Sertraline HCl Tablets USP 50mg Technical Specification:
Product Name: | Sertraline HCl Tablets USP |
Brand Name: | Generics |
Strength: | 25mg, 50mg, 100mg |
Dosage Form: | Tablets (Film-coated) |
Route of Administration: | Via oral Route |
Packing: | 30s, 90s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antidepressants, Central Nervous System |
Indication: | Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder |
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:
- Sertraline HCl Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sertraline HCl Tablets USP 50mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………….50mg
Excipients………………………………………q.s.
Colour: Brilliant Blue
THERAPEUTIC INDICATIONS:
Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder.
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?
Taj Pharmaceuticals is a renowned name in the pharmaceutical industry, known for its unwavering commitment to quality, innovation, and patient-centric healthcare. Our pride lies in offering Sertraline HCl Tablets, and there are compelling reasons why we are the preferred choice for pharmaceutical needs. At the core of our operations is an unwavering commitment to quality. Rigorous quality control measures are meticulously adhered to throughout the manufacturing process, ensuring that our Sertraline HCl Tablets consistently meet and exceed industry standards, prioritizing the safety and well-being of our customers. With a rich history in the pharmaceutical sector, Taj Pharmaceuticals brings a wealth of experience and expertise to the forefront. Our Sertraline tablets come with a proven track record of efficacy and safety, a testament to our dedication to providing reliable treatment options. Taj Pharmaceuticals boasts a diverse portfolio of pharmaceutical products, catering to a wide spectrum of healthcare needs. Whether it’s psychiatric medications like Sertraline or treatments spanning various therapeutic areas, we offer comprehensive solutions. At Taj Pharmaceuticals, we put patients at the center of our focus. Our Sertraline HCl Tablets are meticulously developed with the patient’s well-being in mind, providing effective treatment options and contributing to an improved quality of life. Additionally, we maintain strict adherence to regulatory guidelines and stringent quality assurance protocols, ensuring that our Sertraline products are fully compliant with all relevant regulations, instilling confidence and peace of mind in our customers. With a global presence, Taj Pharmaceuticals possesses the reach and capability to supply Sertraline HCl Tablets to patients and healthcare providers worldwide. Our mission is clear: to make quality healthcare accessible to all, reflecting our unwavering dedication to the health and welfare of our valued customers. Choose Taj Pharmaceuticals for Sertraline HCl Tablets, and experience the assurance of quality, reliability, and a genuine commitment to healthcare excellence.
What is Sertraline HCl Tablets and its uses?
Sertraline HCl Tablets, containing the active ingredient sertraline hydrochloride, are a valuable resource in the realm of mental health. Classified as selective serotonin reuptake inhibitors (SSRIs), they play a pivotal role in treating various mental health conditions. Chief among these is depression, where sertraline’s action in increasing serotonin levels in the brain proves effective in improving mood and alleviating symptoms of sadness, hopelessness, and loss of interest. Furthermore, Sertraline is a frontline treatment for obsessive-compulsive disorder (OCD), helping to manage distressing obsessions and repetitive behaviors. It extends its therapeutic reach to panic disorder, mitigating the frequency and intensity of panic attacks. Individuals grappling with social anxiety disorder find relief as sertraline eases their fears of social situations. The medication also serves those with post-traumatic stress disorder (PTSD), reducing symptoms like flashbacks and nightmares following traumatic events. In cases of premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome, sertraline helps alleviate mood-related symptoms. It is important to recognize that the use of Sertraline should be overseen by a healthcare provider, as its efficacy, dosage, and treatment duration vary based on individual responses and specific diagnoses. This ensures safe and effective management of mental health conditions and improves overall well-being.
How do Sertraline HCl Tablets work?
Sertraline HCl Tablets are renowned for their effectiveness in addressing mental health conditions, and their mechanism of action lies in the intricate modulation of neurotransmitters, particularly serotonin, within the brain. Operating as selective serotonin reuptake inhibitors (SSRIs), Sertraline tablets impact the transmission of signals between nerve cells, playing a pivotal role in mood regulation. The key to their action is inhibiting the reuptake of serotonin by neurons. Normally, after serotonin is released into the synaptic gap to convey a signal, it is swiftly reabsorbed by the sending neuron, effectively terminating the signal. Sertraline disrupts this reuptake process. By obstructing the reabsorption of serotonin, it allows this neurotransmitter to linger in the synaptic gap for an extended duration. The result is an elevation in serotonin levels within the brain—a critical factor in mood regulation. Heightened serotonin concentrations are believed to have a stabilizing and uplifting impact on mood. This mechanism proves particularly beneficial in conditions such as depression and anxiety disorders, where an imbalance in serotonin levels may be a contributing factor. Furthermore, Sertraline’s influence extends beyond mood modulation. It can promote neuroplasticity, which is the brain’s ability to adapt and reorganize itself. By enhancing serotonin transmission, Sertraline may facilitate positive changes in neural circuits. These changes can contribute to improved mood and a reduction in the symptoms of depression and anxiety over time. It’s worth noting that the full therapeutic effects of Sertraline HCl Tablets may not be immediately apparent, often taking several weeks to become noticeable. This delay is due to the complex alterations in serotonin levels and neuronal adaptations occurring in the brain. Consequently, individuals prescribed Sertraline are advised to adhere to their treatment regimen and heed the guidance of their healthcare provider for optimal results. Any concerns or potential side effects should be openly discussed with a healthcare professional to ensure appropriate management and a successful treatment journey.
Benefits and Side Effects of Sertraline HCl Tablets?
Sertraline HCl Tablets offer a range of benefits in the realm of mental health. First and foremost, they are a highly effective treatment for depression (major depressive disorder or MDD). By elevating serotonin levels in the brain, Sertraline helps alleviate the profound sadness, hopelessness, and loss of interest often associated with depression, leading to an improved overall mood and emotional well-being. Beyond depression, Sertraline is a valuable tool in managing obsessive-compulsive disorder (OCD). It aids in reducing the frequency and intensity of obsessions and compulsions, enabling individuals to regain control over their thoughts and behaviors. Additionally, for those grappling with panic disorder, Sertraline offers relief by managing and reducing the frequency of panic attacks, along with associated symptoms like palpitations and shortness of breath. Social anxiety disorder, characterized by an intense fear of social situations, can also be effectively treated with Sertraline. It empowers individuals to feel more at ease during social interactions and public speaking engagements. Furthermore, Sertraline plays a role in post-traumatic stress disorder (PTSD) management, alleviating symptoms like flashbacks, nightmares, and hyperarousal, providing much-needed relief for individuals who have experienced traumatic events. For those with severe premenstrual symptoms, Sertraline offers relief from mood-related symptoms such as irritability and mood swings, making it a valuable tool in the management of premenstrual dysphoric disorder (PMDD). While the benefits of Sertraline are substantial, it’s important to be aware of potential side effects. Common side effects include mild symptoms like nausea, diarrhea, dry mouth, and insomnia, which often improve as the body adapts to the medication. However, some individuals may experience sexual side effects or weight changes, necessitating discussion with a healthcare provider to explore potential solutions. Rare but serious side effects include serotonin syndrome, which requires immediate medical attention, and withdrawal symptoms if the medication is abruptly stopped. Additionally, in some individuals, especially young adults, there may be an increased risk of suicidal thoughts when starting or adjusting the dosage of Sertraline, underscoring the importance of close monitoring by a healthcare provider, particularly during the initial weeks of treatment. Individuals taking Sertraline HCl Tablets are encouraged to maintain open communication with their healthcare provider, promptly report any side effects, and adhere to their prescribed treatment plan. Careful consideration of the medication’s benefits and potential side effects under the guidance of a healthcare professional is essential for effective and safe treatment.
Frequently Asked Questions About Sertraline HCl Tablets:
Certainly, here are some frequently asked questions (FAQs) about Sertraline HCl Tablets:
- What is Sertraline HCl, and how does it work?
Sertraline HCl is an antidepressant medication that belongs to the class of selective serotonin reuptake inhibitors (SSRIs). It works by increasing the levels of serotonin in the brain, which helps regulate mood and alleviate symptoms of depression and anxiety.
- What conditions are Sertraline HCl Tablets used to treat?
Sertraline HCl Tablets are primarily used to treat major depressive disorder (depression), obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder, and posttraumatic stress disorder (PTSD). It may also be prescribed for premenstrual dysphoric disorder (PMDD) and other off label uses.
- How long does it take for Sertraline to start working for depression and anxiety?
The onset of action can vary from person to person, but it often takes several weeks for individuals to experience the full therapeutic effects of Sertraline. It’s essential to continue taking the medication as prescribed, even if improvements are not immediately noticeable.
- Are there any common side effects of Sertraline HCl Tablets?
Common side effects may include nausea, diarrhea, dry mouth, and insomnia. These side effects are generally mild and tend to improve with time. Other potential side effects include sexual side effects and weight changes.
- Can Sertraline be used in children or adolescents?
Sertraline may be prescribed to children and adolescents for specific conditions, but its use in pediatric populations should be closely monitored by a healthcare provider, and the potential risks and benefits should be carefully considered.
- Is Sertraline safe during pregnancy or while breastfeeding?
The use of Sertraline during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential risks and benefits must be evaluated on an individual basis.
- Can Sertraline HCl Tablets be abruptly stopped?
Abruptly discontinuing Sertraline can lead to withdrawal symptoms. It’s important to follow your healthcare provider’s guidance and taper the dosage gradually if you decide to stop taking the medication.
- How often should I have follow-up appointments while taking Sertraline?
Regular follow-up appointments with your healthcare provider are important to monitor your progress, assess the effectiveness of the medication, and address any side effects or concerns.
- What should I do if I experience serious side effects or worsening of symptoms while taking Sertraline HCl Tablets?
If you experience serious side effects or a worsening of your symptoms, contact your healthcare provider promptly. It’s crucial to report any adverse reactions for proper evaluation and management.
As Sertraline HCl Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Sertraline HCl 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
Sertraline HCl 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 Sertraline HCl 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) Sertraline HCl Tablets USP 25mg
B) Sertraline HCl Tablets USP 50mg
C) Sertraline HCl Tablets USP 100mg
B) Sertraline HCl Tablets USP 50mg
C) Sertraline HCl Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Sertraline HCl Tablets USP 25mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline………………25mg
Excipients………………………………………q.s.
Colour: Indigo Carmine
B) Sertraline HCl Tablets USP 50mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………....50mg
Excipients………………………………………q.s.
Colour: Brilliant Blue
C) Sertraline HCl Tablets USP 100mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………....100mg
Excipients………………………………………q.s.
Colour: Sunset Yellow
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline………………25mg
Excipients………………………………………q.s.
Colour: Indigo Carmine
B) Sertraline HCl Tablets USP 50mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………....50mg
Excipients………………………………………q.s.
Colour: Brilliant Blue
C) Sertraline HCl Tablets USP 100mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………....100mg
Excipients………………………………………q.s.
Colour: Sunset Yellow
THERAPEUTIC INDICATIONS:
Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder.
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.