KETOROLAC TROMETHAMINE spray, metered

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Prasco Laboratories

Администрация маршрут:

NASAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Ketorolac Tromethamine is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.  Limitations of Use          • Ketorolac Tromethamine is not for use in pediatric patients less than 2 years of age. Ketorolac Tromethamine is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ketorolac or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] - Use in patients with active peptic ulcer disease and in patients with recent gastrointestinal bleeding or perforation [see Warnings and Precautions (5.2) ] - Use as a prophylactic analgesic before any major surgery [see Warnings and Precautions (5.12) ] - Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion [see Warnings and Precautions (5.6) ] - Use in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage [see Use in Specific Populations (8.1) ] - Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical [see Warnings and Precautions (5.12), Drug Interactions (7) ] - Concomitant use with probenecid [see Drug Interactions (7) ] - Concomitant use with pentoxifylline [see Drug Interactions (7) ] Risk Summary Use of NSAIDs, including Ketorolac Tromethamine, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Ketorolac Tromethamine use between about 20 and 30 weeks of gestation, and avoid Ketorolac Tromethamine use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ketorolac Tromethamine, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies in rabbits and rats tested at 0.6 and 1.5 times the human systemic exposure, respectively, at the recommended maximum IN dose of 31.5 mg four times a day, there was no evidence of teratogenicity or other adverse developmental outcomes (see Data ). Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ketorolac, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.  Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Ketorolac Tromethamine, can cause premature closure of the fetal ductus arteriosus (see Data ). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Ketorolac Tromethamine treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Ketorolac Tromethamine and follow up according to clinical practice (see Data ). Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. Methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use. Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain.  Animal Data Reproduction studies have been performed during organogenesis using daily oral doses of ketorolac tromethamine at 3.6 mg/kg (0.6 times the human systemic exposure at the recommended maximum IN dose of 31.5 mg qid, based on area-under-the-plasma-concentration curve [AUC]) in rabbits and at 10 mg/kg (1.5 times the human AUC) in rats. These studies did not reveal evidence of teratogenicity or other adverse developmental outcomes. However, because animal dosing was limited by maternal toxicity, these studies do not adequately assess ketorolac’s potential to cause adverse developmental outcomes in humans. Risk Summary Ketorolac is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ketorolac Tromethamine and any potential adverse effects on the breastfed infant from the Ketorolac Tromethamine or from the underlying maternal condition. Clinical Considerations Exercise caution when administering Ketorolac Tromethamine to a nursing woman. Available information has not shown any specific adverse events in nursing infants; however, instruct patients to contact their infant’s health care provider if they note any adverse events Data Limited data from one published study involving ten nursing mothers 2-6 days postpartum showed low levels of ketorolac in breast milk. Levels were undetectable (less than 5 ng/mL) in 4 of the patients. After a single administration of 10 mg ketorolac, the maximum milk concentration observed was 7.3 ng/mL, and the maximum milk to plasma ratio was 0.037. After 1 day of dosing (10 mg every 6 hours), the maximum milk concentration was 7.9 ng/mL, and the maximum milk-to-plasma ratio was 0.025. Assuming a daily intake of 400-1000 mL of human milk per day and a maternal body weight of 60 kg, the calculated maximum daily infant exposure was 0.00263 mg/kg/day, which is 0.4% of the maternal weight adjusted dose. Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including Ketorolac Tromethamine, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including Ketorolac Tromethamine, in women who have difficulties conceiving or who are undergoing investigation of infertility. Ketorolac Tromethamine is not for use in pediatric patients less than 2 years of age. The safety and effectiveness of ketorolac in pediatric patients 17 years of age and younger have not been established. Exercise caution when treating the elderly (65 years and older) with Ketorolac Tromethamine. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Dosage and Administration (2.4), Warnings and Precautions (5.1, 5.2, 5.3, 5.6, 5.14), Clinical Pharmacology (12.3) ]. After observing the response to initial therapy with Ketorolac Tromethamine, adjust the dose and frequency to suit an individual patient’s needs. Ketorolac and its metabolites are known to be substantially excreted by the kidneys, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, use caution in this patient population, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3) ]. Instructions for Use Ketorolac Tromethamine Nasal Spray Read this Instructions for Use before you start using Ketorolac Tromethamine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important information: - Ketorolac Tromethamine is for use in your nose only. Do not breathe in (inhale) Ketorolac Tromethamine. - Each Ketorolac Tromethamine bottle has enough pain medicine for 1 day. - Throw away each Ketorolac Tromethamine bottle within 24 hours of taking your first dose, even if the bottle still contains unused medicine. Your healthcare provider has prescribed Ketorolac Tromethamine to treat moderate to severe pain. - Use Ketorolac Tromethamine exactly as your healthcare provider tells you to use it. - Your healthcare provider will tell you how many sprays you should use each time you use Ketorolac Tromethamine. - Do not use Ketorolac Tromethamine for more than 5 days. If you still have pain after 5 days, contact your healthcare provider. - Do not use Ketorolac Tromethamine more than every 6 hours. - It is important that you drink plenty of fluids while you are using Ketorolac Tromethamine. Tell your healthcare provider if you urinate less while using Ketorolac Tromethamine. You may have discomfort or irritation in your nose when using Ketorolac Tromethamine.  This usually lasts for a short time. Do not breathe in (inhale) Ketorolac Tromethamine while spraying. Using Ketorolac Tromethamine Nasal Spray Parts of your Ketorolac Tromethamine bottle Follow the instructions below to use Ketorolac Tromethamine. Before you use Ketorolac Tromethamine for the first time, you will need to prime the bottle. Priming Ketorolac Tromethamine: Step 1. Hold the finger flange with your fingers (see Figure A) , and remove the clear plastic cover with your opposite hand. Keep the clear plastic cover for later. Remove and throw away the blue plastic safety clip. If the clear plastic cover is improperly removed, the tip of the bottle may be pulled off of the glass vial. If this happens, place the tip back onto the glass vial by lining it up carefully and gently pushing it back on until it is back in the correct position (see Figure B) . The Ketorolac Tromethamine bottle should work properly again. Step 2. Hold the Ketorolac Tromethamine bottle upright at arm’s length away from you with your index finger and middle finger resting on the top of the finger flange and your thumb supporting the base (see Figure C) . Press down on the finger flange and release the pump 5 times. You may not see a spray the first few times you press down. Now the pump is primed and ready to use. You do not need to prime the pump again if you use more doses from this bottle. Step 3. Blow your nose to clear your nostrils. Step 4. Sit up straight or stand. Step 5. Keep your head tilted downward toward your toes. Step 6. Place the tip of the Ketorolac Tromethamine bottle into your right nostril. Step 7. Hold the Ketorolac Tromethamine bottle upright and aim the tip toward the back of your nose (see Figure D) . Step 8. Hold your breath and spray 1 time into your right nostril, pressing down on both sides of the finger flange (see Figure D) . Step 9. Breathe in gently through your mouth after you use Ketorolac Tromethamine. You may also pinch your nose to help keep the medicine in your nose. Step 10. If your healthcare provider has prescribed only 1 spray per dose for you, you have now finished your dose, skip to Step 12 below. Step 11. If your healthcare provider has prescribed 2 sprays for you, repeat steps 3 - 9 above for your left nostril. Be sure to point the spray away from the center of your nose. Spray 1 time into your left nostril. Step 12. When you are finished using Ketorolac Tromethamine, put the clear plastic cover back on the Ketorolac Tromethamine bottle. How should I store Ketorolac Tromethamine? - Store unopened Ketorolac Tromethamine bottles between 36°F to 46°F (2°C to 8°C). - Keep opened bottles of Ketorolac Tromethamine at room temperature. - Keep Ketorolac Tromethamine out of direct sunlight. - Do not freeze Ketorolac Tromethamine. - Ketorolac Tromethamine does not contain a preservative. Throw away each Ketorolac Tromethamine bottle within 24 hours of taking your first dose, even if the bottle still contains unused medicine. Keep Ketorolac Tromethamine and all medicines out of the reach of children. General information about the safe and effective use of Ketorolac Tromethamine. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not give Ketorolac Tromethamine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ketorolac Tromethamine that is written for health professionals. What are the ingredients in Ketorolac Tromethamine? Active ingredient: ketorolac tromethamine Inactive ingredient: edetate disodium (EDTA), monobasic potassium phosphate, sodium hydroxide, and water for injection This Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Prasco Laboratories Mason, OH 45040 USA  LBL # 112.01 Revised:04/2021

Обзор продуктов:

Ketorolac Tromethamine Nasal Spray, 15.75 mg/spray, are single-day preservative-free spray bottles, supplied as: NDC 66993-193-95 Carton containing 5 single-day nasal spray bottles              Each single-day nasal spray bottle contains a sufficient quantity of solution to deliver 8 sprays for a total of 126 mg of ketorolac tromethamine. Each spray delivers 15.75 mg of ketorolac tromethamine. The delivery system is designed to administer precisely metered doses of 100 µL per spray. Storage Protect from light and freezing. Store unopened Ketorolac Tromethamine between 2°C to 8°C (36°F to 46°F). During use, keep containers of Ketorolac Tromethamine Nasal Spray at controlled room temperature, between 15°C to 30°C (59°F to 86°F), out of direct sunlight. Bottles of Ketorolac Tromethamine should be discarded within 24 hours of priming.

Статус Авторизация:

New Drug Application Authorized Generic

тонкая брошюра

Prasco Laboratories
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal 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, or stomach or intestinal bleeding with
use
of NSAIDs
•
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or
"SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver
disease
•
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 have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including

Характеристики продукта

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE SPRAY, METERED
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETOROLAC TROMETHAMINE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KETOROLAC
TROMETHAMINE.
KETOROLAC TROMETHAMINE NASAL SPRAY
INITIAL U.S. APPROVAL: 1989
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE (5.1)
KETOROLAC TROMETHAMINE IS CONTRAINDICATED IN THE SETTING OF CORONARY
ARTERY BYPASS
GRAFT (CABG) SURGERY (4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR
INTESTINES, WHICH
CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (5.10)
04/2021
Warnings and Precautions, Fetal Toxicity (5.11)
04/2021
INDICATIONS AND USAGE
Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug
indicated in adult patients for the short
term (up to 5 days) management of moderate to moderately severe pain
that requires analgesia at the
opioid level. (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals.
(2.1)
Ketorolac Tromethamine is not an inhaled product. For adult patients <
65 years of age: 31.5 mg (one
15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily
dose is 126 mg. (2.2, 2.3)
For patients ≥ 65 years