Trade Name: Felbamate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 600 mg/5mL

Storage and handling

FELBAMATE Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • 1. n
  • THE USE OF FELBAMATE IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBAMATE WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.
  • AMONG FELBAMATE TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST.
  • THERE ARE TOO FEW FELBAMATE ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME'S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK. u00a0
  • IN MANAGING PATIENTS ON FELBAMATE, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBAMATE FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBAMATE EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBAMATE REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS. u00a0u00a0u00a0u00a0
  • IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBAMATE WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK. u00a0
  • IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBAMATE AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
  • IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
  • APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF INFECTION, BLEEDING, OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT, IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBAMATE SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS. u00a0u00a0
  • 2. n
  • EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF FELBAMATE. THE REPORTED RATE IN THE U.S. HAS BEEN ABOUT 6 CASES OF LIVER FAILURE LEADING TO DEATH OR TRANSPLANT PER 75,000 PATIENT YEARS OF USE. THIS RATE IS AN UNDERESTIMATE BECAUSE OF UNDER REPORTING, AND THE TRUE RATE COULD BE CONSIDERABLY GREATER THAN THIS. FOR EXAMPLE, IF THE REPORTING RATE IS 10%, THE TRUE RATE WOULD BE ONE CASE PER 1,250 PATIENT YEARS OF USE.
  • OF THE CASES REPORTED, ABOUT 67% RESULTED IN DEATH OR LIVER TRANSPLANTATION, USUALLY WITHIN 5 WEEKS OF THE ONSET OF SIGNS AND SYMPTOMS OF LIVER FAILURE. THE EARLIEST ONSET OF SEVERE HEPATIC DYSFUNCTION FOLLOWED SUBSEQUENTLY BY LIVER FAILURE WAS 3 WEEKS AFTER INITIATION OF FELBAMATE. ALTHOUGH SOME REPORTS DESCRIBED DARK URINE AND NONSPECIFIC PRODROMAL SYMPTOMS (E.G., ANOREXIA, MALAISE, AND GASTROINTESTINAL SYMPTOMS), IN OTHER REPORTS IT WAS NOT CLEAR IF ANY PRODROMAL SYMPTOMS PRECEDED THE ONSET OF JAUNDICE.
  • IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING HEPATIC FAILURE CHANGES WITH DURATION OF EXPOSURE.
  • IT IS NOT KNOWN WHETHER OR NOT THE DOSAGE OF FELBAMATE AFFECTS THE INCIDENCE OF HEPATIC FAILURE.
  • IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECT THE INCIDENCE OF HEPATIC FAILURE.
  • FELBAMATE SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION.
  • TREATMENT WITH FELBAMATE SHOULD BE INITIATED ONLY IN INDIVIDUALS WITHOUT ACTIVE LIVER DISEASE AND WITH NORMAL BASELINE SERUM TRANSAMINASES. IT HAS NOT BEEN PROVED THAT PERIODIC SERUM TRANSAMINASE TESTING WILL PREVENT SERIOUS INJURY BUT IT IS GENERALLY BELIEVED THAT EARLY DETECTION OF DRUG u00ad INDUCED HEPATIC INJURY ALONG WITH IMMEDIATE WITHDRAWAL OF THE SUSPECT DRUG ENHANCES THE LIKELIHOOD FOR RECOVERY. THERE IS NO INFORMATION AVAILABLE THAT DOCUMENTS HOW RAPIDLY PATIENTS CAN PROGRESS FROM NORMAL LIVER FUNCTION TO LIVER FAILURE, BUT OTHER DRUGS KNOWN TO BE HEPATOTOXINS CAN CAUSE LIVER FAILURE RAPIDLY (E.G., FROM NORMAL ENZYMES TO LIVER FAILURE IN 2-4 WEEKS). ACCORDINGLY, MONITORING OF SERUM TRANSAMINASE LEVELS (AST AND ALT) IS RECOMMENDED AT BASELINE AND PERIODICALLY THEREAFTER. WHILE THE MORE FREQUENT THE MONITORING THE GREATER THE CHANCES OF EARLY DETECTION, THE PRECISE SCHEDULE FOR MONITORING IS A MATTER OF CLINICAL JUDGEMENT.
  • FELBAMATE SHOULD BE DISCONTINUED IF EITHER SERUM AST OR SERUM ALT LEVELS BECOME INCREASED u2265 2 TIMES THE UPPER LIMIT OF NORMAL, OR IF CLINICAL SIGNS AND SYMPTOMS SUGGEST LIVER FAILURE (SEE PRECAUTIONS). PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON FELBAMATE AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR LIVER INJURY IF FELBAMATE IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT BE CONSIDERED FOR RE-TREATMENT
  • Felbamate, USPu00a0is an antiepileptic available as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate.
  • Felbamate, USPu00a0is 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, USP's molecular formula is CHNO; its structural formula is:
  • The inactive ingredients for Felbamate Oral Suspension, USPu00a0600 mg/5 mL are noncrystallizing sorbitol solution, microcrystalline cellulose and carboxymethylcellulose sodium, glycerin, methylparaben, propylparaben, polysorbate 80, simethicone emulsion, saccharin sodium monohydrate, bubblegum flavor (contains arabic gum, and natural and artificial flavor), FD&C Red No. 40, FD&C Yellow No. 6, and purified water.
  • Mechanism of Action:
  • 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 electroshocku00adinduced 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 n
  • The monocarbamate, p-hydroxy, and 2-hydroxy metabolites were inactive in the maximal electroshocku00adinduced 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.
  • The results of controlled clinical trials established the efficacy of felbamate as monotherapy and adjunctive therapy in adults with partial-onset seizures with or without secondary generalization and in partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
  • Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see ). Felbamate oral suspension 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, felbamate oral suspension 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.
  • Felbamate oral suspension is contraindicated in patients with known hypersensitivity to felbamate, 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 Boxed Warning regarding aplastic anemia and hepatic failure.
  • Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.
  • Antiepileptic drugs (AEDs) including felbamate, 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 felbamate 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.
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  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or n- Arrayn- Array
  • The most common adverse reactions seen in association with felbamate in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with felbamate in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache.
  • The most common adverse reactions seen in association with felbamate 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:
  • The prescriber should be aware that the figures cited in the following table cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different investigators, treatments, and uses including the use of felbamate as adjunctive therapy where the incidence of adverse events may be higher due to drug interactions. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
  • Arrayn- Array
  • Incidence in Controlled Clinical Trials-Monotherapy Studies in Adults:
  • The table that follows enumerates adverse events that occurred at an incidence of 2% or more among 58 adult patients who received felbamate monotherapy at dosages of 3600 mg/day in double-blind controlled trials. Table 3 presents reported adverse events that were classified using standard WHO-based dictionary terminology.
  • Arrayn- Array
  • Incidence in Controlled Add-On Clinical Studies in Adults:
  • Table 4 enumerates adverse events that occurred at an incidence of 2% or more among 114 adult patients who received felbamate adjunctive therapy in add-on controlled trials at dosages up to 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.
  • 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.
  • Arrayn- Children
  • Incidence in a Controlled Add-On Trial in Children with Lennox-Gastaut Syndrome:
  • Table 5 enumerates adverse events that occurred more than once among 31 pediatric patients who received felbamate up to 45 mg/kg/day or a maximum of 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.
  • Other Events Observed in Association with the Administration of Felbamate:
  • In the paragraphs that follow, the adverse clinical events, other than those in the preceding tables, that occurred in a total of 977 adults and 357 children exposed to felbamate and that are reasonably associated with its use are presented. They are listed in order of decreasing frequency. Because the reports cite events observed in open-label and uncontrolled studies, the role of felbamate in their causation cannot be reliably determined.
  • 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 felbamate.
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  • Arrayn- : n- Frequent:n- Infrequent:n- Rare:
  • Arrayn- : n- Rare:
  • Postmarketing Adverse Event Reports:
  • Voluntary reports of adverse events in patients taking felbamate (usually in conjunction with other drugs) have been received since market introduction and may have no causal relationship with the drug(s). These include the following by body system:
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  • Abuse:
  • Dependence:
  • Four subjects inadvertently received 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 felbamate 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.
  • Felbamate oral suspension has been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As felbamate oral suspensionu00a0is 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 u00a0subsection).
  • Dosage Adjustment in the Renally Impaired:n- Arrayn- Array
  • u00a0n
  • The majority of patients received 3600 mg/day in clinical trials evaluating its use as both monotherapy and adjunctive therapy.
  • Arrayn- Monotherapy:
  • Arrayn- Conversion to Monotherapy:
  • Arrayn- Adjunctive Therapy:
  • While the above felbamate conversion guidelines may result in a felbamate 3600 mg/day dose within 3 weeks, in some patients titration to a 3600 mg/day felbamate dose has been achieved in as little as 3 days with appropriate adjustment of other AEDs.
  • Arrayn- Children with Lennox-Gastaut Syndrome (Ages 2-14 years)
  • Arrayn- Adjunctive Therapy:
  • Felbamate Oral Suspension, USP 600 mg/5 mL, is a pink colored suspension available in 8 oz. bottles (NDC 66689-825-08) and 16 oz. bottles (NDC 66689-825-16).
  • Shake suspension well before using. Store oral suspension at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature].
  • Dispense in a tight container.
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or n- Arrayn- Array
  • VistaPharm, Inc. Largo, FL 33771 USA
  • VP2233R1Rev. 03/19n
  • FELBAMATE SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS.All patients treated with felbamate should acknowledge that they understand the risks and other information about felbamate discussed below, and physicians should acknowledge this discussion.
  • IMPORTANT INFORMATION AND WARNING:
  • Felbamate, taken by itself or with other prescription and/or non-prescription drugs, can result in a severe, potentially fatal blood abnormality (u201caplastic anemiau201d) and/or severe, potentially fatal liver damage.
  • PATIENT ACKNOWLEDGMENT:
  • Do not sign this form if there is anything you do not understand about the information you have received.u00a0 Ask your doctor about anything you do not understand before you initial any of the items below or sign this form.
  • My [My son, daughter, ward_____________________________________________________'s] treatment with felbamate has been personally explained to me by Dr. _____________________ . The following points of information, among others, have been specifically discussed and made clear and I have had the opportunity to ask any questions concerning this information:
  • 1. I, ____________________________________________________________(Patient's Name), understand that felbamate is used to treat certain types of seizures and my physician has told me that I have this type(s) of seizures;
  • INITIALS: ________________ u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • 2. I understand that felbamate is being used because my seizures have not been satisfactorily treated with other antiepileptic drugs;
  • INITIALS: ________________ u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • 3. I understand that there is a serious risk that I could develop aplastic anemia and/or liver failure, both of which are potentially fatal, by using felbamate;
  • INITIALS: _________________u00a0 u00a0u00a0u00a0u00a0
  • 4. I understand that there are no laboratory tests which will predict if I am at an increased risk for one of the potentially fatal conditions;
  • INITIALS: __________________ u00a0u00a0u00a0
  • 5. I understand that I should have the recommended blood work before my treatment with felbamate is begun (baseline) and periodically thereafter as clinical judgement warrants. I understand that although this blood work may help detect if I develop one of these conditions, it may do so only after significant, irreversible and potentially fatal damage has already occurred;
  • INITIALS: _______________ u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • 6. If I am currently taking other antiepileptic drugs, I understand that the manufacturer of felbamate recommends that the dosage of these other drugs be decreased by a certain amount when felbamate is started; if my physician determines that this should not be done in my case, he/she has explained the reason(s) for this decision;
  • INITIALS: _________________ u00a0u00a0u00a0u00a0u00a0 u00a0
  • 7. I understand that I must immediately report any unusual symptoms to Dr. _______________ u00a0 u00a0and be especially aware of any rashes, easy bruising, bleeding, sore throats, fever, and/or dark urine;u00a0u00a0
  • INITIALS: _________________u00a0 u00a0u00a0u00a0u00a0
  • 8. I understand that antiepileptic drugs such as felbamate may increase the risk of suicidal thoughts and behavior. I understand that I must immediately report any unusual changes in mood or behavior, symptoms of depression or thoughts about self-harm to Dr. __________________ .
  • INITIALS: __________________ u00a0
  • _______________________________
  • Patient, Parent, or Guardian
  • _______________________________
  • Address
  • _______________________________
  • Telephone
  • Arrayn- :
  • I have fully explained to the patient, ___________________________________________, the nature and purpose of the treatment with felbamate and the potential risks associated with that treatment. I have asked the patient if he/she has any questions regarding this treatment or the risks and have answered those questions to the best of my ability. I also acknowledge that I have read and understand the prescribing information.
  • ______________________________________________________________________
  • Physicianu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Date
  • Arrayn- NOTE TO PHYSICIAN:
  • Arrayn- SUPPLY OF PATIENT/PHYSICIAN ACKNOWLEDGMENT FORMS:
  • A supply of u201cPatient/Physician Acknowledgementu201d Forms as printed above is available, free of charge, from VistaPharm, Inc. representative, or may be obtained by calling 1-888-655-1505. Permission to use the above Patient/Physician Acknowledgment Form by photocopy reproduction is also hereby granted by VistaPharm, Inc.
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771 USA
  • VP2234
  • Rev. 01/19
  • Felbamate (fel-BAM-ate) Oral Suspension, USP
  • Read this Medication Guide before you start taking felbamate oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about felbamate oral suspension?
  • Do not stop taking felbamate oral suspension without first talking to your healthcare provider.
  • Stopping felbamate oral suspension suddenly can cause serious problems.
  • Felbamate oral suspension can cause serious side effects, including:
  • 1. Felbamate oral suspension may cause serious blood problems that may be life-threatening.
  • Call your healthcare provider right away if you have any of the following symptoms:
  • 2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms:
  • 3. Like other antiepileptic drugs, felbamate oral suspension may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: n
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • Do not stop felbamate oral suspension without first talking to a healthcare provider.
  • Stopping felbamate oral suspension suddenly can cause serious problems. You should talk to your healthcare provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
  • What is Felbamate oral suspension?
  • Felbamate oral suspension is a prescription medicine used when other treatments have failed in:
  • What should I tell my healthcare provider before taking felbamate oral suspension?
  • Before you take felbamate oral suspension, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Taking felbamate oral suspension with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take felbamate oral suspension?
  • What should I avoid while taking felbamate oral suspension?
  • What are the possible side effects of felbamate oral suspension?
  • See u201cWhat is the most important information I should know about felbamate oral suspension?u201d
  • Felbamaten- oral suspension may cause serious side effects including:
  • The most common side effects of felbamate oral suspension include:
  • These are not all the possible side effects of felbamate oral suspension. For more information, ask your healthcare provider or pharmacist.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to
  • FDA at 1-800-FDA-1088 or contact VistaPharm, Inc., at 1-888-655-1505. u00a0
  • How should I store felbamate oral suspension?
  • Keep felbamate oral suspension and all medicines out of the reach of children.
  • General information about felbamate oral suspension.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use felbamate oral suspensionu00a0for a condition for which it was not prescribed. Do not give felbamate oral suspension to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about felbamate. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about felbamate that is written for health professionals.
  • What are the ingredients in felbamate oral suspension?
  • Active Ingredient:
  • Inactive Ingredients:
  • For more information, call VistaPharm, Inc., at 1-888-655-1505.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Rx Only
  • Distributed by:
  • VistaPharm, Inc. Largo, FL 33771 USAn
  • VP2235Rev. 01/19
  • NDC 66689-825-08
  • FelbamateOral Suspension, USP
  • 600 mg per 5 mL(120 mg per mL)
  • Dispense the accompanyingMedication Guide to each patient.n
  • SHAKE THE BOTTLE WELL BEFORE EACH USE.
  • 237 mL
  • Rx Only
  • VistaPharm, Inc.
  • NDC 66689-825-16
  • FelbamateOral Suspension, USP
  • 600 mg per 5 mL(120 mg per mL)
  • Dispense the accompanyingMedication Guide to each patient.n
  • SHAKE THE BOTTLE WELL BEFORE EACH USE.
  • 473 mL
  • Rx Only
  • VistaPharm, Inc.
  • NDC 66689-825-08
  • FelbamateOral Suspension, USP
  • 600 mg per 5 mL(120 mg per mL)
  • Dispense the accompanyingMedication Guide to each patient.
  • SHAKE THE BOTTLE WELL BEFORE EACH USE.
  • 237 mL
  • Rx Only
  • VistaPharm, Inc.
  • NDC 66689-825-16
  • FelbamateOral Suspension, USP
  • 600 mg per 5 mL(120 mg per mL)
  • Dispense the accompanyingMedication Guide to each patient.
  • SHAKE THE BOTTLE WELL BEFORE EACH USE.
  • 473u00a0mL
  • Rx Only
  • VistaPharm, Inc.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Felbamate (Felbamate) which is also known as Felbamate and Manufactured by VistaPharm, Inc.. It is available in strength of 600 mg/5mL.

Felbamate (Felbamate) 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.

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