Lamotren tablets

Lamotren

  • Active Ingredient: Lamotrigine
  • 200 mg, 100 mg, 50 mg, 25 mg
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What is Lamotren?

The active ingredient of Lamotren brand is lamotrigine. Lamotrigine is an anti-epileptic medication, also called an anticonvulsant. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of Lamotrigine and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. In addition, the 200 mg tablets contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Meets USP Dissolution Test 3.

Used for

Lamotren is used to treat diseases such as: Anxiety, Bipolar Disorder, Borderline Personality Disorder, Cyclothymic Disorder, Depression, Epilepsy, Migraine Prevention, Post Traumatic Stress Disorder, Restless Legs Syndrome, Schizoaffective Disorder, Seizure Prevention.

Side Effect

Possible side effects of Lamotren include: Clumsiness or unsteadiness (severe); Diarrhea; general body swelling; menstrual pain; swelling of the face, mouth, hands, or feet; increase in seizures; nosebleeds; loss of balance control.

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Before taking this medicine

You should not take Lamotren if you are allergic to it.

Lamotren may cause a severe or life-threatening skin rash, especially in children and in people who take a very high starting dose, or those who also take valproic acid (Depakene) or divalproex (Depakote).

Tell your doctor if you have ever had:

a rash or allergic reaction after taking another seizure medication;

depression, suicidal thoughts or actions; or

meningitis (inflammation of the tissue that covers the brain and spinal cord) after taking Lamotren.

Some people have thoughts about suicide while taking Lamotren. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Lamotren on the baby.

Birth control pills can make Lamotren less effective, resulting in increased seizures. Tell your doctor if you start or stop using birth control pills. Your Lamotren dose may need to be changed.

It may not be safe to breastfeed while using Lamotren. Ask your doctor about any risk.

How does Lamotren work?

Lamotren delays the time between mood changes and manic or depressive states in people with bipolar disorder by decreasing the intensity of irregular electrical activity in the brain. People with bipolar disorder are at high risk of experiencing recurrent and relapsing episodes of mood change. Maintenance treatment with Lamotren helps reduce the risk by preventing or delaying these recurrences and relapses.

“Many clinicians think that Lamotren helps achieve and sustain even moods over time by virtue of its antidepressant properties, rather than anti-manic (mood-stabilizing) properties,” says Dr. Goldberg. “It works with mood stabilizers like lithium and Divalproex, but it’s not interchangeable with these drugs and cannot be used in their place.”

Lamotren is used over time as a preventative medication. Clinical trials that looked at Lamotren’s potential for treating acute (in-the-moment) episodes of mania found no difference between the medication and placebo. 2

1. About Lamotren

Lamotren is a medicine used to treat epilepsy.

It can also help prevent low mood (depression) in adults with bipolar disorder.

Lamotren is available on prescription. It comes as tablets that you can either chew or dissolve in water to make a drink.

For the Consumer

Applies to Lamotren: oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Michael Stewart, Reviewed by Sid Dajani | Last edited 21 Dec 2017 | Certified by The Information Standard

Lamotren is prescribed to treat two different conditions - epilepsy and bipolar disorder.

Take your doses regularly. Do not stop taking Lamotren unless your doctor tells you to.

You can take your doses either before or after food.

Getting the most from your treatment

  • When you first start a new treatment for epilepsy there may be a change in the number or type of seizures you experience. Your doctor will advise you about this.
  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
  • Different formulations and makes of Lamotren can act in a slightly different way in your body. Because of this, your doctor may recommend that you continue to take Lamotren from the same manufacturer each time you obtain a new supply. If so, each time you collect a prescription, check to make sure your supply looks the same and that the name is the same. If you are unsure, or if you have any questions about your prescription, please ask your pharmacist to advise you.
  • If you buy any medicines, check with a pharmacist that they are suitable for you to take.
  • While you are being treated for epilepsy there is a small risk that you may develop mood changes, distressing thoughts and feelings about suicide. If this happens, you must tell your doctor about it straightaway.
  • People with epilepsy must stop driving at first. Your doctor will advise you about when it may be possible for you to start driving again. This will usually be after a year free of seizures.
  • Antiepileptic medicines can harm an unborn child. If you are a woman, make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. If you want to have a family, discuss this with your doctor so that you can be given advice from a specialist before you become pregnant.
  • You need to take Lamotren regularly every day. Do not stop taking it unless your doctor tells you to stop. Stopping treatment suddenly can cause problems and your doctor will probably want you to reduce your dose gradually if this becomes necessary.
  • If you drink alcohol, ask your doctor for advice. Your doctor may advise you not to drink alcohol while you are on this medicine.

DESCRIPTION

LAMICTAL (Lamotren), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotren's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotren is a white to pale cream-colored powder and has a pKa of 5.7. Lamotren is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:

LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of Lamotren and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only).

LAMICTAL chewable dispersible tablets are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of Lamotren and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The chewable dispersible tablets meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotren Tablets for Oral Suspension.

LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of Lamotren and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose.

LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps® and AdvaTab®) designed to mask the bitter taste of Lamotren and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108 healthy volunteers.

In Summary

Commonly reported side effects of Lamotren include: ataxia, skin rash, headache, insomnia, and nausea. Other side effects include: infection, dyspepsia, abnormal gait, constipation, and drowsiness. See below for a comprehensive list of adverse effects.

Before taking Lamotren

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Lamotren it is important that your doctor knows:

  • If you are pregnant, trying for a baby or breastfeeding.
  • If you have any problems with the way your k >

Important Information

Lamotren may cause a severe or life-threatening skin rash, especially in children and in people who take a very high starting dose, or those who also take valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a skin rash, hives, blistering, peeling, or sores in your mouth or around your eyes.

Call your doctor at once if you have signs of other serious side effects, including: fever, swollen glands, severe muscle pain, bruising or unusual bleeding, yellowing of your skin or eyes, headache, neck stiffness, vomiting, confusion, or increased sensitivity to light.

Some people have thoughts about suicide while taking Lamotren. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

For Healthcare Professionals

Applies to Lamotren: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release

Lamotren Side Effects

Some people who take Lamotren may experience adverse reactions or side effects. In approximately 8 in 10,000 people, Lamotren can cause severe, life-threatening rashes and other skin disorders, typically between the second and eighth weeks of treatment. The risk of rash increases with higher starting doses, higher escalating doses and use of Lamotren in combination with valproate. Early clinical trials and follow-up research showed that the overall incidence of any skin disorders was 11 to 12% in both bipolar I and bipolar II patients treated with Lamotren. 2

“Most of these skin issues are benign,” Dr. Goldberg emphasizes. “Serious rashes from Lamotren are not due to an allergy, but rather, a systemic reaction that also usually includes fever, sore throat, swollen glands, and other physical symptoms.”

But as with any medication, Dr. Goldberg adds, allergic reactions to Lamotren can occur. Get immediate emergency help if you show any signs of an allergic reaction, such as hives, facial or throat swelling, or difficulty breathing. Notify your doctor if you develop a skin rash, especially if it occurs within your mouth or on soft body tissue such as eyelids or around nasal openings, and if it is blistering, peeling, painful, burning, or involves a fever or sore throat. Be sure to report all medications you are taking to medical staff.

Serious side effects that should be reported immediately to your doctor include:

  • Any skin rash, blistering or peeling of skin
  • Painful (burning) sores in or around the mouth, eyes or genitals
  • Jaundice (yellowish skin or eyes)
  • Swollen gland, fever, severe muscle pain
  • Weakness, drowsiness, confusion
  • Stiff neck, headache
  • Increased sensitivity to light
  • Mood or behavior changes, such as depression, anxiety, agitation, hostility, restlessness, mental or physical hyperactivity, suicidal thoughts

Common side effects of Lamotren that are not emergencies but should also be reported to your doctor include:

  • Headache or dizziness
  • Blurred or double vision
  • Dry mouth
  • Gastrointestinal distress such as nausea, vomiting, diarrhea or stomach pain
  • Fever, sore throat, runny nose
  • Drowsiness or fatigue
  • Tremor
  • Insomnia

3. Who can and can't take Lamotren

Lamotren can be taken by adults, and by children aged 2 years and over.

Lamotren is not suitable for some people.

To make sure Lamotren is safe for you, tell your doctor if you:

  • have ever had an allergic reaction to Lamotren or other medicines in the past
  • have liver or kidney problems
  • have bipolar disorder and have ever had thoughts of harming or killing yourself
  • have ever had meningitis or a rash caused by Lamotren
  • are pregnant or trying to get pregnant
  • have an intolerance to or cannot digest lactose (lactose intolerance) - some brands of Lamotren contain lactose


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