KETOROLAC TROMETHAMINE NORMON 30 mg/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketorolac Tromethamine Normon 30 mg/ml injectable solution EFG

Ketorolac Tromethamine

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What Ketorolac Tromethamine Normon 30 mg/ml injectable solution is and what it is used for
2. Before you use Ketorolac Tromethamine Normon 30 mg/ml injectable solution
3. How to use Ketorolac Tromethamine Normon 30 mg/ml injectable solution
4. Possible side effects
5. Storing Ketorolac Tromethamine Normon 30 mg/ml injectable solution

Additional information

1. What is Ketorolac Tromethamine Normon 30 mg/ml injectable solution and what is it used for

Ketorolac Tromethamine Normon 30 mg/ml injectable solution is a medicine that belongs to the group of non-steroidal anti-inflammatory drugs.

Ketorolac Tromethamine Normon 30 mg/ml injectable solution is indicated for:

• Short-term treatment of moderate to severe pain in postoperative period.
• Treatment of pain caused by renal colic (acute pain due to the presence of stones in the duct that goes from the kidneys to the urinary tract).

2. Before using Ketorolac Tromethamine Normon 30 mg/ml injectable solution

• Do not use Ketorolac Tromethamine Normon:

• If you have active peptic ulcer (gastric or duodenal ulcer).
• If you have a history of gastrointestinal ulceration, bleeding, or perforation.
• If you are allergic (hypersensitive) to ketorolac tromethamine or other non-steroidal anti-inflammatory drugs or to any of the other components of Ketorolac Tromethamine Normon.
• If you have complete or incomplete syndrome of nasal polyps (mass formed by nasal mucosa), angioedema (hives), or bronchospasm (constriction of the bronchi).
• If you have asthma.
• If you have severe heart disease.
• If you have moderate to severe kidney disease.
• If you have hypovolemia (decreased blood volume) or dehydration (lack of body water).
• If you have bleeding diathesis (tendency to bleeding), coagulation disorders (alteration of clot formation), or cerebral hemorrhage (bleeding in the brain).
• If you are undergoing high-risk surgical interventions with a high risk of bleeding or incomplete hemostasis (stop of blood flow).
• If you are taking other non-steroidal anti-inflammatory drugs, including aspirin, or selective inhibitors of cyclooxygenase-2 (COX-2).
• If you are being treated with high-dose anticoagulants.
• If you are being treated with probenecid, lithium salts, or pentoxifylline.
• If you are pregnant or breastfeeding.
• If you are under 16 years old.
• As a preventive analgesic before or during surgical intervention, given the risk of bleeding.
• The injectable form of Ketorolac Tromethamine Normon should not be used for epidural or intrathecal administration (administration in the spinal cord or brain fluid), as it contains alcohol.

• Be careful with Ketorolac Tromethamine Normon:

• If you have or have had gastrointestinal bleeding, ulcers, and/or perforations. Severe gastrointestinal toxicity, including gastrointestinal irritation, bleeding, ulceration, and perforation, may occur.
• If you have or have had inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have kidney disease, your doctor may consider it necessary to perform certain tests during treatment with this medicine.
• If you have heart disease, high blood pressure, or similar conditions.
• If you take medications that increase the risk of gastrointestinal ulcers or bleeding, such as heparin, antiplatelet agents, pentoxifylline, corticosteroids, thrombolytics, and antidepressants (of the type selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors).
• If you are being treated with anticoagulants (dicumarinics or heparin).
• In elderly patients, precautions should be taken and the minimum effective dose of Ketorolac Tromethamine Normon should be used during treatment.
• Rarely, severe skin reactions (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) may occur with the use of ketorolac. Their appearance is more likely at the beginning of treatment. Administration should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity.
• If you experience systemic manifestations of liver dysfunction such as itching or skin redness during treatment, you should discontinue treatment immediately and inform your doctor as soon as possible.
• If you have difficulty getting pregnant or are undergoing fertility treatment.
• If you experience skin redness, mucosal lesions, or any other sign of hypersensitivity or anaphylactic reaction (severe allergic reaction), you should discontinue treatment and inform your doctor immediately.
• If you are taking other medications, such as methotrexate, as Ketorolac Tromethamine Normon may modify or enhance the effect of these medications.
• Tell your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before receiving/taking/using Ketorolac Tromethamine Normon, as Ketorolac Tromethamine Normon may worsen wound healing in the intestine after surgery.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

• Use of other medications

Tell your doctor or pharmacist if you are using or have recently used any other medications, including those obtained without a prescription.

Concomitant administration of the following is contraindicated:

• Other non-steroidal anti-inflammatory drugs (including aspirin), as it may increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulants (dicumarinics, heparin), may enhance the effects on bleeding time.
• Antiplatelet agents (such as aspirin, ticlopidine, or clopidogrel): may increase the risk of gastrointestinal bleeding.
• Pentoxifylline (a medication that improves blood flow through blood vessels), probenecid (a medication used to treat gout).
• Lithium (a medication used to treat manic-depressive disorder).

Be careful if you are using or being treated with:

• Corticosteroids (anti-inflammatory medications).
• Thrombolytics (medications that dissolve blood clots).
• Antidepressants.
• Methotrexate (an antirheumatic medication).
• Antihypertensives.
• Furosemide (a medication used to eliminate excess fluids and to treat high blood pressure).

• Pregnancy

Consult your doctor or pharmacist before using any medication.

Ketorolac Tromethamine Normon is contraindicated during pregnancy.

• Breastfeeding

Consult your doctor or pharmacist before using any medication.

Ketorolac Tromethamine Normon is contraindicated during breastfeeding.

• Childbirth

Consult your doctor or pharmacist before using any medication.

Ketorolac Tromethamine Normon is contraindicated during childbirth, as it may harm fetal circulation and inhibit uterine contractions.

• Driving and using machines

Some patients may experience drowsiness, dizziness, vertigo, insomnia, or depression during treatment with Ketorolac Tromethamine Normon. Therefore, caution is recommended when driving vehicles or using machinery, especially at the beginning of treatment.

• Ketorolac Tromethamine Normon contains ethanol and sodium

This medication contains 12.25% ethanol (alcohol), which corresponds to 98 mg/ampoule.

This medication contains less than 23 mg of sodium (1 mmol) per ampoule, which is essentially "sodium-free".

3. How to use Ketorolac Tromethamine Normon 30 mg/ml injectable solution

Follow these instructions, unless your doctor has given you different instructions.

Treatment with Ketorolac Tromethamine Normon should be started in a hospital setting. The maximum duration of treatment should not exceed 2 days. If oral treatment is subsequently initiated, the total duration of treatment with ketorolac should not exceed 7 days.

In the treatment of pain caused by renal colic, a single dose of 30 mg is recommended by intramuscular or intravenous route.

The dose of Ketorolac Tromethamine Normon should be adjusted according to the severity of the pain and the patient's response, aiming to administer the minimum effective dose. The recommended initial dose of Ketorolac Tromethamine Normon by intramuscular or intravenous route is 10 mg, followed by doses of 10-30 mg every 4 to 6 hours, as needed to control pain. In cases of intense or very intense pain, the recommended initial dose is 30 mg of ketorolac.

The maximum recommended daily dose is 90 mg for non-elderly adults and 60 mg for elderly patients.

In patients who have received ketorolac by parenteral route and are switched to oral treatment, the total daily combined dose of both oral and parenteral formulations should not exceed 90 mg in adults and 60 mg in elderly patients.

Intramuscular injection should be administered slowly and deeply into the muscle.

Administration with morphine

In most patients, intramuscular or intravenous therapy with ketorolac provides adequate analgesia. However, opioid analgesics may be used concomitantly when the maximum recommended doses of ketorolac are not sufficient or when it is desired to reduce the requirements for opioids.

When morphine is administered in combination with ketorolac, the daily dose of morphine required is significantly reduced.

Elderly patients (≥ 65 years)

Since elderly patients may eliminate ketorolac more slowly and be more sensitive to the side effects of non-steroidal anti-inflammatory drugs, precautions should be taken and lower doses should be used in elderly patients (at the lower end of the recommended dosage range). It is recommended not to exceed a daily dose of 60 mg.

Children and adolescents (<16 years)< p>

Ketorolac Tromethamine Normon should not be administered to children or adolescents.

Renal impairment

Ketorolac is contraindicated in moderate to severe renal impairment. In patients with mild renal impairment, lower doses of ketorolac should be used (half of the recommended dose, not exceeding a daily dose of 60 mg), with periodic monitoring of renal function tests.

• If you use more Ketorolac Tromethamine Normon than you should

Since administration should be started in a hospital setting, it is unlikely that you will be given too much Ketorolac Tromethamine Normon. However, if this happens, contact your doctor or pharmacist as soon as possible. In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20.

In case of overdose or accidental ingestion, abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastroduodenal ulcer, erosive gastritis, and renal dysfunction may occur, which resolve upon discontinuation of the medication.

4. Possible side effects

Like all medications, Ketorolac Tromethamine Normon can have side effects, although not everyone gets them.

If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Gastrointestinal disorders:the most frequently observed side effects are of gastrointestinal type. Peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, stomach inflammation, abdominal pain, blood in stool, blood in vomit, stomatitis (mouth lesions), exacerbation of ulcerative colitis and Crohn's disease (inflammatory bowel diseases), abdominal discomfort, belching, feeling of fullness, esophagitis, pancreatitis, rectal bleeding, taste alteration.

Metabolic and nutritional disorders:loss of appetite, increased potassium in blood, and decreased sodium in blood.

Nervous system and musculoskeletal disorders:aseptic meningitis (inflammation of the meninges), seizures, dizziness, drowsiness, dry mouth, headache, excessive activity, decreased concentration, insomnia, muscle pain, nervousness, loss of sensation, sweating.

Psychiatric disorders:abnormal dreams, altered thinking, anxiety, depression, euphoria, hallucinations, psychotic reactions.

Renal and urinary disorders:acute renal failure, "kidney pain" with blood in urine and accumulation of nitrogen in blood or without them, frequent urination of small amounts, urinary retention, interstitial nephritis (kidney inflammation), nephrotic syndrome (abnormal protein excretion in urine), decreased urine production.

As with other inhibitors of prostaglandin synthesis, signs of renal failure (e.g., elevated creatinine and potassium levels) may occur after a dose of Ketorolac Tromethamine Normon.

Cardiovascular disorders:edema (swelling due to fluid accumulation), high blood pressure, and heart failure are associated with treatment with non-steroidal anti-inflammatory drugs. Decreased heart rate, hot flashes, palpitations, decreased blood pressure, chest pain.

Reproductive system and breast disorders:infertility.

Respiratory, thoracic, and mediastinal disorders:bronchial asthma, shortness of breath, pulmonary edema (fluid accumulation in the lungs), bronchospasm (constriction of the bronchi), nosebleeds.

Hepatobiliary disorders:altered liver function tests, liver inflammation, cholestatic jaundice (yellowing of the skin), liver failure (liver damage).

Skin and subcutaneous tissue disorders:very rarely, skin reactions of hypersensitivity (allergy) of vesiculobullous type, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (skin and mucous membrane lesions), may occur. Exfoliative dermatitis, maculopapular rash (rash with small bumps on the skin), pruritus, urticaria, facial erythema (redness of the face).

Immune system disorders:hypersensitivity reactions, anaphylaxis (severe allergic reaction), laryngeal edema (inflammation of the larynx), angioedema (hives), anaphylactoid reactions (acute allergic reaction). Anaphylactoid reactions, such as anaphylaxis, can be fatal.

Blood and lymphatic system disorders:skin bleeding, decreased platelet count, anemia, and blood in stool, pallor.

Eye disorders:vision changes.

Ear disorders:tinnitus (ringing in the ears), decreased hearing, vertigo.

General disorders and administration site conditions:lack of strength, edema (swelling due to fluid accumulation), injection site reactions, fever, increased thirst.

Investigations:elevated serum urea and creatinine levels, elevated potassium levels, weight gain, prolonged bleeding time.

Lesions, poisoning, and complications of surgical and medical procedures:hematomas, postoperative bleeding.

If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. Storing Ketorolac Tromethamine Normon 30 mg/ml injectable solution

Keep out of the reach and sight of children.

Store below 25°C. Store in the original package to protect from light.

Do not use Ketorolac Tromethamine Normon after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Ketorolac Tromethamine Normon 30 mg/ml injectable solution

The active ingredient is ketorolac tromethamine. Each ml of solution contains 30 mg of ketorolac tromethamine.

The other components are: sodium chloride, ethanol, sodium hydroxide, and water for injection.

Ketorolac Tromethamine Normon can be administered as a direct bolus injection of no less than 15 seconds in duration. The injectable is compatible with saline solution, 5% dextrose solutions, Ringer's solution, Ringer's lactate solution, or Plasmalyte solutions. Ketorolac Tromethamine Normon is pharmaceutically compatible with aminophylline, lidocaine hydrochloride, morphine sulfate, meperidine hydrochloride, dopamine hydrochloride, insulin, and sodium heparin when mixed in intravenous solutions in standard infusion bottles or bags. However, ketorolac should not be mixed in the same syringe with morphine sulfate, meperidine, promethazine hydrochloride, or hydroxyzine hydrochloride, as precipitation of ketorolac from the solution may occur.

Appearance of the product and packaging content

Ketorolac Tromethamine Normon is an injectable solution presented in 1 ml ampoules. Each package contains six or one hundred ampoules.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this leaflet:June 2023