Topiramate (Topiramate)

Trade Name : Topiramate

Teva Pharmaceuticals USA, Inc.

CAPSULE, COATED PELLETS

Strength 15 mg/1

TOPIRAMATE Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Topiramate (Topiramate) which is also known as Topiramate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 15 mg/1 per ml. Read more

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

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No data

Topiramate capsules (sprinkle) are indicated for:

Epilepsy: initial monotherapy in patients u2265 2 years of age with partial onset or primary generalized tonic-clonic seizures (); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients u2265 2 years of age with seizures associated with Lennox-Gastaut syndrome ()
Prophylaxis of migraine in patients 12 years of age and older ()

Topiramate capsules (sprinkle) initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis (, , , 2.4, , )

Topiramate capsules (sprinkle) are available as hard gelatin capsules in the following strengths and colors:
15 mg u2013 white cap and body, filled with off-white to beige pellets, imprinted u201cTEVAu201d on the cap and u201c7335u201d on the body
25 mg u2013 white cap and body, filled with off-white to beige pellets, imprinted u201cTEVAu201d on the cap and u201c7336u201d on the body

Capsules (Sprinkle): 15 mg and 25 mg ()

None.
None ()

No data

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate as soon as possible ()
Visual field defects: consider discontinuation of topiramate ()
Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients ()
Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate if clinically appropriate ()
Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation ()
Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars; depression and mood problems may occur ()
Fetal Toxicity: use during pregnancy can cause cleft lip and/or palate and being small for gestational age ()
Withdrawal of AEDs: withdraw topiramate gradually ()
Hyperammonemia/encephalopathy: measure ammonia if encephalopathic symptoms occur ()
Kidney stones: avoid use with other carbonic anhydrase inhibitors, drugs causing metabolic acidosis, or in patients on a ketogenic diet (0)
Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use ()

The following serious adverse reactions are discussed in more detail in other sections of the labeling:
The data described in the following sections were obtained using topiramate tablets.
Epilepsy
Migraine
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

Oral contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day ()
Monitor lithium levels if lithium is used with high-dose topiramate ()

No data

Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate.
Topiramate overdose has resulted in severe metabolic acidosis [].
A patient who ingested a dose of topiramate between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.
In acute topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate . Hemodialysis is an effective means of removing topiramate from the body.

Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules (sprinkle) are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.
Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP 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. Topiramate, USP is designated chemically as 2,3:4,5-Di--isopropylidene-u03b2-D-fructopyranose sulfamate and has the following structural formula:
CHNOS M.W. 339.36
Topiramate capsules (sprinkle) contain topiramate coated beads in a hard gelatin capsule. The inactive ingredients are: black iron oxide, ethylcellulose, gelatin, povidone, polyethylene glycol, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate.

No data

Carcinogenesis
An increase in urinary bladder tumors was observed in mice given topiramate (0, 20, 75, and 300 mg/kg/day) in the diet for 21 months. The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Plasma exposures in mice receiving 300 mg/kg/day were less than or equal to steady-state exposures in patients receiving topiramate monotherapy at the maximum recommended human dose (MRHD) for epilepsy (400 mg), and 1.5 to 2 times steady-state topiramate exposures in patients receiving 400 mg of topiramate plus phenytoin. The relevance of this finding to human carcinogenic risk is uncertain. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg/day (approximately 3 times the MRHD for epilepsy and 12 times the MRHD for migraine on a mg/m basis).
Mutagenesis
Topiramate did not demonstrate genotoxic potential when tested in a battery of and assays. Topiramate was not mutagenic in the Ames test or the mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes ; and it did not increase chromosomal aberrations in human lymphocytes or in rat bone marrow .
Impairment of Fertility
No adverse effects on male or female fertility were observed in rats administered topiramate orally at doses up to 100 mg/kg/day (2.5 times the MRHD for epilepsy and 10 times the MRHD for migraine on a mg/m basis).

The studies described in the following sections were conducted using topiramate tablets.

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Eye Disorders
Instruct patients taking topiramate to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [].
Oligohidrosis and Hyperthermia
Closely monitor topiramate-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [].
Metabolic Acidosis
Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [].
Suicidal Behavior and Ideation
Counsel patients, their caregivers, and families that AEDs, including topiramate, may increase the risk of suicidal thoughts and behavior, and advise 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, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [].
Interference with Cognitive and Motor Performance
Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on topiramate to gauge whether it adversely affects their mental performance, motor performance, and/or vision [].
Even when taking topiramate or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Therefore, advise all patients taking topiramate for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). Some patients with refractory epilepsy will need to avoid such activities altogether. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities.
Fetal Toxicity
Inform pregnant women and women of childbearing potential that use of topiramate during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Also inform patients that infants exposed to topiramate monotherapy may be SGA []. There may also be risks to the fetus from chronic metabolic acidosis with use of topiramate during pregnancy []. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options.
Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using topiramate, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [].
Encourage pregnant women using topiramate, to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The registry is collecting information about the safety of antiepileptic drugs during pregnancy [].
Hyperammonemia and Encephalopathy
Warn patients about the possible development of hyperammonemia with or without encephalopathy. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. This hyperammonemia and encephalopathy can develop with topiramate treatment alone or with topiramate treatment with concomitant valproic acid (VPA).
Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [n n ].
Kidney Stones
Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [n n ].
Instructions for a Missing Dose
Instruct patients that if they miss a single dose of topiramate, it should be taken as soon as possible. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of topiramate, and to skip the missed dose. Tell patients that they should not take a double dose in the event of a missed dose. Advise patients to contact their healthcare provider if they have missed more than one dose.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. T 1/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Arrayn- 7335
Topiramaten- Capsules (Sprinkle)n- 15 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only
60 CAPSULES
TEVA

Arrayn- 7336
Topiramaten- Capsules
(Sprinkle)
25 mg
PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
Rx only
60 CAPSULES
TEVA

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Topiramate (Topiramate)

Trade Name : Topiramate

CAPSULE, COATED PELLETS

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Topiramate (Topiramate)

Trade Name : Topiramate

CAPSULE, COATED PELLETS

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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