Description
Salbutamol & Theophylline Tablets (2 mg / 100 mg)
Healthy Inc is a specialized global supplier and exporter of advanced respiratory, pulmonology, and critical-care therapeutics. We provide ultra-high-purity, kinetically synchronized Salbutamol (2 mg) & Theophylline (100 mg) Uncoated / Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Action Bronchodilator Synergy” is a massive-volume, high-priority export to pulmonology centers, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, highly accessible intervention for severe Asthma, Chronic Obstructive Pulmonary Disease (COPD), and chronic bronchitis.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes a rapid-acting beta-2 agonist with a sustained methylxanthine derivative, delivering a powerful, two-pronged strike against severe bronchospasm and airway constriction.
The “Dual-Pathway Bronchodilator” Specialist:
- Mechanism 1 (The Rapid Airway Opener – Salbutamol 2mg): Salbutamol is a potent, highly selective beta-2 adrenergic receptor agonist. It rapidly binds to receptors on the smooth muscle lining the airways (bronchi). This triggers the production of cyclic AMP (cAMP), immediately causing the violently constricted muscles to relax and open, providing rapid relief from wheezing and breathlessness.
- Mechanism 2 (The Sustained Airway Stabilizer – Theophylline 100mg): While Salbutamol creates the cAMP to open the airways, the body naturally produces an enzyme called phosphodiesterase (PDE) to destroy that cAMP. Theophylline aggressively inhibits this PDE enzyme. By stopping the destruction of cAMP, Theophylline locks the airways in an open, relaxed state for a much longer duration. It also possesses mild anti-inflammatory properties, reducing swelling in the respiratory tract.
- The Economic Compliance Advantage: Inhalers (MDI/DPI) are expensive and frequently misused by patients who cannot coordinate their breathing. This oral tablet delivers guaranteed, systemic bronchodilation, making it the preferred, high-compliance choice for chronic asthma and COPD management in developing healthcare networks.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Pulmonology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Respiratory/Bronchodilators) |
| CAS Numbers | 18559-94-9 (Salbutamol) / 58-55-9 (Theophylline) |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the sensitive formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Narrow Therapeutic Index (NTI) Engineering: Theophylline has a dangerously narrow therapeutic index—the difference between a clinical dose and a toxic, seizure-inducing dose is incredibly small. Distributing a micro-dose of Salbutamol alongside Theophylline requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact milligram dose, completely eliminating the risk of catastrophic cardiac or neurological toxicity.
Therapeutic Indications (Human Use)
Indicated for the targeted, systemic management of reversible airway obstruction:
- Asthma: Management and routine prophylaxis of chronic bronchial asthma.
- Chronic Obstructive Pulmonary Disease (COPD): Symptomatic relief of reversible bronchospasm associated with chronic bronchitis and emphysema.
Dosage & Administration
Recommended Dosage (Strictly as per Pulmonologist Guidelines):
- Standard Adult Dosing: 1 tablet taken 3 to 4 times a day (TID/QID), depending on the severity of the bronchospasm and the patient’s individual tolerance to Theophylline.
- Administration (THE CONSISTENCY RULE): Tablets must be swallowed whole with a glass of water. Food can alter the clearance of Theophylline. Patients should take the medication consistently (either always with food or always without food) to maintain stable blood levels.
- Dose Titration: Doses should be carefully titrated based on clinical response and, if available, Theophylline serum concentration monitoring.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Tachycardia & Cardiovascular Overload: Both Salbutamol and Theophylline aggressively stimulate the heart. This combination will cause an increased heart rate (tachycardia) and palpitations. It must be used with extreme caution in patients with severe hypertension, ischemic heart disease, or pre-existing cardiac arrhythmias.
- Theophylline Toxicity (Seizures & Arrhythmias): High levels of Theophylline in the blood are violently toxic, leading to intractable vomiting, severe cardiac arrhythmias, and fatal grand mal seizures.
- The Smoking Interaction (CYP1A2 Induction): Tobacco smoking dramatically accelerates the liver’s ability to destroy Theophylline. If a patient is stabilized on this drug while smoking and then suddenly quits smoking, the drug will rapidly build up to toxic, seizure-inducing levels in their blood. Doses must be heavily adjusted if smoking habits change.
- Hypokalemia Risk: High doses of Salbutamol drive potassium out of the blood and into the cells, potentially causing severe, life-threatening hypokalemia. Serum potassium should be monitored during severe exacerbations.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Respiratory Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Government Tender Supplier for pulmonology programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our logistics network ensures timely delivery. We actively support Pharmaceutical Bulk Indenting, ensuring that every Authorized Medicine Wholesaler receives WHO-GMP certified products at competitive rates.










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