VALPROIC ACID - valproic acid solution
Morton Grove Pharmaceuticals, Inc.
Read this Medication Guide before you start taking valproic acid oral solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about valproic acid oral solution?
Do not stop taking valproic acid oral solution without first talking to your healthcare provider.
Stopping valproic acid oral solution suddenly can cause serious problems.
Valproic acid oral solution can cause serious side effects, including:
1. Serious liver damage that can cause death, especially in children younger than 2 years old.
The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.
Call your healthcare provider right away if you get any of the following symptoms:
2. Valproic acid oral solution may harm your unborn baby.
If you take valproic acid oral solution during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen.
Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.
If you take valproic acid oral solution during pregnancy for any medical condition, your child is at risk for having a lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder.
There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child.
Women who are pregnant must not take valproic acid oral solution to prevent migraine headaches.
All women of child-bearing age (including girls from the start of puberty)should talk to their healthcare provider about using other possible treatments instead of valproic acid oral solution. If the decision is made to use valproic acid oral solution, you should use effective birth control (contraception).
Tell your healthcare provider right away if you become pregnant while taking valproic acid oral solution. You and your healthcare provider should decide if you will continue to take valproic acid oral solution while you are pregnant.
Call your healthcare provider right away if you have any of these symptoms:
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
Do not stop valproic acid oral solution without first talking to a healthcare provider. Stopping valproic acid oral solution suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What is valproic acid oral solution?
Do not take valproic acid oral solution if you:
Before you take valproic acid oral solution, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.
Taking valproic acid oral solution with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take valproic acid oral solution?
The common side effects of valproic acid oral solution include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store valproic acid oral solution?
General information about the safe and effective use of valproic acid oral solution
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use valproic acid oral solution for a condition for which it was not prescribed. Do not give valproic acid oral solution to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about valproic acid oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about valproic acid oral solution that is written for health professionals.
What are the ingredients in valproic acid oral solution?
Active ingredient: valproic acid
Inactive ingredients: alchohol (less than 0.05%), artificial cherry flavor, artificial wild cherry flavor, corn syrup solids, FD&C Red No. 40, glycerin, hydrochloric acid, liquid sugar, methylparaben, potassium phosphate dibasic, propylene glycol, purified water, sodium benzoate and sodium hydroxide
Product No.: 8621
Wockhardt USA, LLC
Parsippany, NJ 07054
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053