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felbamate
Overview
What is Felbatol?
Felbatol® (felbamate) is an antiepileptic available as
400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral
administration. Its chemical name is 2-phenyl-1,3-propanediol
dicarbamate.
Felbamate is a white to off-white crystalline powder with a
characteristic odor. It is very slightly soluble in water, slightly
soluble in ethanol, sparingly soluble in methanol, and freely soluble in
dimethyl sulfoxide. The molecular weight is 238.24; felbamate's
molecular formula is C H N O
; its structural formula is:
The inactive ingredients for Felbatol® (felbamate)
Tablets 400 mg and 600 mg are starch, microcrystalline cellulose,
croscarmellose sodium, lactose, magnesium stearate, FD&C Yellow
No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg
tablets only). The inactive ingredients for Felbatol®
(felbamate) Oral Suspension 600 mg/5 mL are sorbitol, glycerin,
microcrystalline cellulose, carboxymethylcellulose sodium, simethicone,
polysorbate 80, methylparaben, saccharin sodium, propylparaben,
FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and
purified water.
What does Felbatol look like?
What are the available doses of Felbatol?
Sorry No records found.
What should I talk to my health care provider before I take Felbatol?
Sorry No records found
How should I use Felbatol?
Felbatol® is not indicated as a first line antiepileptic
treatment (see ). Felbatol® is recommended for use only in those
patients who respond inadequately to alternative treatments and whose
epilepsy is so severe that a substantial risk of aplastic anemia and/or
liver failure is deemed acceptable in light of the benefits conferred by
its use.
If these criteria are met and the patient has been fully advised
of the risk, and has provided written acknowledgement,
Felbatol® can be considered for either monotherapy or
adjunctive therapy in the treatment of partial seizures, with and
without generalization, in adults with epilepsy and as adjunctive
therapy in the treatment of partial and generalized seizures associated
with Lennox-Gastaut syndrome in children.
Felbatol® (felbamate) has been studied as monotherapy
and adjunctive therapy in adults and as adjunctive therapy in children
with seizures associated with Lennox-Gastaut syndrome. As
Felbatol® is added to or substituted for existing AEDs, it is
strongly recommended to reduce the dosage of those AEDs in the range of
20-33% to minimize side effects (see subsection).
Dosage Adjustment in the Renally
Impaired:
Adults (14 years of age and
over)
Monotherapy:
Conversion to Monotherapy:
Adjunctive Therapy:
While the above Felbatol® conversion guidelines may
result in a Felbatol® 3600 mg/day dose within 3 weeks, in some
patients titration to a 3600 mg/day Felbatol® dose has been
achieved in as little as 3 days with appropriate adjustment of other
AEDs.
Children with Lennox-Gastaut
Syndrome (Ages 2-14 years)
Adjunctive Therapy:
What interacts with Felbatol?
Felbatol® is contraindicated in patients with known hypersensitivity to Felbatol®, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.
What are the warnings of Felbatol?
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (See PRECAUTIONS: ).
See regarding aplastic anemia and hepatic
failure. Antiepileptic drugs should not be suddenly discontinued
because of the possibility of increasing seizure frequency.
Suicidal Behavior and
Ideation
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 Felbatol or 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 and 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.
What are the precautions of Felbatol?
Dosage Adjustment in the
Renally Impaired:
Array
Suicidal Thinking and
Behavior:
Pregnancy:
Array
*Not administered but an active metabolite of carbamazepine. | ||
**No significant effect. | ||
AEDCoadministered | AEDConcentration | Felbatol®Concentration |
Phenytoin | ↑ | ↓ |
Valproate | ↑ | ↔** |
Carbamazepine (CBZ)*CBZ epoxide | ↓↑ | ↓ |
Phenobarbital | ↑ | ↓ |
Drug/Laboratory Test Interactions:
Labor and Delivery:
Nursing Mothers:
Array
Pediatric Use:
Geriatric Use:
What are the side effects of Felbatol?
Sorry No records found
What should I look out for while using Felbatol?
Felbatol® is contraindicated in patients with known
hypersensitivity to Felbatol®, its ingredients, or known
sensitivity to other carbamates. It should not be used in patients with
a history of any blood dyscrasia or hepatic dysfunction.
See regarding aplastic anemia and hepatic
failure. Antiepileptic drugs should not be suddenly discontinued
because of the possibility of increasing seizure frequency.
Suicidal Behavior and
Ideation
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 Felbatol or 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 and 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.
What might happen if I take too much Felbatol?
Four subjects inadvertently received Felbatol®
(felbamate) as adjunctive therapy in dosages ranging from 5400 to 7200
mg/day for durations between 6 and 51 days. One subject who received
5400 mg/day as monotherapy for 1 week reported no adverse experiences.
Another subject attempted suicide by ingesting 12,000 mg of
Felbatol® in a 12-hour period. The only adverse experiences
reported were mild gastric distress and a resting heart rate of 100 bpm.
No serious adverse reactions have been reported. General supportive
measures should be employed if overdosage occurs. It is not known if
felbamate is dialyzable.
How should I store and handle Felbatol?
Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.MEDA Pharmaceuticals® MEDA Pharmaceuticals Inc. Somerset, NJ 08873 IN-00431-18 Rev. 7/11 Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.MEDA Pharmaceuticals® MEDA Pharmaceuticals Inc. Somerset, NJ 08873 IN-00431-18 Rev. 7/11 Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.MEDA Pharmaceuticals® MEDA Pharmaceuticals Inc. Somerset, NJ 08873 IN-00431-18 Rev. 7/11 Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.MEDA Pharmaceuticals® MEDA Pharmaceuticals Inc. Somerset, NJ 08873 IN-00431-18 Rev. 7/11 Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.MEDA Pharmaceuticals® MEDA Pharmaceuticals Inc. Somerset, NJ 08873 IN-00431-18 Rev. 7/11
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism by which felbamate exerts its
anticonvulsant activity is unknown, but in animal test systems
designed to detect anticonvulsant activity, felbamate has
properties in common with other marketed anticonvulsants.
Felbamate is effective in mice and rats in the maximal
electroshock test, the subcutaneous pentylenetetrazol seizure
test, and the subcutaneous picrotoxin seizure test. Felbamate
also exhibits anticonvulsant activity against seizures induced
by intracerebroventricular administration of glutamate in rats
and N-methyl-D,L-aspartic acid in mice. Protection against
maximal electroshock-induced seizures suggests that felbamate
may reduce seizure spread, an effect possibly predictive of
efficacy in generalized tonic-clonic or partial seizures.
Protection against pentylenetetrazol-induced seizures suggests
that felbamate may increase seizure threshold, an effect
considered to be predictive of potential efficacy in absence
seizures.
Receptor-binding studies indicate that felbamate has weak inhibitory
effects on GABA-receptor binding, benzodiazepine receptor
binding, and is devoid of activity at the MK-801 receptor
binding site of the NMDA receptor-ionophore complex. However,
felbamate does interact as an antagonist at the
strychnine-insensitive glycine recognition site of the NMDA
receptor-ionophore complex. Felbamate is not effective in
protecting chick embryo retina tissue against the neurotoxic
effects of the excitatory amino acid agonists NMDA, kainate, or
quisqualate .
The monocarbamate, p-hydroxy, and 2-hydroxy metabolites
were inactive in the maximal electroshock-induced seizure test
in mice. The monocarbamate and p-hydroxy metabolites had only
weak (0.2 to 0.6) activity compared with felbamate in the
subcutaneous pentylenetetrazol seizure test. These metabolites
did not contribute significantly to the anticonvulsant action of
felbamate.
Non-Clinical Toxicology
Felbatol® is contraindicated in patients with known hypersensitivity to Felbatol®, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.See regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.
Suicidal Behavior and Ideation
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 Felbatol or 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 and 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.
Drug Interactions:
Use in Conjunction with Other Antiepileptic Drugs (see ):
The addition of Felbatol® to antiepileptic drugs (AEDs) affects the steady-state plasma concentrations of AEDs.
In a controlled clinical trial, a 20% reduction of the phenytoin dose at the initiation of Felbatol® therapy resulted in phenytoin levels comparable to those prior to Felbatol® administration.
Carbamazepine:
In clinical trials, similar changes in carbamazepine and carbamazepine epoxide were seen.
Valproate:
Phenobarbital:
Carbamazepine:
Valproate:
Phenobarbital:
Effects of Antacids on Felbatol®:
Effects of Erythromycin on Felbatol®:
Effects of Felbatol® on Low-Dose Combination Oral Contraceptives:
Dosage Adjustment in the Renally Impaired:
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or
The most common adverse reactions seen in association with Felbatol® (felbamate) in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with Felbatol® in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache.
The most common adverse reactions seen in association with Felbatol® in children during adjunctive therapy are anorexia, vomiting, insomnia, headache, and somnolence.
The dropout rate because of adverse experiences or intercurrent illnesses among adult felbamate patients was 12 percent (120/977). The dropout rate because of adverse experiences or intercurrent illnesses among pediatric felbamate patients was six percent (22/357). In adults, the body systems associated with causing these withdrawals in order of frequency were: digestive (4.3%), psychological (2.2%), whole body (1.7%), neurological (1.5%), and dermatological (1.5%). In children, the body systems associated with causing these withdrawals in order of frequency were: digestive (1.7%), neurological (1.4%), dermatological (1.4%), psychological (1.1%), and whole body (1.0%). In adults, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency were: anorexia (1.6%), nausea (1.4%), rash (1.2%), and weight decrease (1.1%). In children, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency was rash (1.1%).
Incidence in Clinical Trials:
Adults
Incidence in Controlled Clinical Trials--Monotherapy Studies in Adults:
Incidence in Controlled Add-On Clinical Studies in Adults:
Many adverse experiences that occurred during adjunctive therapy may be a result of drug interactions. Adverse experiences during adjunctive therapy typically resolved with conversion to monotherapy, or with adjustment of the dosage of other antiepileptic drugs.
Children
Incidence in a Controlled Add-On Trial in Children with Lennox-Gastaut Syndrome:
Other Events Observed in Association with the Administration of Felbatol® (felbamate):
Events are classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100-1/1000 patients; and rare events are those occurring in fewer than 1/1000 patients.
Event frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N=1334) exposed to Felbatol®.
Body as a Whole:
Frequent:
Rare:
Cardiovascular:
Frequent:
Rare:
Central Nervous System:
Frequent:
Infrequent:
Digestive:
Frequent:
Infrequent:
Rare:
Hematologic:
Infrequent:
Rare:
Metabolic/Nutritional:
Infrequent:
Rare:
Musculoskeletal:
Infrequent:
Dermatological:
Frequent:
Infrequent:
Rare:
Special Senses:
Rare:
Postmarketing Adverse Event Reports:
Body as a Whole:
Cardiovascular:
Central & Peripheral Nervous System:
Dermatological:
Digestive:
Fetal Disorders:
Hematologic:
Metabolic/Nutritional:
Musculoskeletal:
Respiratory:
Special Senses:
Urogenital:
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.
Review
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. 315.72Tips
Tips
Interactions
Interactions
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