LAMICTAL XR STARTER (BLUE) (lamotrigine)

There are 0 contraindications.

There are 11 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Child-pugh class B hepatic impairment
Child-pugh class C hepatic impairment
Chronic heart failure
Complete atrioventricular block
Disease of liver
HLa-B *15:02 positive
Myocardial ischemia
Non-infective meningitis
Second degree atrioventricular heart block
Structural disorder of heart
Suicidal ideation

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Aplastic anemia
Brugada syndrome
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Depression
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Neutropenic disorder
Thrombocytopenic disorder

There are 60 severe adverse reactions.

More Frequent	Less Frequent
Fever Skin rash	Accidental injury Altered mental status Hemorrhage Irritability

Rare/Very Rare

Abnormal hepatic function tests Acute eruptions of skin Acute renal failure Agranulocytosis Alcohol intolerance Anemia Angioedema Aplastic anemia Apnea Blood dyscrasias DRESS syndrome Dyskinesia Eosinophilia Epididymitis Erythema multiforme Esophagitis Exfoliative dermatitis Gastrointestinal hemorrhage Hearing loss Hemolytic anemia Hemophagocytic lymphohistiocytosis Hemorrhagic colitis Hyperbilirubinemia Hypersensitivity drug reaction Hypertension Hypogammaglobulinemia Immunosuppression Increased alanine transaminase Increased aspartate transaminase Interstitial nephritis Intraventricular conduction delay Leukopenia Lupus-like syndrome Multiple organ failure Neoplasm of breast Neutropenic disorder Non-infective meningitis Orthostatic hypotension Pancreatitis Pancytopenia Petechiae Pure red cell aplasia Rhabdomyolysis ST segment changes Status epilepticus Stevens-johnson syndrome Suicidal Suicidal ideation Thrombocytopenic disorder Tongue swelling Toxic epidermal necrolysis Uveitis Vasculitis Ventricular arrhythmias

There are 107 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Ataxia Back pain Blurred vision Chest pain Diplopia Dizziness Drowsy Fatigue Headache disorder Infection Insomnia Nausea Pharyngitis Rhinitis Tremor Vomiting Xerostomia	Acute cognitive impairment Anorexia Arthralgia Constipation Depression Diarrhea Dysmenorrhea Dyspepsia Mood changes Neck pain Nystagmus Pain Symptoms of anxiety Vaginitis Visual changes Weight loss

Rare/Very Rare

Accidental fall Acne vulgaris Aggressive behavior Alopecia Aphthous stomatitis Arthritis Blepharoptosis Bloody vomit Bullous dermatitis Bursitis Chills Cramps in legs Cystitis Drug-induced hot flash Dry eye Dysarthria Dyschromia Dysgeusia Dysphagia Dysuria Earache Ecchymosis Eructation Erythema Flushing Galactorrhea not associated with childbirth Gastritis General weakness Gingival hyperplasia Gingivitis Glossitis Goiter Hallucinations Herpes zoster Hiccups Hirsutism Hostility Hyperglycemia Hyperkinesis Hyperventilation Hypothyroidism Increased appetite Loss of taste Lymphadenopathy Maculopapular rash Malaise Memory impairment Motor tic disorder Muscle atrophy Muscle fasciculation Muscle weakness Nocturia Orgasm disorder Palpitations Panic disorder Paresthesia Parosmia Photophobia Pruritus of skin Sinusitis Skin hypopigmentation Skin photosensitivity Sleep disorder Stomatitis Syncope Tachycardia Tinnitus Toxic amblyopia Urinary retention Urinary urgency Urticaria Vasodilation of blood vessels Yawning

There are no adequate and well-controlled studies of lamotrigine in pregnant women. Women who are pregnant while receiving lamotrigine should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 or http://www.aedpregnancyregistry.org/.

Data from several prospective pregnancy exposure registries and epidemiological studies of pregnant women have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population. The majority of lamotrigine pregnancy exposure data are from women with epilepsy. In animal reproduction studies, lamotrigine produced developmental toxicity (e.g., increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities) when administered to pregnant animals at doses lower than those used clinically.

Lamotrigine decreased fetal folate concentrations in rats, an effect known to be associated with adverse pregnancy outcomes in animals and humans. Although preliminary information from the NAAED Pregnancy Registry suggested a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and an increased incidence of cleft lip or cleft palate in infants, this finding has not be observed in other international registries. The effect of lamotrigine on labor and delivery in humans is unknown.

Physiologic changes during pregnancy may affect plasma lamotrigine concentrations and/or therapeutic effect. Decreased lamotrigine concentrations during pregnancy and restoration of prepartum concentrations after delivery have been reported. Dosage adjustment of lamotrigine may be necessary to maintain clinical response.

Lamotrigine is distributed into human milk. There is some evidence that lamotrigine plasma concentrations in breast-fed infants may be as high as 50% of maternal serum levels. Exposure to lamotrigine in these infants may be further increased due to the immaturity of the infant glucuronidation process required for drug clearance.

Apnea, drowsiness, and poor sucking have been reported in nursing infants whose mothers were receiving lamotrigine, although it is not known whether these effects were caused by lamotrigine. It is not known whether lamotrigine can affect milk production. The known benefits of breast-feeding should be considered along with the mother's clinical need for lamotrigine and any potential adverse effects on the breast-fed infant from the drug or underlying condition.

No enhanced Geriatric Use information available for this drug.