READYSHARP ANESTHETICS PLUS KETOROLAC- lidocaine hydrochloride, bupivacaine hydrochloride, and ketorolac tromethamine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

Terrain Pharmaceuticals

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Administration route:

EPIDURAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recomm

Product summary:

Lidocaine Hydrochloride Injection, USP is supplied as follows: NDC Container Concentration Size Total (mg) Single-dose: 0409-4278-01 Glass Teartop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4713-01 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 400 units) 20 0409-4713-02 Glass Ampul 1% (10 mg/mL) 5 mL 50 0409-4713-05 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 400 units) 50 0409-4713-20 Glass Ampul 1% (10 mg/mL) 20 mL 200 0409-4713-32 Glass Ampul 1% (10 mg/mL) 2 mL 20 0409-4713-62 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 800 units) 20 0409-4713-65 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 800 units) 50 0409-4279-02 Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4270-01 Sterile Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4776-01 Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4056-01 Sterile Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4282-01 Glass Ampul 2% (20 mg/mL) 2 mL 40 0409-4282-02 Glass Ampul 2% (20 mg/mL) 10 mL 200 Multiple-dose: 0409-4275-01 Plastic Fliptop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4276-01 Plastic Fliptop Vial 1% (10 mg/mL) 20 mL 200 0409-4276-02 Plastic Fliptop Vial 1% (10 mg/mL) 50 mL 500 0409-4277-01 Plastic Fliptop Vial 2% (20 mg/mL) 20 mL 400 0409-4277-02 Plastic Fliptop Vial 2% (20 mg/mL) 50 mL 1000 Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: February, 2010 Printed in USA                            EN-2421 Hospira, Inc., Lake Forest, IL 60045 USA These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. MARCAINE with epinephrine 1:200,000 (as bitartrate)― Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Revised: 10/2011   Printed in USA                           EN-2916         Hospira, Inc., Lake Forest, IL 60045 USA Ketorolac Tromethamine Injection, USP is supplied as follows: Fill Volume/ Container Size Total Ketorolac Tromethamine (Per Container) NDC 0409-3793-01 Tray of 25 NDC 0409-3793-19 2mL Single-Dose Glass Fliptop Vial 15 mg NDC 0409-3795-01 Tray of 25 NDC 0409-3795-19 2mL Single-Dose Glass Fliptop Vial NDC 0409-3796-01* Tray of 25 NDC 0409-3796-19* 2mL Single-Dose Glass Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015 EN-3996 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

New Drug Application

Patient Information leaflet

READYSHARP ANESTHETICS PLUS KETOROLAC- LIDOCAINE HYDROCHLORIDE,
BUPIVACAINE
HYDROCHLORIDE, AND KETOROLAC TROMETHAMINE
Terrain Pharmaceuticals
----------
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 a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
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:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
• past history of stomach ulcers, • increasing doses of NSAIDs
or stomach or intestinal • longer use of NSAIDS
bleeding with the use of • smoking
NSAIDs • drinking alcohol
• taking medicines called • older age
“corticosteroids”, • poor health
“anticoagulants”, “SSRIs”, or • advanced liver disease
“SNRIs” • bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are 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 NSAIDs?
Do not take NSAIDs:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
ri

Summary of Product characteristics

READYSHARP ANESTHETICS PLUS KETOROLAC- LIDOCAINE HYDROCHLORIDE,
BUPIVACAINE
HYDROCHLORIDE, AND KETOROLAC TROMETHAMINE
TERRAIN PHARMACEUTICALS
----------
READYSHARP ANESTHETICS + KETOROLAC
LIDOCAINE HYDROCHLORIDE INJECTION, USP
AQUEOUS SOLUTIONS FOR INFILTRATION
AND NERVE BLOCK
AMPUL
PLASTIC MULTIPLE-DOSE FLIPTOP VIAL
GLASS TEARTOP VIAL
Rx only
DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine hydrochloride
in water for injection for parenteral administration in various
concentrations with characteristics as
follows:
Concentration
0.5% 1% 1.5% 2%
mg/mL lidocaine HCl (anhyd.)
5
10
15
20
mg/mL sodium chloride
8
7
6.5
6
Multiple-dose vials contain 0.1% of methylparaben added as
preservative. May contain sodium
hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5
(5.0 to 7.0). See _HOW_
_SUPPLIED_ section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethylamino)-N-(2,6-dimethylphenyl)-
acetamide monohydrochloride monohydrate, a white powder freely soluble
in water. The molecular
weight is 288.82. It has the following structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated polyolefin. It is a
copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals
according to USP biological standards for plastic containers. The
container requires no vapor barrier to
maintain the proper drug concentration.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine stabilizes the neuronal membrane by
inhibiting the ionic fluxes
required for the initiation and conduction of impulses, thereby
effecting local anesthetic action.
HEMODYNAMICS: Excessive blood levels may cause changes in cardiac
output, total peripheral
resistance, and mean arterial pressure. With central neural blockade
these changes may be attributable to
block of autonomic fibers, a direct depressant effect of the local
an