Carbatrol

Name: Carbatrol

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Carbatrol Overview

Carbamazepine is a prescription medication used to treat epilepsy and trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activities in the brain that cause seizures. It also works by blocking nerve signals that cause pain in trigeminal neuralgia.

Carbamazepine comes in the form of an immediate-release tablet, an extended-release tablet, extended-release capsules, a chewable immediate-release tablet, and an oral suspension form. Carbamazepine may be taken 2 to 4 times daily, with or without food.

Common side effects of carbamazepine include dizziness, drowsiness, nausea, and vomiting. Do not drive or operate heavy machinery until you know how carbamazepine will affect you.

Manufacturer

Shire US Inc.

Carbatrol Usage

Take carbamazepine exactly as prescribed. Your healthcare provider will tell you how much carbamazepine to take.
Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
Your healthcare provider may change your dose. Do not change your dose of carbamazepine without talking to your healthcare provider.
Take carbamazepine with food.

Extended-release tablets and capsules:

Do not crush, chew, or break.
Tell you healthcare provider if you can not swallow the extended-release tablets whole

Carbamazepine Suspension:  

Shake the bottle well each time before use.  
Do not take carbamazepine suspension at the same time you take other liquid medicines.
If you take too much carbamazepine, call your healthcare provider or local Poison Control Center right away.

Other Requirements

Do not store extended-release tablets above 30°C (86°F).  
Keep tablets dry.
Do not store chewable tablets above 30°C (86°F).
Keep chewable tablets out of the light.
Keep chewable tablets dry.
Store capsules between 15°C to 30°C (59°F to 86°F).
Keep capsules dry.
Do not store carbamazepine suspension above 30°C (86°F).
Shake suspension well before using.
Keep carbamazepine suspension in a tight, light-resistant container.
Keep carbamazepine and all medicines out of the reach of children.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Carbatrol (carbamazepine) side effects

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

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

the first sign of any skin rash, no matter how mild;
slow, fast, or pounding heartbeats;
feeling light-headed or short of breath;
blood problems--sudden weakness or ill feeling, fever, chills, pale skin, sore throat, bleeding gums, nosebleeds;
liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, feeling unsteady;
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

dizziness, loss of coordination, problems with walking;
nausea, vomiting; or
drowsiness.

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.

Commonly used brand name(s)

In the U.S.

Carbatrol
Epitol
Equetro
TEGretol
TEGretol-XR

Available Dosage Forms:

Tablet, Chewable
Tablet, Extended Release
Suspension
Capsule, Extended Release
Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Dibenzazepine Carboxamide

Before Using Carbatrol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of carbamazepine extended-release capsules in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of carbamazepine to treat epilepsy in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of carbamazepine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of carbamazepine in the elderly. However, elderly patients are more likely to have confusion or agitation, which may require caution and an adjustment in the dose for patients receiving carbamazepine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Artemether
Atazanavir
Boceprevir
Clorgyline
Cobicistat
Daclatasvir
Darunavir
Dasabuvir
Delamanid
Delavirdine
Efavirenz
Elbasvir
Elvitegravir
Furazolidone
Grazoprevir
Iproniazid
Isavuconazonium
Isocarboxazid
Linezolid
Lumefantrine
Lurasidone
Maraviroc
Methylene Blue
Moclobemide
Nefazodone
Nialamide
Ombitasvir
Pargyline
Paritaprevir
Phenelzine
Praziquantel
Procarbazine
Ranolazine
Rasagiline
Rilpivirine
Ritonavir
Selegiline
Telaprevir
Toloxatone
Tranylcypromine
Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone
Adenosine
Afatinib
Alfentanil
Almotriptan
Alprazolam
Amphetamine
Amprenavir
Apixaban
Apremilast
Aprepitant
Aripiprazole
Axitinib
Bedaquiline
Benzphetamine
Blinatumomab
Bosutinib
Brexpiprazole
Brigatinib
Buprenorphine
Bupropion
Butorphanol
Cabozantinib
Calcifediol
Cariprazine
Ceritinib
Chlorpromazine
Clarithromycin
Clonazepam
Clozapine
Cobimetinib
Codeine
Conivaptan
Crizotinib
Cyclophosphamide
Cyclosporine
Dabigatran Etexilate
Dasatinib
Deflazacort
Desmopressin
Desogestrel
Desvenlafaxine
Dextroamphetamine
Dienogest
Dihydrocodeine
Diltiazem
Dolasetron
Dolutegravir
Doxorubicin
Doxorubicin Hydrochloride Liposome
Dronedarone
Drospirenone
Eliglustat
Enzalutamide
Erlotinib
Erythromycin
Eslicarbazepine Acetate
Estradiol
Ethinyl Estradiol
Ethynodiol
Etonogestrel
Etravirine
Everolimus
Exemestane
Ezogabine
Felodipine
Fentanyl
Fluconazole
Fluoxetine
Fosamprenavir
Fosaprepitant
Fosphenytoin
Gefitinib
Gestodene
Golimumab
Granisetron
Guselkumab
Hydromorphone
Hydroxytryptophan
Ibrutinib
Idelalisib
Ifosfamide
Imatinib
Indinavir
Irinotecan
Irinotecan Liposome
Isoniazid
Itraconazole
Ivabradine
Ivacaftor
Ixabepilone
Ixazomib
Ketoconazole
Lamotrigine
Lapatinib
Ledipasvir
Levomilnacipran
Levonorgestrel
Levorphanol
Linagliptin
Lisdexamfetamine
Lomitapide
Lopinavir
Lorcaserin
Loxapine
Macitentan
Manidipine
Medroxyprogesterone
Meperidine
Mestranol
Methadone
Methamphetamine
Midostaurin
Mifepristone
Mirtazapine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Naloxegol
Nelfinavir
Netupitant
Nifedipine
Nilotinib
Nimodipine
Nintedanib
Norethindrone
Norgestimate
Norgestrel
Olanzapine
Olaparib
Orlistat
Osimertinib
Oxycodone
Oxymorphone
Palbociclib
Palonosetron
Panobinostat
Pazopanib
Pentazocine
Perampanel
Phenytoin
Piperaquine
Pixantrone
Ponatinib
Propoxyphene
Quetiapine
Quinine
Regorafenib
Remifentanil
Ribociclib
Rivaroxaban
Rolapitant
Romidepsin
Saquinavir
Secukinumab
Simvastatin
Sofosbuvir
Sonidegib
Sufentanil
Sunitinib
Tacrolimus
Tapentadol
Tasimelteon
Telithromycin
Temsirolimus
Tenofovir Alafenamide
Terfenadine
Thioridazine
Thiotepa
Ticagrelor
Tipranavir
Tofacitinib
Tolvaptan
Trabectedin
Tramadol
Trazodone
Ulipristal
Valbenazine
Vandetanib
Velpatasvir
Vemurafenib
Venetoclax
Verapamil
Vigabatrin
Vilazodone
Vincristine
Vincristine Sulfate Liposome
Vinflunine
Vorapaxar
Vortioxetine
Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetaminophen
Acetylcysteine
Aminophylline
Amitriptyline
Amoxapine
Anisindione
Caspofungin
Dalfopristin
Danazol
Desipramine
Dicumarol
Doxepin
Etretinate
Felbamate
Flunarizine
Furosemide
Ginkgo
Haloperidol
Hydrochlorothiazide
Imipramine
Influenza Virus Vaccine
Levetiracetam
Lithium
Methylphenidate
Methylprednisolone
Metronidazole
Mianserin
Midazolam
Miokamycin
Nafimidone
Niacinamide
Nortriptyline
Omeprazole
Ospemifene
Oxcarbazepine
Paliperidone
Phenobarbital
Phenprocoumon
Pipecuronium
Primidone
Protriptyline
Psyllium
Quinupristin
Remacemide
Rifampin
Rifapentine
Risperidone
Rocuronium
Rufinamide
Sabeluzole
Sertraline
St John's Wort
Theophylline
Tiagabine
Ticlopidine
Topiramate
Troleandomycin
Valnoctamide
Valproic Acid
Vecuronium
Viloxazine
Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Black Tea

What are some other side effects of Carbatrol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Dizziness.
Feeling sleepy.
Upset stomach or throwing up.
Dry mouth.
Hard stools (constipation).
Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Drug Abuse and Dependence

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

For the Consumer

Applies to carbamazepine: oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

Other dosage forms:

intravenous solution

Along with its needed effects, carbamazepine (the active ingredient contained in Carbatrol) 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 carbamazepine:

More common

Blurred vision or double vision
continuous back-and-forth eye movements

Less common

Actions that are out of control
behavioral changes (especially in children)
confusion, agitation, or hostility (especially in the elderly)
diarrhea (severe)
discouragement
drooling
fear
feeling of unreality
feeling sad or empty
headache (continuing)
increase in seizures
irritability
lack of appetite
loss of balance control
loss of interest or pleasure
muscle trembling, jerking, or stiffness
nausea and vomiting (severe)
other problems with muscle control or coordination
sense of detachment from self or body
shakiness and unsteady walk
shuffling walk
stiffness of the limb
sudden, wide mood swings
talking, feeling, and acting with excitement
thoughts or attempts of killing oneself
tiredness
trouble concentrating
trouble sleeping
twisting movements of the body
uncontrolled movements, especially of the face, neck, and back
unusual drowsiness

Rare

Black, tarry stools
blood in the urine or stools
bone or joint pain
chest pain
cough or hoarseness
darkening of the urine
difficulty with speaking or slurred speech
fainting
frequent urination
irregular, pounding, or unusually slow heartbeat
lower back or side pain
mental depression with restlessness and nervousness or other mood or mental changes
muscle or stomach cramps
nosebleeds or other unusual bleeding or bruising
numbness, tingling, pain, or weakness in the hands and feet
pain, tenderness, swelling, or bluish color in the leg or foot
painful or difficult urination
pale stools
pinpoint red spots on the skin
rapid weight gain
rigidity
ringing, buzzing, or other unexplained sounds in the ears
skin rash, hives, or itching
sore throat, chills, and fever
sores, ulcers, or white spots on the lips or in the mouth
swelling of the face, hands, feet, or lower legs
swollen or painful glands
sudden decrease in the amount of urine
tightness in the chest
trembling
troubled breathing
uncontrolled body movements
unusual tiredness or weakness
visual hallucinations (seeing things that are not there)
yellow eyes or skin

Some side effects of carbamazepine 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: