A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Toradol Indications, Dosage, Storage, Stability - Ketorolac
Toradol Indications, Dosage, Storage, Stability - Ketorolac
INDICATIONS
Ketorolac tromethamine
is indicated for the short-term (£5
days) management of moderately severe, acute
pain that requires analgesia
at the opioid level,
usually in a postoperative setting. Therapy should always be initiated
with ketorolac tromethamine
IV/IM and oral ketorolac
tromethamine is to be used only as continuation treatment,
if necessary. Combined use of ketorolac tromethamine
IV/IM and oral ketorolac
tromethamine is
not to exceed 5 days of use because of the potential
of increasing the frequency and severity of adverse reactions associated
with the recommended doses (see WARNINGS,
PRECAUTIONS, DOSAGE
AND ADMINISTRATION, and ADVERSE
REACTIONS). Patients should be switched to alternative analgesics
as soon as possible, but ketorolac tromethamine
therapy is not to exceed
5 days.
Ketorolac tromethamine
IV/IM has been used concomitantly with morphine and meperidine,
and has shown an opioid-sparing effect. For breakthrough pain, it
is recommended to supplement the lower end
of the ketorolac tromethamine IV/IM dosage
range with low doses of
narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine
IV/IM and narcotics should not be administered in the same syringe
(see DOSAGE AND ADMINISTRATION
, Pharmaceutical
Information for ketorolac tromethamine IV/IM.)
Ophthalmic Solution: Acular ophthalmic
solution is indicated
for the relief of ocular
itching due to seasonal allergic
conjunctivitis.
DOSAGE AND ADMINISTRATION
THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE IV/IM
AND KETOROLAC TROMETHAMINE ORAL
IS NOT TO EXCEED FIVE (5)
DAYS.
THE USE OF KETOROLAC TROMETHAMINE ORAL
IS ONLY INDICATED AS
CONTINUATION THERAPY TO KETOROLAC
TROMETHAMINE IV/IM.
Ketorolac Tromethamine IV/IM: Ketorolac tromethamine
IV/IM may be used as a single or multiple
dose, on a regular or
"pm" schedule for the management of moderately severe,
acute pain
that requires analgesia at the opioid
level, usually in a postoperative setting. Hypovolemia should be
corrected prior to the administration
of ketorolac tromethamine
(see WARNINGS, Renal Effects).
Patients should be switched to alternative analgesics as soon as
possible, but ketorolac tromethamine therapy
is not to exceed 5 days.
When administering ketorolac tromethamine
IV/IM, the IV bolus
must be given over no less
than 15 seconds. The IM administration
should be given slowly and deeply into the muscle. The analgesic
effect begins in ∼30
minutes with maximum
effect 1 to 2 hours after
dosing IV or IM. Duration
of analgesic effect
is usually 4 to 6 hours.
Multiple-Dose Treatment (IV or IM)
- Patients <65 years of age : The recommended dose
is 30 mg ketorolac tromethamine
IV/IM every 6 hours. The maximum
daily dose should not
exceed 120 mg.
- For patients ³65 years of age,
renally impaired patients (see WARNINGS),
and patients less than 50 kg
(110 lbs): The recommended dose
is 15 mg ketorolac tromethamine
IV/IM every 6 hours. The maximum
daily dose for these
populations should not exceed 60 mg.
For breakthrough pain,
do not increase the dose
or the frequency of
ketorolac tromethamine. Consideration should be given to supplementing
these regiments with low doses of opioids "pm" unless
otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine IV/IM:
Parenteral drug products
should be inspected visually for particulate
matter and discoloration prior to administration, whenever solution
and container permit.
Ketorolac tromethamine
IV/IM should not be mixed
in a small volume (e.g.,
in a syringe) with morphine
sulfate, meperidine hydrochloride, promethazine hydrochloride or
hydroxyzine hydrochloride; this will
result in precipitation of ketorolac from solution.
Ketorolac Tromethamine Oral: Oral ketorolac tromethamine
is indicated ONLY as continuation therapy
to ketorolac tromethamine
IV/IM for the management of moderately severe, acute
pain that requires analgesia
at the opioid level. See also PRECAUTIONS,
Information for Patients.
Transition from Ketorolac Tromethamine IV/IM to Ketorolac Tromethamine
Oral: The recommended oral
ketorolac tromethamine dose
is as follows:
- Patients <65 years of age: Two (2) tablets as a first
oral dose for patients who received 60 mg
IM single dose, 30 mg IV
single dose or 30 mg multiple
dose ketorolac tromethamine
IV/IM followed by one (1) tablet
oral ketorolac tromethamine
every 4 to 6 hours, not to exceed 40 mg/24 h of oral
ketorolac tromethamine.
- Patients ³65 years of age,
renally impaired and/or less than 50 kg
(110 lbs) of body weight:
One (1) tablet as a
first oral dose for patients
who received 30 mg IM
single dose, 15 mg IV
single dose or 15 mg
multiple dose
ketorolac tromethamine
IV/IM followed by one (1) tablet
oral ketorolac tromethamine
every 4 to 6 hours, not to exceed 40 mg/24 h of oral
ketorolac tromethamine.
Shortening the recommended dosing intervals may result in increased
frequency and severity of adverse reactions.
The maximum combined
duration of use (parenteral
and oral ketorolac tromethamine)
is limited to 5 days.
Ophthalmic Solution: The recommended dose
of Acular is one drop (0.25 mg) four times a day for relief
of ocular itching due
to seasonal allergic conjunctivitis. The efficacy
of Acular (ketorolac tromethamine) ophthalmic solution
has not been established beyond one week of therapy.
HOW SUPPLIED
Store injectionables at controlled room
temperature 15°
to 30°C (59° to 86° F) with protection from light.
Store oral tablets at
controlled room temperature,
15° to 30°C (59° to 86°F). Store blister
packages at controlled room
temperature, 15° to 30°C (59° to 86°F). Protect
from excessive humidity and light.
Acular Ophthalmic Solution: Store at controlled room
temperature, 15- 30°C (59-86°F) with protection from light.
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