Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Levocetirizine Tablets product pack

Levocetirizine Tablets

Composition: Levocetirizine Dihydrochloride 5 mg (strength from supplied description; check approved pack label).

Usage: Allergic rhinitis and urticaria.

Category: Anti-allergic drugs

Therapeutic category: Second-generation H1 antihistamine

SKU: Levocetirizine Tablets

Categories: Tablets Manufacturer, Uncategorized

Product Information

Levocetirizine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Levocetirizine Tablets (5 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (as supplied)
Exported by: Healthy Inc (as supplied)

1. Product Introduction

Levocetirizine Tablets 5 mg contain a selective, second-generation H1 antihistamine used to relieve symptoms of allergic rhinitis and urticaria. Levocetirizine is the active R-enantiomer of cetirizine. It can reduce sneezing, runny nose, itching, watery eyes and hives, but some patients experience drowsiness.

Manufacturer: Healthy Life Pharma Pvt. Ltd. (as supplied). Exporter: Healthy Inc (as supplied). Contract manufacturing, export availability and certifications should be confirmed directly before procurement.

2. Product Specifications

ParameterSpecification
Product NameLevocetirizine Tablets
Generic NameLevocetirizine Dihydrochloride Tablets
CAS Number130018-77-8 (levocetirizine dihydrochloride; verify against API documentation)
Strength5 mg (per supplied description)
Dosage FormFilm-coated tablet (per supplied description; verify approved artwork)
Pharmacological ClassSecond-generation H1 antihistamine
UsesAllergic rhinitis and urticaria
Shelf LifeConfirm from approved stability data
PackagingConfirm available configurations with manufacturer
StandardConfirm approved pharmacopoeial standard on batch documentation

3. Manufacturing Technology

Manufacturing a low-dose tablet requires validated blending, content-uniformity controls, compression and suitable film coating. Enantiomeric identity, stability and impurity control are important quality considerations. Specific direct-compression, coating and packaging processes must be confirmed from the actual product manufacturing record; they are not independently verified here.

4. Quality Assurance

Quality assessment may include identity, assay, content uniformity, dissolution, related substances, microbial controls where applicable, and stability testing in accordance with the registered product specification. Numerical assay and dissolution acceptance criteria should come from the applicable validated method and pharmacopoeial monograph, rather than assumed values.

5. Pharmacology and Clinical Use

Levocetirizine acts as a selective peripheral histamine H1-receptor antagonist. It helps manage seasonal or perennial allergic rhinitis and urticaria (hives). It is not an antibiotic and does not treat the underlying viral infection responsible for a common cold. It is not a substitute for epinephrine in anaphylaxis.

6. Export and Regulatory Support

Business customers may enquire about batch certificates of analysis, approved specifications, stability data, product dossiers, packaging options and shipping terms. CTD/ACTD dossiers, COPP, free-sale certificates, WHO-GMP documentation and country-specific registration status are subject to verification and availability.

7. Frequently Asked Questions

Q: Is Levocetirizine the same as Cetirizine?
A: No. Levocetirizine is the active R-enantiomer of cetirizine; these are different labeled medicines and strengths should not be interchanged without advice.

Q: Does it cause drowsiness?
A: It can. Avoid driving or hazardous tasks until its effects are known.

Q: Is it used for the common cold?
A: It is primarily indicated for allergic conditions, not for treating a viral cold.

Q: Is it suitable for kidney disease?
A: Dose adjustments or avoidance may be necessary, depending on kidney function and age.

8. Dosage and Administration

For adults and eligible adolescents, the commonly labeled oral dose is 5 mg once daily, but the approved instructions depend on jurisdiction and patient factors. Children may require a lower-strength formulation; do not assume a 5 mg tablet can safely be split. Kidney impairment can require a reduced dose or longer dosing interval, and severe kidney failure may contraindicate use. Follow the locally approved label and prescriber instructions. Tablets may generally be taken with or without food.

9. Side Effects and Precautions

Possible effects include sleepiness, fatigue and dry mouth. Alcohol or other sedating medicines can increase impairment. Use caution in people at risk of urinary retention. Serious hypersensitivity reactions require urgent medical attention. After stopping prolonged daily use, some patients report severe itching; discuss persistent symptoms with a clinician. Dose adjustment is important in renal impairment.

10. Storage Instructions

Store in the original packaging, protected from moisture and excessive heat, according to the temperature range on the approved product label. Keep out of reach of children.

Medical and regulatory notice: Product information is educational and intended for professional review. Use only as directed by a qualified clinician and the approved local prescribing information. Claims about GMP certification, bioequivalence, manufacturing process, shelf life and market authorization require documentary verification.