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Etofylline and Theophylline Tablets

Etofylline Theophylline Tablets

ET Phyllin (100 mg): Each sugar-coated, immediate release tablet contains Etofylline IP 77 mg + Theophylline IP 23 mg.

ET Phyllin Retard (150 mg): Each sugar-coated, sustained release tablet contains Etofylline IP 115 mg + Theophylline IP 35 mg.

ET Phylline Retard Plus (300 mg): Each sugar-coated, sustained release tablet contains Etofylline BP 231 mg + Theophylline BP 69 mg.

Usage: Selected maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD), when prescribed.

Category: Anti Allergic Drugs

Therapeutic Category: Antiasthmatic / Methylxanthine Bronchodilator

SKU: Etofylline Theophylline Tablets

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

Product Information

Etofylline Theophylline 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

Etofylline & Theophylline Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. offers Etofylline and Theophylline combination tablets for markets where these products are approved. Both ingredients are methylxanthine bronchodilators. Oral methylxanthines are not usually preferred first-line maintenance therapy for asthma or COPD when suitable inhaled treatments are available, because theophylline has a narrow therapeutic index and important interactions. These tablets are not rescue treatment for an acute asthma attack.

2. Product Specifications

PresentationTotal StrengthComposition per TabletRelease Form
ET Phyllin100 mgEtofylline IP 77 mg + Theophylline IP 23 mgSugar-coated, immediate release
ET Phyllin Retard150 mgEtofylline IP 115 mg + Theophylline IP 35 mgSugar-coated, sustained release
ET Phylline Retard Plus300 mgEtofylline BP 231 mg + Theophylline BP 69 mgSugar-coated, sustained release

Therapeutic class: Methylxanthine bronchodilator. Packaging, shelf life and storage: As supported by the registered product specifications and stability data.

3. Manufacturing Technology

Immediate-release and sustained-release formulations are separate products with distinct dissolution specifications. Sustained-release tablets use a validated release-controlling formulation; the exact release duration and dosing interval depend on the approved product. Tablet uniformity and release testing are especially important because of theophylline's narrow therapeutic index. Coating, packaging and process controls are determined by the registered formula.

4. Quality Assurance

  • Identity, assay, content uniformity, related substances and dissolution are assessed according to the applicable approved specifications.
  • Immediate-release and sustained-release products have different dissolution methods and acceptance criteria; no single release percentage or time applies to all presentations.
  • Stability data determine labeled storage conditions and shelf life.

5. Pharmacology and Clinical Use

Etofylline and theophylline are methylxanthines with bronchodilator activity. Theophylline has multiple mechanisms, including phosphodiesterase inhibition and adenosine-receptor antagonism. Selected patients with asthma or COPD may receive an oral methylxanthine as part of an individualized regimen, but inhaled therapies are generally preferred in contemporary treatment guidelines. This combination does not replace inhaled rescue medication.

6. Export and Regulatory Support

Healthy Inc coordinates export inquiries. CTD/ACTD dossiers, certificates of analysis and other regulatory documents may be provided where available for the relevant registered formulation and destination market. Brand interchangeability or bioequivalence should not be assumed without supporting evidence.

7. Frequently Asked Questions

Who manufactures these tablets? Healthy Life Pharma Pvt. Ltd., India.

Are these the same as Deriphyllin? Deriphyllin is a branded combination; comparable ingredient names or ratios do not establish regulatory equivalence or interchangeability.

Can I drink coffee? Excess caffeine can increase stimulant adverse effects such as palpitations, tremor and insomnia.

Does smoking matter? Tobacco smoking can increase theophylline clearance. Starting or stopping smoking can alter blood levels and may require clinician-supervised adjustment and monitoring.


Clinical Pharmacology & Safety Information

8. Dosage and Administration

Dose and schedule must be individualized according to the exact immediate-release or sustained-release product, age, liver function, smoking status, interacting medicines and clinical response. Theophylline serum concentration monitoring may be necessary. Do not crush or chew sustained-release tablets unless the specific product instructions explicitly permit it. Follow the registered label for food instructions.

9. Side Effects and Precautions

  • Common: Nausea, vomiting, abdominal discomfort, headache, tremor, insomnia and palpitations.
  • Serious toxicity: Dangerous heart rhythm disturbances and seizures may occur, including after dosing errors or interactions. Severe vomiting, marked palpitations, confusion or seizures require urgent medical care.
  • Interactions: Some antibiotics, other drugs, smoking changes, fever and liver disease can significantly change theophylline concentrations.
  • Monitoring: Consider serum theophylline levels and clinical monitoring as directed by the prescriber. Avoid combining with other theophylline-containing products without medical review.

10. Storage Instructions

Store as stated on the approved pack label, protected from excess moisture and heat. Keep in original packaging and out of reach of children.