KETOROLAC TROMETHAMINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients 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 IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection 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

Product summary:

KETOROLAC TROMETHAMINE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1488-1 KETOROLAC TROMETHAMINE INJECTION, USP 60mg/2mL (30mg/mL) 2mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ketorolac Tromethamine Injection, USP is supplied as follows: NDC Ketorolac Tromethamine Injection, USP (30 mg per mL) Package Factor 72266-118-25 30 mg/mL Single-Dose Vial 25 vials per carton 72266-119-25* 60 mg/2 mL Single-Dose Vial 25 vials per carton *FOR IM USE ONLY Storage Conditions Store at20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India Issue date: January 2019 LEA-020148-00

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
HF Acquisition Co LLC, DBA HealthFirst
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called
a"coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines: o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with: o past
history of stomach ulcers, or stomach or
intestinal bleeding with use of NSAIDs
o taking medicines called "corticosteroids","anticoagulants", "SSRIs",
or "SNRIs"
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAID medicines should only be used: o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs are
used to treat pain and redness,
swelling, and heat (inflammation) from medical conditions such as
different types of arthritis, menstrual
cramps, and other types of short-term pain.
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine: • if you have had an asthma attack,
hives, or other allergic reaction with
aspirin or any other NSAIDs.
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Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
KETOROLAC TROMETHAMINE INJECTION, USP 60MG/2ML (30MG/ML) 2ML VIAL
BOXED WARNING
DESCRIPTION
Ketorolac tromethamine Injection, USP 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-1 H-pyrrolizine-1-carboxylic acid, compound with
2-amino-2-(hydroxymethyl)-1,3-
propanediol (1:1), and the structural formula is presented in Figure 1
FIGURE 1
C 15H 13NO 3 • C 4H 11NO 3
Ketorolac tromethamine 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 376.40.
Ketorolac Tromethamine Injection , USP 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 range is 6.9 to 7.9 and is adjusted with sodium
hydroxide and/or hydrochloric
acid. The sterile solutions are clear to slightly yellow in color.
CLINICALPHARMACOLOGY
Pharmacodynamics
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug
(NSAID) that exhibits analgesic
activity in animal models. The mechanism of action of ketorolac, like
that of other NSAIDs, is not
completely understood but may be related to prostaglandin synthetase
inhibition. The biological activity
of ketorolac tromethamine is associated with the S-form.
Ketorolac tromethamine possesses no sedative or anxiolytic properties.
The peak analgesic effect of ketorolac tromethamine occurs within 2 to
3 hour