Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

[Posted 12/12/2007] FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine, http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm and http://www.fda.gov/cder/drug/infopage/carbamazepine/default.htm.

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carbamazepine
(kar ba MAZ e peen)

What is carbamazepine?
Carbamazepine is in a group of drugs called anticonvulsants. It works by decreasing nerve impulses that cause seizures and pain. Carbamazepine is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Carbamazepine is also used to treat bipolar disorder. Carbamazepine may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Carbamazepine 100MG Chewable Tablets TEVA PHARMACEUTICALS USA60/$12.99 or 120/$18.98
Carbamazepine 100MG/5ML Suspension MORTON GROVE PHARMACEUTICALS450/$28.26 or 1350/$74.39
Carbamazepine 200MG Tablets TEVA PHARMACEUTICALS USA90/$22.48 or 270/$47.2
Carbatrol 100MG 12-hour Capsules SHIRE US INC.30/$45.99 or 90/$126.08
Carbatrol 200MG 12-hour Capsules SHIRE US INC.60/$86.66 or 120/$161.57
Carbatrol 300MG 12-hour Capsules SHIRE US INC.60/$82 or 180/$234.97
Equetro 100MG 12-hour Capsules VALIDUS PHARMACEUTICALS60/$78.61 or 180/$226.85
Equetro 200MG 12-hour Capsules VALIDUS PHARMACEUTICALS60/$97.19 or 180/$280.48
Equetro 300MG 12-hour Capsules VALIDUS PHARMACEUTICALS60/$120.05 or 180/$346.46
Tegretol 100MG Chewable Tablets NOVARTIS60/$35.99 or 180/$85.97
Tegretol 100MG/5ML Suspension NOVARTIS450/$58.28 or 1350/$153.36
Tegretol 200MG Tablets NOVARTIS60/$56.99 or 180/$152.96
Tegretol XR 200MG 12-hour Tablets NOVARTIS30/$35.99 or 90/$79.97
Tegretol XR 400MG 12-hour Tablets NOVARTIS30/$57.14 or 90/$153.82

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What are the possible side effects of carbamazepine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms 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 any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • pale skin, easy bruising or bleeding, unusual weakness;

  • white patches or sores inside your mouth or on your lips;

  • feeling short of breath, swelling of your ankles or feet;

  • nausea, stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes); or

  • urinating less than usual.

Less serious side effects may include:

  • feeling dizzy, drowsy, or unsteady;

  • vomiting, diarrhea, constipation, stomach pain;

  • confusion, headache, blurred vision;

  • ringing in your ears;

  • dry mouth, swollen tongue; or

  • joint or muscle pain, leg cramps.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take carbamazepine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill would cause too much of the drug to be released at one time. You may open the extended-release capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

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What is the most important information I should know about carbamazepine?
You should not take this medicine if you have a history of bone marrow suppression, or if you are allergic to an antidepressant such as amitriptyline (Elavil), desipramine (Norpramin), imipramine (Tofranil), or nortriptyline (Pamelor). Do not take carbamazepine if you have taken an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) in the past 14 days. You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect carbamazepine?
There are many other medicines that could cause a drug interaction if you take them together with carbamazepine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Carbamazepine has been assigned to pregnancy category C by the FDA. Anomalies similar to the fetal hydantoin syndrome have been described and include minor craniofacial defects, fingernail hypoplasia, and developmental delay. Other investigators have reported a variety of defects including spina bifida and a decrease in intelligence. Carbamazepine may be a teratogen, although studies of its effects during pregnancy are inconclusive. Carbamazepine should only be given during pregnancy if benefit outweighs risk.

A prospective controlled study of 210 women treated with carbamazepine at least during the first trimester has suggested a twofold increase in the rate of major congenital anomalies. The results were 12/160 in the carbamazepine group versus 18/560 in the general control. There was also a birth weight reduction of approximately 250 g after in utero exposure to carbamazepine. A prospective case control cohort study of pregnant women with epilepsy has reported an association between carbamazepine therapy and fetal death and anomalies. In that study, carbamazepine was associated with the lowest risk of three major antiepileptic drugs (phenytoin, phenobarbital, and carbamazepine). The relative risk of abnormal outcome was 0.019 in carbamazepine-treated women. In one study of 100 pregnancies in which the mothers were taking carbamazepine, 7 malformed offspring were reported. No significant differences in carbamazepine and metabolite levels were observed between those pregnancies which ended in malformation and those pregnancies which ended in normal offspring. Many of the epileptic women in this study were taking other antiseizure medications. Another study has suggested that carbamazepine exerts no negative effects on neurodevelopment in children exposed to carbamazepine in utero. In one case of massive overdose of carbamazepine during the third or fourth week post-conception, the fetus developed a large neural tube defect. A case of transient cholestatic hepatitis has been reported in an infant between the third and seventh weeks of life. The author of the report stated that it was "most likely due to carbamazepine exposure during pregnancy and breast feeding." Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

Carbamazepine is excreted into human milk in small amounts. Serum concentrations in infants are often low but occasionally approach the therapeutic range. Dose-related effects have not been reported. Carbamazepine is considered compatible with breast-feeding by the American Academy of Pediatrics.

A case of transient cholestatic hepatitis has been reported in an infant between the third and seventh weeks of life. The author of the report stated that it was "most likely due to carbamazepine exposure during pregnancy and breast feeding."

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Who should NOT use this medication?

  • History of previous bone marrow depression.
  • Acute intermittent porphyria.
  • Hypersensitivity to carbamazepine or demonstrated sensitivity to any tricyclic antidepressant (e.g., amitriptyline, desipramine, imipramine, nortriptyline, protriptyline).
  • Current or recent (i.e., within 2 weeks) MAO inhibitor therapy. (See Specific Drugs, Foods, and Laboratory Tests under Interactions.)

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include shallow breathing, fast heartbeat, nausea, vomiting, urinating less or not at all, muscle twitches, restlessness, tremors, slurred speech, staggering walk, and feeling light-headed or fainting.

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What should I discuss with my healthcare provider before taking carbamazepine?
You should not use this medication if you are allergic to carbamazepine or to certain antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Tofranil), and others. Do not use carbamazepine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. You should not take carbamazepine if you have a history of bone marrow suppression, or if you are also taking nefazodone.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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