PERK

FORTRAL - KT TAB / INJ / E/E Drops

 KETROLAC TROMETHAMINE 10 MG / 30 MG / 0.5%w/v

USES AND ADMINISTRATION

FORTRAL-KT (Ketorolac), a pyrrolizine carboxylic acid derivative structurally related to indomethacin. It is a non-narcotic, non-steroidal anti-inflammatory drug  used principally for its pronounced analgesic activity. It is used intramuscularly, intravenously, or orally as the  salt in the short-term management of moderate to severe pain in :-

(1) Post operative pains after Major surgery, abdominal surgery, gynaecological surgery, orthopaedic surgery etc.

(2) Acute musculoskeletal painful conditions like acute strain and sprain, dislocation, fracture and soft tissue injury.

(3) Dental pain including pain after oral surgery.

(4) Cancer pain , sciatica, chronic pain states, and as an adjuvant in renal colic and biliary colic.

PHARMACOLOGY :

FORTRAL-KT is a highly potent member of a new class of analgesic compounds. It is both an analgesic and an anti-inflammatory agent.  In standard animal models of analgesic activity, Ketorolac has exhibited upto 800 times the potency of aspirin (weight by weight). In all essay, Ketorolac has shown to be more potent analgesic activity than indometacin, naproxen and phenylbutazone. Single dose efficacy of Ketorolac 10-20mg orally appeared superior to that of aspirin 650 mg, paracetamol 500 - 1000 mg, naproxen 550 mg. FORTRAL-KT has no effect on psychomotor performance which in contrast is significantly impaired by centrally acting analgesics such as morphine, pethidine and buprenorphine. In dental surgery, FORTRAL-KT in 10 - 20 mg dose is superior than aspirin, paracetamol or ibuprofen.

PHARMACOKINETICS

FORTRAL-KT acts at the cyclo-oxygenase pathway of arachidonic acid metabolism to inhibit prostaglandin biosynthesis. The peak plasma concentration of FORTRAL-KT is reached within about 30 to 60 minutes. FORTRAL-KT is over 99% bound to plasma protein. It does not readily penetrate the blood-brain barrier. FORTRAL-KT crosses the placenta and small amounts of drug have been detected in breast milk. The terminal plasma half-life is about 4 to 6 hours, but is about 6 to 7 hours in the elderly and 9 to 10 hours in patients with renal dysfunction.

DOSAGE

The recommended initial dose by the parental route is 10 mg of Ketorolac followed by 10 to 30 mg every 4 to 6 hours as required up to a total maximum daily dose of 90 mg (60 mg in the elderly, patients with mild renal impairment, and in those weighing less than 50 kg). Intravenous injections should be administered over at least 15 seconds. The recommended maximum duration for parental therapy is 2 days and patients should  be transferred to oral therapy as soon as possible. During transfer from parental to oral therapy the combined daily  dose for all forms of FORTRAL-KT  should not exceed 90 mg (60 mg in the elderly, patients with mild renal impairment, and in those weighing less than 50 kg) of which no more than 40 mg should be given orally. The recommended oral dose  is 10 mg every 4 to 6 hours to a maximum of 40 mg daily for a maximum total of 7 days.

CONTRA - INDICATIONS

FORTRAL-KT is contra-indicated in patients with moderate or severe renal impairment, and patients with mild renal impairment taking FORTRAL-KT should have their renal function closely monitored.

ADVERSE EFFECTS AND PRECAUTIONS

Adverse effects reported include gastro-intestinal disturbances , Hypersensitivity reactions like drowsiness, dizziness, headache . Liver function changes may occur.  FORTRAL-KT should not be used during pregnancy or labour and that it should not be given to mothers who are breast feeding. FORTRAL-KT should not be given to patients with coagulation or haemorrhagic disorders or those undergoing procedures with a high risk of haemorrhage. Ketorolac is not recommended for use in children.

PRESENTATION

FORTRAL-KT is available as :

*           TABLETS       :           Blister of Ten Tablet

                                                Each film coated tablet contains :

                                                Ketorolac Tromethamine    10mg

**         INJECTIONS :           1 ml Ampoules

                                                Each 1 ml ampoule contains :

                                                Ketorolac Tromethamine    30mg

***       EYE DROP    :           Contains :

                                                Ketorolac Tromethamine USP 0.5%w/v

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