Depakote Er | Valproic Acid 500 Mg Breastfeeding
Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. Sometime its due to need of medication usage. Because of these statics its important to provide good information on safety of drugs in breastfeeding so that it can be improved when possible. In this FAQ sheet we will discuss about exposure to Depakote Er | Valproic Acid 500 Mg while breastfeeding. We will also discuss about common side effects and warnings associated with Depakote Er | Valproic Acid 500 Mg.

What is Depakote Er | Valproic Acid 500 Mg used for?


Depakote ER is an anti-epileptic drug 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 Depakote ER is a valproate and is 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 Depakote ER is based in part on studies of Depakote (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 Depakote ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient. 1.2 Epilepsy Depakote ER is 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. Depakote ER is 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 Depakote ER is indicated for prophylaxis of migraine headaches. There is no evidence that Depakote ER is useful in the acute treatment of migraine headaches. 1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4) , Use in Specific Populations (8.1), and Patient Counseling Information (17.3)]. Depakote ER is contraindicated for prophylaxis of migraine headaches in women who are pregnant.
1.1 Mania Depakote ER is a valproate and is 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 Depakote ER is based in part on studies of Depakote (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 Depakote ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
1.2 Epilepsy Depakote ER is 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. Depakote ER is 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 Depakote ER is indicated for prophylaxis of migraine headaches. There is no evidence that Depakote ER is useful in the acute treatment of migraine headaches.
1.4 Important Limitations Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4) , Use in Specific Populations (8.1), and Patient Counseling Information (17.3)]. Depakote ER is contraindicated for prophylaxis of migraine headaches in women who are pregnant.

Depakote Er | Valproic Acid 500 Mg while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Depakote Er | Valproic Acid 500 Mg safe for breastfeeding
As per our analysis Depakote Er | Valproic Acid 500 Mg 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 Depakote Er | Valproic Acid 500 Mg 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 Nursing Mothers Valproate is excreted in human milk. Caution should be exercised when valproate is administered to a nursing woman.

Depakote Er | Valproic Acid 500 Mg 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.


Depakote Er | Valproic Acid 500 Mg 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 should I do if already breastfed my kid after using Depakote Er | Valproic Acid 500 Mg?

As usage of Depakote Er | Valproic Acid 500 Mg is mostly safe while breastfeeding hence there should not be any concern. In case of any change in behavior or health of your baby you should inform your health care provider about usage of Depakote Er | Valproic Acid 500 Mg else no further action is required.


I am nursing mother and my doctor has suggested me to use Depakote Er | Valproic Acid 500 Mg, is it safe?

Usage of Depakote Er | Valproic Acid 500 Mg is safe for nursing mothers and baby, No worries.


If I am using Depakote Er | Valproic Acid 500 Mg, will my baby need extra monitoring?

No


Who can I talk to if I have questions about usage of Depakote Er | Valproic Acid 500 Mg 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