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Loratadine Tablets product packshot

Loratadine Tablets (Lotadin)

Composition: Each uncoated tablet contains Loratadine 10 mg.

Brand: Lotadin

Usage: Relief of hay fever and hives symptoms.

Category: Anti Allergic Drugs

Therapeutic category: Antihistamine / Anti Allergic

SKU: Loratadine Tablets

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

Product Information

Loratadine Tablets (Lotadin) 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

Loratadine Tablets (10 mg)

1. Product Introduction

Loratadine Tablets 10 mg contain a second-generation, relatively non-sedating antihistamine for relief of seasonal allergic rhinitis (hay fever) and urticaria (hives). It helps reduce sneezing, runny nose, itchy or watery eyes, and itching associated with allergies.

Brand listed: Lotadin. Manufacturer: Healthy Life Pharma Pvt. Ltd. Exporter: Healthy Inc. Manufacturing certifications, supply territories, and third-party manufacturing arrangements should be confirmed against current documentation.

2. Product Specifications

Product NameLoratadine Tablets
BrandLotadin
Active ingredientLoratadine 10 mg per tablet
Dosage FormUncoated tablet (as supplied composition)
CAS Number79794-75-5
Therapeutic ClassSecond-generation H1 antihistamine
UsageAllergic rhinitis and urticaria
SKULoratadine Tablets
Pharmacopoeial standardVerify applicable IP / BP / USP specification against approved batch documents
Packaging and shelf lifeAs per approved product label and stability data

3. Manufacturing Technology

Low-dose tablet manufacturing requires validated blending, content-uniformity controls, compression and disintegration testing. Because loratadine has low aqueous solubility, particle-size control and dissolution performance may be important formulation considerations.

Specific claims about micronization, particle size, excipients, processing equipment or coating should be supported by approved manufacturing records before publication.

4. Quality Assurance

Appropriate finished-product tests can include identification, assay, uniformity of dosage units, dissolution, related substances, and stability testing according to the applicable registered pharmacopoeial or product specification.

Do not claim specific assay limits, dissolution thresholds, a 36-month shelf life or bioequivalence without batch-specific and regulatory evidence.

5. Pharmacology and Clinical Use

Loratadine selectively blocks peripheral histamine H1 receptors and reduces symptoms triggered by histamine. It is less likely to cause drowsiness than older antihistamines, but sleepiness can still occur in some people.

  • Allergic rhinitis: sneezing, runny nose, itchy nose or throat, and itchy/watery eyes.
  • Urticaria: relief of itching and hives.

Loratadine treats allergy symptoms; it does not cure the underlying allergy or treat anaphylaxis.

6. Export and Regulatory Support

For B2B enquiries, request current product registration status, certificate of analysis, approved packaging specifications, stability data and relevant export documentation. CTD/ACTD dossiers, COPP, FSC and WHO-GMP documentation are subject to availability and verification.

7. Frequently Asked Questions

Q: What is the correct generic name?
A: Loratadine, not “Loratidine”.

Q: What is Lotadin?
A: The supplied product information lists Lotadin as the brand name for loratadine 10 mg.

Q: Will it make me sleepy?
A: Loratadine is generally less sedating than first-generation antihistamines, but some patients may experience drowsiness.

Q: How long does it last?
A: It is generally used once daily and provides symptom relief for about 24 hours in many patients.

Q: Is it the same as Claritin?
A: Claritin is a brand containing loratadine. Pharmaceutical equivalence or bioequivalence of a specific manufactured product must not be assumed without supporting approval data.

8. Dosage and Administration

For many approved 10 mg tablet labels, adults and children aged 6 years and older take 10 mg once daily, subject to the local product label and clinical advice. This tablet strength may not be appropriate for younger children. People with significant liver or kidney impairment may require different dosing guidance.

May be taken with or without food. Follow the approved label; do not exceed the recommended dose.

9. Side Effects and Precautions

  • Possible side effects include headache, fatigue, dry mouth and occasional drowsiness.
  • Seek urgent medical care for swelling of the face or throat, breathing difficulty, or another severe allergic reaction.
  • Discuss use in pregnancy, breastfeeding, and liver or kidney disease with a healthcare professional.
  • Check potential medicine interactions with a pharmacist or prescriber.

Not for emergency treatment of anaphylaxis.

10. Storage Instructions

Store according to the approved package label, protected from excessive heat and moisture. Keep in the original packaging and out of reach of children. A specific temperature limit and shelf life should be confirmed from the registered product label.