Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Ketorolac Tablets product packshot

Kevitee – Ketorolac Tromethamine Tablets USP

Composition: Each film-coated tablet contains Ketorolac Tromethamine USP 10 mg.

Usage: Short-term relief of moderately severe acute pain, as prescribed.

Category: Anti-inflammatory drug (NSAID)

Therapeutic category: NSAID / Analgesic

SKU: Ketorolac Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Kevitee – Ketorolac Tromethamine Tablets USP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Ketorolac Tablets (10 mg) – Description

Manufactured by: Healthy Life Pharma Pvt. Ltd. (certification status subject to verification)
Exported by: Healthy Inc (export status subject to verification)

Important: Ketorolac may cause serious gastrointestinal bleeding, kidney injury, cardiovascular events and bleeding complications. It is intended for short-term treatment only.

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. presents Kevitee Ketorolac Tromethamine Tablets USP 10 mg, a prescription non-steroidal anti-inflammatory drug (NSAID) used for short-term management of moderately severe acute pain. Healthy Inc is listed as the exporter.

Ketorolac is not suitable for chronic pain or minor discomfort. In the United States, oral ketorolac is indicated only as continuation after IV/IM ketorolac, and the combined treatment duration must not exceed five days. Requirements vary by country and approved product label.

2. Product Specifications

BrandKevitee
Product nameKetorolac Tromethamine Tablets USP
CompositionEach film-coated tablet contains Ketorolac Tromethamine USP 10 mg
CAS number74103-07-4 (ketorolac tromethamine)
Dosage formFilm-coated oral tablet
Therapeutic classNSAID / analgesic
UsageShort-term management of moderately severe acute pain where an NSAID is appropriate
SKUKetorolac Tablets
Shelf life and packagingConfirm from approved product artwork and stability records

3. Manufacturing Technology

For a low-dose film-coated product, relevant manufacturing controls include validated blend uniformity, compression consistency, film-coating quality, disintegration and dissolution testing. Actual processing methods, coating function, batch capacity and equipment must be verified against manufacturing records.

Note: Film coating should not be described as preventing NSAID-related gastrointestinal bleeding or ulcers; systemic GI risks remain.

4. Quality Assurance

Appropriate quality controls include identity, assay, content uniformity, dissolution, related substances, microbial quality where applicable, and packaging integrity according to the approved specification and relevant pharmacopoeial monograph. Do not assume numerical acceptance limits without the current approved specification and test method.

5. Pharmacology and Clinical Use

Ketorolac inhibits cyclooxygenase enzymes and reduces prostaglandin synthesis, providing analgesic and anti-inflammatory activity. It is a non-opioid analgesic but has important gastrointestinal, kidney, cardiovascular and bleeding risks.

Use is limited to appropriately selected patients with acute pain requiring short-term treatment. It is not a substitute for medical evaluation of severe or unexplained pain.

6. Export and Regulatory Support

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied product information. Contract manufacturing, CTD/ACTD dossiers, certificate of pharmaceutical product, certificates of analysis, export documentation and country-specific approvals should be confirmed for each order and destination market. Claims of WHO-GMP certification or Star Export House status should be supported by current documentation.

7. Frequently Asked Questions

Q: What does Kevitee contain?
A: Ketorolac Tromethamine USP 10 mg per film-coated tablet.

Q: Can I take it for chronic back pain?
A: No. Ketorolac is intended for short-term acute pain treatment, not chronic pain.

Q: Is it an opioid?
A: No. It is an NSAID, but serious adverse effects can occur even with short use.

Q: Can I combine it with ibuprofen or aspirin?
A: Do not combine with other NSAIDs unless specifically directed by a clinician; bleeding and other risks increase.

8. Dosage and Administration

Prescription-only. Dosing must follow the locally approved prescribing information, clinical indication, age, kidney function and patient risk factors. For US-labelled oral ketorolac, tablets are used only after IV/IM therapy, and the total combined duration must not exceed 5 days. The US oral maximum is 40 mg per day; these figures are not a universal recommendation for every market or patient.

Do not increase the dose or extend treatment to improve pain control. Follow the prescriber's instructions.

9. Side Effects and Precautions

  • GI injury: ulcers, bleeding and perforation may occur without warning.
  • Kidney injury: avoid in advanced renal impairment and patients at risk of renal failure from volume depletion.
  • Bleeding: inhibits platelet function; contraindicated in certain bleeding-risk situations and around coronary artery bypass graft surgery.
  • Cardiovascular: NSAIDs increase risk of serious thrombotic events, including heart attack and stroke.
  • Drug interactions: do not use with other NSAIDs; check anticoagulants, antiplatelets, corticosteroids and other interacting medicines.
  • Pregnancy: NSAIDs carry fetal risks, particularly from about 20 weeks onward; follow approved pregnancy restrictions.

Seek urgent medical care for vomiting blood, black tarry stools, chest pain, difficulty breathing, sudden weakness or severe allergic symptoms.

10. Storage Instructions

Store in the original protective packaging under the conditions printed on the approved product label; protect from excess moisture and light as specified. Keep out of reach of children.