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Lamotrigine is an anti-epileptic medication, also called an anticonvulsant.
Lamotrigine is used alone or with other medications to treat epileptic seizures in adults and children. Lamotrigine is also used to delay mood episodes in adults with bipolar disorder (manic depression).
Immediate-release lamotrigine can be used in children as young as 2 years old when it is given as part of a combination of seizure medications. However, this form should not be used as a single medication in a child or teenager who is younger than 16 years old.
Extended-release lamotrigine is for use only in adults and children who are at least 13 years old.
Lamotrigine may also be used for purposes not listed in this medication guide.
Lamotrigine 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 lamotrigine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
You should not take lamotrigine if you are allergic to it.
Lamotrigine 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;
kidney or liver disease;
depression, suicidal thoughts or actions; or
meningitis (inflammation of the tissue that covers the brain and spinal cord) after taking lamotrigine.
Some people have thoughts about suicide while taking lamotrigine. 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 lamotrigine on the baby.
Birth control pills can make lamotrigine less effective, resulting in increased seizures. Tell your doctor if you start or stop using birth control pills. Your lamotrigine dose may need to be changed.
It may not be safe to breastfeed while using lamotrigine. Ask your doctor about any risk.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Taking too much lamotrigine at the start of treatment may increase your risk of a severe life-threatening skin rash.
You may need frequent blood tests to help your doctor make sure you are taking the right dose.
Extended-release and immediate-release lamotrigine may be used for different conditions. Always check your refills to make sure you have received the correct size, color, and shape of tablet. Avoid medication errors by using only the form and strength your doctor prescribes.
If you switch to lamotrigine from another seizure medicine, carefully follow your doctor's instructions about the timing and dosage of your medicine.
Swallow the tablet whole and do not crush, chew, or break it.
Read and carefully follow any Instructions for Use provided with the orally disintegrating or dispersible tablets. Ask your doctor or pharmacist if you do not understand these instructions.
Do not stop using lamotrigine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.
In case of emergency, wear or carry medical identification to let others know you use seizure medication.
Lamotrigine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use lamotrigine.
Store at room temperature away from light and moisture.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include blurred vision, problems with coordination, increased seizures, feeling light-headed, or fainting.
Avoid driving or hazardous activity until you know how lamotrigine will affect you. Your reactions could be impaired.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
fever, swollen glands, weakness, severe muscle pain;
any skin rash, especially with blistering or peeling;
painful sores in your mouth or around your eyes;
headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;
jaundice (yellowing of the skin or eyes); or
pale skin, cold hands and feet, easy bruising, unusual bleeding.
Common side effects may include:
headache, dizziness;
blurred vision, double vision;
tremor, loss of coordination;
dry mouth, nausea, vomiting, stomach pain, diarrhea;
fever, sore throat, runny nose;
drowsiness, tired feeling;
back pain; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect lamotrigine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Lamotrigine (www.drugs.com/mtm/lamotrigine.html).
Commonly reported side effects of lamotrigine 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.
Applies to lamotrigine: oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release
Oral route (Tablet; Tablet, Chewable; Tablet, Disintegrating; Tablet, Extended Release)
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: (1) coadministration with valproate; (2) exceeding recommended initial dose of lamotrigine; or (3) exceeding recommended dose escalation for lamotrigine. Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related.
Along with its needed effects, lamotrigine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lamotrigine:
More common
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking lamotrigine:
Symptoms of overdose
Some side effects of lamotrigine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release
The more commonly reported adverse reactions have included dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, and rash.
Postmarketing reports: Progressive immunosuppression, Lupus-like reaction, vasculitis, drug reaction with eosinophilia and systemic symptoms (DRESS), hemophagocytic lymphohistiocytosis (HLH)
In cases of hemophagocytic lymphohistiocytosis (HLH), patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported within 8 to 24 days.
Uncommon (0.1% to 1%): Allergic reaction, chills, malaise
Very common (10% or more): Dizziness (38%), headache (29%), ataxia (22%), somnolence (14%)
Common (1% to 10%): Seizure exacerbation, incoordination, insomnia, tremor, speech disorder, amnesia, hypoesthesia, pain, gait abnormality, vertigo, dyspraxia, confusion, paresthesia
Uncommon (0.1% to 1%): Akathisia, aphasia, central nervous system depression, dysarthria, dyskinesia, hyperkinesia, hypertonia, movement disorder, myoclonus, sudden unexplained death in Epilepsy (SUDEP)
Rare (less than 0.1%): Choreoathetosis, dystonia, extrapyramidal syndrome, faintness, grand mal seizures, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, neuralgia, muscle spasm, neuralgia, paralysis, peripheral neuritis
Very rare (less than 0.01%): Muscle spasm, paralysis, peripheral neuritis
Postmarketing reports: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics
Sudden unexplained death in epilepsy (SUDEP) was reported in 20 of 4700 patients with epilepsy during premarketing development. While this exceeds the expected rate in healthy populations, it is within the range for patients with epilepsy.
Common (1% to 10%): Depression, anxiety, irritability, disturbance of concentration, emotional lability, abnormal thinking, nervousness
Uncommon (0.1% to 1%): Apathy, euphoria, hallucinations, hostility, depersonalization, memory decrease, mind racing, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation
Rare (less than 0.1%): Delirium, delusions, dysphoria, manic depression reaction, neurosis
Postmarketing reports: Aggression, nightmares
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior. Pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs (monotherapy or adjunctive therapy) showed twice the risk compared with placebo patients; an estimated incidence of 0.43% (n=27,863) in AED-treated patients compared to 0.24% (n=16,029) in placebo. The median treatment duration was 12 weeks. There were 4 suicides in AED-treated patients (placebo=0). The risk of suicidal thoughts or behavior was considered similar among the drugs studied despite their varying mechanisms of action suggesting the risk applies to all AEDs used for any indication. Additionally, the risk did not vary substantially by age.
Very common (10% or more): Diplopia (28%), blurred vision (16%)
Common (1% to 10%): Vision abnormality, nystagmus, photosensitivity, amblyopia
Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, dry eyes, photophobia
Rare (less than 0.1%): Lacrimation disorder, oscillopsia, ptosis, strabismus, uveitis, visual field defect
Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)
Common (1% to 10%): Abdominal pain, vomiting, dyspepsia, constipation, anorexia, dry mouth, rectal hemorrhage, peptic ulcer, flatulence
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, mouth ulceration
Rare (less than 0.1%): Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, melena, stomach ulcer, stomatitis, tongue edema
Very rare (less than 0.01%): Pancreatitis, esophagitis
Very common (10% or more): Rhinitis (14%)
Common (1% to 10%): Pharyngitis, increased cough, epistaxis, dyspnea, bronchitis, sinusitis, bronchospasm
Uncommon (0.1% to 1%): Yawn
Rare (less than 0.1%): Hiccup, hyperventilation
Postmarketing reports: Apnea
In adult patients (n=3348), serious rash associated with hospitalization and discontinuation was reported in 0.3% of patients in premarketing epilepsy trials. In bipolar trials, serious rash occurred in 0.08% of patients receiving this drug as initial monotherapy and 0.13% of patients receiving this drug as adjunctive therapy. In worldwide postmarketing experience, rash-related death has been reported, but the numbers are too few to permit a precise estimate of rate.
In a prospectively followed cohort of pediatric patients 2 to 17 years old, the incidence of serious rash was approximately 0.3% to 0.8%. In a prospectively followed cohort of patients 2 to 16 years old (n=1983), 1 rash-related death occurred in a patient with epilepsy taking this drug as adjunctive therapy.
Evidence has show the inclusion of valproate in a multidrug regimen increases the risk of serious, potentially life-threatening rash in both adult and pediatric patients. In pediatric patients who used valproate concomitantly for epilepsy, 1.2% (6 of 482) experienced a serious rash (placebo=0.6%). In adults, 1% of patients of patients receiving this drug in combination with valproate (n=584) experienced a rash (placebo=0.16%).
Very common (10% or more): Rash (14%)
Common (1% to 10%): Contact dermatitis, dry skin, sweating, eczema, pruritus
Uncommon (0.1% to 1%): Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria, ecchymosis, leukopenia
Rare (less than 0.1%): Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash, anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, thrombocytopenia
Common (1% to 10%): Dysmenorrhea, vaginitis, amenorrhea, libido increase, urinary tract infection (both male and female), urinary frequency
Uncommon (0.1% to 1%): Libido decreased, abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence
Rare (less than 0.1%): Anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, nocturia, urinary retention, urinary urgency
Very common (10% or more): Fever (15%), accidental injury (14%)
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Ear pain, taste perversion, tinnitus
Rare (less than 0.1%): Alcohol intolerance, deafness, taste loss, parosmia, taste loss
Common (1% to 10%): Weight decrease, weight gain, peripheral edema, facial edema
Rare (less than 0.1%): Bilirubinemia, general edema, gamma glutamyl transpeptidase increase, hyperglycemia
Common (1% to 10%): Neck pain, arthralgia, myalgia, decreased reflexes, back pain, increased reflexes, asthenia
Uncommon (0.1% to 1%): Arthritis, leg cramps, myasthenia, twitching
Rare (less than 0.1%): Bursitis, muscle atrophy, pathological fracture, tendinous contracture
Postmarketing reports: Rhabdomyolysis (among patients experiencing hypersensitivity reactions)
Common (1% to 10%): Chest pain, migraine
Uncommon (0.1% to 1%): Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation
Postmarketing reports: Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder
Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased
Rare (less than 0.1%): Hepatitis, alanine transaminase ALT) increased, acute kidney failure, kidney failure, kidney pain
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Lamotrigine (www.drugs.com/mtm/lamotrigine.html).
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