Ketolac 10 mg 20 tablets

Ketolac 10 mg 20 tablets

Composition:

Ketorolac tromethamine — 10 mg (per tablet).
Excipients:
Calcium phosphate dibasic, Microcrystalline cellulose, Crospovidone, Magnesium stearate, Ethanol.

Product Description:

Ketolac is a non‑steroidal anti‑inflammatory drug (NSAID) with strong analgesic properties.
It also has anti‑inflammatory and moderate antipyretic effects.
The mechanism of action is associated with non‑selective inhibition of COX‑1 and COX‑2 enzymes, mainly in peripheral tissues, resulting in suppression of prostaglandin biosynthesis — mediators of pain sensitivity, inflammation, and thermoregulation.
Ketorolac is a racemic mixture of R(+) and S(–) enantiomers, with the analgesic effect attributed to the S(–) enantiomer.
It does not act on opioid receptors, does not depress respiration, does not cause drug dependence, and has no sedative or anxiolytic effects.
Its analgesic efficacy is comparable to morphine and significantly exceeds other NSAIDs.
After oral administration, onset of analgesia occurs within 1 hour, with maximum effect reached in 2–3 hours.

Indications for use:

• Moderate to severe pain: trauma, dental pain, postoperative pain, oncological diseases.
• Myalgia, arthralgia, neuralgia, radiculitis.
• Dislocations, sprains.
• Rheumatic diseases Intended for symptomatic therapy to reduce pain and inflammation; does not affect disease progression.

Method of administration and dosage:

• Administer orally, either as a single dose or repeated depending on pain severity.
• Single dose — 10 mg.
• Repeated administration — 10 mg up to 4 times daily. 
• Maximum daily dose — 40 mg. 
• Course duration — not more than 5 days.

Contraindications:

• Bronchial asthma, nasal/sinus polyposis, intolerance to aspirin or other NSAIDs.
• Urticaria, rhinitis induced by NSAIDs.
• Intolerance to pyrazolone derivatives.
• Dehydration, hypovolemia.
• Active bleeding or high risk of bleeding.
• Post‑coronary artery bypass graft surgery.
• Confirmed hyperkalemia.
• Inflammatory bowel disease.
• Active erosive or ulcerative gastrointestinal lesions, peptic ulcers.
• Hypocoagulation (including hemophilia).
• Severe renal insufficiency (creatinine clearance < 30 ml/min).
• Severe hepatic insufficiency or active liver disease.
• Hemorrhagic stroke, hemorrhagic diathesis.
• Hematopoietic disorders.
• Pregnancy, labor, lactation.
• Children under 16 years (safety and efficacy not established).
• Hypersensitivity to ketorolac or other NSAIDs.

Precautions:

Concomitant use with other NSAIDs may cause fluid retention, cardiac decompensation, or arterial hypertension.
To reduce risk of NSAID‑induced gastropathy, antacids, misoprostol, or omeprazole may be prescribed.

Side effects:

Digestive system: common — gastralgia, diarrhea (especially in elderly patients with GI ulcer history).
Central nervous system: common — headache, dizziness, drowsiness.
Other: common — edema (face, legs, ankles, fingers, feet), weight gain; less common — increased sweating; rare — tongue swelling, fever.

Pregnancy and lactation:

Contraindicated during pregnancy, labor, and breastfeeding.

Storage conditions:

Store at temperatures not exceeding 30 °C.

Packaging:

Carton box contains 2 blisters of 10 tablets each and an instruction leaflet.