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Carbatrol
Overview
What is Carbatrol?
CARBATROL is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is:
Carbatrolis a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice daily dosing of Carbatrol.
Inactive ingredients
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and titanium dioxide and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, FD&C Red #3, FD&C Yellow #6, Yellow Iron Oxide, FD&C Blue #2, and titanium dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&C Blue #2, FD&C Yellow #6, Red Iron Oxide, Yellow Iron Oxide, and titanium dioxide, and are imprinted with white ink.
What does Carbatrol look like?
What are the available doses of Carbatrol?
Sorry No records found.
What should I talk to my health care provider before I take Carbatrol?
Sorry No records found
How should I use Carbatrol?
Carbatrolis indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see ). Dosage should be adjusted to the needs of the individual patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Carbatrolmay be taken with or without food. Carbatrolcapsules may be swallowed whole or may be opened and all the beads sprinkled on a teaspoon of soft food such as applesauce. Make sure all of the food and medicine mixture is swallowed. Do not crush or chew Carbatrolcapsules or the sprinkled beads.
Carbatrolis an extended-release formulation for twice a day administration. When converting patients from immediate release carbamazepine to Carbatrolextended-release capsules, the same total daily mg dose of carbamazepine should be administered. Following conversion to Carbatrol, patients should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions.
Epilepsy (see )
Adults and children over 12 years of age. Initial:
Maintenance:
Children under 12 years of age:
Combination Therapy:
Trigeminal Neuralgia (see )
Initial:
Maintenance:
What interacts with Carbatrol?
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.
Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Coadministration of Carbatrolis contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
What are the warnings of Carbatrol?
Serious Dermatologic Reactions
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbatrolshould be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
SJS/TEN and HLA-B*1502 Allele
Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity.
Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2 to 4%, but higher in some groups. HLA-B*1502 is present in <1% of the population in Japan and Korea.
HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans).
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Over 90% of carbamazepine treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on Carbatrol.
The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from carbamazepine, such as maculopapular eruption [MPE] or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other anti-epileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable.
Patients should be made aware that Carbatrolcontains carbamazepine and should not be used in combination with any other medications containing carbamazepine.
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Hypersensitivity Reactions and HLA-A*3101 Allele
Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-A*3101, an inherited allelic variant of the HLA-A gene, in patients using carbamazepine. These hypersensitivity reactions include SJS/TEN, maculopapular eruptions, and Drug Reaction with Eosinophilia and Systemic Symptoms (see below).
HLA-A*3101 is expected to be present in the following approximate frequencies: greater than 15% in patients of Japanese and Native American ancestry; up to about 10% in patients of Han Chinese, Korean, European, and Latin American ancestry; and up to about 5% in African-Americans and patients of Indian, Thai, Taiwanese, and Chinese (Hong Kong) ancestry.
The risks and benefits of carbamazepine therapy should be weighed before considering carbamazepine in patients known to be positive for HLA-A*3101.
General Information on HLA Genotyping and Hypersensitivity
Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management. Many HLA-B*1502-positive and HLA-A*3101-positive patients treated with carbamazepine will not develop SJS/TEN or other hypersensitivity reactions, and these reactions can still occur infrequently in HLA-B*1502-negative and HLA-A*3101-negative patients of any ethnicity. The role of other possible factors in the development of, and morbidity from, SJS/TEN and other hypersensitivity reactions, such as AED dose, compliance, concomitant medications, co-morbidities, and the level of dermatologic monitoring have not been studied.
Aplastic Anemia and Agranulocytosis
Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. (See
.) Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, have occurred with carbamazepine. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Carbatrolshould be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Hypersensitivity
Hypersensitivity reactions to carbamazepine have been reported in patients who previously experienced this reaction to anticonvulsants including phenytoin, primidone, and phenobarbital. A history of hypersensitivity reactions should be obtained for patients and their immediate family members. If such history is present, benefits and risks should be carefully considered, and, if carbamazepine is initiated, the signs and symptoms of hypersensitivity should be carefully monitored.
In patients who have exhibited hypersensitivity reactions to carbamazepine, approximately 25 to 30% may experience hypersensitivity reactions with oxcarbazepine (Trileptal).
Withdrawal Precipitated Seizure, Status Epilepticus
Antiepileptic drugs should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus. When in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative anticonvulsant medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Carbatrol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing Carbatrolor any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts or behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
| Indication | Placebo Patients with Events Per 1000 Patients | Drug Patients with Events Per 1000 Patients | Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients | |
| Epilepsy | 1.0 | 3.4 | 3.5 | 2.4 |
| Psychiatric | 5.7 | 8.5 | 1.5 | 2.9 |
| Other | 1.0 | 1.8 | 1.9 | 0.9 |
| Total | 2.4 | 4.3 | 1.8 | 1.9 |
Usage in Pregnancy
Carbamazepine can cause fetal harm when administered to a pregnant woman.
Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida. The prescribing physician will wish to weigh the benefits of therapy against the risks in treating or counseling women of childbearing potential. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Retrospective case reviews suggest that, compared with monotherapy, there may be a higher prevalence of teratogenic effects associated with the use of anticonvulsants in combination therapy.
In humans, transplacental passage of carbamazepine is rapid (30-60 minutes), and the drug is accumulated in the fetal tissues, with higher levels found in liver and kidney than in brain and lung.
Carbamazepine has been shown to have adverse effects in reproduction studies in rats when given orally in dosages 10-25 times the maximum human daily dosage (MHDD) of 1200 mg on a mg/kg basis or 1.5-4 times the MHDD on a mg/m basis. In rat teratology studies, 2 of 135 offspring showed kinked ribs at 250 mg/kg and 4 of 119 offspring at 650 mg/kg showed other anomalies (cleft palate, 1; talipes, 1; anophthalmos, 2). In reproduction studies in rats, nursing offspring demonstrated a lack of weight gain and an unkempt appearance at a maternal dosage level of 200 mg/kg.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
Tests to detect defects using current accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine.
There have been a few cases of neonatal seizures and/or respiratory depression reported in association with maternal carbamazepine and other concomitant anticonvulsant drug use. A few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal carbamazepine use. These symptoms may represent a neonatal withdrawal syndrome.
To provide information regarding the effects of in utero exposure to Carbatrol, physicians are advised to recommend that pregnant patients taking Carbatrolenroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website .
General
Carbamazepine has shown mild anticholinergic activity; therefore, patients with increased intraocular pressure should be closely observed during therapy.
Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be considered.
The use of Carbatrolshould be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Acute attacks have been reported in such patients receiving Carbatroltherapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria.
What are the precautions of Carbatrol?
General
Before initiating therapy, a detailed history and physical examination should be made.
Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions (see ).
Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac, hepatic, or renal damage; adverse hematologic reaction to other drugs; or interrupted courses of therapy with carbamazepine.
Hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone Secretion, and Water Intoxication
Hyponatremia can occur as a result of treatment with Carbatrol. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The risk of developing SIADH with Carbatroltreatment may be dose-related. Elderly patients may be at greater risk of developing hyponatremia. Patients treated with diuretics can be at greater risk. Consider discontinuing Carbatrolin patients with symptomatic hyponatremia. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls.
Information for Patients
Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking Carbatrol.
Patients should be made aware of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Patients should be advised that, because these signs and symptoms may signal a serious reaction, they must report any occurrence immediately to their physicians. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use.
Patients, their caregivers, and families should be counseled that AEDs, including Carbatrolmay increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Caution should be exercised if alcohol is taken in combination with Carbatroltherapy, due to a possible additive sedative effect.
Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks.
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see ).
If necessary, the Carbatrolcapsules can be opened and the contents sprinkled over food, such as a teaspoon of applesauce or other similar food products. Carbatrolcapsules or their contents should not be crushed or chewed.
Carbatrolmay interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or non-prescription medication or herbal products.
Patients, their caregivers, and families should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking Carbatrol. See .
Laboratory Tests
For genetically at-risk patients [See ], high-resolution '' is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.
Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, 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.
Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with this drug since liver damage may occur. In addition, rare cases of hepatic failure have been reported (see ). The drug should be discontinued immediately in cases of aggravated liver dysfunction or active liver disease.
Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes.
Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction.
Increases in total cholesterol, LDL and HDL have been observed in some patients taking anticonvulsants. Therefore, periodic evaluation of these parameters is also recommended.
Monitoring of blood levels (see ) has increased the efficacy and safety of anticonvulsants. This monitoring may be particularly useful in cases of dramatic increase in seizure frequency and for verification of compliance. In addition, measurement of drug serum levels may aid in determining the cause of toxicity when more than one medication is being used.
Thyroid function tests have been reported to show decreased values with carbamazepine administered alone.
Interference with some pregnancy tests has been reported.
Drug Interactions
Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:
Agents Highly Bound to Plasma Protein:
Carbamazepine is not highly bound to plasma proteins; therefore, administration of Carbatrol to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.
Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase:
Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of Carbatrol are the following:
Acetazolamide, azole antifungals, cimetidine, clarithromycin(), dalfopristin, danazol, delavirdine, diltiazem, erythromycin(), fluoxetine, fluvoxamine, grapefruit juice, isoniazid, itraconazole, ketoconazole, loratadine, nefazodone, niacinamide, nicotinamide, protease inhibitors, propoxyphene, quinine, quinupristin, troleandomycin, valproate(), verapamil, zileuton.
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Thus, if a patient has been titrated to a stable dosage of Carbatrol, and then begins a course of treatment with one of these CYP3A4 or epoxide hydrolase inhibitors, it is reasonable to expect that a dose reduction for Carbatrol may be necessary.
Agents that Induce Cytochrome P450 Isoenzymes:
Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of Carbatrol are the following:
Cisplatin, doxorubicin HCL, felbamate, rifampin, phenobarbital, phenytoin(), primidone, methsuximide, and theophylline
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Thus, if a patient has been titrated to a stable dosage on Carbatrol, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for Carbatrol may be necessary.
Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes:
Carbamazepine is known to induce CYP1A2 and CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent metabolized by one (or more) of these enzymes. Agents that have been found, or are expected to have decreased plasma levels in the presence of Carbatrol due to induction of CYP enzymes are the following:
Acetaminophen, alprazolam, amitriptyline, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, doxycycline, ethosuximide, felbamate, felodipine, glucocorticoids, haloperidol, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, midazolam, mirtazapine, nortriptyline, olanzapine, oral and other hormonal contraceptives(), oxcarbazepine, phenytoin(), praziquantel, protease inhibitors, quetiapine, risperidone, theophylline, topiramate, tiagabine, tramadol, triazolam, trazodone(), valproate, warfarin(), ziprasidone, and zonisamide.
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Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose increase for the concomitant agent may be necessary.
Agents with Increased Levels in the Presence of Carbamazepine:
Carbatrol increases the plasma levels of the following agents:
Clomipramine HCl, phenytoin(), and primidone
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Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with Carbatrol, it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.
Pharmacological/Pharmacodynamic Interactions with Carbamazepine:
Coadministration of Carbatrolwith delavirdine may lead to loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors (see ).
Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Given the anticonvulsant properties of carbamazepine, Carbatrol may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of carbamazepine.
Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose adjustment may be necessary.
Because of its primary CNS effect, caution should be used when Carbatrol is taken with other centrally acting drugs and alcohol.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Administration of carbamazepine to Sprague-Dawley rats for two years in the diet at doses of 25, 75, and 250 mg/kg/day (low dose approximately 0.2 times the maximum human daily dose of 1200 mg on a mg/m basis), resulted in a dose-related increase in the incidence of hepatocellular tumors in females and of benign interstitial cell adenomas in the testes of males.
Carbamazepine must, therefore, be considered to be carcinogenic in Sprague-Dawley rats. Bacterial and mammalian mutagenicity studies using carbamazepine produced negative results. The significance of these findings relative to the use of carbamazepine in humans is, at present, unknown.
Usage in Pregnancy
Carbamazepine can cause fetal harm when administered to a pregnant woman (See )
Labor and Delivery
The effect of carbamazepine on human labor and delivery is unknown.
Nursing Mothers
Carbamazepine and its epoxide metabolite are transferred to breast milk and during lactation. The concentrations of carbamazepine and its epoxide metabolite are approximately 50% of the maternal plasma concentration. Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Substantial evidence of carbamazepine effectiveness for use in the management of children with epilepsy (see for specific seizure types) is derived from clinical investigations performed in adults and from studies in several systems which support the conclusion that (1) the pathogenic mechanisms underlying seizure propagation are essentially identical in adults and children, and (2) the mechanism of action of carbamazepine in treating seizures is essentially identical in adults and children.
Taken as a whole, this information supports a conclusion that the generally acceptable therapeutic range of total carbamazepine in plasma (i.e., 4-12 μg/mL) is the same in children and adults.
The evidence assembled was primarily obtained from short-term use of carbamazepine. The safety of carbamazepine in children has been systematically studied up to 6 months. No longer term data from clinical trials is available.
Geriatric Use
No systematic studies in geriatric patients have been conducted.
What are the side effects of Carbatrol?
General:
The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see ), and the cardiovascular system.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.
The following additional adverse reactions were previously reported with carbamazepine:
Hemopoietic System:
Skin:
Cardiovascular System:
Immune system disorders
Liver:
Pancreatic:
Respiratory System:
Genitourinary System:
Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg/day and higher. Relevance of these findings to humans is unknown.
Nervous System:
There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.
Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs.
Digestive System:
Eyes:
Musculoskeletal System:
Metabolism:
Other:
A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
What should I look out for while using Carbatrol?
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.
Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Coadministration of Carbatrolis contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
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What might happen if I take too much Carbatrol?
How should I store and handle Carbatrol?
Store at 20° to 25°C (68° to 77°F)Protect from moisture.Store at 20° to 25°C (68° to 77°F)Protect from moisture.Carbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade Office
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Carbamazepine has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Carbamazepine greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats. Carbamazepine is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.
The principal metabolite of carbamazepine, carbamazepine-10,11-epoxide, has anticonvulsant activity as demonstrated in several animal models of seizures. Though clinical activity for the epoxide has been postulated, the significance of its activity with respect to the safety and efficacy of carbamazepine has not been established.
Non-Clinical Toxicology
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Coadministration of Carbatrolis contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:
Agents Highly Bound to Plasma Protein:
Carbamazepine is not highly bound to plasma proteins; therefore, administration of Carbatrol to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.
Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase:
Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of Carbatrol are the following:
Acetazolamide, azole antifungals, cimetidine, clarithromycin(), dalfopristin, danazol, delavirdine, diltiazem, erythromycin(), fluoxetine, fluvoxamine, grapefruit juice, isoniazid, itraconazole, ketoconazole, loratadine, nefazodone, niacinamide, nicotinamide, protease inhibitors, propoxyphene, quinine, quinupristin, troleandomycin, valproate(), verapamil, zileuton.
Array
Thus, if a patient has been titrated to a stable dosage of Carbatrol, and then begins a course of treatment with one of these CYP3A4 or epoxide hydrolase inhibitors, it is reasonable to expect that a dose reduction for Carbatrol may be necessary.
Agents that Induce Cytochrome P450 Isoenzymes:
Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of Carbatrol are the following:
Cisplatin, doxorubicin HCL, felbamate, rifampin, phenobarbital, phenytoin(), primidone, methsuximide, and theophylline
Array
Thus, if a patient has been titrated to a stable dosage on Carbatrol, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for Carbatrol may be necessary.
Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes:
Carbamazepine is known to induce CYP1A2 and CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent metabolized by one (or more) of these enzymes. Agents that have been found, or are expected to have decreased plasma levels in the presence of Carbatrol due to induction of CYP enzymes are the following:
Acetaminophen, alprazolam, amitriptyline, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, doxycycline, ethosuximide, felbamate, felodipine, glucocorticoids, haloperidol, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, midazolam, mirtazapine, nortriptyline, olanzapine, oral and other hormonal contraceptives(), oxcarbazepine, phenytoin(), praziquantel, protease inhibitors, quetiapine, risperidone, theophylline, topiramate, tiagabine, tramadol, triazolam, trazodone(), valproate, warfarin(), ziprasidone, and zonisamide.
Array
Array
Array
Array
Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose increase for the concomitant agent may be necessary.
Agents with Increased Levels in the Presence of Carbamazepine:
Carbatrol increases the plasma levels of the following agents:
Clomipramine HCl, phenytoin(), and primidone
Array
Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with Carbatrol, it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.
Pharmacological/Pharmacodynamic Interactions with Carbamazepine:
Coadministration of Carbatrolwith delavirdine may lead to loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors (see ).
Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Given the anticonvulsant properties of carbamazepine, Carbatrol may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of carbamazepine.
Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose adjustment may be necessary.
Because of its primary CNS effect, caution should be used when Carbatrol is taken with other centrally acting drugs and alcohol.
Before initiating therapy, a detailed history and physical examination should be made.
Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions (see ).
Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac, hepatic, or renal damage; adverse hematologic reaction to other drugs; or interrupted courses of therapy with carbamazepine.
Hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone Secretion, and Water Intoxication
Hyponatremia can occur as a result of treatment with Carbatrol. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The risk of developing SIADH with Carbatroltreatment may be dose-related. Elderly patients may be at greater risk of developing hyponatremia. Patients treated with diuretics can be at greater risk. Consider discontinuing Carbatrolin patients with symptomatic hyponatremia. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls.
General:
The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see ), and the cardiovascular system.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.
The following additional adverse reactions were previously reported with carbamazepine:
Hemopoietic System:
Skin:
Cardiovascular System:
Immune system disorders
Liver:
Pancreatic:
Respiratory System:
Genitourinary System:
Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg/day and higher. Relevance of these findings to humans is unknown.
Nervous System:
There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.
Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs.
Digestive System:
Eyes:
Musculoskeletal System:
Metabolism:
Other:
A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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