CARBATROL (carbamazepine)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Hepatic porphyria

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bone marrow depression
HLa-A *31:01 positive
HLa-B *15:02 positive
Pregnancy
Suicidal ideation

There are 14 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic heart failure
Complete atrioventricular block
Coronary artery disease
Depression
Disease of liver
Glaucoma
Hypercholesterolemia
Hypertension
Hyponatremia
Kidney disease with reduction in glomerular filtration rate (GFr)
Mood changes
Ocular hypertension
SIADH syndrome
Urinary retention

There are 58 severe adverse reactions.

More Frequent	Less Frequent
Ataxia Blurred vision Diplopia Nystagmus	Behavioral disorders Hyponatremia Lupus-like syndrome SIADH syndrome Stevens-johnson syndrome Toxic epidermal necrolysis

Rare/Very Rare

Abnormal hepatic function tests Accidental fall Acute generalized exanthematous pustulosis Acute intermittent porphyria Agranulocytosis Anaphylaxis Anemia Angioedema Aplastic anemia Atrioventricular block Bone marrow depression Cardiac arrhythmia Cholestasis Chronic heart failure Depression DRESS syndrome Edema Eosinophilia Erythema multiforme Exfoliative dermatitis Hepatic failure Hepatitis Hypersensitivity pneumonitis Hypertension Hypocalcemia Hypogammaglobulinemia Hypotension Kidney disease with reduction in glomerular filtration rate (GFr) Leukocytosis Leukopenia Lymphadenopathy Nephritis Neuroleptic malignant syndrome Non-infective meningitis Obstructive hyperbilirubinemia Osteopenia Pancreatitis Pancytopenia Peripheral neuropathy Porphyria Renal failure Suicidal Suicidal ideation Syncope Thrombocytopenic disorder Thromboembolic disorder Thrombophlebitis Urticaria

There are 45 less severe adverse reactions.

More Frequent	Less Frequent
Acute cognitive impairment Dizziness Drowsy Nausea Unsteady gait Vomiting	Constipation Paresthesia Pruritus of skin Vertigo

Rare/Very Rare

Acute abdominal pain Alopecia Anorexia Anticholinergic toxicity Arthralgia Cataracts Conjunctivitis Cramps in legs Diarrhea Dysarthria Dyschromia Erectile dysfunction Fatigue Fever Gastrointestinal irritation General weakness Glossitis Headache disorder Hirsutism Hyperacusis Hypercholesterolemia Hyperhidrosis Increased urinary frequency Maculopapular rash Muscle fasciculation Myalgia Nail disorders Ocular hypertension Purpura Skin photosensitivity Skin rash Stomatitis Tinnitus Urinary retention Xerostomia

Safe use of carbamazepine during pregnancy has not been established. Adverse fetal effects have been observed in reproduction studies in rats. Although several reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women, a causal relationship to many of these drugs has not been established.

However, epidemiologic data suggest that an association between carbamazepine use during pregnancy and certain congenital abnormalities such as spina bifida may exist. Other congenital anomalies and developmental disorders (e.g., craniofacial defects, cardiovascular malformations, anomalies involving various body systems) also have been reported in association with carbamazepine use. Anticonvulsants should not be discontinued in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.

In individual cases, when the severity and frequency of the seizure disorder are such that discontinuance of therapy does not pose a serious threat to the patient, discontinuance of the drugs may be considered prior to and during pregnancy; however, it cannot be said with any certainty that even minor seizures do not pose some hazard to the fetus. Clinicians should carefully weigh these considerations in treating or counseling epileptic women of childbearing potential. Because carbamazepine can cause fetal harm when administered to pregnant women, the benefits of therapy must be weighed against the risks in women of childbearing potential.

If carbamazepine is used during pregnancy, or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential hazard to the fetus. Tests to detect fetal abnormalities using currently accepted procedures should be considered part of routine prenatal care in women of childbearing potential receiving carbamazepine. There have been a few cases of seizures and/or respiratory depression in neonates born to women receiving carbamazepine concomitantly with other anticonvulsant agents.

A few cases of vomiting, diarrhea, and/or decreased feeding also have been reported in neonates born to women receiving carbamazepine; these symptoms may represent a neonatal withdrawal syndrome. Women who are pregnant while receiving carbamazepine should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 888-233-2334. Information on the registry also can be found on the website https://www.aedpregnancyregistry.org.

Carbamazepine and its epoxide metabolite (carbamazepine 10,11-epoxide (CBZ-E)) are distributed into milk. Safe use of carbamazepine during lactation has not been established. Because of the potential for serious adverse reactions from carbamazepine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Following daily oral administration of carbamazepine in nursing women, the milk-to-maternal plasma ratio of carbamazepine is about 0.4 and that of CBZ-E is about 0.5; it is estimated that neonates may receive about 2-5 and 1-2 mg of carbamazepine and CBZ-E, respectively, daily.

No enhanced Geriatric Use information available for this drug.