If you have bipolar disorder, epilepsy, or seizures, your medical professional may recommend a prescription drug called Lamictal.

Lamictal is used to treat the following in certain situations:

  • bipolar I disorder in adults
  • some kinds of epilepsy in adults, as well as children ages 2 and older
  • partial-onset seizures in adults, as well as children ages 16 years and older who are switching to Lamictal alone from a different treatment

For more information about how Lamictal is used, see the “What do you take Lamictal for?” section below.

Lamictal details

Lamictal contains the active drug lamotrigine. (The active drug is the ingredient that makes a medication work). Lamictal belongs to a group of medications called antiepileptic drugs.

Lamictal is a brand-name drug. It’s available as the generic drug lamotrigine.

Comparing Lamictal’s forms

Lamictal is available in the following forms:

  • immediate-release tablets that you swallow
  • tablets that dissolve in your mouth
  • tablets that you can swallow, chew, or dissolve in liquid and drink

Another form of Lamictal is called Lamictal XR. (“XR” stands for extended release.) This form of the drug is made to slowly release the dose over time.

This article focuses on the first three forms of Lamictal. For more information about these forms, you can see the “How do you take Lamictal?” section below.

We suggest that you read on to learn more about Lamictal’s uses, side effects, and more.

Most medications, including Lamictal, may cause side effects that can be serious or mild. To give you an idea of what might occur with Lamictal, we’ve listed some of the medication’s more common side effects below. We haven’t included all the potential side effects.

For more complete information about possible side effects of Lamictal, you can talk with your medical professional or pharmacist. They may also be able to recommend ways to help prevent and ease side effects.

Note: Certain factors may affect a medication’s side effects. These factors can include other health conditions you may have, other drugs you may be taking, and your age.

Mild side effects

Some of the mild side effects that Lamictal may cause are listed below. For information about other mild side effects of the drug, we suggest that you talk with your medical professional or pharmacist. It may also be helpful to refer to the medication guide for Lamictal.

Mild side effects of Lamictal that have been reported in studies include:

Mild side effects of many drugs tend to lessen in a couple of days or a few weeks. But if you find that the side effects bother you, talk with your medical professional or pharmacist.

* For details about this side effect, see “Side effects: A closer look” below.
† To learn more about this side effect, see the “What’s a Lamictal rash?” section below.

Serious side effects

Lamictal may cause serious side effects, but this isn’t common. If you do develop serious side effects while taking Lamictal, it’s important to call your medical professional immediately. If you feel as if you’re having a medical emergency, it’s vital to call 911 or your local emergency number right away.

Serious side effects of Lamictal that have been reported in studies include:

* For details about this side effect, see “Side effects: A closer look” below.

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Long-term side effects

If your medical professional prescribes Lamictal, you may wonder whether the drug’s side effects go away.

Like most drugs, Lamictal can cause mild and serious side effects. Mild side effects of many drugs may go away within a few days or a couple of weeks.

You may have long-term effects of Lamictal if you experience a serious skin reaction, such as toxic epidermal necrolysis. Another of these serious skin reactions is a multiorgan hypersensitivity reaction, which is also known as drug reaction with eosinophilia and systemic symptoms (DRESS).

DRESS can affect organs such as your liver, heart, and kidneys. For example, although extremely rare, there have been cases of liver failure due to DRESS. (For more information about DRESS and Lamictal, see “Allergic reaction” below.)

If you have any concerns about long-term side effects of your Lamictal treatment, we encourage you to talk with your medical professional.

Side effects: A closer look

This section provides a close-up look at key side effects of Lamictal.

Boxed warning: Serious skin rashes

Lamictal has a boxed warning about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks.

Rare but life threatening skin rashes have been reported in people taking Lamictal. These rashes include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

Children appear to have a higher risk of serious skin rashes than adults. You may also have a higher risk if:

  • you take Lamictal with the epilepsy drug valproate, valproic acid, or divalproex sodium (Depakote)
  • your starting dose of Lamictal is higher than recommended
  • your dose of Lamictal is increased faster than recommended

These reactions can happen at any time while you’re taking Lamictal. But they’re more likely to occur during the first 2 to 8 weeks of taking the drug.

Tips for managing

If you notice any of the following symptoms while taking Lamictal, it’s vital to talk with your medical professional immediately. These could be symptoms of a life threatening side effect:

If you have a serious skin reaction while taking Lamictal, they’ll typically have you stop taking the drug and suggest other treatments for your condition.

Weight gain or weight loss

Weight gain or weight loss is possible while taking Lamictal. Both were reported as side effects by people taking the drug in clinical studies. Weight loss was slightly more common than weight gain, but both side effects were rare.

Tips for managing

If you’re concerned about your weight while taking Lamictal, we recommend that you talk with your medical professional. They can suggest ways for you to manage your weight.

Hair loss

It’s possible that you’ll experience hair loss from taking Lamictal. But this side effect wasn’t commonly reported in clinical studies.

Tips for managing

If you have concerns about hair loss during your Lamictal treatment, you can talk with your medical professional. They may suggest a treatment for this side effect. Or they may recommend a treatment other than Lamictal for your condition.

Allergic reaction

Many drugs, including Lamictal, can cause an allergic reaction.

Symptoms that can occur with a mild allergic reaction may include:

  • itchiness
  • skin rash
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction may also occur, but this is rare. Symptoms of a severe allergic reaction may include swelling of your mouth, tongue, or throat, which may cause trouble breathing. You may also experience swelling under your skin, often in your lips, eyelids, hands, or feet.

Rarely, an allergy to Lamictal can result in a serious skin rash* called multiorgan hypersensitivity. This is also known as drug reaction with eosinophilia and systemic symptoms (DRESS). The reaction can be life threatening, so a medical professional should examine you right away.

* Lamictal has a boxed warning about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks. To learn more, see “Boxed warning: Serious skin rashes” above.” section above.

Tips for managing

If you have symptoms of an allergic reaction to Lamictal, it’s important to call your medical professional immediately. If you feel as if you’re having a medical emergency, it’s vital to call 911 or your local emergency number right away.

If you’re concerned about DRESS while taking Lamictal, we recommend that you talk with your medical professional.

A rash is a common side effect of Lamictal. The rash is mild in most cases, but in rare instances, it can be life threatening.

In fact, Lamictal has a boxed warning about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks. A boxed warning is the most serious warning the Food and Drug Administration (FDA) can give a drug.

Rare but life threatening skin rashes have been reported in people taking Lamictal. These reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

For more information, see “Side effects: A closer look” in the “Does Lamictal have side effects?” section above.

Find answers to some commonly asked questions about Lamictal.

Can Lamictal be prescribed for depression or anxiety?

Lamictal isn’t approved to treat depression or anxiety. But the medication may be prescribed off-label for this purpose. (Off-label use is when a drug is prescribed to treat a condition that it isn’t approved for.)

Lamictal may also be used off-label to treat borderline personality disorder (BPD).

If you have questions about off-label uses of Lamictal, we suggest that you talk with your medical professional.

Is Lamictal a mood stabilizer?

Yes, Lamictal is considered to be a mood stabilizer when used to treat bipolar I disorder. (Lamictal isn’t an antipsychotic or a controlled substance.)

A mood stabilizer is a type of drug used in bipolar disorder to help prevent mood episodes. These episodes can include manic, depressive, and mixed episodes.

Lamictal belongs to a group of medications called antiepileptic drugs.

Like Lamictal, antipsychotics such as aripiprazole (Abilify) and other mood stabilizers may be used to treat bipolar disorder.

Your medical professional can advise you on whether Lamictal or a different medication is right for your condition.

How does Lamictal make you feel?

Like all drugs, Lamictal affects each person differently when they take it.

For example, Lamictal typically doesn’t give you energy. In fact, you may have fatigue (lack of energy) as a side effect. You may also have problems coordinating body movements. Rarer side effects that could affect how you feel include memory problems and suicidal thoughts or behaviors.

Before you start taking Lamictal, we encourage you to talk with your medical professional. You can ask them what you may feel when you begin the treatment. They can provide answers to questions or concerns you may have about taking the drug.

How does Lamictal work? And what’s its half-life?

How Lamictal works isn’t fully understood. The drug’s half-life is about 25 hours.

It’s thought that Lamictal works by stabilizing levels of certain compounds called amino acids. This affects how some messages are sent in your brain. When used to treat bipolar I disorder, the drug reduces the number of mood episodes. And when used to treat seizures, the drug decreases the number of seizures.

A drug’s half-life describes how long it takes your body to get rid of half a dose. With a half-life of about 25 hours, Lamictal takes about 100 to 125 hours to leave your system. That’s about 4 to 5 days.

Your medical professional can help answer other questions about how Lamictal works or how long it stays in your body.

What happens if you take Lamictal and don’t have bipolar I disorder?

In addition to treating bipolar I disorder, Lamictal is also prescribed to treat certain types of epilepsy and seizures. So the drug can be used in people with conditions besides bipolar I disorder.

If you take Lamictal and don’t have bipolar I disorder or certain kinds of epilepsy or seizures, you’re still at risk of side effects from the drug. These are detailed in the “Does Lamictal have side effects?” section above.

It’s not advised to take Lamictal unless your medical professional has prescribed the drug for you.

How does Lamictal compare with lithium?

Lamictal and lithium are both mood stabilizers used to treat bipolar I disorder. Both drugs can cause side effects, including some serious and long-term side effects. Your medical professional may decide to check the level of Lamictal in your body. But checking the drug level is more common with lithium treatment.

If you have other questions about how Lamictal compares with lithium, we suggest that you talk with your medical professional.

Your medical professional can advise you on how much Lamictal to take and how often. It’s important to follow the instructions that they provide. Commonly prescribed dosages are mentioned below, but be sure to always take the dosage your medical professional recommends.

Forms and strengths

Lamictal is available in the following forms and strengths:

  • Immediate-release tablets. You swallow these tablets, which are available in these strengths: 25 milligrams (mg), 100 mg, 150 mg, and 200 mg.
  • Disintegrating tablets. These tablets dissolve in your mouth. They’re available in these strengths: 25 mg, 50 mg, 100 mg, and 200 mg.
  • Tablets for making a suspension.* These are tablets that you can swallow, chew, or dissolve in liquid and drink. They’re available in these strengths: 2 mg, 5 mg, and 25 mg.

* A suspension is a liquid with particles in it.

Dosage for bipolar disorder

The following table details Lamictal dosages for bipolar I disorder in adults. (“Mg” refers to milligrams.)

Your medical professional will start you with a low dosage, then increase it over time. This is to lower your risk of a serious skin rash* from Lamictal.

Your dosage also depends on other drugs you’re taking for bipolar disorder.

  • Dosage A: If you take Lamictal with valproate* (Depakote).
  • Dosage B: If you take Lamictal but not carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, primidone (Mysoline), or valproate.
  • Dosage C: If you take Lamictal with carbamazepine, phenytoin, phenobarbital, or primidone, but not valproate.
Week of therapyDosage ADosage BDosage C
1 and 225 mg every other day25 mg once per day50 mg once per day
3 and 425 mg once per day50 mg once per day100 mg daily, in divided doses
550 mg once per day100 mg once per day200 mg daily, in divided doses
6100 mg once per day200 mg once per day300 mg daily, in divided doses
7100 mg once per day200 mg once per dayup to 400 mg daily, in divided doses

* Lamictal has a boxed warning about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks. To learn more, see “Side effects: A closer look” in the “Does Lamictal have side effects?” section above.

Dosage for epilepsy when taken with other medications

Lamictal is used to treat epilepsy in adults as well as some children who have:

Dosage for adults, as well as children ages 12 and older

For this purpose, the table below details Lamictal dosages for adults, as well as children ages 12 years and older.

Your medical professional will start you on a low dosage, then increase it over time. This is to lower your risk of a serious skin rash* from Lamictal.

Your dosage also depends on other drugs you’re taking for bipolar disorder.

  • Dosage A: If you take Lamictal with valproate* (Depakote).
  • Dosage B: If you take Lamictal but not carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, primidone (Mysoline), or valproate.
  • Dosage C: If you take Lamictal with carbamazepine, phenytoin, phenobarbital, or primidone, but not valproate.
Week of therapyDosage ADosage BDosage C
1 and 225 mg every other day25 mg once per day50 mg once per day
3 and 425 mg once per day50 mg once per day50 mg twice per day
5 and onwardIncrease dosage by 25 mg to 50 mg as needed every 1 to 2 weeksIncrease dosage by 50 mg as needed every 1 to 2 weeksIncrease daily dosage by 100 mg as needed every 1 to 2 weeks
Usual maintenance dosage100 mg to 200 mg per day, in one or two doses225 mg to 375 mg per day, divided into two doses300 mg to 500 mg per day, divided into two doses

* Lamictal has a boxed warning about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks. To learn more, see “Side effects: A closer look” in the “Does Lamictal have side effects?” section above.

Dosage for children ages 2 to 12

For treating the kinds of epilepsy mentioned above in children ages 2 to 12, Lamictal is dosed based on weight. Your child’s medical professional can provide more information.

Dosage for epilepsy when taken alone

Lamictal is prescribed alone for epilepsy in adults, as well as children ages 16 and older who have partial-onset seizures.

For this purpose, the Lamictal dosage you’ll likely take when first starting the treatment depends on the epilepsy drug you previously took. Your medical professional can give you more information.

The recommended dosage of Lamictal for this use is 250 mg twice per day.

Maximum dosage

The maximum dosage of Lamictal is 500 mg per day, in divided doses. This is for all the conditions that the drug is used to treat.

Some important things to discuss with your medical professional when considering treatment with Lamictal include your overall health and any medical conditions you may have.

It’s recommended that you tell your medical professional about any medications you may take.

Interactions

Taking a medication with certain drugs, foods, vaccines, and other substances may affect how that medication works. These effects are known as interactions.

Before you take Lamictal, be sure to tell your medical professional about any other drugs you take. This includes prescription and over-the-counter medications. It’s also important to mention any herbs, supplements, and vitamins you may take. They can tell you about possible interactions that these substances may have with Lamictal.

Interactions with drugs or supplements

Lamictal can interact with several types of drugs, including:

  • birth control pills that contain ethinyl estradiol and levonorgestrel, such as Altavera and Seasonique
  • the following epilepsy drugs, which may affect the level of Lamictal in your body:
    • carbamazepine (Tegretol)
    • phenobarbital
    • primidone (Mysoline)
    • valproate
    • valproic acid
  • the antiretrovirals lopinavir, atazanavir, and ritonavir (Norvir)
  • the antibiotic rifampin (Rifadin)

We haven’t listed all the types of drugs that may interact with Lamictal. Your medical professional or pharmacist can provide more details, as well as information about other possible interactions.

Note: Lamictal isn’t known to interact with bupropion (Wellbutrin).

Other interactions

Lamictal may cause false positives in urine drug tests. The presence of phencyclidine (PCP) is the most common false positive in people taking Lamictal, according to the drug’s manufacturer.

If you need to have a urine drug test while taking Lamictal, it’s advised that you talk with your medical professional. They can write a note explaining that you’re taking Lamictal and that the drug can cause false positives on a drug test.

FDA boxed warning

Lamictal has a boxed warning from the Food and Drug Administration (FDA) about serious skin rashes. The boxed warning appears on the drug’s label and alerts you to possible serious risks.

For details, see “Side effects: A closer look” in the “Does Lamictal have side effects?” section above.

Other warnings

If you have certain medical conditions or other factors that affect your health, Lamictal may not be the right choice for you. Before you take Lamictal, it’s important to discuss your health history with your medical professional. The list below includes some factors to consider.

Depression, mood problems, or suicidal thoughts or behaviors. Taking Lamictal can affect your mood and cause side effects such as depression, mood problems, and suicidal thoughts and behaviors. Your risk may be increased if any of these currently affect you. Your medical professional can help determine if Lamictal is safe for you to take.

Heart problems. If you have a heart problem, such as heart failure, Lamictal may cause you to have heart problems that include heart rhythm changes. Your medical professional can help determine if Lamictal is right for you.

Allergic reaction. If you’ve had an allergic reaction to Lamictal or any of its ingredients, it’s advised that you do not take Lamictal. You can ask your medical professional what other treatments might be better choices for you.

It’s also recommended that you do not take Lamictal if you’ve had an allergic reaction, including a rash, to a different epilepsy drug. You may have an increased risk of this same reaction with Lamictal.

Lamictal and alcohol

Drinking alcohol with Lamictal may increase your risk of some side effects. These include nausea, sleep problems, dizziness, and coordination problems.

If you drink alcohol, it’s recommended that you talk with your medical professional before you start taking Lamictal. They can advise you on how much is safe for you to consume.

Lamictal use while pregnant or breastfeeding

Here’s some information about Lamictal, pregnancy, and breastfeeding.

Lamictal may harm the fetus if taken during pregnancy, according to animal studies. But animal studies don’t always predict how a drug will affect people. If you plan to become pregnant or do become pregnant while taking Lamictal, it’s recommended that you talk with your medical professional. They can review your treatment plan.

You can also consider joining the North American Antiepileptic Drug Pregnancy Registry. This registry collects information about the safety of epilepsy drugs during pregnancy. To learn more, we suggest that you visit the registry site or call 888-233-2334.

Lamictal passes into breast milk and can cause side effects in breastfed children. These side effects can include a rash and drowsiness. If you’re breastfeeding or plan to, it’s important to talk with your medical professional. They can review your treatment plan and advise you on healthy ways to feed your child.

If you have bipolar disorder, epilepsy, or seizures, your medical professional may recommend a prescription drug called Lamictal.

Lamictal is used to treat the following in certain situations:

  • bipolar I disorder in adults
  • some kinds of epilepsy in adults, as well as children ages 2 and older
  • partial-onset seizures in adults, as well as children ages 16 years and older who are switching to Lamictal alone from a different treatment

Lamictal for bipolar disorder

Lamictal is used to treat bipolar I disorder in adults.

With bipolar I disorder, you experience extreme mood shifts. You may have periods of mania (high energy), depression (low energy), or mixed episodes (mania and depression). Each person’s experience of bipolar disorder is unique.

Lamictal is prescribed to help increase the time without having either a high or low mood episode. The drug should be taken with other medications for bipolar I disorder.

Lamictal shouldn’t be taken to treat a sudden manic or mixed episode.

Lamictal taken alone for epilepsy

Lamictal is used alone to treat epilepsy in certain people who have partial-onset seizures. The drug is for use in adults, as well as children ages 16 years and older.

For this purpose, Lamictal is prescribed while you’re still taking another epilepsy drug but plan to stop the treatment with the other drug. Your medical professional will slowly decrease the other drug’s dosage while slowly increasing your Lamictal dosage. These other epilepsy drugs include:

  • carbamazepine (Tegretol)
  • phenytoin (Dilantin)
  • phenobarbital
  • primidone (Mysoline)
  • valproate

With epilepsy, you experience recurring seizures. A seizure happens when your brain has a sudden rush of electrical activity.

Lamictal taken with other treatments for epilepsy

Lamictal is also prescribed with other treatments for epilepsy in adults, as well as children ages 2 and older.

When taken with other treatments for epilepsy, Lamictal may be used to treat:

How Lamictal works

It’s not understood how Lamictal works. It’s thought that the drug stabilizes levels of certain compounds called amino acids. This affects how some messages are sent in your brain.

Yes, stopping Lamictal treatment can cause withdrawal.

Withdrawal symptoms

If you suddenly stop taking Lamictal, you may have withdrawal seizures. These occur when you stop taking an epilepsy medication.

Because of the risk of withdrawal seizures, you shouldn’t suddenly stop taking Lamictal. Instead, your medical professional will typically taper your dosage. This is when they decrease your dosage slowly over time.

It’s important to not stop taking Lamictal unless you speak with them first.

Yes, it’s possible to overdose on Lamictal. It’s important that you don’t take more Lamictal than your medical professional recommends. Taking more than the recommended dosage can lead to severe side effects.

Symptoms of overdose

Symptoms caused by an overdose can include:

What to do in case you take too much Lamictal

If you believe you’ve taken too much Lamictal, call your medical professional right away. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. But if your symptoms are severe, immediately call 911 (or your local emergency number) or go to the closest emergency room.

Your medical professional can help explain how to take Lamictal. It’s important to follow the instructions they provide. Be sure to follow your medical professional’s instructions. Below are common dosages, but it’s recommended that you always take the dosage they prescribe.

Tips for taking Lamictal

Lamictal is available in the following forms:

  • Immediate-release tablets. These are tablets that you swallow whole. Your medical professional may be able to recommend a different form of Lamictal if you have trouble swallowing the tablets.
  • Disintegrating tablets. You place these tablets on your tongue and move them around your mouth. They’ll dissolve and release the medication. You shouldn’t chew or split this form of Lamictal.
  • Tablets for making a suspension.* You can swallow these tablets whole or chew them. You can also mix them with water or fruit juice plus water. The tablets will dissolve after about 1 minute. Then it’s advised that you mix the liquid and drink it immediately.

* A suspension is a liquid with particles in it.

Taking Lamictal with other drugs

Depending on the condition you’re taking Lamictal to treat, your medical professional may prescribe it alone or with other medications.

For more information about Lamictal’s use with other drugs, you can see the “What do you take Lamictal for?” section above.

Frequently asked questions about taking Lamictal

Below are answers to frequently asked questions about taking Lamictal.

  • How long does Lamictal take to work? Lamictal begins working as soon as you take a dose. But it may take a few weeks before you notice its effects on your condition.
  • Are there any symptoms of missing a dose of Lamictal? It depends on the condition you’re taking Lamictal to treat. If you take the drug to treat a type of epilepsy, missing Lamictal doses could increase your risk of a seizure.
  • What should I do if I miss a dose of Lamictal? If you miss a dose of Lamictal, it’s advised that you take it as soon as you remember. But if it’s almost time for your next dose, it’s recommended that you skip the missed dose. You can take your next dose at the scheduled time. It’s important to not take two doses at the same time because this can increase your risk of side effects from Lamictal. (To learn more, you can see the “Does Lamictal have side effects?” section above.)
  • Is Lamictal meant for long-term use? If you and your medical professional agree Lamictal is working to treat your condition, you’ll likely take it long term.
  • Should you take Lamictal with food? You may take Lamictal with or without food.
What should you ask your medical professional?

It’s common to have questions about your treatment plan for Lamictal. Your medical professional is there to work with you and help address any concerns you have.

To help guide your discussion, here are some suggestions:

  • You can write down questions you have before your visit. For example, “How will taking Lamictal affect my mood, body, and lifestyle?”
  • You can ask a loved one or friend to come with you to your appointment. Having in-person support may help you feel more at ease.
  • You can ask your medical professional to explain anything that you find unclear.

Working with your healthcare team may help you stay on track with your treatment. If you find that you’re not getting answers to your questions or receiving the care you deserve, you can consider seeking a second opinion.

Lamictal is a prescription drug. The costs of prescription medications may depend on several factors, such as your insurance coverage and the pharmacy you use. To find current prices of Lamictal tablets near you, visit GoodRx.com.

If you’re wondering how to pay for Lamictal, check out the Medicine Assistance Tool website.

If you still have questions about Lamictal after reading this article, we recommend that you talk with your medical professional. Together you can decide if Lamictal might be a good choice for you.

You can also discuss other treatments, forms of support, and resources that may benefit you. We’ve listed some helpful suggestions below.

Additional treatment options

While you take Lamictal, additional treatments or remedies may help you better manage your condition. These can include:

Finding support

Whether you’re looking for a therapist, support group, or information about how to afford therapy, these resources may help:

Other resources

To receive weekly information about mental health, you may want to sign up for the Psych Central newsletter. You’ll find stories directly from other people about their mental health journeys, as well as the latest information about treatments.

Disclaimer: Psych Central has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.