Description
Ketorolac Tromethamine Tablets
Healthy Inc is a specialized global supplier and exporter of high-potency analgesics. We provide high-purity Ketorolac Tromethamine Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Opioid-Sparing” agent is a top export to trauma centers, dental surgery clinics, and postoperative recovery wards in Africa, LATAM, and Southeast Asia, serving as the most powerful non-narcotic option for the short-term management of moderately severe acute pain.
Product Overview
This formulation contains Ketorolac Tromethamine, a pyrrolizine carboxylic acid derivative non-steroidal anti-inflammatory drug (NSAID).
The “Hospital-Grade” Painkiller:
- Opioid-Level Potency: Ketorolac provides analgesia comparable to morphine or pethidine but without the sedative effects, respiratory depression, or potential for addiction associated with opioids.
- Mechanism: It is a potent inhibitor of the cyclooxygenase (COX-1 and COX-2) enzymes, completely blocking the synthesis of prostaglandins that sensitize pain receptors.
- Rapid Onset: Designed for acute situations, it offers rapid absorption with significant pain relief typically starting within 30 to 60 minutes.
- Short-Term Specialist: specifically engineered for the “transition phase”—used to manage pain for up to 5 days, often bridging the gap between injectable therapy and milder oral painkillers.
Product Composition & Strength
We supply this product as Film Coated Tablets (White/Round). The standard oral dosage is strictly limited due to potency.
| Active Ingredient | Strength (Standard) | Role |
|---|---|---|
| Ketorolac Tromethamine USP/BP | 10 mg | Standard Adult Dose |
| Excipients | Q.S. | Microcrystalline Cellulose / Lactose |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 15s, or 20s. Note: Bulk packs are rare due to the strict 5-day usage limit.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Oral) |
| Packaging | PVC-Alu Blister or Alu-Alu Blister (Light Sensitive) |
| 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.
- Light Protection: Ketorolac is sensitive to light. Our tablets are film-coated with opacifying agents (Titanium Dioxide) and packed in opaque blisters to maintain stability.
- Gastric Dissolution: Formulated to disintegrate rapidly to ensure quick onset, but with buffering agents to minimize immediate contact irritation with the stomach lining.
Therapeutic Indications (Human Use)
Indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level:
- Postoperative Pain: General surgery, orthopedic surgery, and gynecological procedures.
- Dental Pain: Severe pain following extractions or oral surgery.
- Acute Trauma: Management of fractures or dislocations (short-term).
- Renal Colic: Acute kidney stone pain (often after initial injectable dose).
Dosage & Administration
Recommended Dosage (Strictly as per Surgeon/Physician):
- Route: Oral.
- Duration Limit (CRITICAL): Do not use for more than 5 days. The risk of severe bleeding and kidney failure increases exponentially after day 5.
- Adults (< 65 yrs): 10 mg every 4 to 6 hours as needed. Max 40 mg/day.
- Adults (> 65 yrs or Renal Impairment): 10 mg every 6 to 8 hours. Max 40 mg/day.
- Transitioning: Oral tablets are usually started *after* initial IV/IM Ketorolac therapy. The total combined duration of use (IV/IM + Oral) must not exceed 5 days.
Safety Warnings:
- GI Bleeding (Black Box Warning): Ketorolac can cause severe peptic ulcers and gastrointestinal bleeding with practically zero warning. Contraindicated in patients with active peptic ulcer disease.
- Renal Toxicity: Can cause acute kidney failure, especially in dehydrated patients. Ensure adequate hydration.
- Bleeding Risk: Inhibits platelet function. Contraindicated before surgery (pre-operative) or during labor/delivery as it increases bleeding time.
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 OSD (Oral Solid Dosage) forms, 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.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
