Topiramate Tablets USP 100mg Technical Specification: 

Product Name:                             Topiramate Tablets USP 100mg
Brand Name:Generics
Strength:15mg, 25mg, 50mg, 100mg, 200mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s, 1000s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Epileptic, Anticonvulsant, Central Nervous System
Indication: Topiramate medicine is used to treat epilepsy and migraine – NHS.
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Topiramate Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Topiramate Tablets USP 100mg
    Each film-coated tablet contains:
    Topiramate USP……………………100mg
    Excipients…………………………q.s.
    Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage:  As directed by the Physician.

Attach dispensing label as per end county.

Why Taj pharmaceuticals?

Discover why Taj Pharmaceuticals is your trusted choice for Topiramate Tablets. With a commitment to excellence, quality assurance, and patient well-being, Taj Pharmaceuticals stands at the forefront of pharmaceutical innovation. Explore the reasons why Taj Pharmaceuticals is the right partner for your healthcare needs, and experience the difference in every Topiramate Tablet.

What is Topiramate Tablets and its uses?

Topiramate is a medication available in tablet form with various medical uses. It primarily falls into the category of anticonvulsants and is approved for the treatment of epilepsy, either alone or in combination with other antiepileptic drugs. Additionally, it is prescribed for the prevention of migraine headaches in adults and may be employed off-label to aid in weight loss by curbing appetite. Topiramate has also been explored as a potential treatment for bipolar disorder, alcohol dependence, and post-traumatic stress disorder (PTSD), although research in these areas is ongoing. It may also be used off-label to manage neuropathic pain. However, it is crucial to take topiramate as directed by a healthcare professional and be aware of potential side effects, including dizziness and memory problems. Consultation with a healthcare provider is essential to determine its suitability for a specific condition and to weigh the potential risks and benefits.

How does Topiramate Tablets Work?

Topiramate tablets work by modulating brain activity through several mechanisms. While the exact details are not fully understood, it is believed that topiramate enhances the inhibitory neurotransmitter GABA, inhibits voltage-gated sodium channels, reduces the activity of the excitatory neurotransmitter glutamate, and inhibits the enzyme carbonic anhydrase. These actions collectively help stabilize brain function, making topiramate effective in treating epilepsy by reducing abnormal electrical signaling. It also prevents migraines, possibly by mitigating excessive neuronal firing and neurotransmitter activity. Additionally, topiramate’s appetite-suppressing effects are thought to contribute to its off-label use for weight loss. Despite its multiple mechanisms, the exact workings of topiramate remain an area of ongoing research, and individuals should use it under the guidance of a healthcare provider, considering its potential benefits and side effects.

Benefits:

Topiramate tablets offer several therapeutic benefits for various medical conditions. Firstly, they are highly effective in the management of epilepsy, serving to control seizures either as a standalone treatment or in conjunction with other antiepileptic drugs. Additionally, topiramate has gained approval for the prevention of migraine headaches in adults, significantly reducing both their frequency and intensity. For some individuals, one of its notable advantages is its potential for weight loss, making it a valuable tool in weight management. Furthermore, topiramate may play a role in mood stabilization when used in combination with other medications, particularly for individuals with bipolar disorder. It has also shown promise in the treatment of alcohol dependence, helping to curb cravings and reduce the urge to consume alcohol. Ongoing research is exploring its potential in managing symptoms of post-traumatic stress disorder (PTSD) and neuropathic pain, further extending its therapeutic reach.

Side Effects:

Despite its benefits, topiramate is associated with several potential side effects that individuals should be aware of. These side effects encompass cognitive issues, including memory difficulties and impaired concentration, particularly at higher doses. Dizziness and drowsiness are common, which can impact activities requiring mental alertness. Some people may experience tingling or numbness in their extremities, and alterations in taste perception, often described as a metallic or bitter taste, can occur. Additionally, topiramate may lead to changes in appetite and weight, with some individuals losing weight while others gain. Mood-related side effects, such as irritability or depression, have been reported. There is also a risk of developing kidney stones, especially with inadequate fluid intake, and vision problems or glaucoma in some cases. Importantly, topiramate is associated with an increased risk of birth defects if taken during pregnancy, necessitating careful consideration and consultation with a healthcare provider if pregnancy is a concern. Lastly, though rare, it has been linked to an elevated risk of suicidal thoughts, particularly in individuals with a history of mood disorders. To maximize its benefits while minimizing potential side effects, topiramate should be used under the guidance of a healthcare professional, with close monitoring throughout the treatment course. Any concerning side effects should be promptly reported for evaluation and possible adjustments to the treatment plan.

Frequently Asked Questions About Topiramate Tablets:

  1. What is Topiramate used for?

Topiramate is a medication used for various medical purposes. It is primarily prescribed for epilepsy to control seizures, for migraine prevention, and it may also be used for off-label purposes like weight management, bipolar disorder, alcohol dependence, and more.

  1. How does Topiramate work?

The exact mechanism of action is not fully understood, but topiramate is thought to work by enhancing the inhibitory neurotransmitter GABA, inhibiting voltage-gated sodium channels, reducing glutamate activity, and inhibiting carbonic anhydrase. These actions collectively help stabilize brain function, making it effective for epilepsy, migraine prevention, and other conditions.

  1. What are the common side effects of Topiramate?

Common side effects of topiramate include cognitive issues (memory problems, difficulty concentrating), dizziness, drowsiness, tingling or numbness in extremities, changes in taste, alterations in appetite and weight, mood changes, and a risk of kidney stones. It can also affect vision and may be associated with birth defects if taken during pregnancy.

  1. How is Topiramate dosed?

The dosage of topiramate varies depending on the medical condition being treated and individual response. It is typically started at a low dose and gradually increased to achieve the desired therapeutic effect while minimizing side effects. The exact dosing regimen should be determined by a healthcare provider.

  1. Can Topiramate be used for weight loss?

Topiramate may lead to weight loss in some individuals due to its appetite-suppressing effects. It has been used off-label for weight management, but its use for this purpose should be carefully considered, and it may not be suitable for everyone.

  1. Is Topiramate safe during pregnancy?

Topiramate is associated with an increased risk of birth defects when taken during pregnancy. It is essential for women of childbearing age to discuss the potential risks and benefits with their healthcare provider and use effective contraception if they are on topiramate.

  1. Can Topiramate be used in children?

Topiramate is approved for use in children for certain epilepsy types. The dosage and suitability for pediatric use should be determined by a healthcare provider.

  1. What should I do if I miss a dose of Topiramate?

If you miss a dose, take it as soon as you remember. If it’s close to the next scheduled dose, skip the missed one and continue with the regular dosing schedule. Do not take a double dose to make up for a missed one.

  1. Can I drink alcohol while taking Topiramate?

Alcohol may increase the risk of certain side effects of topiramate, such as dizziness and drowsiness. It’s important to discuss alcohol consumption with your healthcare provider and follow their recommendations.

  1. How long does it take for Topiramate to start working?

The time it takes for topiramate to show its full therapeutic effects can vary from person to person and depends on the medical condition being treated. It may take several weeks to months to see the full benefits in some cases.

  1. Can Topiramate interact with other medications?

Topiramate can interact with other drugs, so it’s crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.

As Topiramate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Topiramate Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Topiramate Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Topiramate Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Topiramate Tablets USP 15mg
b) Topiramate Tablets USP 25mg
c) Topiramate Tablets USP 50mg
d) Topiramate Tablets USP 100mg
e) Topiramate Tablets USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Topiramate Tablets USP 15mg
Each film-coated tablet contains:
Topiramate USP……………………15mg
Excipients…………………………q.s.
Colour: Quinoline Yellow

b) Topiramate Tablets USP 25mg
Each film-coated tablet contains:
Topiramate USP……………………25mg
Excipients…………………………q.s.
Colour: Yellow Oxide of Iron

c) Topiramate Tablets USP 50mg
Each film-coated tablet contains:
Topiramate USP……………………50mg
Excipients…………………………q.s.
Colour: Sunset Yellow

d) Topiramate Tablets USP 100mg
Each film-coated tablet contains:
Topiramate USP……………………100mg
Excipients…………………………q.s.
Colour: Quinoline Yellow


e) Topiramate Tablets USP 200mg
Each film-coated tablet contains:
Topiramate USP……………………200mg
Excipients…………………………q.s.
Colour: Quinoline Yellow Lake

THERAPEUTIC INDICATIONS:

Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.