Ketorol DT Tablet: Uses, Side effects & Dosage Guide

Ketorol DT (ketorolac tromethamine) side effects may occur, but the medication is often well-tolerated when taken as prescribed. Uncommonly, patients may experience one or more of the following symptoms.

Serious side effects of Ketorol DT

The affected organ system, which is severely affected and not safe to use ketorol DT, includes:

Gastrointestinal side effects

• Severe abdominal pain
• Bleeding/perforation
• Dyspepsia (indigestion)
• Gastric ulcers
• Duodenal ulcers
• Postoperative bleeding
• Hematemesis (blood vomiting)

Renal side effects

• Kidney failure
• Cystitis (inflammation of the bladder)
• Hematuria (loss of blood in urine)
• Urinary retention
• Increased urinary frequency
• Interstitial nephritis (inflammation of the kidneys' interstitial tissues)

Hypersensitivity side effects 

• Angioedema (sudden swelling of lips, tongue, throat and hands because of severe allergy)
• Shock   

Cardiovascular side effects

• Heart attack
• Stroke
• Heart failure (fluid retention)
• High blood pressure
• Shortness of breath
• Blood disorder side effects
• Anemia

Rare but serious side effects

Neurological side effects

• Confusion
• Hallucinations
• Blurred vision
• Convulsions
• Vision changes

Hepatic side effects

• Hepatitis (inflammation of the hepatocytes in the liver)
• Liver failure
• Common side effects of ketorol DT (usually mild)
• Diarrhea
• Constipation
• Nausea
• Vomiting
• Dizziness
• Stomach pain
• Flatulence (gas)
• Heartburn

NOTE: If any of the above symptoms are noticed, it is recommended to contact the concerned doctor immediately.

Ketorolac tromethamine (ketorolac DT) is a non-selective cyclooxygenase COX-1 and COX-2 inhibitor, a class of non-steroidal anti-inflammatory drugs (NSAIDs), used to treat conditions such as postoperative pain, migraine, toothache, menstrual cramps and musculoskeletal pain.

Ketorol DT tablet dosage in the following population includes:

Ketorol DT dosage for adults

• Ketorol DT is available as a 10mg oral dose.
• The oral form of ketorolac is administered as continuation of treatment only after intravenous (i.v.) or intramuscular (i.m.) administration during the operative scenario.
• The recommended dosage in adults is 20mg as a single dose, followed by 10mg every 4-6 hours, depending on the patient's requirements.
• The daily average dose per day should not exceed 40mg/day.
• The combined duration of oral and IV therapy is limited to 5 days, and alternative analgesics are preferred after 5 days of treatment with ketorol DT.
• The risks of bleeding tendencies, renal failure, peptic ulcers and cardiac thrombus formation may occur during ketorol DT toxicity.

Ketorol DT dosage in paediatrics

• Oral Ketorol DT is not indicated/approved for pediatrics <17 years (FDA). Parenteral (IV/IM) forms have limited off-label use ≥2 years at 0.5 mg/kg (max 15-30 mg/dose) under specialist supervision only.

Ketorol DT dosage in older patients

• For patients 65 years of age with less than 50kg of bodyweight and with renal impairment, 10mg once followed by 10mg every 4-6 hours based on necessity, is recommended.
• The maximum daily dosage is restricted to 40mg.

Ketorol DT dosage in hepatic and renal impairment

• There is no information available on the adjustment of the ketorol DT dosage in patients with hepatic impairment.
• All NSAIDs, including ketorol DT, are not recommended if creatinine clearance is less than 30ml/min. It is because 92% of the drug and its metabolites are excreted via the kidneys.

Ketorol DT dosage for pregnancy and lactation

• There is no clear clinical data availability regarding ketorol DT usage in pregnancy. So, it is not recommended during pregnancy unless the advantage is more than the risks to the fetus.
• It is not preferred during labour and delivery because of the prostaglandin inhibition, which may further increase the risk of uterine haemorrhage due to decreased uterine contractions.
• Ketorol DT is not recommended for use in women planning to conceive due to impaired fertility.
• Breastfeeding women should be used with caution when the patient is already taking the Ketorol DT tablet.

Ketorol DT overdose

The following symptoms are limited to acute poisoning, which are reversible with therapeutic care and include:

• Lethargy
• Drowsiness
• Nausea
• Vomiting
• Epigastric pain
• Headache
• Indigestion
• Severe But Rare symptoms of overdose
• Gastrointestinal bleeding (GI)
• Hypertension (high blood pressure)
• Coma
• Renal failure
• Respiratory depression (a condition where breathing becomes abnormally low).

Treatment of overdose

• No standard antidote is available for treating ketorolac poisoning, but it is managed symptomatically.
• Firstly, if a large overdose occurs 5 -10 times higher than the regular dosage, within 4 hours of ingestion, emesis or activated charcoal 60g to 100g in adults and 1g/kg to 2g/kg is recommended to manage serious adverse effects and symptoms.
• Secondly, an osmotic cathartic may be advised. [Osmotic cathartics are laxatives used for easy evacuation of stools by withdrawing water from the intestines, making the stool softer].
  

• Gastrointestinal risks: Patients with severe active or with a history of peptic ulcers that affect the stomach, small intestines, large intestines, gastrointestinal bleeding or perforation can occur at any time during the treatment, with or without warning symptoms, and can be fatal. So, ketorolac is strictly prohibited in such patients; special care should be taken in such populations who are on active corticosteroids, anticoagulants, using NSAIDs for a long time, etc. To avoid serious side effects, the lowest effective dose for the shortest duration is preferred. Patients with inflammatory bowel disease (ulcerative colitis, Crohn’s disease), ketorol DT can be given carefully because of the risk of exacerbation. Simultaneous use of aspirin and NSAIDs increases the risk of Gastrointestinal bleeding.

• Haemorrhage: Use of ketorol DT increases the risk of bleeding tendency by inhibiting prostaglandins, which play an essential role in platelet aggregation during the coagulation cascade. Patients currently on anticoagulants such as heparin, warfarin, etc, are at higher risk. Some studies suggest postoperative complications with the use of ketorolac, including bleeding from wounds, hematomas (internal bleeding) and should be used with caution where hemostasis is not stable.

• Renal caution: Ketorol DT inhibits prostaglandins, which are essential for kidney blood perfusion. So, it may lead to acute renal failure and high risks for patients with active therapy of diuretics and ACE inhibitors. Kidney injury is reversible once ketorolac is discontinued, and renal function should be monitored regularly.

• Hypersensitive reactions: Patients who are severely allergic to aspirin in such patients' ketorolac are highly contraindicated because of the risks of bronchospasm, urticaria and fatal respiratory depression. Immediate action is required in case of any emergency.

• Cardiovascular effects: Patients with a history of diabetes, hypertension (high blood pressure), smoking, and alcohol consumption are at higher risk due to the inhibition of selective or non-selective COX-2 enzyme, which can develop heart attacks, stroke, which may be fatal, and the risks can appear early. So, this can be overcome by using the lowest effective dose, preferably 5 days in combination with the i.v. Therapy for a shorter duration.

• Hypertension (high blood pressure): Ketorol DT can be used with caution in patients with hypertension because it worsens the condition, and regular blood pressure monitoring is recommended.

• Congestive heart failure: Patients with hypertension and heart failure are at higher risk because ketorolac impairs sodium and water retention, which leads to oedema and increased serum creatinine. So, it should be avoided or used with extreme caution.

• Pregnancy: Ketorol DT should be contraindicated in late pregnancy because it may cause premature closure of the ductus arteriosus (a fetal blood vessel connecting the pulmonary artery to the aorta, which constricts and seals after birth to adapt to postnatal circulation).

• Severe skin reactions: Serious toxic epidermal necrolysis can occur with the use of ketorolac with or without any warning symptoms, which can be fatal. In such cases, patients need to withdraw the drug and report to the concerned doctor immediately.
  

When two or more pharmaceuticals interact, it's called a drug interaction; when a drug and food interact, it's called a food interaction. An interaction between a medication and a disease is called a disease-drug interaction.

Drug-drug interactions

• Diuretics such as furosemide and thiazides are inhibited with the use of concomitant ketorolac because it blocks the effect of prostaglandins, which helps in removing fluid from the body (diuretic effect), thereby increasing blood pressure and fluid accumulation in case of congestive heart failure.
• Patients are at risk of seizures with drugs such as phenytoin and carbamazepine when used with ketorolac.
• Use of ACE inhibitors and ARBs with ketorolac may lead to acute kidney failure.
• Concomitant use of lithium with ketorolac will decrease the clearance of lithium from the kidneys, therefore increasing serum lithium levels, resulting in lithium toxicity.
• Methotrexate with ketorolac combination may lead to methotrexate toxicity because of the decreased renal clearance.
• Combined use of selective serotonin reuptake inhibitors with ketorolac increases the bleeding tendency because this combination of drugs impairs platelet function.

Drug-food interactions

• It is advisable to take the drug with food to avoid gastric irritation.
• Meals with higher fat content decrease the peak concentration and delay the absorption by approximately 1 hour.

Drug-disease interactions

• Patients with a history of or active gastrointestinal diseases, such as peptic ulcer disease or gastrointestinal bleeding/perforation, may experience gastric irritation with ketorolac tablets because it inhibits prostaglandins, which play an essential role in protecting the gastric mucosa.
• Post-CABG surgery and having a history of ischemic heart disease, with the use of ketorolac, can cause complications such as myocardial infarction (heart attack) and stroke.
• The use of ketorolac in patients with advanced renal impairment may increase the risk of renal failure because prostaglandin inhibition further decreases renal perfusion.
• Patients suffering from conditions such as vomiting and dehydration are highly prone to the risk of acute kidney injury.
• Active gastrointestinal bleeding, cerebrovascular bleeding and hemorrhagic diathesis (prolonged bleeding) conditions risk the lives of patients with concomitant use of ketorol DT because it inhibits platelet aggregation, which increases bleeding tendencies.
• Ketorolac is avoided during labour in pregnant women because it affects the fetal circulation and inhibits uterine contractions, which increases the risks of uterine haemorrhage.
• Elderly patients with age > 65 years have a high risk of gastrointestinal disorders and renal impairment, with ketorolac, resulting in increased side effects. In such patients, dose modification is required.
  

Storage

Ketorol DT should be stored at 15-30 °C.