Drug Interaction:
NSAIDs include-
Propionic acid- Fenoprofen, Flurbiprofen, Ibiprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin
Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin
Fenamates (anthralic acids) - Meclofenamate, Mefenamic acxid
Oxicams- Piroxicam
Refer- Ibuprofen
Drug interactions- summary
Ketrolac +
Methotrexate
delayed excretion of methotrexate
Frusemide
reduced diuretic response of frusimide
Lithium
clearance reduced ,higher lithium levels
Warfarin
induced coagulalopathy
NSAIDs
incresed adverse effects of NSAIDs
Morphine
enhances morphine anagesia
Probenecid
reduced excretion
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
166. Ketorolac Tromethamine 4mg 24-07-08
+ Gatifloxacin 3mg Eye drops
For the reduction of post operative inflammatory condition
of the eyes
Approved by FDA in November 1989
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ketorolac Tromethamine NSAIDs April 1992
2.Ketorolac Tromethamine 0.4% w/v 21-09-2010
+ Moxifloxacin 0.5% w/w
ophthalmic solution
Additional lower strength
3.Ketorolac Tromethamine 4mg 24-07-2008
+ Gatifloxacin 3mg Eye drops
For the reduction of post operative inflammatory conditions of
the eye
4.Ketorolac Tromethamine Gel 31-03-2009
2%w/w
For the treatment of muscle, joint, and post -traumatic stress
5.Ketorolac Tromethamine 10-02-2010
Ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following
cataract surgery
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Ketorolac Tromethamine 5mg + 12-07-2005
Ofloxacin 3mg per ml Eye drops
Ophthalmic
2.Ketorolac Tromethamine IP 4mg + 21-11-2011
Olopatadine Hcl eq. to Olopatadine 1mg+
Benzalkonium Chloride IP 0.05mg ophthalmic solution
For the treatment of seasonal allergic conjunctivitis in
adults only
Short term management of pain.
NSAIDs include- Propionic acid- Fenoprofen, Flurbiprofen, Ibiprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin Fenamates (anthralic acids) - Meclofenamate, Mefenamic acxid Oxicams- Piroxicam
Refer- Ibuprofen
Indicated for the treatment of pain and inflammation following
Adverse Reaction:
Nausea,dyspepsia,GI pain,drowsiness.diarrhoea, dizziness,headache,sweating,oedema. Other adverse effects are encountered rarely in less than 1% patients.
Adverse reactions are minimal in short term therapy, but use for 3-6mths,it may cause gastric irritation,ulcer,bleeding,and perforation.
Overdose may cause diarrhoea,pallor,laboured breathing,vomiting.
Contra-Indications:
Asthma,hypovolaemia,dehydration History of peptic ulcer or coagulation disorders. Hypersens to drug or other NSAIDs. Allergy to aspirin or other prostaglandin synthesis inhibitors . Patients with complete or partial syndrome of nasal polyps,angioedma,brochospasm.
Concomittant lithium treatment. Pregnancy,labour,delivery,lactation. Moderate to severe renal impairment. Suspected or confirmed GI and/or cardiovasular bleeding.
Haemorrrhagic disathesis. Surgical patients with risk of haemorrhage or incomplete haemostasis. Concomitant use with other NSAIDs,pentoxyfyline,probenecid.
Warnings:
Ketrolac is indicated for short term ( upto 5 days) management of moderately acute pain that requires analgesia at the opiod level. Some of these agents may cause headache ( highest incidence with fenoprofen, indomethicin, and ketorolac ).
If headache pesists despite dosage reduction, discontinue use It is not indicated for minor or chronic painful conditions.
Ketrolac is a potent NSAID analgesic and its administration carries many risks. The resulting NSAID- related adverse events can be serious in certain patients for whom ketrolac is indicated, especially when the drug is used inappropiately.
Increasing the dose beyond the label recommended will not provide better eficacy but will result in increasing the risk of developing serious adverse events
GI effects - Ketrolac can cause peptic ulcers, GI bleeding or perforation. Therefore it is contraindicated in patients with active peptic disease , recent GI bleeding or perforation, or a history of peptic ulcer disease or GI bleeding
Renal effects- ketrolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion
Risk of bleeding- Ketrolac inhibits platelet function and therefore contraindicated in patients with suspected or confirmed cerebrovascular bleeding , haemorrhagic diathesis, incomplete hemostatis and those with higher risks of bleeding Ketrolac is contraindicated as prophylactic analgesia before any major surgery and is contraindicated intra-operatively when hemostatis is critical because of increased risk of bleeding
Hypersensitivity- Reactions - ranging from bronchspasm to anaphtlactic shock , have occured, and appropiate counteractive measures must be available when administering the first dose of ketrolac.
Ketrolac is contraindicated in persons with previuosly demonstrated hypersensitivity to ketrolac or allergic malnifestation to aspirin or other NSAIDs Intrathecal or epidural admin.- Ketrolac is contraindicated for inrathecal or epidural admin. due to alcohol content.
Labor, delivery ,lactation- Use in labor and dellivery is contraindicated becuase ketrolac may adversely affect fetal circulation and inhibit uterine contrations.
Use in nursing mothers is contraindicated because of potential adverse effects on prostagladin -inhibiting drugs on neonates
Concomittant use with NSAIDs- Ketrolac is contraindicated in patients currently receiving aspirin or other NSAIDs because of the cumilative risk of inducing NSAID -related side effects.
Admin. and dosage- ketrolac ( oral ) is indicated inly as continuation therapy to ketrolac IV/IM the combined duration of IM/IV is not exceed 5 days because the increased risk of serious adverse events.
Recommended total daily oral dose - maximum 40mg is significantly lower than for IM/IV - ( maximum 120mg )
Special populations- adjust dosage for patients > 65 years old for patients < 50 kg ( 110 lb) or for patients with moderately serum creatinine . IM/IV doses ae not exceed 60mg/day in these patients
Dosages/ Overdosage Etc:
Approved by FDA in November 1989
Indications: Short term management of pain.
Dosage:
IM- may be used on a regular scheduled as needed. Initial dose is 30 or 60mg IM. as a loading dose,followed by half of the loading dose(15 or 30mg) every 6 hours.
Oral - 10mg as needed every 4 or 6 hours for a limited duration. Do not use chronic doses of 10mg 4 times daily.
Maximum dose - 40mg daily.
Patient Information:
NSAIDs include- Propionic acid- Fenoprofen, Flurbiprofen, Ibuprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin Fenamates (anthralic acids) - Meclofenamate, Mefenamic acxid Oxicams- Piroxicam
Refer- Ibuprofen
1. NSAIDs can cause discomfort and rarely more serious side effects such as GI bleeding which may result in hospitalisation and even fatalities.
2.Avoid aspirin and alcoholic beverages while taking medication.
3. If GI upset occurs, take with food, milk or antacids. For GI upset with tolmetin, use antacids other than sodium bicarbonate.
4. Notify physician, if skin rash, itching, visual disturbances, weight gain, edema occurs
5. Mefanamic acid and metclofenate: if rash, diarrhoea, or digestive problem occr discontinue use and consult physician
6. Ibuprofen- Do not take for more than 3 days for fever or 10 days for pain. If these symptoms persists,consult a physican.
Interaction with Food:
Not reported.
Pregnancy and lactation:
Pregnancy:
Use in nursing mothers is contraindicated because of the the potential adverse effects of prostaglandin-inhibiting drugs on neonates.