Carbamazepine Extended-Release Tablets USP 100mg Technical Specification:
| Product Name: | Carbamazepine Extended-Release Tablets USP |
| Brand Name: | Carbetol CR |
| Strength: | 100mg, 200mg, 300mg, 400mg |
| Dosage Form: | Tablets (Film-Coated-Extended Release) |
| Route of Administration: | Via oral Route |
| Packing: | 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, Antipsychotic, Anticonvulsant, |
| Indication: | Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia) |
| 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:
- Carbamazepine Extended-Release Tablets USP 100mg (Carbetol CR)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Carbamazepine Extended-Release Tablets USP 100mg
Each Extended-Release tablet contains:
Carbamazepine USP……………….100mg
Excipients……………………………. q.s.
Colures: Yellow Iron Oxide
THERAPEUTIC INDICATIONS:
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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 country. |
Why Taj Pharmaceuticals?
Choose Taj Pharma for your Carbamazepine Extended-Release Tablets, and experience a pharmaceutical brand dedicated to excellence in epilepsy and bipolar disorder management. With a proven track record of quality, Taj Pharma ensures consistent and reliable medication, providing peace of mind for both patients and healthcare professionals. Our commitment to patient well-being extends beyond just quality assurance. Taj Pharma prioritizes affordability and accessibility, making essential medications like Carbamazepine Extended-Release Tablets accessible to a broader population. Trust in Taj Pharma for cost-effective solutions without compromising on safety and efficacy.
Backed by extensive research and development, Taj Pharma’s Carbamazepine Extended-Release Tablets offer precise dosing and long-lasting relief, contributing to improved patient outcomes. Make the smart choice for your epilepsy or bipolar disorder treatment—choose Taj Pharma for trusted medication that puts your health first. With Taj Pharma, you’re not just getting a medication; you’re getting a partner in your journey to better health.
What is Carbamazepine Extended-Release Tablets and its use?
Carbamazepine Extended-Release Tablets are a medication primarily used to treat various neurological and psychiatric conditions. They are a form of the drug carbamazepine, which belongs to a class of medications known as anticonvulsants or antiepileptics. Carbamazepine is available in different formulations, including immediate-release and extended-release tablets. Here’s an overview of its use:
- Epilepsy: Carbamazepine Extended-Release Tablets are often prescribed as an antiepileptic medication to control seizures in individuals with epilepsy. It helps stabilize electrical activity in the brain, reducing the frequency and severity of seizures.
- Bipolar Disorder: This medication is also used to manage certain types of mood disorders, particularly bipolar disorder. It can help stabilize mood swings and prevent or reduce the intensity of manic or depressive episodes.
- Trigeminal Neuralgia: Carbamazepine may be prescribed to alleviate the intense facial pain associated with trigeminal neuralgia, a nerve-related condition that causes sudden, severe facial pain.
- Neuropathic Pain: In some cases, it may be used to manage neuropathic pain, which is chronic pain caused by nerve damage or dysfunction.
- Off-Label Uses: Carbamazepine may have off-label uses, meaning it can be prescribed for conditions other than those listed above, at a doctor’s discretion and when deemed clinically appropriate.
Carbamazepine Extended-Release Tablets should only be taken under the supervision of a healthcare provider who can determine the correct dosage and monitor for any potential side effects or drug interactions. The extended-release formulation is designed to provide a more consistent release of the medication over time, allowing for less frequent dosing compared to immediate-release versions. Patients should follow their healthcare provider’s instructions carefully and report any unusual symptoms or side effects.
How does Carbamazepine Extended-Release Tablets Work?
Carbamazepine Extended-Release Tablets work by affecting the electrical activity in the brain and nerves. The exact mechanism of action is not fully understood, but it is believed to involve several complex processes. Here’s an overview of how Carbamazepine Extended-Release Tablets work:
- Sodium Channel Blockade: Carbamazepine primarily exerts its effects by blocking sodium channels in nerve cells. These channels are responsible for the flow of sodium ions in and out of nerve cells during the generation and propagation of nerve impulses (action potentials). By blocking these channels, carbamazepine reduces the abnormal firing of nerve cells, which can be responsible for seizures in epilepsy and excessive firing in certain types of pain conditions.
- Stabilizing Neural Activity: By reducing the excitability of nerve cells, carbamazepine helps stabilize neural activity. In epilepsy, this helps prevent the abnormal bursts of electrical activity that lead to seizures. In bipolar disorder, it can help stabilize mood swings by modulating neural excitability.
- Reduction of Abnormal Pain Signals: In conditions like trigeminal neuralgia and neuropathic pain, carbamazepine can reduce the transmission of abnormal pain signals along the nerves. This can help alleviate intense pain episodes.
- Neurotransmitter Modulation: Carbamazepine may also influence the levels of certain neurotransmitters (chemical messengers) in the brain, such as serotonin and norepinephrine. These neurotransmitters play a role in mood regulation, and by modulating their levels, carbamazepine can contribute to mood stabilization in bipolar disorder.
The specific way carbamazepine works may vary depending on the condition it’s being used to treat. Additionally, the extended-release formulation of the medication is designed to provide a more controlled and sustained release of the active ingredient, which can help maintain consistent therapeutic levels in the bloodstream and reduce the need for frequent dosing. The precise mechanism of action and the effectiveness of carbamazepine may vary from person to person, and its use should always be supervised by a healthcare professional who can monitor its effects and adjust the dosage as needed.
Benefits of Carbamazepine Extended-Release Tablets:
- Seizure Control: Carbamazepine Extended-Release Tablets are effective in controlling seizures in individuals with epilepsy. They can help reduce the frequency and severity of seizures, improving overall quality of life for those affected by epilepsy.
- Bipolar Disorder Management: Carbamazepine is often used as a mood stabilizer in the treatment of bipolar disorder. It can help prevent or reduce the intensity of manic and depressive episodes, leading to more stable and balanced moods.
- Trigeminal Neuralgia Relief: For individuals suffering from trigeminal neuralgia, Carbamazepine can provide significant pain relief by reducing the intensity and frequency of the facial pain associated with this condition.
- Neuropathic Pain Management: In some cases, Carbamazepine may be prescribed to manage chronic neuropathic pain, such as that resulting from nerve damage or dysfunction.
- Extended-Release Convenience: The extended-release formulation allows for less frequent dosing compared to immediate-release versions, which can improve medication adherence and convenience for patients.
Common Side Effects of Carbamazepine Extended-Release Tablets:
- Dizziness: Dizziness is a common side effect, especially when starting the medication or when the dosage is increased. It can impair coordination and concentration, so caution is advised when operating machinery or driving.
- Drowsiness: Many people experience drowsiness while taking Carbamazepine. This side effect can affect daily activities and may improve over time as the body adjusts to the medication.
- Nausea and Vomiting: Some individuals may experience nausea and vomiting. Taking the medication with food or as directed by a healthcare provider can help reduce this side effect.
- Headache: Headaches can occur as a side effect of Carbamazepine, particularly during the initial stages of treatment.
- Skin Reactions: Rarely, Carbamazepine can cause serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. These are severe conditions that require immediate medical attention.
- Blood Cell Abnormalities: Carbamazepine can affect blood cell counts, leading to conditions like leukopenia (low white blood cell count) and thrombocytopenia (low platelet count). Regular blood tests may be required to monitor these effects.
- Liver Function: In some cases, Carbamazepine can affect liver function, leading to abnormal liver enzyme levels. Regular monitoring of liver function may be necessary.
- Hyponatremia: Carbamazepine can cause low sodium levels in the blood, which can lead to symptoms like confusion, headache, and nausea.
It’s essential to discuss any potential benefits and side effects of Carbamazepine Extended-Release Tablets with a healthcare provider before starting the medication. Dosage adjustments or alternative treatments may be considered based on individual health needs and tolerance to the medication. Additionally, any unusual or severe side effects should be promptly reported to a healthcare professional.
Frequently asked questions (FAQs) about Carbamazepine Extended-release Tablets:
- What is Carbamazepine Extended Release (ER) used for?
Carbamazepine ER is primarily used to treat epilepsy, bipolar disorder, trigeminal neuralgia, and certain types of neuropathic pain.
- How does Carbamazepine ER differ from regular Carbamazepine?
Carbamazepine ER is an extended-release formulation, which means it releases the medication slowly over time, requiring less frequent dosing compared to immediate release forms.
- How should I take Carbamazepine ER?
Follow your healthcare provider’s instructions precisely. Typically, it’s taken by mouth with or without food, as directed. Swallow the tablets whole; do not crush or chew them.
- How long does it take for Carbamazepine ER to start working?
The onset of action can vary, but it may take a few weeks of consistent use to see the full therapeutic effects. Your healthcare provider will monitor your progress and adjust the dosage as needed.
- What should I do if I miss a dose?
Take the missed dose as soon as you remember. If it’s close to the time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses to make up for a missed one.
- What are the common side effects of Carbamazepine ER?
Common side effects may include dizziness, drowsiness, nausea, vomiting, headache, and skin reactions. However, individual responses can vary.
- Are there any serious side effects I should watch for?
Yes, there are potential serious side effects, such as skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis), blood cell abnormalities, liver problems, and hyponatremia (low sodium levels). Report any unusual or severe symptoms to your healthcare provider immediately.
- Can Carbamazepine ER interact with other medications?
Yes, it can interact with various drugs, including some antidepressants, anticoagulants, and certain anti-fungal medications. Inform your healthcare provider about all the medications you are taking to avoid potential interactions.
- Can I drink alcohol while taking Carbamazepine ER?
It’s generally advisable to avoid alcohol or drink it in moderation while taking this medication. Alcohol can increase the risk of drowsiness and other side effects.
- Is it safe to use Carbamazepine ER during pregnancy and breastfeeding?
You should discuss the risks and benefits with your healthcare provider if you are pregnant or planning to become pregnant. It can pass into breast milk, so consult your doctor if you are breastfeeding.
- How often will I need blood tests while on Carbamazepine ER?
Regular blood tests may be necessary to monitor blood cell counts and liver function. Your healthcare provider will determine the appropriate frequency.
- Can Carbamazepine ER be used in children?
It can be prescribed to children for specific conditions, but the dosing and suitability should be determined by a pediatric specialist.
As Carbamazepine Extended-Release Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Carbamazepine Extended-Release 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
Carbamazepine Extended-Release 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 Carbamazepine Extended-Release 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. Carbamazepine Extended-Release Tablets USP 100mg (Carbetol CR)
B. Carbamazepine Extended-Release Tablets USP 200mg (Carbetol CR)
C. Carbamazepine Extended-Release Tablets USP 300mg (Carbetol CR)
D. Carbamazepine Extended-Release Tablets USP 400mg (Carbetol CR)
B. Carbamazepine Extended-Release Tablets USP 200mg (Carbetol CR)
C. Carbamazepine Extended-Release Tablets USP 300mg (Carbetol CR)
D. Carbamazepine Extended-Release Tablets USP 400mg (Carbetol CR)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Carbamazepine Extended-Release Tablets USP 100mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………100mg
Excipients……………………………. q.s.
Colures: Yellow Iron Oxide
B. Carbamazepine Extended-Release Tablets USP 200mg
Each Extended-Release tablet contains:
Carbamazepine USP……………….200mg
Excipients……………………………. q.s.
Colures: D&C Yellow 11
C. Carbamazepine Extended-Release Tablets USP 300mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………300mg
Excipients……………………………. q.s.
Colures: Quinoline Yellow
D. Carbamazepine Extended-Release Tablets USP 400mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………400mg
Excipients……………………………. q.s.
Colures: Orange 4
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………100mg
Excipients……………………………. q.s.
Colures: Yellow Iron Oxide
B. Carbamazepine Extended-Release Tablets USP 200mg
Each Extended-Release tablet contains:
Carbamazepine USP……………….200mg
Excipients……………………………. q.s.
Colures: D&C Yellow 11
C. Carbamazepine Extended-Release Tablets USP 300mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………300mg
Excipients……………………………. q.s.
Colures: Quinoline Yellow
D. Carbamazepine Extended-Release Tablets USP 400mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………400mg
Excipients……………………………. q.s.
Colures: Orange 4
THERAPEUTIC INDICATIONS:
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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 country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.










