Description
Terbutaline Sulphate Tablets IP
Healthy Inc is a specialized global supplier and exporter of advanced respiratory, pulmonology, and critical-care therapeutics. We provide ultra-high-purity, kinetically rapid Terbutaline Sulphate Tablets IP (2.5 mg / 5 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Selective Beta-2 Adrenergic Agonist” is a massive-volume, essential export to respiratory clinics, primary care networks, asthma NGOs, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as a globally trusted intervention for reversing severe bronchospasm in Asthma, Chronic Bronchitis, and Emphysema.
Product Overview
This formulation contains Terbutaline Sulphate, a highly potent bronchodilator engineered to rapidly relax the smooth muscles of the airways, drastically reducing airway resistance and restoring normal breathing.
The “Bronchial Smooth Muscle” Specialist:
- Mechanism (Beta-2 Receptor Agonism): During an asthma attack or COPD exacerbation, the muscles surrounding the airways violently contract (bronchospasm), cutting off the patient’s oxygen supply. Terbutaline acts as a targeted key, binding specifically to the beta-2 receptors located in the lungs. This binding triggers a chemical cascade (increasing cAMP) that commands the bronchial smooth muscles to relax and dilate immediately, forcing the airways open.
- The Oral Maintenance Advantage: While inhalers are used for immediate rescue, oral Terbutaline provides a longer, more sustained duration of action (up to 4-8 hours). It is highly prescribed as a systemic maintenance therapy for patients with severe, chronic reactive airway diseases who require constant, baseline bronchodilation throughout the day and night to prevent attacks.
- Mucociliary Clearance: Beyond just relaxing the muscles, Terbutaline actively stimulates the cilia (microscopic hairs) in the respiratory tract. This helps the lungs expel the thick, sticky mucus that often traps dangerous bacteria in chronic bronchitis patients.
Product Composition & Strength
We supply this product as a Precision-Blended Uncoated Tablet, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips, ensuring optimal API stability across diverse and challenging tropical climates.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Terbutaline Sulphate IP/BP/Ph.Eur. | 2.5 mg | Standard Initiation: Pediatric dosing and adult initiation for mild-to-moderate bronchospasm. |
| Terbutaline Sulphate IP/BP/Ph.Eur. | 5 mg | Maximum Adult Maintenance: Chronic systemic therapy for severe, refractory asthma or COPD. |
| Excipients | Lactose Monohydrate / Maize Starch / Magnesium Stearate | Diluent / Glidant / Lubricant (Engineered for highly predictable, immediate gastric dissolution) |
*Pack Sizes: 10×10 Blisters (Optimized for standard 30-day chronic respiratory dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Respiratory Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Respiratory/Bronchodilators) |
| CAS Number | 23031-25-6 (Terbutaline Sulphate) |
| Dosage Form | Uncoated Tablet (Immediate Release) |
| Packaging | Alu-PVC or Alu-Alu Blisters. Protects the formulation from hydrolytic degradation, ensuring a stable, multi-year shelf life. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Cross-Contamination Eradication: Because Terbutaline is a potent beta-agonist, trace cross-contamination with cardiovascular drugs (like Beta-Blockers) could cause catastrophic, counter-active physiological effects in patients. Our manufacturing utilizes strictly isolated powder-handling protocols, rigorous HVAC segregation, and advanced HPLC swab testing during changeovers to guarantee absolute product purity and patient safety.
- Immediate-Release Validation: In respiratory distress, absorption speed is critical. Our multi-point dissolution profiling ensures the tablet disintegrates within minutes in the gastric fluid, flooding the systemic circulation with the active bronchodilator rapidly.
Therapeutic Indications (Human Use)
Indicated for the comprehensive systemic management of reversible airway obstruction:
- Bronchial Asthma: Maintenance treatment to prevent and relieve bronchospasm.
- Chronic Obstructive Pulmonary Disease (COPD): Systemic bronchodilation in chronic bronchitis and emphysema.
Dosage & Administration
Recommended Dosage (Strictly as per Pulmonologist/Physician Guidelines):
- Standard Adult Dosing: Initially 2.5 mg taken two or three times daily. If an adequate response is not achieved, the dose may be increased to 5 mg two or three times daily.
- Administration: Best taken at regular intervals to maintain a steady baseline of bronchodilation. Can be taken with or without food.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX EQUIVALENT (Strict Contraindication for Tocolysis): Oral Terbutaline is STRICTLY CONTRAINDICATED for the prevention or prolonged treatment of preterm labor (tocolysis) in pregnant women. Global regulators (including the FDA) have banned its use for this indication due to the massive risk of fatal maternal cardiovascular complications, including arrhythmias, pulmonary edema, and myocardial ischemia.
- Cardiovascular Effects: Even though it is “selective” for beta-2 receptors in the lungs, systemic oral dosing frequently spills over to stimulate beta-1 receptors in the heart. This frequently causes severe tachycardia (rapid heart rate), palpitations, and elevated blood pressure. It must be used with extreme caution in patients with ischemic heart disease or severe hypertension.
- Hypokalemia Risk: High doses of beta-2 agonists can drive potassium from the blood into the cells, causing severe, potentially fatal hypokalemia (low blood potassium). Potassium levels should be monitored, especially if the patient is taking concurrent loop diuretics (like Torsemide).
- CNS Stimulation: Frequently causes fine muscle tremors (especially in the hands), nervousness, and insomnia.
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 Retail Pharmacy 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 Hospital Tender Supplier for asthma programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.










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