Description

Ketorolac Tablets (10mg)

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. is a specialized Manufacturer of Ketorolac Tromethamine Tablets in India. Ketorolac is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) often described as having “opioid-level strength.” It is indicated strictly for the Short-Term Management (≤ 5 days) of moderate to severe acute pain, particularly following surgery or dental procedures, where powerful relief is needed without the sedation or addiction risks of narcotics.

We offer Contract Manufacturing (Third Party) services for this high-potency analgesic. Because Ketorolac is a potent gastric irritant, our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to protect the stomach lining during the initial dissolution phase and to mask the bitter taste. Healthy Inc manages the export logistics, supplying hospitals, dental clinics, and emergency care centers across the USA, Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Potency without the narcotic risk.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Ketorolac is potent at low doses (10mg). We use Geometric Blending and automated weight control systems to ensure every tablet contains the precise dose. A variation here could lead to toxicity (if high) or breakthrough pain (if low).

  • Dissolution Control: We engineer the tablet to disintegrate rapidly (< 15 mins) to ensure quick onset of action, which is critical for acute pain patients.

  • Light Protection: The active ingredient is sensitive to light. We process it in controlled environments and recommend Alu-Alu Blisters or opaque coating to ensure stability.

• The Exporter: Healthy Inc

  • Safety Packaging: Given the strict 5-day usage limit, we offer smaller pack sizes (e.g., 10s or 20s blisters) to prevent patients from having leftover medication, reducing the risk of chronic misuse.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products (ketone analog) to ensure safety.

5. Why Use Ketorolac?

Morphine power, non-narcotic safety.

• Mechanism: It is a non-selective COX inhibitor. It powerfully inhibits the enzymes Cyclooxygenase-1 (COX-1) and COX-2, stopping the production of prostaglandins that cause inflammation and pain sensitization. Its analgesic potency is comparable to low doses of morphine.

• Key Indications:

  • Post-Operative Pain: Used after general surgeries (orthopedic, abdominal) as a transition from IV injection to oral tablets.

  • Dental Pain: Highly effective for pain after tooth extraction or root canal.

  • Acute Trauma: Fractures or severe sprains.

  • Renal Colic: Kidney stone pain (often superior to opioids).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Ketorolac Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Toradol?

  A: Toradol is the brand name (Roche). We manufacture the Generic Equivalent (Ketorolac Tromethamine), which works exactly the same way.

   

• Q: Can I take it for chronic back pain?

  A: ABSOLUTELY NOT. It is strictly for Short-Term Use (Max 5 Days). Long-term use carries a very high risk of stomach ulcers, bleeding, and kidney failure.

• Q: Is it addictive?

  A: No. Unlike opioids (Tramadol, Oxycodone), Ketorolac is not a narcotic and is not addictive.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 10mg every 4 to 6 hours as needed.

• Max Dose: 40mg per day.

• Duration: DO NOT EXCEED 5 DAYS (combined IV/IM and Oral).

• Administration: Swallow whole with water. Taking with food helps reduce stomach upset.

9. Side Effects and Precautions

• Gastrointestinal: High Risk. Peptic ulcers, GI bleeding, and perforation can occur without warning. Contraindicated in patients with active ulcers.

• Renal Failure: Inhibits renal blood flow. Contraindicated in patients with moderate to severe kidney disease or dehydration.

• Bleeding Risk: Inhibits platelet function. Do not use before surgery (risk of operative bleeding).

• Cardiovascular: Increased risk of thrombotic events (stroke/MI) with NSAID use.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and excessive humidity.