Search Article Directory Nauru: Carbatrol

Generic Name: carbamazepine (Oral route)

kar-ba-MAZ-e-peen

Oral route(Tablet;Tablet, Chewable;Suspension;Tablet, Extended Release;Capsule, Extended Release)

Serious and sometimes fatal dermatologic reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported, especially in patients with the inherited allelic variant HLA-B*1502. Genetically at-risk patients should be screened prior to receiving carbamazepine. Carbamazepine should not be started in patients who test positive for the allele. Aplastic anemia and agranulocytosis have also been reported. Complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops .

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

Uses For Carbatrol

Carbamazepine is used to control certain types of seizures in the treatment of epilepsy. It is also used to relieve pain due to trigeminal neuralgia (tic douloureux). It should not be used for other more common aches or pains. This medicine can also be used in the treatment of bipolar disorder (manic-depressive illness).

Carbamazepine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, carbamazepine is used in certain patients with the following medical conditions:

Alcohol withdrawal.

Bipolar disorder (manic-depressive illness), prevention.

Central partial diabetes insipidus (water diabetes).

Neurogenic pain (a type of continuing pain).

Psychotic disorders (severe mental illness).

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 to treat bipolar disease 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 in patients receiving carbamazepine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Boceprevir

Clorgyline

Iproniazid

Isocarboxazid

Moclobemide

Nefazodone

Nialamide

Nifedipine

Pargyline

Phenelzine

Praziquantel

Procarbazine

Ranolazine

Rilpivirine

Selegiline

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

Cabazitaxel

Clozapine

Crizotinib

Darunavir

Dasatinib

Delavirdine

Dronedarone

Erlotinib

Etravirine

Everolimus

Ezogabine

Imatinib

Irinotecan

Ixabepilone

Ketorolac

Lapatinib

Linagliptin

Lopinavir

Maraviroc

Naproxen

Nelfinavir

Nilotinib

Pazopanib

Propoxyphene

Rivaroxaban

Roflumilast

Romidepsin

Sirolimus

Sunitinib

Tacrolimus

Temsirolimus

Ticagrelor

Tolvaptan

Tramadol

Vandetanib

Vemurafenib

Vigabatrin

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

Alprazolam

Amitriptyline

Amoxapine

Anisindione

Aprepitant

Aripiprazole

Caspofungin

Clarithromycin

Clonazepam

Dalfopristin

Danazol

Desipramine

Desogestrel

Dicumarol

Dienogest

Diltiazem

Doxepin

Drospirenone

Efavirenz

Erythromycin

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethosuximide

Ethynodiol Diacetate

Etonogestrel

Etretinate

Felbamate

Fentanyl

Fluconazole

Flunarizine

Fluoxetine

Fosphenytoin

Ginkgo

Haloperidol

Hydrochlorothiazide

Imipramine

Indinavir

Influenza Virus Vaccine

Isoniazid

Lamotrigine

Levetiracetam

Levonorgestrel

Lithium

Loxapine

Medroxyprogesterone Acetate

Mestranol

Methylphenidate

Methylprednisolone

Metronidazole

Mianserin

Midazolam

Miokamycin

Nafimidone

Nevirapine

Niacinamide

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Nortriptyline

Olanzapine

Omeprazole

Oxcarbazepine

Phenprocoumon

Phenytoin

Pipecuronium

Primidone

Protriptyline

Psyllium

Quinine

Quinupristin

Remacemide

Rifampin

Rifapentine

Risperidone

Ritonavir

Rocuronium

Rufinamide

Sabeluzole

Sertraline

Simvastatin

St John's Wort

Telithromycin

Terfenadine

Theophylline

Tiagabine

Ticlopidine

Topiramate

Trazodone

Troleandomycin

Valnoctamide

Valproic Acid

Vecuronium

Verapamil

Viloxazine

Warfarin

Ziprasidone

Zolpidem

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 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.

Grapefruit Juice

Proper Use of carbamazepine

This section provides information on the proper use of a number of products that contain carbamazepine. It may not be specific to Carbatrol. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand before taking this medicine.

Carbamazepine suspension and tablets should be taken with meals to lessen the chance of stomach upset (nausea and vomiting).

Carbamazepine extended-release capsules do not need to be taken with meals unless they upset your stomach. The contents of the extended-release capsules may be sprinkled over a teaspoonful of applesauce or other similar food. The capsule or its contents should not be crushed or chewed.

The extended-release tablets must be swallowed whole and should not be crushed or chewed. Do not take extended-release tablets that are damaged or have chips or cracks.

Grapefruit and grapefruit juice may increase the effects of carbamazepine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

If you are taking this medicine for pain relief:

Carbamazepine is not an ordinary pain reliever. It should be used only when a doctor prescribes it for certain kinds of pain. Do not take carbamazepine for any other aches or pains.

If you are taking Tegretol® oral suspension:

Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Do not take any other liquid medicines at the same time that you take your dose of Tegretol® without first checking with your doctor.

Tegretol® tablets works differently than Tegretol® oral suspension, even at the same dose (number of milligrams). Do not switch from the tablets to the oral suspension unless your doctor tells you to.

Tegretol® may be used alone or together with other seizure medicines. Ask your doctor first before taking any other seizure medicine together with Tegretol®.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release capsules):
- For bipolar disorder:
  - Adults—At first, 400 milligrams (mg) per day, given in divided doses, two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1600 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For epilepsy:
  - Adults and teenagers—At first, 200 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
  - Children younger than 12 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually not more than 1000 mg per day.
- For trigeminal neuralgia:
  - Adults and teenagers—At first, 200 milligrams (mg) a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (extended-release tablets):
- For epilepsy:
  - Adults and teenagers—At first, 200 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
  - Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For trigeminal neuralgia:
  - Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (suspension):
- For epilepsy:
  - Adults and teenagers—100 milligrams (mg) or 1 teaspoon four times a day (400 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
  - Children 6 to 12 years of age—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
  - Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 35 mg/kg of body weight per day.
- For trigeminal neuralgia:
  - Adults and teenagers—At first, 50 milligrams (mg) or one-half teaspoon four times a day (200 mg per day). Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets and chewable tablets):
- For epilepsy:
  - Adults and teenagers—At first, 200 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 to 1600 mg per day.
  - Children 6 to 12 years of age—At first, 100 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1000 mg per day.
  - Children younger than 6 years of age—Dose is based on body weight and will be determined by your doctor. The dose is 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, taken two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 35 mg/kg of body weight per day.
- For trigeminal neuralgia:
  - Adults and teenagers—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 1200 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Carbatrol

It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to have certain tests done to see if you are receiving the right amount of medicine or if certain side effects may be occurring without your knowing it. Also, the amount of medicine you or your child are taking may have to be changed often.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

Birth control pills containing estrogen may not work properly if you take them while you are taking carbamazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking carbamazepine. If you have any questions about this, check with your doctor. .

Do not take carbamazepine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitors (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Also, do not take nefazodone (Serzone®) and other medicines (prescription, over-the-counter [OTC] or herbal products) unless they have been discussed with your doctor.

Carbamazepine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Carbamazepine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally, especially when they are starting treatment or increasing the dose. It may also cause blurred or double vision, weakness, or loss of muscle control in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well-coordinated or able to see well.

Some people who take carbamazepine may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

For diabetic patients:

Carbamazepine may affect urine sugar levels. While you are using this medicine, be especially careful when testing for sugar in your urine. If you notice a change in the results of your urine sugar tests or have any questions about this, check with your doctor.

Before having any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some pregnancy tests and the metyrapone test may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking carbamazepine together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects and cause other unwanted effects.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent worsening of seizures.

Carbatrol Side Effects

Along with its needed effects, a medicine 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:

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 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

shortness of breath

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

trembling

uncontrolled body movements

unusual tiredness or weakness

visual hallucinations (seeing things that are not there)

wheezing, tightness in the chest, or troubled breathing

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Body spasm in which head and heels are bent backward and body is bowed forward

clumsiness or unsteadiness

convulsions (seizures)—especially in small children

dizziness (severe) or fainting

drowsiness (severe)

fast or irregular heartbeat

irregular, slow, or shallow breathing

large pupils

nausea or vomiting (severe)

overactive reflexes followed by underactive reflexes

poor control in body movements (for example, when reaching or stepping)

trembling, twitching, or abnormal body movements

Some side effects 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:

More common

Dizziness (mild)

drowsiness (mild)

lightheadedness

nausea or vomiting (mild)

Less common or rare

Accidental injury

aching joints or muscles

acid or sour stomach

back pain

belching

constipation

diarrhea

dryness of mouth

headache

heartburn

increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)

increased sweating

indigestion

irritation or soreness of the tongue or mouth

itching skin

lack or loss of strength

loss of hair

loss of memory

problems with memory

sexual problems in males

sleepiness

stomach pain, upset, or discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Carbatrol side effects (in more detail)

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More Carbatrol resources

Carbatrol Side Effects (in more detail)
Carbatrol Use in Pregnancy & Breastfeeding
Drug Images
Carbatrol Drug Interactions
Carbatrol Support Group
5 Reviews for Carbatrol - Add your own review/rating

Carbatrol Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Carbatrol Prescribing Information (FDA)

Carbamazepine Professional Patient Advice (Wolters Kluwer)

Carbamazepine Prescribing Information (FDA)

Carbamazepine Monograph (AHFS DI)

Carbamazepine MedFacts Consumer Leaflet (Wolters Kluwer)

Epitol Prescribing Information (FDA)

Equetro Consumer Overview

Equetro Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Equetro Prescribing Information (FDA)

Tegretol Prescribing Information (FDA)

Tegretol Consumer Overview

Tegretol XR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carbatrol with other medications

Bipolar Disorder
Diabetic Nerve Damage
Dystonia
Epilepsy
Peripheral Neuropathy
Reflex Sympathetic Dystrophy Syndrome
Schizoaffective Disorder
Trigeminal Neuralgia
Vulvodynia

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Thursday, September 29, 2016

Carbatrol