Tegretol (generic: carbamazepine) is a prescription medication used to treat epilepsy and trigeminal neuralgia (a condition that causes facial nerve pain) Tegretol belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activities in the brain that cause seizures, and by blocking nerve signals that cause pain in trigeminal neuralgia.
Tegretol is a prescription medicine used to treat certain types of seizures (partial, tonic-clonic, mixed), as well as certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).
Tegretol can cause serious side effects, including:
1. Tegretol may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking Tegretol within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take Tegretol to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:
- skin rash
- sores in your mouth
- blistering or peeling of the skin
2. Tegretol may cause rare but serious blood problems. Symptoms may include:
- fever, sore throat or other infections that come and go or do not go away
- easy bruising
- red or purple spots on your body
- bleeding gums or nose bleeds
- severe fatigue or weakness
3. Like other antiepileptic drugs, Tegretol may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
Watch for early symptoms of suicidal thoughts and actions:
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Tegretol may cause other serious side effects. These include:
Irregular heartbeat - symptoms include:
- Fast, slow, or pounding heartbeat
- Shortness of breath
- Feeling lightheaded
Liver problems - symptoms include:
- yellowing of your skin or the whites of your eyes
- dark urine
- pain on the right side of your stomach area (abdominal pain)
- easy bruising
- loss of appetite
- nausea or vomiting
Get medical help right away if you have any of the symtoms listed above.
- problems with walking and coordination (unsteadiness)
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:
- cimetidine, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, nefazodone, trazodone, loxapine, olanzapine, quetiapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e.g., ketaconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors, valproate.
The medicines listed above may inhibit the metabolism of Tegretol, thereby increasing the levels of Tegretol in your body.
There are other medicines that may increase the rate of metabolism of Tegretol, thereby decreasing the amount of Tegretol available in your body. They include:
- cisplatin, doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.
Tegretol may cause an increase in the metabolism of other medicines. In doing so, Tegretol causes, or would be expected to cause, decreased levels of the following:
- acetaminophen, alprazolam, bupropion, dihydropyridine calcium channel blockers (e.g., felodipine), citalopram, cyclosporine, corticosteroids (e.g., prednisolone, dexamethasone), clonazepam, clozapine, dicumarol, doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.
If you must take one of the above medicines along with Tegretol, your doctor may adjust your dosage.
Other medicines that may interact with Tegretol include:
- diuretics (hydrochlorothiazide, furosemide)
- hormonal contraceptives
Do not take Tegretol if you:
- have a history of bone marrow depression.
- are allergic to carbamazepine or any of the ingredients in Tegretol.
- take nefazodone.
- are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
- have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Tegretol until you talk to your healthcare provider. Tegretol taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Tegretol affects you. Tegretol may slow your thinking and motor skills.
Grapefruit and grapefruit juice may interact with Tegretol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before you take Tegretol, tell your healthcare provider if you:
- have or have had suicidal thoughts or actions, depression or mood problems
- have or ever had heart problems
- have or ever had blood problems
- have or ever had liver problems
- have or ever had kidney problems
- have or ever had allergic reactions to medicines
- have or ever had increased pressure in your eye
- have any other medical conditions
- drink grapefruit juice or eat grapefruit
- use birth control. Tegretol may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and Tegretol.
- are pregnant or plan to become pregnant. Tegretol may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Tegretol. You and your healthcare provider should decide if you should take Tegretol while you are pregnant.
- are breastfeeding or plan to breastfeed. Tegretol passes into breast milk. You and your healthcare provider should discuss whether you should take Tegretol or breastfeed; you should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Tegretol with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Tell your doctor if you are pregnant or plan to become pregnant. Tegretol may harm your unborn baby. Tell your doctor right away if you become pregnant while taking Tegretol. You and your doctor should decide if you should take Tegretol while you are pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed. Tegretol is excreted in human breast milk. You and your doctor should discuss whether you should take Tegretol or breastfeed; you should not do both.
- Do not stop taking Tegretol without first talking to your healthcare provider. Stopping Tegretol suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
- Take Tegretol exactly as prescribed. Your healthcare provider will tell you how much Tegretol to take.
- Your healthcare provider may change your dose. Do not change your dose of Tegretol without talking to your healthcare provider.
- Take Tegretol with food.
- Do not crush, chew, or break Tegretol-XR tablets.
- Tell you healthcare provider if you can not swallow Tegretol-XR whole.
- Shake the bottle well each time before use.
- Do not take Tegretol suspension at the same time you take other liquid medicines.
- If you take too much Tegretol, call your healthcare provider or local Poison Control Center right away.
Take Tegretol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. You will likely begin with a low dosage and gradually increase the daily amount taken until an effective dose is achieved.
In adults and children over 12, the recommended maintenance dose is usually 800 to 1200 mg daily.
In children 6 to 12 years of age, the recommended maintenance dose is usually 400 to 800 mg daily.
In children under 6 years of age, the recommended maintenance dose is usually below 35 mg/kg daily.
The usual daily dosage range is 200 to 1200 mg.
If you take too much Tegretol, call your local Poison Control Center or seek emergency medical attention right away.
Tegretol is available in the following forms:
- chewable tablets 100 mg
- tablets 200 mg
- XR tablets 100 mg
- XR tablets 200 mg
- XR tablets 400 mg
- suspension 100 mg/5 mL (teaspoon)
Active ingredient: carbamazepine
- Tegretol tablets: colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake (chewable tablets only), FD&C Red No. 40 (200-mg tablets only), flavoring (chewable tablets only), gelatin, glycerin, magnesium stearate, sodium starch glycolate (chewable tablets only), starch, stearic acid, and sucrose (chewable tablets only).
- Tegretol Suspension: Citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol, purified water, sorbitol, sucrose, and xanthan gum.
- Tegretol-XR tablets: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200-mg tablets only).
- Do not store Tegretol Tablets above 30°C (86°F).
- Keep Tegretol tablets dry.
- Do not store Tegretol Chewable Tablets above 30°C (86°F).
- Keep Tegretol Chewable Tablets out of the light.
- Keep Tegretol Chewable Tablets tablets dry.
- Store Tegretol-XR tablets between 15°C to 30°C (59°F to 86°F).
- Keep Tegretol XR tablets dry.
- Do not store Tegretol Suspension above 30°C (86°F).
- Shake well before using.
- Keep Tegretol Suspension in a tight, light-resistant container. Keep Tegretol and all medicines out of the reach of children.
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
- SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH TEGRETOL.
- THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE.
- HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH TEGRETOL.
- PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK.
APLASTIC ANEMIA AND AGRANULOCYTOSIS
- APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF TEGRETOL. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5-8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.
- ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF TEGRETOL, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
- BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON TEGRETOL ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, 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.
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