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Carbamazepine

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Overview

What is CARNEXIV?

CARNEXIV (carbamazepine) injection is available as a clear, colorless, sterile solution for intravenous infusion. 

The chemical name of carbamazepine, an anticonvulsant, is 5-dibenz[]azepine-5-carboxamide, and its molecular weight is 236.27.  It has the following structural formula:

Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone.

CARNEXIV injection is supplied in single-dose 20 mL vials containing 200 mg carbamazepine.  Each mL contains 10 mg of carbamazepine, 250 mg of betadex sulfobutyl ether sodium, and 0.78 mg of sodium phosphate monobasic dihydrate in water for injection. The product may contain sodium hydroxide and/or hydrochloric acid for pH adjustment to pH 6.2.



What does CARNEXIV look like?



What are the available doses of CARNEXIV?

Injection: 200 mg/20 mL (10 mg/mL) single-dose vial ()

What should I talk to my health care provider before I take CARNEXIV?

How should I use CARNEXIV?

CARNEXIV is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types:

Limitations of Usage

CARNEXIV is not indicated for the treatment of absence seizures (including atypical absence). Carbamazepine has been associated with increased frequency of generalized convulsions in these patients.

CARNEXIV is a replacement therapy for oral carbamazepine. Carbamazepine treatment should generally be initiated with an oral carbamazepine formulation.

 

The total daily dose of CARNEXIV is 70% of the total daily oral carbamazepine dose from which patients are being switched (see Table 1). The total daily dose of CARNEXIV should be equally divided in four 30-minute infusions, separated by 6 hours.

 

Patients should be switched back to oral carbamazepine administration at their previous total daily oral dose and frequency of administration as soon as clinically appropriate. The use of CARNEXIV for periods of more than 7 days has not been studied.

 

Table 1.                                 Determination of Total Daily Dose for CARNEXIV Infusion

 


What interacts with CARNEXIV?

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What are the warnings of CARNEXIV?

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What are the precautions of CARNEXIV?

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What are the side effects of CARNEXIV?

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What should I look out for while using CARNEXIV?

CARNEXIV is contraindicated in patients with:

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have occurred in patients treated with carbamazepine. There is 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 that is found almost exclusively in patients with Asian ancestry. Avoid use of CARNEXIV in patients testing positive for the allele unless the benefit clearly outweighs the risk. Discontinue CARNEXIV if you suspect that the patient is having a serious dermatologic reaction .

Aplastic anemia and agranulocytosis can occur during treatment with CARNEXIV. Obtain a complete blood count (CBC) before beginning treatment with CARNEXIV, and monitor CBC periodically. Consider discontinuing CARNEXIV if significant bone marrow depression develops


What might happen if I take too much CARNEXIV?


How should I store and handle CARNEXIV?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] 75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.75 mg controlled-release tablets in bottles of 100.Each white, capsule-shaped tablet is debossed .Bottle of 14 - 68788-0686-1Bottle of 20 - 68788-0686-2Bottle of 30 - 68788-0686-3Bottle of 60 - 68788-0686-6Keep tightly closed. Store at room temperature, below 30°C (86°F).Rx onlyDistributed By:Manufactured By:Content Updated: March 201470025263Repackaged by Preferred Pharmaceuticals, Inc.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The mechanism by which carbamazepine exerts its anticonvulsant activity is unknown. The principal metabolite of carbamazepine, carbamazepine-10,11-epoxide, has demonstrated anticonvulsant activity in animal models of seizures. However, its contribution to the therapeutic effect of carbamazepine is unknown.

Non-Clinical Toxicology
CARNEXIV is contraindicated in patients with:

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have occurred in patients treated with carbamazepine. There is 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 that is found almost exclusively in patients with Asian ancestry. Avoid use of CARNEXIV in patients testing positive for the allele unless the benefit clearly outweighs the risk. Discontinue CARNEXIV if you suspect that the patient is having a serious dermatologic reaction .

Aplastic anemia and agranulocytosis can occur during treatment with CARNEXIV. Obtain a complete blood count (CBC) before beginning treatment with CARNEXIV, and monitor CBC periodically. Consider discontinuing CARNEXIV if significant bone marrow depression develops

Because diethylpropion hydrochloride is a monoamine, hypertension may result when this agent is used with monoamine oxidase (MAO) inhibitors (see ).

Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated.

Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, α-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash. Over 90% of carbamazepine-treated patients who experienced SJS/TEN developed these reactions within the first few months of treatment. The risk of these reactions 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. Discontinue CARNEXIV if you suspect that the patient is having a serious dermatologic reaction. If signs or symptoms suggest SJS/TEN, do not resume treatment with CARNEXIV.

SJS, TEN, and HLA-B*1502 Allele

The prevalence of the HLA-B*1502 allele may be higher in Asian populations: Hong Kong, Thailand, Malaysia, and parts of the Philippines (greater than 15%); Taiwan (10%); North China (4%); South Asians, including Indians (2% to 4%); and Japan and Korea (less than 1%). HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans). The accuracy of estimated rates of the HLA-B*1502 allele in these populations may be limited by wide variability in rates within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry.

The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from carbamazepine, such as maculopapular rash, hypersensitivity syndrome or non-serious rash (maculopapular eruption [MPE]) or 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 antiepileptic drugs (AED) 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.

Hypersensitivity Reactions and HLA-A*3101 Allele

[see Warnings and Precautions ()]

HLA-A*3101 is expected to be present in the following 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.

Hypersensitivity and Limitations of HLA Genotyping

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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. 315.72
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Tips

Tips

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Interactions

Interactions

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