Topiramat Actavis 50mg Uses

Was this medicine useful for you?

 No   Yes 

• Topiramat Actavis 50mg indications
• Uses of Topiramat Actavis 50mg in details
• Topiramat Actavis 50mg description
• Topiramat Actavis 50mg dosage
• Topiramat Actavis 50mg interactions
• Topiramat Actavis 50mg side effects
• Topiramat Actavis 50mg contraindications

What is Topiramat Actavis 50mg?

Topiramat Actavis 50mg is a seizure medicine, also called an anticonvulsant. Topiramat Actavis 50mg is used to treat seizures in adults and children who are at least 2 years old. Trokendi XR is for use in adults and children who are at least 6 years old.

Extended-release Topiramat Actavis 50mg has a higher minimum age (at least 10 years old) when used as the child's only seizure medicine.

The Topiramat Actavis 50mg brand of this medicine is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topiramat Actavis 50mg will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

Topiramat Actavis 50mg may also be used for purposes not listed in this medication guide.

Topiramat Actavis 50mg indications

Monotherapy Epilepsy

Topiramat Actavis 50mg Tablets and Topiramat Actavis 50mg capsules (sprinkle) are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

Adjunctive Therapy Epilepsy

Topiramat Actavis 50mg Tablets and Topiramat Actavis 50mg capsules (sprinkle) are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.'s Topiramat Actavis 50mg (Topiramat Actavis 50mg) Tablets and Sprinkle Capsules. However, due to Janssen Pharmaceuticals, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Migraine

Topiramat Actavis 50mg Tablets and Topiramat Actavis 50mg capsules (sprinkle) are indicated for adults for the prophylaxis of migraine headache. The usefulness of Topiramat Actavis 50mg in the acute treatment of migraine headache has not been studied.

How should I use Topiramat Actavis 50mg?

Use Topiramat Actavis 50mg extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Topiramat Actavis 50mg extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Topiramat Actavis 50mg extended-release capsules refilled.
• Take Topiramat Actavis 50mg extended-release capsules by mouth with or without food.
• Swallow Topiramat Actavis 50mg extended-release capsules whole. Do not sprinkle on food, break, crush, chew, open, or dissolve before swallowing. If you cannot swallow Topiramat Actavis 50mg extended-release capsules whole, talk to your doctor. You may need a different medicine.
• Drinking extra fluids while you are taking Topiramat Actavis 50mg extended-release capsules is recommended. Doing so may help to prevent kidney stones from forming. Check with your doctor for instructions.
• Do not suddenly stop taking Topiramat Actavis 50mg extended-release capsules. Suddenly stopping Topiramat Actavis 50mg extended-release capsules may increase the risk of seizures. If you need to stop Topiramat Actavis 50mg extended-release capsules, your doctor will gradually lower your dose.
• If you miss a dose of Topiramat Actavis 50mg extended-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Contact your doctor if you miss more than 1 dose of Topiramat Actavis 50mg extended-release capsules.

Ask your health care provider any questions you may have about how to use Topiramat Actavis 50mg extended-release capsules.

Uses of Topiramat Actavis 50mg in details

Use: Labeled Indications

Migraine (prevention): Prophylaxis of migraine headache in patients ≥12 years of age

Seizures: Monotherapy or adjunctive therapy in patients ≥2 years of age (immediate release and Topiramat Actavis 50mg) or ≥6 years of age (Trokendi XR) with focal (partial) onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients ≥2 years of age (immediate release and Topiramat Actavis 50mg) or ≥6 years of age (Trokendi XR only) with seizures associated with Lennox-Gastaut syndrome

Off Label Uses

Antipsychotic-induced weight gain

Data from multiple meta-analyses with varying degrees of heterogeneity support the use of Topiramat Actavis 50mg in promoting modest weight loss and preventing weight gain associated with second-generation antipsychotics in patients with schizophrenia (evidence is more limited in patients with bipolar disorder).

Based on the American Academy of Neurology practice parameter for the treatment of essential tremor, Topiramat Actavis 50mg is probably effective and may be considered as an alternative agent for the treatment of limb tremor associated with essential tremor.

Topiramat Actavis 50mg description

Topiramat Actavis 50mg is a sulfamate-substituted monosaccharide. Topiramat Actavis 50mg tablets are available as 50 mg round tablets for oral administration.

Topiramat Actavis 50mg is a white crystalline powder with a bitter taste. Topiramat Actavis 50mg is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramat Actavis 50mg has the molecular formula C₁₂H₂₁NO₈S and a molecular weight of 339.36. Topiramat Actavis 50mg is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate.

Excipients/Inactive Ingredients: Microcrystalline cellulose Ph. Eur., mannitol Ph. Eur., sodium starch glycolate Type A Ph. Eur., pregelatinized starch L.M.Ph. Eur., crospovidone Ph. Eur., povidone Ph. Eur., magnesium stearate Ph. Eur., carnauba wax Ph. Eur., acetone Ph. Eur., opadry II white OY-LS-28908, opadry yellow 02H2229, ethyl alcohol Ph. Eur., purified water Ph. Eur.

Topiramat Actavis 50mg dosage

Monotherapy Use

Adults and Pediatric Patients 10 Years and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures

The recommended dose for Topiramat Actavis 50mg monotherapy in adults and pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate Topiramat Actavis 50mg Extended-Release Capsules according to the following schedule:

Adjunctive Therapy Use

Adults (17 Years of Age and Older) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Topiramat Actavis 50mg Extended-Release Capsules as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily. The recommended total dose for adults with primary generalized tonic-clonic seizures is 400 mg orally once daily.

Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg every week. Daily Topiramat Actavis 50mg doses above 1,600 mg have not been studied.

In the study of primary generalized tonic-clonic seizures using Topiramat Actavis 50mg, the assigned dose was reached at the end of 8 weeks.

Pediatric Patients (Ages 2 Years to 16 Years) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Topiramat Actavis 50mg Extended-Release Capsules as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1 or 2 week intervals by increments of 1 mg/kg to 3 mg/kg to achieve optimal clinical response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

In the study of primary generalized tonic-clonic seizures, the assigned dose of 6 mg/kg once daily was reached at the end of 8 weeks.

Dose Modifications in Patients with Renal Impairment

In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

Prior to dosing, obtain an estimated creatinine clearance (CrCl) in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease). CrCl can be estimated using the following equation (multiply by 0.85 for women):

Dosage Modifications in Patients Undergoing Hemodialysis

Topiramat Actavis 50mg is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause Topiramat Actavis 50mg concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in Topiramat Actavis 50mg plasma concentration during hemodialysis, a supplemental dose of Topiramat Actavis 50mg may be required. The actual adjustment should take into account the:

• duration of dialysis period
• clearance rate of the dialysis system being used
• effective renal clearance of Topiramat Actavis 50mg in the patient being dialyzed.

Laboratory Testing Prior to Treatment Initiation

Measurement of baseline and periodic serum bicarbonate during treatment with Topiramat Actavis 50mg Extended-Release Capsules is recommended.

Dosing Modifications in Patients Taking Phenytoin and/or Carbamazepine

The co-administration of Topiramat Actavis 50mg Extended-Release Capsules with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Topiramat Actavis 50mg Extended-Release Capsules may require adjustment of the dose of Topiramat Actavis 50mg Extended-Release Capsules.

Monitoring for Therapeutic Blood Levels

It is not necessary to monitor Topiramat Actavis 50mg plasma concentrations to optimize therapy with Topiramat Actavis 50mg Extended-Release Capsules.

Administration Instructions

Topiramat Actavis 50mg Extended-Release Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed or crushed. Do not store drug/food mixture for further use. Topiramat Actavis 50mg Extended-Release Capsules can be taken without regard to meals.

Topiramat Actavis 50mg interactions

See also:
What other drugs will affect Topiramat Actavis 50mg?

Oral Contraceptives

The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topiramat Actavis 50mg. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.

Antiepileptic Drugs

Concomitant administration of phenytoin or carbamazepine with Topiramat Actavis 50mg decreased plasma concentrations of Topiramat Actavis 50mg.

Concomitant administration of valproic acid and Topiramat Actavis 50mg has been associated with hyperammonemia with and without encephalopathy. Concomitant administration of Topiramat Actavis 50mg with valproic acid has also been associated with hypothermia (with and without hyperammonemia) in patients who have tolerated either drug alone. It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported.

Numerous AEDs are substrates of the CYP enzyme system. In vitro studies indicate that Topiramat Actavis 50mg does not inhibit enzyme activity for CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4/5 isozymes. In vitro studies indicate that immediate-release Topiramat Actavis 50mg is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. The same drug interactions can be expected with the use of Topiramat Actavis 50mg.

CNS Depressants And Alcohol

Topiramat Actavis 50mg is a CNS depressant. Concomitant administration of Topiramat Actavis 50mg with other CNS depressant drugs or alcohol can result in significant CNS depression. Concomitant use of alcohol should be avoided.

Other Carbonic Anhydrase Inhibitors

Concomitant use of Topiramat Actavis 50mg, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Patients should be monitored for the appearance or worsening of metabolic acidosis when Topiramat Actavis 50mg is given concomitantly with another carbonic anhydrase inhibitor.

Metformin

Topiramat Actavis 50mg treatment can frequently cause metabolic acidosis, a condition for which the use of metformin is contraindicated. The concomitant use of Topiramat Actavis 50mg and metformin is contraindicated in patients with metabolic acidosis.

Lithium

In patients, there was an observed increase in systemic exposure of lithium following Topiramat Actavis 50mg doses of up to 600 mg per day. Lithium levels should be monitored when co-administered with high-dose Topiramat Actavis 50mg.

Drug Abuse And Dependence

Controlled Substance

Topiramat Actavis 50mg (Topiramat Actavis 50mg) extended-release capsule is not a controlled substance.

Abuse

The abuse and dependence potential of Topiramat Actavis 50mg has not been evaluated in human studies.

Dependence

Topiramat Actavis 50mg has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

Topiramat Actavis 50mg side effects

See also:
What are the possible side effects of Topiramat Actavis 50mg?

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

• Acute Myopia and Secondary Angle Closure Glaucoma
• Visual Field Defects
• Oligohydrosis and Hyperthermia
• Metabolic Acidosis
• Suicidal Behavior and Ideation
• Cognitive/Neuropsychiatric Adverse Reactions
• Fetal Toxicity
• Hyperammonemia and Encephalopathy
• Kidney Stones
• Hypothermia with Concomitant Valproic Acid Use
• Paresthesia

Clinical Trials Experience With Immediate-Release Topiramat Actavis 50mg

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Increased Risk for Bleeding

Topiramat Actavis 50mg treatment is associated with an increased risk for bleeding. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse event for Topiramat Actavis 50mg than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). In this analysis, the incidence of serious bleeding events for Topiramat Actavis 50mg and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients.

Adverse bleeding reactions reported with Topiramat Actavis 50mg ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants).

Adverse Reactions Observed in Monotherapy Trial

Patients 16 Years and Older

The adverse reactions in the monotherapy controlled trial (Study 1) that occurred most commonly in adults in the 400 mg per day Topiramat Actavis 50mg group and at an incidence ≥ 5% higher than the 50 mg per day group were paresthesia, weight decrease, somnolence, anorexia, and difficulty with memory.

Approximately 21% of the 159 adult patients in the 400 mg per day group who received Topiramat Actavis 50mg as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for Topiramat Actavis 50mg 50 mg per day) adverse reactions causing discontinuation in this trial were difficulty with memory, fatigue, asthenia, insomnia, somnolence and paresthesia.

Pediatric Patients 6 to less than 16 Years of Age

The adverse reactions in Study 1 that occurred most commonly in pediatric patients in the 400 mg per day Topiramat Actavis 50mg group and at an incidence ≥ 5% higher than in the 50 mg per day group were fever, weight decrease, mood problems, cognitive problems, infection, flushing, and paresthesia.

Approximately 14% of the 77 pediatric patients in the 400 mg per day group who received Topiramat Actavis 50mg as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for Topiramat Actavis 50mg 50 mg per day) adverse reactions resulting in discontinuation in this trial were difficulty with concentration/attention, fever, flushing, and confusion.

Table 4: Adverse Reactions in the Immediate-Release Topiramat Actavis 50mg Monotherapy Trial with incidence ≥ 2% in any Topiramat Actavis 50mg group and incidence in the 400 mg per day group greater than in the 50 mg per day group

Laboratory Abnormalities

Topiramat Actavis 50mg decreases serum bicarbonate.

Immediate-release Topiramat Actavis 50mg treatment was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies. Similar effects should be anticipated with use of Topiramat Actavis 50mg.

Controlled trials of adjunctive Topiramat Actavis 50mg treatment of adults for partial onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% Topiramat Actavis 50mg, 2% placebo), markedly increased serum alkaline phosphatase (3% Topiramat Actavis 50mg, 1% placebo), and decreased serum potassium (0.4 % Topiramat Actavis 50mg, 0.1 % placebo).

Changes in several clinical laboratory analytes (i.e., increased creatinine, BUN, alkaline phosphatase, total protein, total eosinophil count and decreased potassium) have been observed in a clinical investigational program in very young (2 years and younger) pediatric patients who were treated with adjunctive Topiramat Actavis 50mg for partial onset seizures.

Topiramat Actavis 50mg treatment produced a dose-related increased shift in serum creatinine from normal at baseline to an increased value at the end of 4 months treatment in adolescent patients (ages 12 years to 16 years) in a double-blind, placebo-controlled study. The incidence of these abnormal shifts was 4% for placebo, 4% for 50 mg, and 18% for 100 mg.

Topiramat Actavis 50mg treatment with or without concomitant valproic acid (VPA) can cause hyperammonemia with or without encephalopathy.

Clinical Trials Experience With Topiramat Actavis 50mg

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the Topiramat Actavis 50mg study, a dose of 200 mg per day was administered to a limited number of patients; therefore, these results cannot be directly compared to immediate-release Topiramat Actavis 50mg experience.

The safety data presented below are from 249 patients with partial epilepsy on concomitant AEDs who participated in the Topiramat Actavis 50mg study.

Table 9 displays the incidence of treatment-emergent adverse reactions that occurred in ≥ 2% of patients and numerically greater than placebo.

Table 9: Incidence ( ≥ 2%) of Treatment-Emergent Adverse Reactions in Placebo-Controlled Adjunctive Therapy Clinical Trial in Patients With Partial Onset Seizures

In the controlled clinical study using Topiramat Actavis 50mg, 8.9% of patients who received Topiramat Actavis 50mg and 4.0% who received placebo discontinued as a result of treatment-emergent adverse reactions.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Topiramat Actavis 50mg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The listing is alphabetized: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic failure (including fatalities), hepatitis, maculopathy, pancreatitis, and pemphigus.

Topiramat Actavis 50mg contraindications

See also:
What is the most important information I should know about Topiramat Actavis 50mg?

Topiramat Actavis 50mg may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking Topiramat Actavis 50mg for seizures. Do not start or stop taking Topiramat Actavis 50mg during pregnancy without your doctor's advice.

Seek emergency medical attention if you have a sudden change in vision or pain around or behind the eyes. These may be early signs of a serious and permanent side effect on your vision.

Do not stop using Topiramat Actavis 50mg without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Topiramat Actavis 50mg suddenly. You may need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking Topiramat Actavis 50mg.

Active ingredient matches for Topiramat Actavis 50mg:

Topiramate in Switzerland.

References

1. DailyMed. "TOPIRAMATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "topiramate". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "topiramate". http://www.drugbank.ca/drugs/DB00273 (accessed September 17, 2018).

Reviews

User reports

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology