Drotaverine Hydrochloride Injection
Healthy Inc is a specialized global supplier and exporter of potent non-anticholinergic antispasmodics. We provide high-purity Drotaverine Hydrochloride Injection (40 mg / 2 ml), sourced from WHO–GMP certified sterile injectable facilities. This “Smooth Muscle Relaxant” is a top export to gastroenterology clinics, maternity wards, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the rapid-action solution for acute abdominal pain, renal colic, and labor augmentation.
Product Overview
This formulation contains Drotaverine Hydrochloride, an isoquinoline derivative that acts directly on smooth muscle.
The “Side-Effect Free” Spasmolytic:
- Mechanism (PDE4 Inhibition): Unlike Dicyclomine or Atropine (which block acetylcholine receptors), Drotaverine works by inhibiting the enzyme Phosphodiesterase IV (PDE4). This increases cyclic AMP (cAMP) levels inside the cells, leading to direct relaxation of smooth muscle.
- No Anticholinergic Effects: Because it does not block cholinergic receptors, it does NOT cause dry mouth, blurred vision, or urinary retention. This makes it safe for patients with glaucoma or prostatic hypertrophy, where other antispasmodics are contraindicated.
- Labor Acceleration: It is widely used in obstetrics to accelerate cervical dilation during labor by relaxing the smooth muscle of the cervix, reducing the duration of the first stage of labor.
Product Composition & Strength
We supply this product as a Sterile Solution in Amber Glass Ampoules.
| Active Ingredient | Strength | Volume |
|---|---|---|
| Drotaverine Hydrochloride USP/BP | 40 mg | 2 ml Ampoule (20 mg/ml) |
| Excipients | Sodium Metabisulfite | Antioxidant |
*Pack Sizes: Tray of 5 Ampoules, 10 Ampoules, or 50 Ampoules.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| Dosage Form | Injection (Liquid Solution) |
| Packaging | Amber Type I Glass Ampoule (Light Sensitive) with Color Break Ring |
| Storage | Store below 30°C. 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.
- Oxidation Control: Drotaverine is sensitive to oxidation, which turns the solution yellow/brown. We use Nitrogen flushing and Sodium Metabisulfite stabilization to ensure the solution remains clear and potent throughout its shelf life.
- pH Balance: The injection is formulated at an optimal pH (3.0 – 5.0) to ensure stability while minimizing pain upon intramuscular injection.
Therapeutic Indications (Human Use)
Indicated for the relief of smooth muscle spasms associated with:
- Biliary Colic: Cholecystolithiasis (Gallstones), Cholecystitis.
- Renal Colic: Nephrolithiasis (Kidney Stones), Ureterolithiasis.
- Gastrointestinal Spasm: Gastritis, Enteritis, IBS, and Peptic Ulcers.
- Gynecology: Dysmenorrhea (Painful periods), Threatened Abortion.
- Obstetrics: Cervical dilation augmentation during labor.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Intramuscular (IM) or Slow Intravenous (IV) Injection.
- Adults: 40 mg to 80 mg (1-2 ampoules) IM daily. Can be repeated up to 3 times a day.
- Acute Colic (Renal/Biliary): 40 mg to 80 mg slowly IV.
- Children (>6 years): 20 mg to 40 mg IM/SC.
Safety Warnings (CRITICAL):
- Hypotension: Rapid IV injection can cause a sudden drop in blood pressure and dizziness. Always inject slowly over 2-3 minutes.
- Levodopa Interaction: Drotaverine can reduce the efficacy of Levodopa in Parkinson’s patients. Avoid co-administration.
- Allergy: Contains Sodium Metabisulfite; may cause allergic reactions in susceptible individuals (asthmatics).
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.