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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 this medicine?
CARBAMAZEPINE (kar ba MAZ e peen) is used to control seizures caused by certain types of epilepsy. This medicine is also used to treat nerve related pain. It is not for common aches and pains.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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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. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

CarBAMazepine 100MG Chewable Tablets TEVA PHARMACEUTICALS USA60/$14.99 or 120/$18.98
CarBAMazepine 100MG/5ML Suspension TARO450/$56.84 or 1350/$149.45
CarBAMazepine 200MG 12-hr Tablets TARO100/$90.99 or 300/$255.96
CarBAMazepine 200MG Tablets TEVA PHARMACEUTICALS USA90/$13.99 or 270/$34.34
CarBAMazepine 400MG 12-hr Tablets TARO100/$175.99 or 300/$499.95
Carbatrol 100MG 12-hr Capsules SHIRE US INC.30/$60.58 or 90/$154.41
Carbatrol 200MG 12-hr Capsules SHIRE US INC.60/$106.91 or 120/$197.16
Carbatrol 300MG 12-hr Capsules SHIRE US INC.60/$108.1 or 180/$296.96
Equetro 100MG 12-hr Capsules VALIDUS PHARMACEUTICALS60/$78.61 or 180/$226.85
Equetro 200MG 12-hr Capsules VALIDUS PHARMACEUTICALS60/$97.19 or 180/$280.48
Equetro 300MG 12-hr Capsules VALIDUS PHARMACEUTICALS60/$120.05 or 180/$346.46
Tegretol 100MG Chewable Tablets NOVARTIS60/$39.55 or 180/$94.46
Tegretol 100MG/5ML Suspension NOVARTIS450/$58.28 or 1350/$153.36
Tegretol 200MG Tablets NOVARTIS60/$65.93 or 180/$175.81
TEGretol XR 100MG 12-hr Tablets NOVARTIS30/$26.37 or 90/$54.93
TEGretol XR 200MG 12-hr Tablets NOVARTIS30/$39.56 or 90/$87.89
TEGretol XR 400MG 12-hr Tablets NOVARTIS30/$65.93 or 90/$182.39

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in vision
  • confusion
  • dark urine
  • fast or irregular heartbeat
  • fever or chills, sore throat
  • mouth ulcers
  • pain or difficulty passing urine
  • redness, blistering, peeling or loosening of the skin, including inside the mouth
  • ringing in the ears
  • seizures
  • stomach pain
  • swollen joints or muscle/joint aches and pains
  • unusual bleeding or bruising
  • unusually weak or tired
  • vomiting
  • worsening of mood, thoughts or actions of suicide or dying
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • clumsiness or unsteadiness
  • diarrhea or constipation
  • headache
  • increased sweating
  • nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • delavirdine
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • nefazodone
  • oxcarbazepine

This medicine may also interact with the following medications:

  • acetaminophen
  • acetazolamide
  • barbiturate medicines for inducing sleep or treating seizures, like phenobarbital
  • certain antibiotics like clarithromycin, erythromycin or troleandomycin
  • cimetidine
  • cyclosporine
  • danazol
  • dicumarol
  • doxycycline
  • female hormones, including estrogens and birth control pills
  • grapefruit juice
  • isoniazid, INH
  • levothyroxine and other thyroid hormones
  • lithium and other medicines to treat mood problems or psychotic disturbances
  • loratadine
  • medicines for angina or high blood pressure
  • medicines for cancer
  • medicines for depression or anxiety
  • medicines for sleep
  • medicines to treat fungal infections, like fluconazole, itraconazole or ketoconazole
  • medicines used to treat HIV infection or AIDS
  • methadone
  • niacinamide
  • praziquantel
  • propoxyphene
  • rifampin or rifabutin
  • seizure or epilepsy medicine
  • steroid medicines such as prednisone or cortisone
  • theophylline
  • tramadol
  • warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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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.)
  • Concomitant use of nefazodone. (See Specific Drugs, Foods, and Laboratory Tests under Interactions.)

    The manufacturer of voriconazole states that concomitant use of carbamazepine and voriconazole is contraindicated. (See Specific Drugs, Foods, and Laboratory Tests under Interactions.)

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What should I watch for while using this medicine?
Visit your doctor or health care professional for a regular check on your progress. Do not change brands or dosage forms of this medicine without discussing the change with your doctor or health care professional. If you are taking this medicine for epilepsy (seizures) do not stop taking it suddenly. This increases the risk of seizures. Wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medications, and doctor or health care professional.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • Asian ancestry
  • bone marrow disease
  • glaucoma
  • heart disease or irregular heartbeat
  • kidney disease
  • liver disease
  • porphyria
  • psychotic disorders
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to carbamazepine, tricyclic antidepressants, phenytoin, phenobarbital or other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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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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