingredients. However we have analyzed all 4 active ingredients and have reached a conclusion that Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir poses low risk while breastfeeding. Below we have summarized our analysis of each 4 ingredients.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® Elixir is administered to a nursing woman.

Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Breastfeeding Analsys


Phenobarbital while Breastfeeding

Low Risk

CAS Number: 50-06-6

It is a barbiturate drug. Because it has a sedative effect, it is being displaced by other anti-epilepsy drugs in the treatment of chronic epilepsy. Excretion into the breast milk is quite variable with concentrations that could reach clinically significant levels. A sedative effect in infants from mothers who were treated has been described, as well as Abstinence Syndrome with spasms after sudden weaning, mostly in newborns. Follow-up for alertness and adequate feeding in the infant is recommended. Plasma level monitoring may be required in infants for both cases in which sedation has occurred or a follow-up for a progressive weaning is desired.

Hyoscyamine sulfate while Breastfeeding

Low Risk

CAS Number: 101-31-5

Use minimal and short-term dosage since anti-cholinergic drug may decrease breast milk production. Not commercially available in Spain

Atropine sulfate while Breastfeeding

Safe

CAS Number: 51-55-8

Either isolated dose or topical medication are safe for breastfed babies. Anti-cholinergic drugs decrease Prolactin and Oxytocin hormone secretion. Long-standing Atropine treatment could affects mother's milk production. American Academy of Pediatrics: Maternal Medication Usually Compatible With Breastfeeding.

Scopolamine hydrobromide while Breastfeeding

Low Risk

CAS Number: 51-34-3

Is Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir safe while breastfeeding

Scopolamine or Hyoscine is a alcaloid which is naturally found in several plants among Solanacea family. With a similar chemical structure of Atropine, it shows anti-muscarinic and anti-cholinergic effects (decrease in saliva, bronchial, sweat and gastric secretion, tachycardia, pupil dilation, anti-spasmodic effect on the intestine and urinary tract) Most frequently used formulations contain buthylbromurate, methybromurate and hydrobromurate. Skin patches contain purified Scopolamine. Used for prevention of motion-sickness of the traveler and treatment of nausea, post-anesthesia vomiting. Also, as anti-spasmodict and treatment of ophthalmologic disorders. At latest update, relevant published data on excretion into breast milk were not found. Due to a low oral bioavailability that minimizes the presence into the infant's plasma from mother's milk ingested, thus, the expert consensus is that the risk of use while breastfeeding is minimal. (American Academy of Pediatrics - 2013 says that is usually compatible with breastfeeding) Since at small dosage Scopolamine poisoning with alarming symptoms may occur (irritability, delirium, redness of skin, mouth dryness, constipation, urine retention), we would recommend a cautious and moderate use with a dose as low as possible with a delay of at least 3 hours for breastfeeding after medication. Avoid use if the infant is younger than 2 months or premature.


Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Breastfeeding Analsys - 2


Phenobarbital while Breastfeeding

CAS Number: 50-06-6

Inter- and intrapatient variability in excretion of phenobarbital into breastmilk is extensive. Phenobarbital in breastmilk apparently can decrease withdrawal symptoms in infants who were exposed in utero, but it can also cause drowsiness in some infants, especially when used with other sedating drugs. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. Sometimes breastfeeding might have to be limited or discontinued because of excessive drowsiness and poor weight gain. If there is concern, measurement of the infant's serum phenobarbital concentration might help rule out toxicity.

Atropine sulfate while Breastfeeding

CAS Number: 51-55-8

No information is available on the use of atropine during breastfeeding. Long-term use of atropine might reduce milk production or milk letdown, but a single systemic or ophthalmic dose is not likely to interfere with breastfeeding. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).

Scopolamine hydrobromide while Breastfeeding

CAS Number: 51-34-3

No information is available on the use of scopolamine during breastfeeding. Use during labor appears to have a detrimental effect on newborn infants' nursing behavior. Long-term use of scopolamine might reduce milk production or milk letdown, but a single systemic or ophthalmic dose is not likely to interfere with breastfeeding. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain). To substantially diminish the amount of drug that reaches the breastmilk 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.



I already used Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir and meanwhile I breastfed my baby should I be concerned?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir then you shall inform your doctor, But you should not be worried too much as Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir comes in category of low risk drug.


My doctor has prescribed me Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir, what should I do?

Though Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


If I am using Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Donnatal | Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir 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

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