Product image

Ketosin

Ketorolac Tromethamine
10mg
SinoHealth Pharmaceuticals LTD

Description

Ketosin – Ketorolac Tromethamine

Manufacturer: SinoHealth Pharmaceuticals LTD

1. Presentation:

  • Tablet: 10 mg

  • Injection: 15 mg/ml or 30 mg/ml (IM/IV)

  • Eye Drops: 0.4% or 0.5% solution

2. Description / Pharmacology:

Ketorolac Tromethamine is a potent nonsteroidal anti-inflammatory drug (NSAID) belonging to the pyrrolo-pyrrole group.
It provides strong analgesic action comparable to opioids but without central nervous system depression or addiction potential.

Mechanism of action:
Ketorolac inhibits the cyclooxygenase (COX-1 and COX-2) enzyme system, thereby suppressing prostaglandin synthesis — responsible for pain, inflammation, and fever.
At analgesic doses, it has minimal anti-inflammatory effect but excellent pain-relieving efficacy.

Pharmacokinetics:

  • Rapidly absorbed following oral or parenteral administration

  • Peak plasma concentration within 30–60 minutes

  • Highly protein-bound (>99%)

  • Metabolized in the liver; excreted primarily via urine

3. Indications:

KETOSIN (Ketorolac Tromethamine) is indicated for:

  • Moderate to severe acute postoperative pain

  • Musculoskeletal pain, dental pain, or trauma-related pain

  • Postpartum uterine cramping or episiotomy pain

  • Ocular pain and inflammation following cataract or refractive surgery

  • Seasonal allergic conjunctivitis (eye drops form)

রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

4. Dosage & Administration:

Oral (Tablet):

  • Adults: 10 mg every 4–6 hours as needed.
    Maximum dose: 40 mg/day.
    Duration: Not to exceed 7 days.

Injection (IM/IV):

  • Adults (<65 years): 30 mg every 6 hours (max 120 mg/day).

  • Elderly (>65 years), renal impairment, or <50 kg: 15 mg every 6 hours (max 60 mg/day).

  • Single-dose IM: 60 mg (<65 years), 30 mg (>65 years).

  • Single-dose IV: 30 mg (<65 years), 15 mg (>65 years).

Children (2–16 years):

  • IM: 1 mg/kg (max 30 mg)

  • IV: 0.5 mg/kg (max 15 mg)

Conversion from injection to tablet:
When switching from parenteral to oral therapy, ensure combined daily total dose (injection + tablet) does not exceed 120 mg in adults or 60 mg in elderly.
Total treatment duration should not exceed 5 days (combined).

Ophthalmic (Eye Drops):

  • Adults: 1 drop in each eye 4 times daily.

রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

5. Drug Interactions:

  • Other NSAIDs / Aspirin: Increase GI and renal toxicity.

  • Anticoagulants: Enhanced bleeding risk.

  • ACE inhibitors / Beta-blockers: May reduce antihypertensive efficacy.

  • Methotrexate: Increases toxicity risk.

  • Diuretics: May reduce natriuretic effect.

6. Contraindications:

  • Hypersensitivity to Ketorolac or other NSAIDs

  • Active peptic ulcer or gastrointestinal bleeding

  • Asthma, renal impairment, or dehydration

  • Pregnancy and lactation (unless essential)

  • Children under 16 years of age

  • Use as prophylactic analgesic before surgery

7. Side Effects:

Common adverse effects include:

  • Gastrointestinal: Nausea, vomiting, dyspepsia, abdominal pain, GI bleeding, peptic ulcer

  • CNS: Headache, dizziness, drowsiness

  • Cardiovascular: Hypertension, palpitations, bradycardia

  • Others: Rash, fatigue, edema, infertility (rare)

Eye drops may cause temporary burning or stinging upon instillation.

8. Pregnancy & Lactation:

  • Pregnancy: Category C – avoid unless clearly needed.

  • Lactation: Excreted in breast milk; avoid unless potential benefit outweighs risk.

9. Precautions & Warnings:

  • Use with caution in elderly or hepatic dysfunction.

  • Avoid in active GI ulcer, bleeding disorders, asthma, or renal disease.

  • Long-term or high-dose use increases GI bleeding and renal impairment risk.

  • For ophthalmic use, discontinue if corneal epithelial damage occurs.

10. Overdose Effects:

Symptoms: Drowsiness, nausea, vomiting, epigastric pain, GI bleeding, renal impairment.
Treatment:

  • Symptomatic and supportive care

  • Gastric lavage or activated charcoal if recent ingestion

11. Therapeutic Class:

Non-Opioid Analgesics / Anti-inflammatory Drugs (NSAIDs)

12. Storage Conditions:

Store below 30°C, away from light and moisture.
Keep out of reach of children.

Related products