Carbatrol Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Carbatrol reports: 16.
Carbatrol FDA safety alerts: 2007 2008 .
Reported hospitalizations: 2.
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FDA Reported Carbatrol Side Effects: convulsion, tooth fracture, oral intake reduced, weight decreased, fall, diarrhoea, tooth loss, tremor, incorrect dose administered, dehydration, constipation.
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Carbatrol Side Effects Report #5307726-6
Consumer or non-health professional from UNITED STATES reported CARBATROL problem on Apr 03, 2007. Male patient, 43 years of age, weighting 164.9 lb, was diagnosed with convulsion and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: convulsion, muscle twitching, nausea. CARBATROL dosage: 300 MG DAILY. Patient recovered.
Carbatrol Side Effects Report #5321266-X
CARBATROL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Male patient, child 6 years of age, weighting 44.09 lb, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: convulsion, headache, screaming, tremor, vomiting. CARBATROL dosage: 300 MG 2X'S DAILY, ORAL. During the same period patient was treated with DEPAKENE. Patient recovered.
Carbatrol Side Effects Report #5334469-5
Physician from UNITED STATES reported CARBATROL problem on May 11, 2007. Female patient, 40 years of age, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: oral intake reduced, tooth fracture, tooth loss. CARBATROL dosage: 300 MG, 2X/DAY: BID, UNK. During the same period patient was treated with VITAMIN D, CALCIUM. Patient recovered.
Carbatrol Side Effects Report #5345375-4
CARBATROL problem was reported by a Physician from UNITED STATES on May 21, 2007. Female patient, 40 years of age, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: oral intake reduced, tooth fracture, tooth loss. CARBATROL dosage: 300 MG, 2X/DAY: BID. During the same period patient was treated with VITAMIN D, CALCIUM. Patient recovered.
Carbatrol Side Effects Report #5371583-2
Physician from JAPAN reported CARBATROL problem on June 12, 2007. Male patient, 32 years of age, was diagnosed with neuralgia and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: central nervous system lesion. CARBATROL dosage: unknown. Patient recovered.
Carbatrol Side Effects Report #5076168-3
CARBATROL problem was reported by a Pharmacist from UNITED STATES on July 27, 2006. Male patient was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: convulsion. CARBATROL dosage: 500 MG 2X/DAY BID. Patient recovered.
Carbatrol Side Effects Report #5089532-3
Pharmacist from UNITED STATES reported CARBATROL problem on Aug 07, 2006. Male patient, 19 years of age, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: convulsion. CARBATROL dosage: 500 MG, 2X/DAY:BID. Patient recovered.
Carbatrol Side Effects Report #5119301-7
CARBATROL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 18, 2006. Female patient, 22 years of age, weighting 121.9 lb, was diagnosed with convulsion and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: diarrhoea, fall, grand mal convulsion. CARBATROL dosage: 400 MG DAILY; 600 MG DAILY, 800 MG DAILY. During the same period patient was treated with MIDOL. Patient recovered.
Carbatrol Side Effects Report #5127219-9
Consumer or non-health professional from UNITED STATES reported CARBATROL problem on Sept 25, 2006. Male patient, 48 years of age, weighting 293.0 lb, was diagnosed with convulsion, deep vein thrombosis and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, international normalised ratio decreased, somnolence, tremor. CARBATROL dosage: 1200 MG DAILY, ORAL. During the same period patient was treated with COUMADIN, KEPRA, TOPAMAX, DILTIAZEM, VYTORIN. Patient recovered.
Carbatrol Side Effects Report #5132058-9
CARBATROL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 04, 2006. Female patient, 50 years of age, was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: amnesia, convulsion, fatigue, feeling abnormal, weight decreased. CARBATROL dosage: 200 MG 3XS DAILY, ORAL. During the same period patient was treated with PHENOBARBITAL, METOPROLOL TARTRATE. Patient was hospitalized. Patient recovered.
Carbatrol Side Effects Report #5155364-0
Physician from UNITED STATES reported CARBATROL problem on Nov 06, 2006. Male patient was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: convulsion. CARBATROL dosage: 800 MG 2XS DAILY. During the same period patient was treated with KEPRA. Patient recovered.
Carbatrol Side Effects Report #5188789-8
CARBATROL problem was reported by a Pharmacist from UNITED STATES on Dec 01, 2006. Male patient, weighting 6.61 lb, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, bicuspid aortic valve, caesarean section, clinodactyly, congenital anomaly, dysmorphism, nail disorder, patent ductus arteriosus. CARBATROL dosage: unknown. During the same period patient was treated with DEPAKOTE. Patient recovered.
Carbatrol Side Effects Report #5378080-9
Health Professional from UNITED STATES reported CARBATROL problem on June 19, 2007. Male patient, 21 years of age, weighting 155.0 lb, was diagnosed with convulsion and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: delusion, hallucination, auditory, paranoia. CARBATROL dosage: unknown. Patient recovered.
Carbatrol Side Effects Report #5379376-7
CARBATROL problem was reported by a Physician from UNITED STATES on June 19, 2007. Female patient, 40 years of age, was diagnosed with epilepsy, convulsion and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: dental caries, excoriation, fall, gingival hyperplasia, joint sprain, oral intake reduced, tooth erosion, tooth fracture, tooth infection. CARBATROL dosage: 300 MG, 2X/DAY;BID. During the same period patient was treated with DILANTIN, VITAMIN D, CALCIUM. Patient recovered.
Carbatrol Side Effects Report #5402149-3
Physician from UNITED STATES reported CARBATROL problem on July 24, 2007. Male patient, 76 years of age, weighting 170.0 lb, was diagnosed with epilepsy and was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: aphonia, constipation, dehydration, diarrhoea, weight decreased. CARBATROL dosage: 400 MG IN AM, 200 MG AT NOON, 400 MG IN PM, ORAL. During the same period patient was treated with FLOMAX, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.
Carbatrol Side Effects Report #5466630-3
CARBATROL problem was reported by a Pharmacist from UNITED STATES on Sept 21, 2007. Male patient was treated with CARBATROL. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered. CARBATROL dosage: unknown. Patient recovered.
Drug Information: Carbamazepine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682237.html
(kar ba maz' e peen)IMPORTANT WARNING:
| [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. |
IMPORTANT WARNING:
| Carbamazepine may cause life-threatening allergic reactions called Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These allergic reactions may cause severe damage to the skin and internal organs. The risk of SJS or TEN is highest in people of Asian ancestry who have a genetic (inherited) risk factor. If you are Asian, your doctor will usually order a test to see if you have the genetic risk factor before prescribing carbamazepine. If you do have this risk factor, your doctor will probably prescribe another medication that is less likely to cause SJS or TEN. If you do not have this genetic risk factor, your doctor may prescribe carbamazepine, but there is still a slight risk that you will develop SJS or TEN. Call your doctor immediately if you develop a rash, blisters, or a fever during your treatment with carbamazepine.Stevens-Johnson syndrome or toxic epidermal necrolysis usually occurs during the first few months of treatment with carbamazepine. If you have taken carbamazepine for several months or longer, you probably will not need to be tested, even if you are Asian.Carbamazepine may decrease the number of blood cells produced by your body. In rare cases, the number of blood cells may decrease enough to cause serious or life-threatening health problems. Tell your doctor if you have ever had a decreased number of blood cells, especially if it was caused by another medication. If you experience any of the following symptoms, call your doctor immediately: sore throat, fever, chills or other signs of infection; unusual bleeding or bruising; tiny purple dots or spots on the skin; mouth sores; or rash.Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to carbamazepine. |
Why is this medication prescribed?
Carbamazepine is used alone or in combination with other medications to treat certain types of seizures in patients with epilepsy. It is also used to treat trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine extended-release capsules (Equetro brand only) are used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen at the same time) in patients with bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Carbamazepine is in a class of medications called anticonvulsants. It works by reducing abnormal excitement in the brain.
How should this medicine be used?
Carbamazepine comes as a tablet, a chewable tablet, an extended-release (long-acting) tablet, an extended-release capsule, and a suspension (liquid) to take by mouth. The regular tablet, chewable tablet, and liquid are usually taken two to four times a day with meals. The extended-release tablet is usually taken twice a day with meals. The extended-release capsule is usually taken twice a day with or without meals. To help you remember to take carbamazepine, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take carbamazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them. The extended-release capsules may be opened and the beads inside sprinkled over food, such as a teaspoon of applesauce or similar food. Do not crush or chew the extended-release capsules or the beads inside them.
Shake the liquid well before each use to mix the medication evenly.
Your doctor will start you on a low dose of carbamazepine and gradually increase your dose.
It may take a few weeks or longer before you feel the full benefit of carbamazepine. Continue to take carbamazepine even if you feel well. Do not stop taking carbamazepine without talking to your doctor. If you have a seizure disorder and you suddenly stop taking carbamazepine, your seizures may become worse. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
Carbamazepine is also sometimes used to treat mental illnesses, depression, posttraumatic stress disorder, drug and alcohol withdrawal, restless legs syndrome, diabetes insipidus, certain pain syndromes, and a disease in children called chorea. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking carbamazepine,
- tell your doctor and pharmacist if you are allergic to carbamazepine, amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), other medications for seizures such as phenobarbital (Luminal, Solfoton) or phenytoin (Dilantin), protriptyline (Vivactil), trimipramine (Surmontil), or any other medications.
- you should know that carbamazepine is the active ingredient in several products that have different names and may be prescribed to treat different conditions. Check the list of brand names at the beginning of this document carefully. All of the products listed contain carbamazepine and you should not take more than one of them at the same time.
- do not take carbamazepine if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil) selegiline (Eldepryl); and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol); acetazolamide (Diamox); alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants such as amitriptyline (Elavil), bupropion (Wellbutrin, Zyban), buspirone (BuSpar), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), mirtazapine (Remeron), nortriptyline (Pamelor); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); cimetidine (Tagamet); cisplatin (Platinol); clarithromycin (Biaxin); clonazepam (Klonopin); clozapine (Clozaril); cyclosporine (Neoral, Sandimmune); daltopristin and quinupristin (Synercid); danazol (Danocrine); delavirdine (Rescriptor);diltiazem (Cardizem, Dilacor, Tiazac); doxorubicin (Adriamycin, Rubex); doxycycline (Vibramycin); erythromycin (E.E.S., E-Mycin, Erythrocin); felodipine (Plendil); haloperidol (Haldol); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); levothyroxine (Levoxyl, Synthroid); lithium (Lithobid); loratadine (Claritin); lorazepam (Ativan); certain medications to treat malaria such as chloroquine (Aralen) and mefloquine (Lariam); medications for anxiety or mental illness; other medications for seizures such as ethosuximide (Zarontin), felbamate (Felbatol), lamotrigine (Lamictal), methsuximide (Celontin), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phensuximide (Milontin) (not available in the United States), phenytoin (Dilantin), primidone (Mysoline), tiagabine (Gabitril), topiramate (Topamax), and valproic acid (Depakene, Depakote); methadone (Dolophine); nefazodone; niacinamide (nicotinamide, Vitamin B3); propoxyphene (Darvon); praziquantel (Biltricide); quinine; rifampin (Rifadin, Rimactane); sedatives; sleeping pills; terfenadine (Seldane) (not available in the United States); theophylline (Theobid, Theo-Dur); tramadol (Ultram); tranquilizers; troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zileuton (Zyflo). Many other medications may also interact with carbamazepine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking any other liquid medications, do not take them at the same time as carbamazepine liquid.
- tell your doctor what herbal products you are taking, especially St. John's Wort.
- tell your doctor if you have or have ever had glaucoma; psychosis; or heart, kidney, thyroid, or liver disease.
- you should know that carbamazepine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices). Use another form of birth control while taking carbamazepine. Tell your doctor if you have unexpected vaginal bleeding or think you may be pregnant while you are taking carbamazepine.
- tell your doctor if you are pregnant or plan to become pregnant. Carbamazepine may harm the fetus. If you become pregnant while taking carbamazepine, call your doctor immediately.
- Do not breastfeed while you are taking carbamazepine.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking carbamazepine.
- you should know that carbamazepine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Carbamazepine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- dizziness
- unsteadiness
- upset stomach
- vomiting
- headache
- anxiety
- memory problems
- diarrhea
- constipation
- heartburn
- dry mouth
- back pain
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- confusion
- loss of contact with reality
- depression
- thinking about killing yourself or planning or trying to do so
- chest pain
- yellowing of the skin or eyes
- vision problems
Carbamazepine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- unconsciousness
- seizures
- restlessness
- muscle twitching
- abnormal movements
- shaking of a part of your body that you cannot control
- unsteadiness
- drowsiness
- dizziness
- blurred vision
- irregular or slowed breathing
- rapid or pounding heartbeat
- upset stomach
- vomiting
- difficulty urinating
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking carbamazepine.
Carbamazepine can interfere with the results of home pregnancy tests. Talk to your doctor if you think you might be pregnant while you are taking carbamazepine. Do not try to test for pregnancy at home.
The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet coating in the stool.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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