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 Divalproex Sodium Capsule, Coated Pellets is safe for baby while breastfed.
What is Divalproex Sodium Capsule, Coated Pellets used for?
Divalproex sodium delayed-release capsules (sprinkle) are anti-epileptic drug indicated for: 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) 1.1 Epilepsy Divalproex sodium delayed-release capsules (sprinkle) 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 delayed-release capsules (sprinkle) are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients 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. 1.2 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)].
What are the risk associated with Divalproex Sodium Capsule, Coated Pellets usage while breastfeeding? What precautions shall I take while using it in breastfeeding?
Active ingredient in Divalproex Sodium Capsule, Coated Pellets is Valproic acid and based on our analysis of Valproic acid it appears that using Divalproex Sodium Capsule, Coated Pellets is safe in breastfeeding. Below is analysis of Valproic acid while breastfeeding.
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.
Divalproex Sodium Capsule, Coated Pellets Breastfeeding Analsys
SafeCAS 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 Capsule, Coated Pellets Breastfeeding Analsys - 2
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 Divalproex Sodium Capsule, Coated Pellets?
Divalproex Sodium Capsule, Coated Pellets is safe in breastfeeding and should not create any health problem for your baby but in case you feel any health issue associated with Divalproex Sodium Capsule, Coated Pellets you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.
My health care provider has asked me to use Divalproex Sodium Capsule, Coated Pellets, what to do?
Definitely, Divalproex Sodium Capsule, Coated Pellets is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Divalproex Sodium Capsule, Coated Pellets, will my baby need extra monitoring?
No extra baby monitoring required while mother is using Divalproex Sodium Capsule, Coated Pellets
Who can I talk to if I have questions about usage of Divalproex Sodium Capsule, Coated Pellets 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