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Felbatol Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Felbatol safely and effectively. Before taking Felbatol please consult with your doctor. See full prescribing information for Felbatol.

Warning

WARNING 1. APLASTIC ANEMIA THE USE OF FELBATOL® (felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBATOL® 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 INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBATOL® WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. AMONG FELBATOL® 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 FELBATOL® 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. IN MANAGING PATIENTS ON FELBATOL®, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBATOL® FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBATOL® 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 FELBATOL® REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS. 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 FELBATOL® WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK. IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBATOL® 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. FELBATOL® SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS. 2. HEPATIC FAILURE EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF FELBATOL®. 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 FELBATOL®. 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 FELBATOL® 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. FELBATOL® SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION. TREATMENT WITH FELBATOL® 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-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. FELBATOL® SHOULD BE DISCONTINUED IF EITHER SERUM AST OR SERUM ALT LEVELS BECOME INCREASED ≥ 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 FELBATOL® AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR LIVER INJURY IF FELBATOL® IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT BE CONSIDERED FOR RE-TREATMENT.

Indications And Usage

Felbatol® is not indicated as a first line antiepileptic treatment (see Warnings ). 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.

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Dosage And Administration

Table 6 Dosage Table (adults)
*See Adjunctive and Conversion to Monotherapy sections.
Dosage reduction of concomitant AEDs WEEK 1 REDUCE original dose by 20–33%* WEEK 2 REDUCE original dose by up to an additional 1/3* WEEK 3 REDUCE as clinically indicated
Felbatol® Dosage 1200 mg/day Initial dose 2400 mg/day Therapeutic dosage range 3600 mg/day Therapeutic dosage range

Contraindications

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.

Adverse Reactions

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 . 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: 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 Felbatol® (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. Adults 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 Felbatol® 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. Table 3 Adults Treatment-Emergent Adverse Event Incidence in Controlled Monotherapy Trials *3600 mg/day;** 15 mg/kg/day Felbatol®* (N=58) Low Dose Valproate** (N=50) Body System Event % % Body as a Whole Fatigue Weight Decrease Face Edema 6.9 3.4 3.4 4.0 0 0 Central Nervous System Insomnia Headache Anxiety 8.6 6.9 5.2 4.0 18.0 2.0 Dermatological Acne Rash 3.4 3.4 0 0 Digestive Dyspepsia Vomiting Constipation Diarrhea SGPT Increased 8.6 8.6 6.9 5.2 5.2 2.0 2.0 2.0 0 2.0 Metabolic/Nutritional Hypophosphatemia 3.4 0 Respiratory Upper Respiratory Tract Infection Rhinitis 8.6 6.9 4.0 0 Special Senses Diplopia Otitis Media 3.4 3.4 4.0 0 Urogenital Intramenstrual Bleeding Urinary Tract Infection 3.4 3.4 0 2.0 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 Felbatol® 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. Table 4 Adults Treatment-Emergent Adverse Event Incidence in Controlled Add-On Trials Felbatol® Placebo (N=114) (N=43) Body System/Event % % Body as a Whole Fatigue Fever Chest Pain 16.8 2.6 2.6 7.0 4.7 0 Central Nervous System Headache Somnolence Dizziness Insomnia Nervousness Tremor Anxiety Gait Abnormal Depression Paraesthesia Ataxia Mouth Dry Stupor 36.8 19.3 18.4 17.5 7.0 6.1 5.3 5.3 5.3 3.5 3.5 2.6 2.6 9.3 7.0 14.0 7.0 2.3 2.3 4.7 0 0 2.3 0 0 0 Dermatological Rash 3.5 4.7 Digestive Nausea Anorexia Vomiting Dyspepsia Constipation Diarrhea Abdominal Pain SGPT Increased 34.2 19.3 16.7 12.3 11.4 5.3 5.3 3.5 2.3 2.3 4.7 7.0 2.3 2.3 0 0 Musculoskeletal Myalgia 2.6 0 Respiratory Upper Respiratory Tract Infection Sinusitis Pharyngitis 5.3 3.5 2.6 7.0 0 0 Special Senses Diplopia Taste Perversion Vision Abnormal 6.1 6.1 5.3 0 0 2.3 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 Felbatol® up to 45 mg/kg/day or a maximum of 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology. Table 5 Children Treatment-Emergent Adverse Event Incidence in Controlled Add-On Lennox-Gastaut Trials Felbatol® Placebo (N=31) (N=27) Body System/Event % % Body as a Whole Fever Fatigue Weight Decrease Pain 22.6 9.7 6.5 6.5 11.1 3.7 0 0 Central Nervous System Somnolence Insomnia Nervousness Gait Abnormal Headache Thinking Abnormal Ataxia Urinary Incontinence Emotional Lability Miosis 48.4 16.1 16.1 9.7 6.5 6.5 6.5 6.5 6.5 6.5 11.1 14.8 18.5 0 18.5 3.7 3.7 7.4 0 0 Dermatological Rash 9.7 7.4 Digestive Anorexia Vomiting Constipation Hiccup Nausea Dyspepsia 54.8 38.7 12.9 9.7 6.5 6.5 14.8 14.8 0 3.7 0 3.7 Hematologic Purpura Leukopenia 12.9 6.5 7.4 0 Respiratory Upper Respiratory Tract Infection Pharyngitis Coughing 45.2 9.7 6.5 25.9 3.7 0 Special Senses Otitis Media 9.7 0 Other Events Observed in Association with the Administration of Felbatol® (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 Felbatol® (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 Felbatol® 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 Felbatol®. Body as a Whole: Frequent: Weight increase, asthenia, malaise, influenza-like symptoms; Rare: anaphylactoid reaction, chest pain substernal. Cardiovascular: Frequent: Palpitation, tachycardia; Rare: supraventricular tachycardia. Central Nervous System: Frequent: Agitation, psychological disturbance, aggressive reaction: Infrequent: hallucination, euphoria, suicide attempt, migraine. Digestive: Frequent: SGOT increased; Infrequent: esophagitis, appetite increased; Rare: GGT elevated. Hematologic: Infrequent: Lymphadenopathy, leukopenia, leukocytosis, thrombocytopenia, granulocytopenia; Rare: antinuclear factor test positive, qualitative platelet disorder, agranulocytosis. Metabolic/Nutritional: Infrequent: Hypokalemia, hyponatremia, LDH increased, alkaline phosphatase increased, hypophosphatemia; Rare: creatinine phosphokinase increased. Musculoskeletal: Infrequent: Dystonia. Dermatological: Frequent: Pruritus; Infrequent: urticaria, bullous eruption; Rare: buccal mucous membrane swelling, Stevens-Johnson Syndrome. Special Senses: Rare: Photosensitivity allergic reaction. Postmarketing Adverse Event Reports: Voluntary reports of adverse events in patients taking Felbatol® (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: Body as a Whole: neoplasm, sepsis, L.E. syndrome, SIDS, sudden death, edema, hypothermia, rigors, hyperpyrexia. Cardiovascular: atrial fibrillation, atrial arrhythmia, cardiac arrest, torsade de pointes, cardiac failure, hypotension, hypertension, flushing, thrombophlebitis, ischemic necrosis, gangrene, peripheral ischemia, bradycardia, Henoch-Schönlein purpura (vasculitis). Central & Peripheral Nervous System: delusion, paralysis, mononeuritis, cerebrovascular disorder, cerebral edema, coma, manic reaction, encephalopathy, paranoid reaction, nystagmus, choreoathetosis, extrapyramidal disorder, confusion, psychosis, status epilepticus, dyskinesia, dysarthria, respiratory depression, apathy, concentration impaired. Dermatological: abnormal body odor, sweating, lichen planus, livedo reticularis, alopecia, toxic epidermal necrolysis. Digestive: (Refer to WARNINGS ) hepatitis, hepatic failure, G.I. hemorrhage, hyperammonemia, pancreatitis, hematemesis, gastritis, rectal hemorrhage, flatulence, gingival bleeding, acquired megacolon, ileus, intestinal obstruction, enteritis, ulcerative stomatitis, glossitis, dysphagia, jaundice, gastric ulcer, gastric dilatation, gastroesophageal reflux. Fetal Disorders: fetal death, microcephaly, genital malformation, anencephaly, encephalocele. Hematologic: (Refer to WARNINGS ) increased and decreased prothrombin time, anemia, hypochromic anemia, aplastic anemia, pancytopenia, hemolytic uremic syndrome, increased mean corpuscular volume (mcv) with and without anemia, coagulation disorder, embolism-limb, disseminated intravascular coagulation, eosinophilia, hemolytic anemia, leukemia, including myelogenous leukemia, and lymphoma, including T-cell and B-cell lymphoproliferative disorders. Metabolic/Nutritional: hypernatremia, hypoglycemia, SIADH, hypomagnesemia, dehydration, hyperglycemia, hypocalcemia. Musculoskeletal: arthralgia, muscle weakness, involuntary muscle contraction, rhabdomyolysis. Respiratory: dyspnea, pneumonia, pneumonitis, hypoxia, epistaxis, pleural effusion, respiratory insufficiency, pulmonary hemorrhage, asthma. Special Senses: hemianopsia, decreased hearing, conjunctivitis. Urogenital: menstrual disorder, acute renal failure, hepatorenal syndrome, hematuria, urinary retention, nephrosis, vaginal hemorrhage, abnormal renal function, dysuria, placental disorder.

Drug Interactions

Drug Interactions: The drug interaction data described in this section were obtained from controlled clinical trials and studies involving otherwise healthy adults with epilepsy. Use in Conjunction with Other Antiepileptic Drugs (see DOSAGE AND ADMINISTRATION): The addition of Felbatol® to antiepileptic drugs (AEDs) affects the steady-state plasma concentrations of AEDs. The net effect of these interactions is summarized in Table 2: Table 2 Steady-State Plasma Concentrations of Felbatol When Coadministered With Other AEDs *Not administered but an active metabolite of carbamazepine. **No significant effect. AED Coadministered AED Concentration Felbatol® Concentration Phenytoin ↑ ↓ Valproate ↑ ↔** Carbamazepine (CBZ) *CBZ epoxide ↓ ↑ ↓ Phenobarbital ↑ ↓ Specific Effects of Felbatol® on Other Antiepileptic Drugs: Phenytoin: Felbatol® causes an increase in steady-state phenytoin plasma concentrations. In 10 otherwise healthy subjects with epilepsy ingesting phenytoin, the steady-state trough (Cmin) phenytoin plasma concentration was 17±5 micrograms/mL. The steady-state Cmin increased to 21±5 micrograms/mL when 1200 mg/day of felbamate was coadministered. Increasing the felbamate dose to 1800 mg/day in six of these subjects increased the steady-state phenytoin Cmin to 25±7 micrograms/mL. In order to maintain phenytoin levels, limit adverse experiences, and achieve the felbamate dose of 3600 mg/day, a phenytoin dose reduction of approximately 40% was necessary for eight of these 10 subjects. 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: Felbatol® causes a decrease in the steady-state carbamazepine plasma concentrations and an increase in the steady-state carbamazepine epoxide plasma concentration. In nine otherwise healthy subjects with epilepsy ingesting carbamazepine, the steady-state trough (Cmin) carbamazepine concentration was 8±2 micrograms/mL. The carbamazepine steady-state Cmin decreased 31% to 5±1 micrograms/mL when felbamate (3000 mg/day, divided into three doses) was coadministered. Carbamazepine epoxide steady-state Cmin concentrations increased 57% from 1.0±0.3 to 1.6±0.4 micrograms/mL with the addition of felbamate. In clinical trials, similar changes in carbamazepine and carbamazepine epoxide were seen. Valproate: Felbatol® causes an increase in steady-state valproate concentrations. In four subjects with epilepsy ingesting valproate, the steady-state trough (Cmin) valproate plasma concentration was 63±16 micrograms/mL. The steady-state Cmin increased to 78±14 micrograms/mL when 1200 mg/day of felbamate was coadministered. Increasing the felbamate dose to 2400 mg/day increased the steady-state valproate Cmin to 96±25 micrograms/mL. Corresponding values for free valproate Cmin concentrations were 7±3, 9±4, and 11±6 micrograms/mL for 0, 1200, and 2400 mg/day Felbatol®, respectively. The ratios of the AUCs of unbound valproate to the AUCs of the total valproate were 11.1%, 13.0%, and 11.5%, with coadministration of 0, 1200, and 2400 mg/day of Felbatol®, respectively. This indicates that the protein binding of valproate did not change appreciably with increasing doses of Felbatol®. Phenobarbital: Coadministration of felbamate with phenobarbital causes an increase in phenobarbital plasma concentrations. In 12 otherwise healthy male volunteers ingesting phenobarbital, the steady-state trough (Cmin) phenobarbital concentration was 14.2 micrograms/mL. The steady-state Cmin concentration increased to 17.8 micrograms/mL when 2400 mg/day of felbamate was coadministered for one week. Effects of Other Antiepileptic Drugs on Felbatol®: Phenytoin: Phenytoin causes an approximate doubling of the clearance of Felbatol® (felbamate) at steady-state and, therefore, the addition of phenytoin causes an approximate 45% decrease in the steady-state trough concentrations of Felbatol® as compared to the same dose of Felbatol® given as monotherapy. Carbamazepine: Carbamazepine causes an approximate 50% increase in the clearance of Felbatol® at steady-state and, therefore, the addition of carbamazepine results in an approximate 40% decrease in the steady-state trough concentrations of Felbatol® as compared to the same dose of Felbatol® given as monotherapy. Valproate: Available data suggest that there is no significant effect of valproate on the clearance of Felbatol® at steady-state. Therefore, the addition of valproate is not expected to cause a clinically important effect on Felbatol® (felbamate) plasma concentrations. Phenobarbital: It appears that phenobarbital may reduce plasma felbamate concentrations. Steady-state plasma felbamate concentrations were found to be 29% lower than the mean concentrations of a group of newly diagnosed subjects with epilepsy also receiving 2400 mg of felbamate a day. Effects of Antacids on Felbatol®: The rate and extent of absorption of a 2400 mg dose of Felbatol® as monotherapy given as tablets was not affected when coadministered with antacids. Effects of Erythromycin on Felbatol®: The coadministration of erythromycin (1000 mg/day) for 10 days did not alter the pharmacokinetic parameters of Cmax, Cmin, AUC, Cl/kg or tmax at felbamate daily doses of 3000 or 3600 mg/day in 10 otherwise healthy subjects with epilepsy. Effects of Felbatol® on Low-Dose Combination Oral Contraceptives: A group of 24 nonsmoking, healthy white female volunteers established on an oral contraceptive regimen containing 30 µg ethinyl estradiol and 75 µg gestodene for at least 3 months received 2400 mg/day of felbamate from midcycle (day 15) to midcycle (day 14) of two consecutive oral contraceptive cycles. Felbamate treatment resulted in a 42% decrease in the gestodene AUC 0-24, but no clinically relevant effect was observed on the pharmacokinetic parameters of ethinyl estradiol. No volunteer showed hormonal evidence of ovulation, but one volunteer reported intermenstrual bleeding during felbamate treatment.

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SAVINGS OF 70%! "While I am blessed to be a Medicaid patient, I know plenty of people which could include me if I didn’t have Medicaid who rely heavily on the WalMart and Target $4 lists. After comparing prices on this and other sites I have seen that there is the greatest free drug card savings potential on this site. I have already printed out 3 cards for loved ones." Jacques M.
SAVINGS OF 70%! "I have been using the RX card for almost a year now. In that time, it has saved my family over $4000. We have no insurance, and the RX card has been a God send. My husband and I are both disabled, and my 65-year old mother is almost blind and diabetic, so we would have simply had to do without. The RX card enabled us to have the meds we need. Thank you so very much!" Sharon H.
SAVINGS OF 70%! "Today, on three different prescriptions, I saved over $70!!! Thank you so much." Susan

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