A1,
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B,
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C2,
D,
E,
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Toradol Online, Description, Chemistry, Ingredients - Ketorolac
Toradol Online, Description, Chemistry, Ingredients - Ketorolac
DESCRIPTION
WARNING
| Ketorolac tromethamine, a nonsteroidal anti-inflammatory
drug (NSAID) is indicated
for the short-term (up to 5 days) management of moderately severe,
acute pain,
that requires analgesia
at the opioid level.
It is NOT indicated for minor
or chronic painful
conditions. Ketorolac tromethamine 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 ketorolac tromethamine
is indicated, especially when the drug is used inappropriately.
Increasing the dose
of ketorolac tromethamine beyond the label
recommendations will
not provide better efficacy
but will result in increasing the risk
of developing serious adverse events.
Gastrointestinal Effects: Ketorolac tromethamine
can cause peptic
ulcers, gastrointestinal
bleeding, and/or
perforation. Therefore, ketorolac tromethamine is CONTRAINDICATED
in patients with active peptic
ulcer disease, in
patients with active peptic
ulcer disease,
in patients with recent gastrointestinal bleeding or perforation,
and in patients with a history
of peptic ulcer
disease or gastrointestinal
bleeding.
Renal Effects: Ketorolac tromethamine
is CONTRAINDICATED in patients with advanced renal
impairment
and in patients at risk
for renal failure
due to volume depletion
(see WARNINGS).
Risk of Bleeding: Ketorolac tromethamine
inhibits platelet
function and is, therefore, CONTRAINDICATED in patients with
suspected or confirmed cerebrovascular bleeding,
patients with hemorrhagic
diathesis, incomplete hemostasis, and those at high risk
of bleeding (see
WARNINGS and PRECAUTIONS).
Ketorolac tromethamine
is CONTRAINDICATED as prophylactic
analgesic before any major surgery,
and it is CONTRAINDICATED intra-operatively when hemostasis
is critical because
of the increased risk
of bleeding.
Hypersensitivity: Hypersensitivity reactions, ranging
from bronchospasm to anaphyl- actic shock, have occurred and
appropriate
counteractive measures must be available when administering
the first dose of
ketorolac tromethamine IV/IM (see CONTRAINDICATIONS
and WARNINGS). Ketorolac
tromethamine
is CONTRAINDICATED in patients with previously demonstrated
hypersensitivity to ketorolac tromethamine
or allergic manifestations
to aspirin or other nonsteroidal anti-inflammatory
drugs (NSAIDs).
Intrathecal or Epidural Administration: Ketorolac
tromethamine is CONTRAINDICATED for intrathecal
or epidural administra-
tion due to its alcohol
content.
Labor, Delivery, and Nursing: The use of ketorolac
tromethamine in labor
and delivery
is CONTRAINDICATED because it may adversely affect fetal circulation
and inhibit uterine
contractions.
The use of ketorolac tromethamine
is CONTRAINDICATED in nursing
mothers because of the potential
adverse effects of prostaglandin-inhibiting drugs on neonates.
Concomittant Use with NSAIDs: Ketorolac tromethamine
is CONTRAINDICATED in patients currently receiving ASA
or NSAIDs because
of the cumulative risk of inducing serious NSAIDs
related side effects.
DOSAGE AND ADMINISTRATION: Oral ketorolac tromethamine
is indicated only as continuation therapy
to ketorolac tromethamine
IV/IM, and the combined duration of use of ketorolac tromethamine
IV/IM and oral ketorolac
tromethamine is not to exceed 5 (five) days because of the
increased risk of
serious adverse events.
The recommended total daily dose
of oral ketorolac
tromethamine
(maximum 40 mg) is significantly lower than for ketorolac
tromethamine
IV/IM (maximum 120 mg) (see DOSAGE
AND ADMINISTRATION: Transition from Ketorolac
Tromethamine IV/IM to Ketorolac Tromethamine Oral).
Special Populations: Dosage should be adjusted for
patients 65 years or older, for patients under 50 kg
(110 lbs) of body
weight (see DOSAGE
AND ADMINISTRATION), and for patients with moderately
elevated serum creatinine
(see WARNINGS). Doses
of ketorolac tromethamine
IV/IM are not to exceed 60 mg
(total dose per day) in these patients.
|
Ketorolac tromethamine
is a member of the pyrrolo-pyrrole
group of nonsteroidal
anti-inflammatory drugs (NSAIDs). The chemical
name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic
acid, 2-amino-2-(hydroxymethyl)-1,3-propanediol.
Toradol is a racemic
mixture of [-]S and
[+]R ketorolac tromethamine. Ketorolac tromethamine
may exist in three crystal
forms. All forms are equally soluble
in water. Ketorolac tromethamine
has a pKa of 3.5 and an n-octanol/water partition coefficient
of 0.26. The molecular weight
of ketorolac tromethamine
is 376.41.
Toradol is available for intravenous
(IV) or intramuscular
(IM) administration as: 15 mg
in 1 ml (1.5%), and 30 mg
in 1 ml (3%) in sterile
solution; 60 mg in 2 ml (3%)
of ketorolac tromethamine
in sterile solution
is available for IM administration
only. The solutions contain 10% (w/v) alcohol,
USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium
chloride in sterile
water. The pH is adjusted
with sodium hydroxide
or hydrochloric acid and the solutions are packaged with nitrogen.
The sterile solutions
are clear and slightly yellow
in color.
Toradol oral is available
as round, white, film-coated, red-printed tablets. Each tablet
contains 10 mg ketorolac
tromethamine, the active ingredient, with added lactose, magnesium
stearate, and microcrystalline cellulose. The white
film-coating contains hydroxypropyl methylcellulose, polyethylene
glycol, and titanium
dioxide.
The tablets are printed with red
ink which includes FD&C Red #40 Aluminum lake
as the colorant. There is a large T printed on both sides of the
tablet, as well as the
word Toradol on one side, and the word SYNTEX on the other.
Ophthalmic Solution: Acular (ketorolac tromethamine) is
a member of the pyrrolo-pyrrole group
of nonsteroidal anti-inflammatory
drugs (NSAIDs). The chemical
name for ketorolac tromethamine
is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic
acid, 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1).
Acular (ketorolac tromethamine) is supplied as a sterile
isotonic aqueous 0.5% solution,
with a pH of 7.4. Acular is a racemic
mixture of R-(+)- and S-(-)-ketorolac
tromethamine. Ketorolac tromethamine
may exist in three crystal forms. All forms are equally soluble
in water. Ketorolac tromethamine has a pKa of 3.5. The white
to off-white crystalline
substance discolors on prolonged
exposure to light. The molecular
weight of ketorolac tromethamine
is 376.41.
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