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Telmisartan and Hydrochlorothiazide Tablets

Telmisartan and Hydrochlorothiazide Tablets

Antihypertensive | ARB + Thiazide Diuretic | Film-coated tablets

Product Composition

Composition: Each film-coated tablet contains Telmisartan 40 mg and Hydrochlorothiazide IP 12.5 mg.

Usage: Management of high blood pressure (hypertension) when combination treatment is appropriate.

Therapeutic category: Cardiovascular / Antihypertensive (ARB + thiazide diuretic).

SKU: Telmisartan HCTZ 40/12.5 mg

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

+91 7710003340

Product Information

Telmisartan and Hydrochlorothiazide Tablets 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

1. Product Introduction

This fixed-dose antihypertensive combines telmisartan, an angiotensin II receptor blocker (ARB), with hydrochlorothiazide, a thiazide diuretic. The supplied product specification confirms a 40 mg/12.5 mg film-coated tablet. The combination helps lower blood pressure through complementary mechanisms. Healthy Life Pharma Pvt. Ltd. and Healthy Inc are identified as manufacturer and exporter in the supplied description; certification and supply claims require documentary confirmation.

2. Product Specifications

ProductTelmisartan and Hydrochlorothiazide Tablets
Confirmed strengthTelmisartan 40 mg + Hydrochlorothiazide 12.5 mg
CompositionEach film-coated tablet: Telmisartan 40 mg; Hydrochlorothiazide IP 12.5 mg
Dosage formFilm-coated tablet
Therapeutic classAngiotensin II receptor blocker (ARB) + thiazide diuretic
IndicationHypertension, according to approved local labeling
StandardHydrochlorothiazide IP; telmisartan standard not specified in supplied composition
Other strengthsTelmisartan 20 mg / 40 mg / 80 mg single-ingredient products mentioned in background text but not confirmed by the supplied combination composition
Packaging / shelf lifeConfirm with approved product artwork and stability records

3. Manufacturing Technology

Telmisartan has pH-dependent aqueous solubility, so formulation development may require appropriate dissolution-enhancement strategies. Combination tablets also require validated blend uniformity for the lower-dose hydrochlorothiazide component, controlled granulation/compression, and suitable film coating. Exact equipment, excipients, process conditions and packaging barriers must be supported by approved manufacturing and stability documentation.

4. Quality Assurance

Quality testing should follow the registered product specification and relevant pharmacopoeial methods: identification of both active ingredients, individual assay, content uniformity, dissolution, related substances, and appropriate packaging and stability controls. Numerical assay or dissolution limits should not be assumed without the current validated method and approved dossier.

5. Therapeutic Uses and Mechanism

Telmisartan selectively blocks angiotensin II at AT1 receptors, reducing vasoconstriction and aldosterone effects. Hydrochlorothiazide increases renal sodium and water excretion, supporting blood-pressure reduction. The combination is used for hypertension when clinically appropriate, for example when blood pressure is not adequately controlled on one agent. Claims for cardiovascular risk reduction associated with telmisartan alone should not automatically be applied to this fixed-dose combination.

6. Export and Regulatory Support

B2B partners should request approved composition and labeling, market-specific registration details, certificate of analysis, stability evidence, packaging configurations and available CTD/ACTD documentation. WHO-GMP status, COPP, FSC and export eligibility must be checked for the actual manufacturing site, product and destination market. Commercial availability and shipping terms are subject to confirmation.

7. Frequently Asked Questions

Q: What is the confirmed composition?
A: Telmisartan 40 mg plus Hydrochlorothiazide IP 12.5 mg in each film-coated tablet.

Q: Is this the same as telmisartan-only 40 mg?
A: No. This combination also contains a diuretic and has different safety considerations.

Q: Is it suitable during pregnancy?
A: No. Medicines acting on the renin–angiotensin system can harm a developing fetus. Contact a clinician promptly if pregnancy occurs.

8. Dosage and Administration

Dosage is individualized by the prescribing clinician according to blood-pressure response, kidney function and the locally approved label. This 40 mg/12.5 mg combination is commonly administered once daily where approved, with or without food. It should not be used as a substitute for unsupervised titration of individual components. Monitor blood pressure, kidney function and electrolytes as directed. Do not change or discontinue therapy without medical advice.

9. Side Effects and Precautions

Possible adverse effects include dizziness, low blood pressure, dehydration, changes in kidney function, and electrolyte abnormalities. Hydrochlorothiazide may cause low sodium or potassium, raised uric acid (gout), and photosensitivity; telmisartan may increase potassium. Potassium, sodium and renal function may require monitoring. Pregnancy warning: discontinue and obtain prompt medical advice if pregnancy is detected. Review interactions with NSAIDs, lithium, potassium supplements and other blood-pressure medicines. Contraindications and precautions depend on the approved local prescribing information.

10. Storage Instructions

Store in the original packaging as stated on the approved product label. Protect from moisture and excessive heat. Exact temperature limit, packaging configuration and shelf life require confirmation from registered labeling and stability data. Keep out of reach of children.

For professional and B2B reference. Prescribing information, manufacturing claims, certification and market-specific approvals require verification.