Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg)

Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg)
  Each film coated tablet contains:
  Etizolam………………………………………………0.5mg
  Escitalopram Oxalate IP
  Equivalent to Escitalopram…………………………..5mg
  Excipients…………………………………………..…q.s
  Colour: Ponceau 4R

THERAPEUTIC INDICATIONS:

Escitalopram Oxalate is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It works by increasing the levels of serotonin, a chemical messenger in the brain. This improves mood and physical symptoms of depression and also relieves symptoms of anxiety, panic attacks and obsessive-compulsive disorders.

CAUTION & SCHEDULE:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG- WARNING: To be sold by retail on the prescription of a Psychiatrist Only. 

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

1. ➤ Introduction to Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg)

Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg) are a prescription-only combination medication that synergistically combines two agents with complementary mechanisms of action, specifically formulated for treatment initiation and sensitive patient populations.

• Escitalopram Oxalate (5mg): This is the optimal starting dose of a highly selective Serotonin Reuptake Inhibitor (SSRI). It works by increasing serotonin levels in the brain, which helps improve mood, sleep, appetite, and energy levels over time. The 5mg strength is ideal for initiating therapy, minimizing initial side effects, and allowing for careful dose titration.

• Etizolam (0.5mg): A thienodiazepine derivative with potent anxiolytic properties, it provides rapid relief from acute anxiety symptoms, panic attacks, and associated insomnia. This offers crucial immediate support during the initial 2-4 weeks before the full therapeutic effects of Escitalopram are realized.

This specific 0.5mg+5mg combination is strategically designed for patients who are new to SSRI therapy, are particularly sensitive to medications, or require a more cautious approach due to comorbid conditions. It effectively bridges the gap between immediate symptom control and long-term therapeutic success.

Global Demand and Therapeutic Applications:
The international demand for this low-dose combination is growing, driven by several key clinical and market factors:

• Focus on Tolerability: There is an increasing clinical preference for starting with lower SSRI doses to enhance patient tolerability and adherence during the critical first weeks of treatment.

• Personalized Medicine: This strength allows physicians to tailor treatment more precisely for a diverse patient demographic, including the elderly and those with somatic comorbidities.

• Management of SSRI Activation Syndrome: The low-dose Escitalopram helps mitigate initial increased anxiety or agitation that some patients experience, with Etizolam providing a counterbalance.

• Cost-Effective Initiation: As a generic combination, it provides a cost-efficient solution for healthcare systems, reducing the need for separate prescriptions and improving accessibility to mental health treatment.

This specialized global demand highlights the necessity for a highly reliable and compliant Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg) Supplier with expertise in handling psychotropic substances and delivering consistent, precision-dosed products.

2. ➤ A Buyer’s Guide: Essential Details for Importers & Distributors

Procuring a combination product that contains a controlled substance like Etizolam demands a manufacturer with robust regulatory expertise, operational integrity, and a flawless track record. Taj Pharma is meticulously structured to provide a seamless, transparent, and fully compliant sourcing experience for our international partners.

➤ Regulatory Documentation and Compliance

We provide an exhaustive and compliant documentation package to facilitate smooth customs clearance and market authorization, which is paramount for psychotropic medicines.

• Certificate of Pharmaceutical Product (COPP): Issued in strict accordance with WHO specifications.

• WHO-GMP Certificate: Our manufacturing facility is fully compliant with WHO Good Manufacturing Practices, a non-negotiable standard for quality.

• Psychotropic Substance Licenses: We hold all requisite licenses from Indian regulatory authorities for the manufacture and export of Etizolam-containing formulations, in full compliance with the Narcotic Drugs and Psychotropic Substances (NDPS) Act.

• Certificate of Analysis (CoA): A batch-specific document providing full analytical results confirming the identity, assay, purity, and dissolution profile of both active ingredients.

• CTD Dossier: A comprehensive Common Technical Document ready for regulatory submissions in your target market.

• Stability Studies Data: Complete data supporting the assigned shelf life under recommended storage conditions.

➤ Custom Packaging & Labeling

We offer highly customizable and secure packaging solutions that respect the sensitive nature of psychotropic products and meet the specific regulatory requirements of the destination country.

• Blister Packing: High-quality Alu-Alu blister packs offering superior moisture and light protection, along with tamper-evidence.

• Bottle Packing: HDPE bottles equipped with child-resistant and tamper-evident closures for enhanced safety.

• Regulatory Labeling: Labels are designed to comply with the destination country’s regulations for psychotropic drugs, including mandatory symbols, warnings, and storage information.

• Private Labeling: Comprehensive private labeling services are available to help distributors build their own brand identity in the market.

➤ Shelf-Life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet for ease of swallowing and patient compliance.

• Shelf-Life: 24 months from the date of manufacture.

• Storage Conditions: Store below 30°C in a dry place. Protect from light. Keep out of reach of children.

➤ Target Export Markets & Certifications

3. ➤ Why Taj Pharma is the Most Trusted Manufacturer & Exporter

Selecting Taj Pharma means partnering with an organization where quality, regulatory compliance, and reliability are deeply ingrained in our operational ethos, especially for sensitive drug categories like psychotropics.

➤ State-of-the-Art Manufacturing & Uncompromising Quality

Our advanced manufacturing plant in Vapi features dedicated, access-controlled production suites for psychotropic substances. We employ sophisticated analytical instrumentation like HPLC for rigorous in-process and finished product testing. For this low-dose formulation, we perform extensive content uniformity testing to ensure each and every tablet delivers the exact 0.5mg of Etizolam and 5mg of Escitalopram Oxalate with batch-to-batch consistency.

➤ Affordable Pricing & Quality Assurance

We leverage our operational efficiencies and vertical integration to offer Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg) at highly competitive prices without any compromise on quality. This commitment makes crucial mental health initiation therapy more accessible worldwide and provides our distribution partners with a significant competitive edge and healthy margins.

➤ Global Presence & Supply Chain Support

Our specialized logistics team is highly proficient in managing the complex documentation, licensing, and shipping protocols for controlled substances. We ensure secure, confidential, and traceable shipments through reliable global freight partners, guaranteeing timely delivery to your designated port.

4. ➤ Technical Product Specification Table

5. ➤ Call to Action: 

Sourcing a low-dose psychotropic combination medication requires a partner you can trust implicitly for precision, quality, and ethical compliance. Taj Pharma offers a partnership defined by these core principles and a shared goal of improving global mental health access.

Contact Taj Pharma today to discuss your requirements, request a competitive quotation, or obtain samples and comprehensive product literature. Let us be your reliable and compliant source for high-quality pharmaceutical combinations.

Contact Taj Pharma

Head Office:
Tel. No.: +91 – 22 – 2637 4592 / 2637 4593 (IST)
Fax: +91 – 22 – 2634 1274
Gen. Enquiry: +91 84484 44095

WhatsApp Support:
Mobile: +91 74 0000 9975 / +91 74 0000 9976

Email: info@tajpharma.com

6. ➤ Top 20 FAQs 

1. What is the key advantage of the 0.5mg+5mg strength?
This low-dose combination is specifically designed as an initiation therapy, offering improved tolerability for patients starting treatment for anxiety and depression, minimizing initial side effects.

2. Who is the manufacturer of this product?
Taj Pharma Ltd. is a leading and certified Etizolam & Escitalopram Oxalate Tablets (0.5mg+5mg) Manufacturer in India.

3. Is Etizolam a controlled substance?
Yes, Etizolam is classified as a psychotropic substance under international drug control conventions and is subject to strict regulatory control.

4. What are the serious side effects to monitor?
Watch for symptoms of serotonin syndrome (agitation, hallucinations, fever, fast heartbeat), severe dizziness, difficulty breathing, or signs of a severe allergic reaction. Seek immediate medical help if these occur.

5. Can this medicine lead to dependence?
Yes, the Etizolam component has a potential for dependence and abuse, particularly with prolonged use. It must be used strictly under medical supervision and for the shortest duration possible.

6. Do you provide export licenses for this combination?
Yes, we hold all necessary Indian licenses for the manufacture and export of this formulation and provide the required legal documentation for international shipments.

7. What is the Minimum Order Quantity (MOQ)?
We offer flexible MOQs to cater to both large and small distributors. Please contact our sales team for specific details tailored to your region.

8. How do you ensure shipping compliance for controlled drugs?
We partner with experienced freight forwarders and ensure all shipments are accompanied by the requisite legal documentation, including import/export permits where required.

9. What is the shelf life of the product?
We provide a 24-month shelf life from the date of manufacture when stored under recommended conditions.

10. Is this combination safe during pregnancy?
It is generally not recommended during pregnancy. The treating physician must perform a careful risk-benefit analysis before prescribing.

11. Why is the 5mg dose of Escitalopram used?
The 5mg dose is the recommended starting dose for Escitalopram, allowing the body to adjust to the medication and reducing the incidence and severity of initial side effects.

12. Do you offer PCD Pharma Franchise for this product?
Yes, we invite inquiries from qualified and licensed pharmaceutical distributors for franchise opportunities.

13. How is content uniformity ensured in such a low-dose tablet?
We employ high-shear granulation and rigorous mixing validation processes, followed by stringent content uniformity testing as per pharmacopoeial standards for every batch.

14. Can you supply to our country?
We export to numerous countries where the product is legally approved. Contact us to verify the regulatory status for your specific market.

15. What is the typical administration schedule?
It is usually taken once daily, as directed by the physician. The timing can be adjusted to manage drowsiness, if it occurs.

16. Are there any specific food or drug interactions?
Alcohol must be avoided. Caution is advised with other CNS depressants. Grapefruit juice may interact with Etizolam and should be avoided.

17. What if a dose is missed?
If it is close to the time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a forgotten one.

18. How should treatment be discontinued?
This medicine should not be stopped abruptly. A doctor will provide a tapering schedule to safely discontinue treatment, especially to prevent Etizolam withdrawal symptoms.

19. Can patients drive while on this medication?
This medicine may cause drowsiness, dizziness, or blurred vision. Patients should avoid driving or operating machinery until they are sure they are not affected.

20. How can a distributor request samples?
Legally qualified and serious distributors can request samples by contacting us with their business details and necessary drug licenses.