Clobazam (Clobazam)

Trade Name : Clobazam

VistaPharm, Inc.

SUSPENSION

Strength 2.5 mg/mL

CLOBAZAM Benzodiazepine [EPC],Benzodiazepines [CS],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clobazam (Clobazam) which is also known as Clobazam and Manufactured by VistaPharm, Inc.. It is available in strength of 2.5 mg/mL per ml. Read more

Clobazam (Clobazam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

WARNING: u00a0RISKS FROM CONCOMITANT USE WITH OPIOIDS
See full prescribing information for complete boxed warning.
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (, ).

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ()

No data

For doses above 5 mg/day administer in two divided doses ()n
Arrayn- Array
Oral suspension: Can be taken with or without food ()

Oral Suspension: 2.5 mg/mL for oral administration. Each bottle contains 120 mL of an opaque white to off-white suspension.

Oral Suspension: 2.5 mg/mL in bottle containing 120 mL of suspension ()

Clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions n n n
History of hypersensitivity to the drug or its ingredients ()

No data

Clinically significant adverse reactions that appear in other sections of the labeling include the following:
Adverse reactions that occurred at least 10% more frequently than placebo in any clobazam oral suspension dose included constipation, somnolence or sedation, pyrexia, lethargy, and drooling ()
To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc. at 1-888-655-1505, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Pregnancy:u00a0 Based on animal data, may cause fetal harm )

No data

No data

Table 4. u00a0Description
Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is insoluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. The melting range of clobazam is from 182u00baC to 185u00baC. The molecular formula is CHONCl and the molecular weight is 300.7.
Clobazam is available for oral administration as an opaque white to off-white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include magnesium aluminum silicate, xanthan gum, citric acid monohydrate, dibasic sodium phosphate dihydrate, simethicone emulsion, polysorbate 80, methylparaben, propylparaben, propylene glycol, sucralose, maltitol solution, wild cherry flavor (contains propylene glycol, artificial flavors, natural flavors, ethyl alcohol), and purified water.

No data

Carcinogenesis
In mice, oral administration of clobazam (0, 6, 12, or 24 mg/kg/day) for 2 years did not result in an increase in tumors. The highest dose tested was approximately 3 times the maximum recommended human dose (MRHD) of 40 mg/day, based on body surface area (mg/m).
In rats, oral administration of clobazam for 2 years resulted in increases in tumors of the thyroid gland (follicular cell adenoma and carcinoma) and liver (hepatocellular adenoma) at the mid and high doses. The low dose, not associated with an increase in tumors, was associated with plasma exposures (AUC) for clobazam and its major active metabolite, N-desmethylclobazam, less than that in humans at the MRHD.
Mutagenesis
Clobazam and the major active metabolite, N-desmethylclobazam, were negative for genotoxicity, based on data from a battery of (bacteria reverse mutation, mammalian clastogenicity) and (mouse micronucleus) assays.
Impairment of Fertility
In a fertility study in which clobazam (50, 350, or 750 mg/kg/day,u00a0corresponding to 12, 84 and 181 times the oral Maximum Recommended Human Dose, MRHD, of 40 mg/day based on mg/m body surface) was orally administered to male and female rats prior to and during mating and continuing in females to gestation day 6, increases in abnormal sperm and pre-implantation loss were observed at the highest dose tested. The no effect level for fertility and early embryonic development in rats was associated with plasma exposures (AUC) for clobazam and its major active metabolite, N-desmethylclobazam, less than those in humans at the maximum recommended human dose of 40 mg/day.

The effectiveness of clobazam for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome was established in two multicenter controlled studies (Study 1 and Study 2). Both studies were similar in terms of disease characteristics and concomitant AED treatments. The most common concomitant AED treatments at baseline included: valproate, lamotrigine, levetiracetam, and topiramate.
Study 1
Study 1 (N=238) was a randomized, double-blind, placebo-controlled study consisting of a 4-week baseline period followed by a 3-week titration period and 12-week maintenance period. Patients age 2 to 54 years with a current or prior diagnosis of LGS were stratified into 2 weight groups (12.5 kg to u226430 kg or >30 kg) and then randomized to placebo or one of three target maintenance doses of clobazam according to Table 5.
Table 5. u00a0Study 1 Total Daily Dose
Doses above 5 mg/day were administered in two divided doses.
The primary efficacy measure was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), also known as drop attacks, from the 4-week baseline period to 12-week maintenance period.
The pre-dosing baseline mean weekly drop seizure frequency was 98, 100, 61, and 105 for the placebo, low-, medium-, and high-dose groups, respectively. Figure 1 presents the mean percent reduction in weekly drop seizures from this baseline. All dose groups of clobazam were statistically superior (pu22640.05) to the placebo group. This effect appeared to be dose dependent.
Figure 1. Mean Percent Reduction from Baseline in Weekly Drop Seizure Frequency n- (Study 1)
Figure 2 shows changes from baseline in weekly drop seizure frequency by category for patients treated with clobazam and placebo in Study 1. Patients in whom the seizure frequency increased are shown at left as u201cworse.u201d Patients in whom the seizure frequency decreased are shown in five categories.
Figure 2. Drop Seizure Response by Category for Clobazam and Placebo (Study 1)
There was no evidence that tolerance to the therapeutic effect of clobazam developed during the 3-month maintenance period.
Study 2
Study 2 (N=68) was a randomized, double-blind comparison study of high- and low-dose clobazam, consisting of a 4-week baseline period followed by a 3-week titration period and 4-week maintenance period. Patients age 2 to 25 years with a current or prior diagnosis of LGS were stratified by weight, then randomized to either a low or high dose of clobazam, and then entered a 3-week titration period.
The primary efficacy measure was the percent reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic), also known as drop attacks, from the 4-week baseline period to the 4-week maintenance period.
A statistically significantly greater reduction in seizure frequency was observed in the high-dose group compared to the low-dose group (median percent reduction of 93% vs 29%; p<0.05).

Clobazam oral suspension is a wild cherry flavored opaque white to off-white liquid supplied in a bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.
Store and dispense clobazam oral suspension in its original bottle in an upright position. Use within 90 days of first opening the bottle, then discard any remainder.
NDC 66689-058-04: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.
Store oral suspension at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). [See USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (u00a0and ).
Risks from Concomitant Use with Opioids
Inform patients and caregivers that potentially fatal additive effects may occur if clobazam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider n n n n .
Somnolence or Sedation
Advise patients or caregivers to check with their healthcare provider before clobazam is taken with other CNS depressants such as other benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or alcohol n n n n .
If applicable, caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that clobazam does not affect them adversely (e.g., impair judgment, thinking or motor skills).
Increasing or Decreasing the Clobazam Dose
Inform patients or caregivers to consult their healthcare provider before increasing the clobazam dose or abruptly discontinuing clobazam. Advise patients or caregivers that abrupt withdrawal of AEDs may increase their risk of seizure n n n n n
Hypersensitivity
Inform patients or caregivers that clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients n n n
Interactions with Hormonal Contraceptives
Counsel women to also use non-hormonal methods of contraception when clobazam is used with hormonal contraceptives and to continue these alternative methods for 28 days after discontinuing clobazam to ensure contraceptive reliability n n n n n
Serious Dermatological Reactions
Advise patients or caregivers that serious skin reactions have been reported in patients taking clobazam. Serious skin reactions, including SJS/TEN, may need to be treated in a hospital and may be life-threatening. If a skin reaction occurs while taking clobazam, patients or caregivers should consult with healthcare providers immediately n n n
Suicidal Thinking and Behavior
Counsel patients, their caregivers, and their families that AEDs, including clobazam, may increase the risk of suicidal thoughts and behavior and advise them 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 of self-harm. Patients should report behaviors of concern immediately to healthcare providers n n n
Pregnancy
Advise pregnant women and women of childbearing potential that the use of clobazam during pregnancy can cause fetal harm which may occur early in pregnancy before many women know they are pregnant. Instruct patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy. When appropriate, prescribers should counsel pregnant women and women of childbearing potential about alternative therapeutic options.
Advise patients that there is a pregnancy exposure registry that collects information about the safety of antiepileptic drugs during pregnancy n
Nursing
Counsel patients that clobazam is excreted in breast milk. Instruct patients to notify their physician if they are breast feeding or intend to breast feed during therapy and counsel nursing mothers to observe their infants for poor sucking and somnolence n
Manufactured and Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
u00a0
VP2191
Issue Date:u00a008/2018

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured and Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
u00a0
VP2192
Issue Date: 08/2018

Clobazam (KLOE-ba-zam)
Oral Suspension, CIV
Read this Instructions for Use before using clobazam oral suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.
Prepare Clobazam Oral Suspension Dose
You will need the following supplies: n
Figure A
u00a0
Step 1.
Step 2. n- See Figure B
Figure B
Arrayn- Array
Step 3.n- See Figure C
Figure C
Arrayn- Array
Once the bottle adapter is in place, it should not be removed.
Step 4.n- See Figure D
Figure D
u00a0
Arrayn- See Figure E
Arrayn- Figure E
Step 6.n- See Figure F
Arrayn- Figure F
Measure the mLs of medicine using the tip of the greenu00a0plunger. n
Figure G
Step 7.n- See Figure H
Arrayn- Figure H
u00a0
Step 8.n- See Figure I
Figure I
Arrayn- Array
Step 9.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured and Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
VP2193
Issue Date: 08/2018

NDC
Clobazam Oral Suspension
2.5 mg/mL CIV
FOR ORAL ADMINISTRATION ONLY.
DISPENSE THE ENCLOSED MEDICATION GUIDE ANDINSTRUCTIONS FOR USE WITH EACH PRESCRIPTION.
120 mL
Rx only
VP2194
01/18
VistaPharm, Inc.
Arrayn- Array
NDC
Clobazam Oral Suspension
2.5 mg/mL CIV
FOR ORAL ADMINISTRATION ONLY.
DISPENSE THE ENCLOSED MEDICATION GUIDE ANDINSTRUCTIONS FOR USE WITH EACH PRESCRIPTION.
120 mL
Rx only
VistaPharm, Inc.

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Clobazam (Clobazam)

Trade Name : Clobazam

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Clobazam (Clobazam)

Trade Name : Clobazam

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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