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Olanzapine Tablets IP

Olanzapine Tablets IP

Composition: Each film-coated tablet contains Olanzapine IP 2.5 mg, 5 mg, 7.5 mg or 10 mg, according to strength.

Usage: Prescription treatment of schizophrenia and bipolar I disorder, as clinically indicated.

Category: Anti Anxiety Drugs (website category)

Therapeutic category: Atypical Antipsychotic / CNS Medicine

SKU: Olanzapine Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Olanzapine Tablets IP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification and product authorization subject to verification)
Exporter: Healthy Inc (export credentials subject to verification)

1. Product Introduction

Olanzapine is a second-generation (atypical) antipsychotic used in the management of schizophrenia and certain episodes of bipolar I disorder. The supplied products are immediate-release, film-coated Olanzapine Tablets IP in four strengths: 2.5 mg, 5 mg, 7.5 mg and 10 mg.

Olanzapine is not classified primarily as an antidepressant or an anti-anxiety medicine. Uses involving depression depend on a specific approved combination and indication. This page does not claim availability of 15 mg, 20 mg or orally disintegrating variants.

2. Product Specifications

Product nameOlanzapine Tablets
CompositionOlanzapine IP 2.5 mg / 5 mg / 7.5 mg / 10 mg
Confirmed strengths2.5 mg, 5 mg, 7.5 mg, 10 mg
Dosage formFilm-coated tablets
CAS number132539-06-1
Therapeutic classSecond-generation (atypical) antipsychotic
Pharmacopoeial standardIP per supplied composition; BP/USP not confirmed
Other strengths / dosage forms15 mg, 20 mg and orally disintegrating tablets not verified for this listing
Packaging and shelf lifeTo be confirmed against approved packaging and stability records

3. Manufacturing Technology

Film-coated olanzapine tablets require validated controls for blend and content uniformity, dissolution, film-coating consistency, impurity control and stability. Moisture and oxidation risks should be assessed using formulation-specific studies.

Claims about dedicated low-humidity suites, geometric mixing, specific polymers, mouth-dissolving technology or Alu-Alu packaging should be confirmed using actual manufacturing records before publication.

4. Quality Assurance

Applicable testing may include identification, assay, content uniformity, dissolution, related substances and stability under the approved pharmacopoeial specification. Do not infer universal release limits, disintegration times or a 24–36-month shelf life without supporting batch and stability data.

5. Pharmacology and Clinical Use

Olanzapine acts on several neurotransmitter receptors, including dopamine D2 and serotonin 5-HT2A receptors. It is used for schizophrenia and for manic or mixed episodes associated with bipolar I disorder; approved indications and maintenance use depend on jurisdiction and product labeling.

In some jurisdictions, olanzapine in combination with fluoxetine is used for specific depressive indications. Olanzapine alone should not be described as a general antidepressant.

6. Export and Regulatory Support

Potential B2B requirements include a valid product license, applicable pharmacopoeial documentation, batch certificate of analysis, stability data and country-specific registration dossiers. Availability of CTD/ACTD dossiers, COPP, FSC, WHO-GMP certificates, export markets and shipping terms must be verified with the responsible company.

7. Frequently Asked Questions

Q: What strengths are listed?
A: 2.5 mg, 5 mg, 7.5 mg and 10 mg film-coated tablets, as supplied.

Q: Does olanzapine cause weight gain?
A: Weight gain and metabolic changes, including increased blood glucose and lipids, are important risks. Clinicians commonly monitor weight and metabolic parameters.

Q: Is a mouth-dissolving version included?
A: No. Only film-coated tablets are confirmed in the supplied compositions.

Q: Can it be stopped suddenly?
A: Patients should discuss any changes with their prescriber; stopping or changing treatment without supervision may worsen symptoms.

Clinical Pharmacology & Safety Information

For registered medical practitioners and patient reference; follow locally approved prescribing information.

8. Dosage and Administration

The dose and titration depend on indication, age, other medicines, response and tolerability. Olanzapine film-coated tablets are generally taken by mouth, with or without food, as prescribed. Do not use a promotional product page to determine an individual dose.

This listing is for standard film-coated tablets, not orally disintegrating tablets.

9. Side Effects and Precautions

Important risks: weight gain, increased blood glucose and lipids, somnolence, dizziness, orthostatic hypotension and possible movement disorders. Rare but serious events include neuroleptic malignant syndrome and tardive dyskinesia. Metabolic monitoring and clinical review are important.

Boxed warning in US labeling: Antipsychotic treatment is associated with increased mortality in elderly patients with dementia-related psychosis; olanzapine is not approved for this use. Safety labeling and restrictions vary by country.

Olanzapine can impair alertness. Avoid driving or hazardous activity until its effects are known, and discuss alcohol and interacting medicines with a clinician.

10. Storage Instructions

Store according to the approved product label, in its original packaging, protected from excessive heat and moisture as directed. A fixed below-25°C requirement should not be asserted without the approved label. Keep out of reach of children.