Download Ketorolac Tromethamine

Ket
Ketorolac Tromethamine
when Methotrexate is administered concurrently, since some prostaglandin
synthesis inhibiting drugs have been reported to reduce the clearance of
Methotrexate and thus possibly enhance its toxicity. Probenecid should not be
administered concurrently with Ket (Ketorolac Tromethamine) because of
increases in Ket plasma level and half-life.
DESCRIPTION
Ket (Ketorolac Tromethamine) is a non-narcotic analgesic belonging to the
non-steroidal anti-inflammatory drug (NSAID) class of medicines with
analgesic, anti-inflammatory and antipyretic properties. Ket (Ketorolac
Tromethamine) inhibits the cyclo-oxygenase enzyme system and hence
synthesis of prostaglandins. It is considered to be a peripherally-acting
analgesic. It does not have known effects on opiate receptors. It has no intrinsic
effects on respiration and does not exacerbate opioid-related respiratory
depression or sedation.
PRECAUTIONS
INDICATIONS
Patients over the age of 65 years may be at a greater risk of experiencing
adverse events than younger patients. Ket (Ketorolac Tromethamine) can cause
gastro-intestinal irritation, ulcers or bleeding in patients with or without a
history of previous symptoms. Bronchospasm may be precipitated in patients
with a history of asthma. Since Ket (Ketorolac Tromethamine) and its
metabolites are excreted primarily by the kidney, patients with moderate to
severe impairment of renal function (serum creatinine greater than 160
micromol/l) should not receive the drug. Fluid retention and oedema have been
reported with the use of Ket (Ketorolac Tromethamine).
Ket (Ketorolac Tromethamine) is indicated for the short-term management of
moderate to severe acute pain following surgical procedures.
PREGNANCY & LACTATION
DOSAGE & ADMINISTRATION
Pregnancy category C. Ket (Ketorolac Tromethamine) is not recommended
for use during pregnancy, labour and delivery.
Adult (Under 65 years of age)
The usual recommended initial intramuscular dose is 10 mg to 30 mg, followed
by 10 mg to 30 mg at 4 to 6 hourly intervals, up to a maximum daily dose of 90
mg.
The usual oral dose of Ket (Ketorolac Tromethamine) is 10 mg every 4 to 6
hours, as required. Doses exceeding 40 mg per day are not recommended.
Ket (Ketorolac Tromethamine) is not recommended for treatment of nursing
mothers.
PACKAGING
Ket tablet: Each box contains 20's tablet in alu-alu blister pack. Each filmcoated tablet contains Ketorolac Tromethamine USP 10 mg.
Elderly (65 years of age and older)
An initial intramuscular dose of 10 mg to 15 mg, followed by 10 mg to 15 mg at
4 to 6 hourly intervals, up to a maximum daily dose of 60 mg.
Ket 30 injection: Each box contains 5 x 1 ml ampoules in blister pack. Each
ampoule contains Ketorolac Tromethamine USP 30 mg.
The usual oral dose of Ket (Ketorolac Tromethamine) in the elderly is 10 mg
every 6 to 8 hours. Daily doses of 30 mg to 40 mg per day should not be
exceeded. The use of Ket (Ketorolac Tromethamine) tablets is recommended
for the shortest possible time.
PHARMACEUTICAL PRECAUTIONS
The total duration of Ket (Ketorolac Tromethamine) administration should not
exceed 5 days because adverse effects may increase with prolonged usage.
WARNING
Store in a cool & dry place, below 30OC. Protect from light & moisture.
Keep out of the reach of children.
Note: When converting from parenteral to oral administration, total combined
dose on the day of converting should not exceed 90 mg (60 mg in the elderly
and patients weighing less than 50 kg) of which the oral component should not
exceed 40 mg.
SIDE EFFECTS
Commonly occurring side-effects are nausea, vomiting, gastro-intestinal
bleeding, melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness,
headache, hallucinations, excessive thirst, inability to concentrate, insomnia,
malaise, fatigue, pruritus, urticaria, skin photosensitivity, flushing, bradycardia,
hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma,
pulmonary oedema, fever, injection side pain.
CONTRAINDICATIONS
Ket (Ketorolac Tromethamine) is contraindicated in patients with severe heart
failure, dehydration or hypovolaemia from any other cause, having
hypersensitivity to this drug or other NSAIDs and those patients in whom
Aspirin or other prostaglandin synthesis inhibitors induce allergic reactions. It is
also contraindicated in a history of peptic ulcer or gastro-intestinal bleeding,
moderate or severe renal impairment (serum creatinine> 160 micromol/l), a
history of asthma and haemorrhagic diatheses including coagulation disorders.
Ket (Ketorolac Tromethamine) is also contraindicated for children under 16
years of age. It is contraindicated as prophylactic analgesia before surgery due
to inhibition of platelet aggregation and is contraindicated intraoperatively
because of the increased risk of bleeding.
DRUG INTERACTIONS
Ket (Ketorolac Tromethamine) should not be used with other NSAIDs or in
patients receiving Aspirin because of the potential for additive side effects. Care
should be taken when administering Ket (Ketorolac Tromethamine) with anticoagulants since co-administration may cause an enhanced anti-coagulant
effect. Ket (Ketorolac Tromethamine) and other non-steroidal antiinflammatory drugs can reduce the anti-hypertensive effect of beta-blockers and
may increase the risk of renal impairment when administered concurrently with
ACE inhibitors, particularly in volume depleted patients. Caution is advised