Topiramat Arcana Side effects

• Side effects of Topiramat Arcana in details
• Topiramat Arcana contraindications
• Topiramat Arcana reviews

What are the possible side effects of Topiramat Arcana?

Get emergency medical help if you have any of these signs of an allergic reaction to Topiramat Arcana: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening mood symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• vision problems, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);

• confusion, slowed thinking, memory problems, trouble concentrating, problems with speech;

• dehydration symptoms - decreased sweating, high fever, hot and dry skin;

• signs of a kidney stone - severe pain in your side or lower back, painful or difficult urination;

• signs of too much acid in your blood - irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or

• signs of too much ammonia in your blood - vomiting, unexplained weakness, feeling like you might pass out.

Common Topiramat Arcana side effects may include:

• numbness or tingling in your arms and legs;

• flushing (warmth, redness, or tingly feeling);

• headache, dizziness, drowsiness, tired feeling;

• mood problems, confusion, feeling nervous, problems with thinking or memory;

• changes in your sense of taste;

• nausea, diarrhea, stomach pain, loss of appetite, indigestion, weight loss; or

• rapid back-and-forth movements of the eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Topiramat Arcana in details

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 Arcana

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 Arcana 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 Arcana 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 Arcana 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 Arcana 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 Arcana 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 Arcana as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for Topiramat Arcana 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 Arcana 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 Arcana as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for Topiramat Arcana 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 Arcana Monotherapy Trial with incidence ≥ 2% in any Topiramat Arcana group and incidence in the 400 mg per day group greater than in the 50 mg per day group

Body System/ Adverse Reaction	Age Group
Pediatric(6 to ≥ 16 Years)	Adult(Age ≥ 16 Years)
Immediate-release Topiramat Arcana Daily Dosage Group (mg per day)
50 (N=74) %Reactions that Occurred in at Least 1% of Topiramat Arcana-Treated Patients and Occurred More Frequently in Topiramat Arcana-Treated Than Placebo-Treated Patients

Laboratory Abnormalities

Topiramat Arcana decreases serum bicarbonate.

Immediate-release Topiramat Arcana 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 Arcana.

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

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

Clinical Trials Experience With Topiramat Arcana

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 Arcana 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 Arcana experience.

The safety data presented below are from 249 patients with partial epilepsy on concomitant AEDs who participated in the Topiramat Arcana 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

Body System/ Adverse Reaction	Placebo (N=125)	Topiramat Arcana (200 mg) (N=124)
General Disorders
Fatigue	5	6
Asthenia	1	2
Irritability	1	2
Nervous System Disorders
Somnolence	2	12
Dizziness	6	7
Paresthesia	2	7
Aphasia	0	2
Dysarthria	1	2
Memory impairment	1	2
Psychiatric Disorder
Psychomotor retardation	0	2
Cardiovascular Disorders, General
Hypertension	1	3
Metabolic and Nutritional Disorders
Weight decrease	0	7
Decreased appetite	2	4
Anorexia	1	2

In the controlled clinical study using Topiramat Arcana, 8.9% of patients who received Topiramat Arcana 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 Arcana. 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.

What is the most important information I should know about Topiramat Arcana?

• Topiramat Arcana sprinkle capsules may cause drowsiness, dizziness, confusion, trouble concentrating, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Topiramat Arcana sprinkle capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not change your dose without checking with your doctor.
• Do not drink alcohol while you are using Topiramat Arcana sprinkle capsules.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Topiramat Arcana sprinkle capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Topiramat Arcana sprinkle capsules may reduce sweating, which could raise body temperature, especially in children. This risk is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. Dress lightly while in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek medical attention right away if you have decreased sweating, fever, mental or mood changes, headache, or dizziness.
• Topiramat Arcana sprinkle capsules may cause high blood acid levels (metabolic acidosis). The risk may be greater in children and in patients with kidney problems, severe breathing problems, or diarrhea. It may also be greater in patients who are taking certain other medicines (eg, acetazolamide), will be having surgery, or are on a ketogenic diet. Over a period of time, metabolic acidosis may cause kidney stones, bone problems, or decreased growth in children. Contact your doctor immediately if you experience fast breathing, unusual tiredness or weakness, sluggishness, persistent loss of appetite, or fast or irregular heartbeat.
• Topiramat Arcana sprinkle capsules may cause high blood ammonia levels (hyperammonemia). This risk may be greater in patients with metabolism problems or certain liver problems. It may also be greater in patients who are taking valproic acid. Contact your doctor immediately if you experience decreased alertness, mental changes, sluggishness, unusual tiredness, or vomiting.
• Patients who take Topiramat Arcana sprinkle capsules may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Topiramat Arcana sprinkle capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Topiramat Arcana sprinkle capsules may cause serious eye problems that could lead to permanent loss of vision if not treated. Seek medical attention right away if you experience new eye symptoms (eg, blurred vision or other vision changes, eye pain or redness).
• Tell your doctor or dentist that you take Topiramat Arcana sprinkle capsules before you receive any medical or dental care, emergency care, or surgery.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Topiramat Arcana sprinkle capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms). Discuss any questions or concerns with your doctor.
• Lab tests, including serum bicarbonate levels, may be performed while you use Topiramat Arcana sprinkle capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Topiramat Arcana sprinkle capsules in CHILDREN; they may be more sensitive to its effects, especially decreased sweating and decreased bicarbonate levels.
• Topiramat Arcana sprinkle capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Topiramat Arcana sprinkle capsules.
• Topiramat Arcana sprinkle capsules may cause birth defects if you take it while you are pregnant. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take Topiramat Arcana sprinkle capsules, use effective birth control while you are taking it. Talk with your doctor about the best kind of birth control to use while taking Topiramat Arcana sprinkle capsules, if you are planning to become pregnant, and if you have questions or concerns about this information.
• PREGNANCY and BREAST-FEEDING: Topiramat Arcana sprinkle capsules may cause birth defects if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of taking Topiramat Arcana sprinkle capsules while you are pregnant. You and your doctor will need to decide if you will continue to take Topiramat Arcana sprinkle capsules while you are pregnant. Topiramat Arcana sprinkle capsules is found in breast milk. If you are or will be breast-feeding while you take Topiramat Arcana sprinkle capsules, check with your doctor. Discuss any possible risks to your baby.

Topiramat Arcana contraindications

Topiramat Arcana 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 Arcana for seizures. Do not start or stop taking Topiramat Arcana 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 Arcana without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Topiramat Arcana 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 Arcana.

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. DTP/NCI. "topiramate: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(-)-BETA-D-FRUCTOPYRANOS-[(3AS,5AR,8AR,8BS)-2,2,7,7-TETRAMETHYLTETRAHYDRO-3AH-BIS[1,3]DIOXOLO[4,5-B:4',5'-D]PYRAN-3A-YL]METHYL SULFAMATE: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Topiramat Arcana are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Topiramat Arcana. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology