Divalproex Sodium | Preferred Pharmaceuticals Inc. Breastfeeding

It is recommended to breastfeed exclusively for six months and then while introducing to other food sources extend it to twelve months. In this duration most mothers will need help of some sort of medication, It could be for short term like could and flue or it could be something chronic like Arthritis or Diabetes and here comes the question of safety of medication in use. In this post we will figure out what is Divalproex Sodium | Preferred Pharmaceuticals Inc. and whether its safe to use Divalproex Sodium | Preferred Pharmaceuticals Inc. while nursing or not.

What is Divalproex Sodium | Preferred Pharmaceuticals Inc. used for?


Divalproex sodium extended-release tablets are indicated for: •Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) •Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) •Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1)]. The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium extended-release tablets for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient. 1.2 Epilepsy Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. 1.3 Migraine Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium extended-release tablets are useful in the acute treatment of migraine headaches. 1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)]. For prophylaxis of migraine headaches, divalproex sodium extended-release tablets are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications (4)].

Is using Divalproex Sodium | Preferred Pharmaceuticals Inc. unsafe in breastfeeding? Can there be bad consequences for baby if I use it while breastfeeding?

Divalproex Sodium | Preferred Pharmaceuticals Inc. safe for breastfeeding
As per our analysis Divalproex Sodium | Preferred Pharmaceuticals Inc. contains only one ingredient and that is Valproic acid. We have analyzed Valproic acid and it seems to be safe to use Valproic acid while breastfeeding, that means usage of Divalproex Sodium | Preferred Pharmaceuticals Inc. shall be safe while breastfeeding. Below you can check more details of Valproic acid usage in breastfeeding. We recommend you to go through provided detailed analysis as below take decision accordingly.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Females and Males of Reproductive Potential Contraception Women of childbearing potential should use effective contraception while taking valproate [see Boxed Warning, Warnings and Precautions (5.4), Drug Interactions (7), and Use in Specific Populations (8.1)]. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headaches [see Contraindications (4)]. Infertility There have been reports of male infertility coincident with valproate therapy [see Adverse Reactions (6.4)]. In animal studies, oral administration of valproate at clinically relevant doses resulted in adverse reproductive effects in males [see Nonclinical Toxicology (13.1)].

Divalproex Sodium | Preferred Pharmaceuticals Inc. Breastfeeding Analsys


Valproic acid while Breastfeeding

Safe

CAS Number: 99-66-1

It is excreted in breast milk in clinically non-significant amount without problems in the short or long term in infants whose mothers were treated. Plasma levels of these infants were undetectable or very low. Cognitive development did not suffer any alteration. An infant was presented with thrombocytopenic purpura and anemia who recovered after removing valproate in the mother. However, doubts were raised on whether it was instead a post-viral reaction that led to idiopathic thrombocytopenic purpura. The administration of valproic acid does not affect prolactin levels. The American Academy of Pediatrics rates it as usual compatible with breastfeeding medication.WHO List of Essential Medicines 2002: compatible with breastfeeding.


Divalproex Sodium | Preferred Pharmaceuticals Inc. Breastfeeding Analsys - 2


Valproic acid while Breastfeeding

CAS Number: 99-66-1

Breastfeeding during valproic acid monotherapy does not appear to adversely affect infant growth or development, and breastfed infants had higher IQs and enhanced verbal abilities than nonbreastfed infants at 6 years of age in one study.[1] If valproic acid is required by the mother, it is not necessarily a reason to discontinue breastfeeding. Because of the low levels of valproic acid in breastmilk and infant serum, no definite adverse reactions to valproic acid during breastfeeding have been reported. Theoretically, breastfed infants are at risk for valproic acid-induced hepatotoxicity, so infants should be monitored for jaundice and other signs of liver damage during maternal therapy. A questionable case of thrombocytopenia has been reported, so monitor the infant for unusual bruising or bleeding. One author recommends monitoring infant serum valproate levels, platelets and liver enzymes during therapy.[1] Combination therapy with sedating anticonvulsants or psychotropics may result in infant sedation or withdrawal reactions.



What if I already have used Divalproex Sodium | Preferred Pharmaceuticals Inc.?

It is always a good idea to keep your healthcare provider or doctor informed about your drug usage during pregnancy and breastfeeding but if you have not informed your doctor about Divalproex Sodium | Preferred Pharmaceuticals Inc. and have used it then do not panic as Divalproex Sodium | Preferred Pharmaceuticals Inc. is mostly safe in breastfeeding and should not cause any harm to your baby.


My health care provider has asked me to use Divalproex Sodium | Preferred Pharmaceuticals Inc., what to do?

Usage of Divalproex Sodium | Preferred Pharmaceuticals Inc. is safe for nursing mothers and baby, No worries.


If I am using Divalproex Sodium | Preferred Pharmaceuticals Inc., will my baby need extra monitoring?

No


Who can I talk to if I have questions about usage of Divalproex Sodium | Preferred Pharmaceuticals Inc. 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