Ketolas Uses

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How old is patient?

What is Ketolas?

Treating eye pain and swelling following cataract surgery. It may also be used for other conditions as determined by your doctor.

Ketolas drops is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking the production of prostaglandin, a substance that causes pain and swelling.

Ketolas indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Carefully consider the potential benefits and risks of Ketolas and other treatment options before deciding to use Ketolas. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

Ketolas 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 intravenous or intramuscular dosing of Ketolas, and oral Ketolas is to be used only as continuation treatment, if necessary.

The total combined duration of use of Ketolas injection and oral Ketolas 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. Patients should be switched to alternative analgesics as soon as possible, but Ketolas therapy is not to exceed 5 days.

Ketolas injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the Ketolas injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketolas injection and narcotics should not be administered in the same syringe.

How should I use Ketolas?

Use Ketolas drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Ketolas drops. Talk to your pharmacist if you have questions about this information.
  • Ketolas drops is only for the eye. Do not get it in your nose or mouth.
  • To use Ketolas drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
  • Each vial of Ketolas drops is intended for single use only. Throw away any unused medicine in the vial immediately after you have used your dose.
  • If you will be using Ketolas drops to treat both eyes after surgery, do not use the same vial for both eyes. Doing so may increase the risk of passing an infection from one eye to the other.
  • If you are using other eye medicines, wait at least 5 minutes before applying them to the eye.
  • Do not wear contact lenses while you are using Ketolas drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
  • Do not use Ketolas drops if it is discolored or contains particles.
  • If you miss a dose of Ketolas drops and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketolas drops.

Uses of Ketolas in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Pain, moderate to moderately severe: Short-term (up to 5 days) management of moderate to moderately severe pain in adults that requires analgesia at the opioid level.

Off Label Uses

Migraine

Data from a prospective, randomized, double-blind, double-dummy, placebo and active comparator, crossover, non-inferiority trial suggests that intranasal Ketolas may be beneficial for acute abortive treatment of migraine in patients with a history of episodic migraines for at least 1 year.

Ketolas description

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Ketolas is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Ketolas dosage

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Carefully consider the potential benefits and risks of Ketolas and other treatment options before deciding to use Ketolas. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of Ketolas and oral Ketolas is not to exceed 5 days. In adults, the use of oral Ketolas is only indicated as continuation therapy to IV or IM dosing of Ketolas. See package insert for Ketolas tablets for transition from IV or IM dosing of Ketolas (single- or multiple-dose) to multiple-dose oral Ketolas.

Note:

Oral formulation should not be given as an initial dose.

Use minimum effective dose for the individual patient.

Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of Ketolas and oral Ketolas is not to exceed 5 days.

Ketolas INJECTION

Ketolas injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of Ketolas. Patients should be switched to alternative analgesics as soon as possible, but Ketolas therapy is not to exceed 5 days.

When administering Ketolas injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment: The following regimen should be limited to single administration use only

IM Dosing

  • Patients <65 years of age: One dose of 60 mg.
  • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.

IV Dosing

  • Patients <65 years of age: One dose of 30 mg.
  • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.

Multiple-Dose Treatment (IV or IM)

  • Patients <65 years of age: The recommended dose is 30 mg Ketolas injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg.
  • For patients ≥65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): The recommended dose is 15 mg Ketolas injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.

For breakthrough pain, do not increase the dose or the frequency of Ketolas. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.

Pharmaceutical Information for Ketolas Injection

Ketolas injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of Ketolas from solution.

NOTE:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Ketolas interactions

See also:
What other drugs will affect Ketolas?

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When this drug applied simultaneously with:

- other NSAIDs may develop additive effects

- pentoxifylline, anticoagulants (heparin, including in low-dose) may increase the risk of bleeding

- ACE inhibitors may increase the risk of renal dysfunction

- probenecid increases the concentration of Ketolas in plasma and its half-life period

- lithium therapy may reduce renal clearance of lithium and increase its concentration in plasma

- furosemide - a decrease in its diuretic action.

During taking Ketolas the need for opioid analgesics to pain relief reduces.

Ketolas side effects

See also:
What are the possible side effects of Ketolas?

Adverse reaction rates increase with higher doses of Ketolas. Practitioners should be alert for the severe complications of treatment with Ketolas, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure. These NSAID-related complications can be serious in certain patients for whom Ketolas is indicated, especially when the drug is used inappropriately.

In patients taking Ketolas or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

* Incidence greater than 10%

Gastrointestinal (GI) experiences including:
abdominal pain constipation/diarrhea dyspepsia
flatulence GI fullness GI ulcers (gastric/duodenal)
gross bleeding/perforation heartburn nausea*
stomatitis vomiting
Other experiences:
abnormal renal function anemia dizziness
drowsiness edema elevated liver enzymes
headaches* hypertension increased bleeding time
injection site pain pruritus purpura
rashes tinnitus sweating

Additional adverse experiences reported occasionally (<1% in patients taking Ketolas or other NSAIDs in clinical trials) include:

Body as a Whole: fever, infections, sepsis

Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope

Dermatologic: alopecia, photosensitivity, urticaria

Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding

Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia

Metabolic and Nutritional: weight change

Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise

Reproductive, female: infertility

Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis

Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss

Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention

Other rarely observed reactions (reported from postmarketing experience in patients taking Ketolas or other NSAIDs) are:

Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema, myalgia

Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis

Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)

Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, post operative wound hemorrhage (rarely requiring blood transfusion — see Boxed WARNING, WARNINGS, and PRECAUTIONS)

Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia

Nervous System: aseptic meningitis, convulsions, coma, psychosis

Respiratory: bronchospasm, respiratory depression, pneumonia

Special Senses: conjunctivitis

Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome

Postmarketing Surveillance Study

A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving Ketolas, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent. This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of Ketolas.

Table 3 Incidence of Clinically Serious G.I. Bleeding as Related to Age, Total Daily Dose, and History of G.I. Perforation, Ulcer, Bleeding (PUB) after up to 5 Days of Treatment with Ketolas Injection

A. Adult Patients without History of PUB

Total Daily Dose of Ketolas Injection
Age of Patients ≤60 mg >60 to 90 mg >90 to 120 mg >120 mg
<65 years of age 0.4% 0.4% 0.9% 4.6%
≥65 years of age 1.2% 2.8% 2.2% 7.7%

B. Adult Patients with History of PUB

Total Daily Dose of Ketolas Injection
Age of Patients ≤60 mg >60 mg to 90 mg >90 to 120 mg >120 mg
<65 years of age 2.1% 4.6% 7.8% 15.4%
≥65 years of age 4.7% 3.7% 2.8% 25.0%

Ketolas contraindications

See also:
What is the most important information I should know about Ketolas?

Ketolas is contraindicated in patients with previously demonstrated hypersensitivity to Ketolas.

Ketolas is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

Ketolas should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Ketolas is contraindicated as prophylactic analgesic before any major surgery.

Ketolas is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Ketolas is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.

Ketolas is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.

Ketolas inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.

Ketolas is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.

The concomitant use of Ketolas and probenecid is contraindicated.

The concomitant use of Ketolas and pentoxifylline is contraindicated.

Ketolas injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.



Active ingredient matches for Ketolas:

Ketorolac tromethamine in India.

Ketorolac


Unit description / dosage (Manufacturer)Price, USD
10 mg x 100's$ 3.89
30 mg x 1 mL x 10's$ 2.14
Ketolas 10 mg Tablet$ 0.04
Ketolas 30 mg Injection$ 0.21
Ketolas Eye 10 ml Drop$ 0.46
Ketolas 10mg TAB / 10$ 0.39
Ketolas 30mg x 1mL INJ / 1ml$ 0.21
KETOLAS dispertab 10 mg x 10's (Dallas)$ 0.71
KETOLAS inj 30 mg x 1 mL x 1ml (Dallas)$ 0.30
Ketolas 10mg TAB / 10$ 0.39
Ketolas 30mg x 1mL INJ / 1ml$ 0.21

List of Ketolas substitutes (brand and generic names):

KETOLAC LD EYE DROP 1 packet / 5 ML eye drop each (Nri Vision Care Pvt Ltd)$ 0.79
0.5 % w/v x 10ml (Dallas)$ 0.46
Ketolas Eye DPS 0.5% w/v EYE DPS / 10ml (Dallas)$ 0.46
KETOLAS EYE DPS eye drops 0.5 % w/v x 10ml (Dallas)$ 0.46
Ketolas Eye DPS 0.5% w/v EYE DPS / 10ml (Dallas)$ 0.46
Ketolead Tablet (Health Guard (India) Pvt. Ltd.)$ 0.06
Ketonic 10mg TAB / 10 (Abbott Healthcare Pvt Ltd (AHPL))$ 0.29
10 mg x 10's (Abbott Healthcare Pvt Ltd (AHPL))$ 0.29
Tablets; Oral; Ketorolac Tromethamine 10 mg (Abbott Healthcare Pvt Ltd (AHPL))
Ketonic 10 mg Tablet (Abbott Healthcare Pvt Ltd (AHPL))$ 0.03
KETONIC tab 10 mg x 10's (Abbott Healthcare Pvt Ltd (AHPL))$ 0.29
Ketonic 10mg Tablet (Abbott Healthcare Pvt Ltd (AHPL))$ 0.03
Ketopain / amp 30 mg/1 mL x 1 mL x 5's (Soho)$ 18.60
KETOPHER TABLET 1 strip / 10 tablets each (Bennet Pharmaceuticals Limited)$ 0.63
Ketopher 10mg Tablet (Bennet Pharmaceuticals Limited)$ 0.06
Ketorac 10 mg x 10 Blister x 10 Tablet
Ketored 5 ml Drop (Redson Labs Pvt Ltd)$ 0.51
Ketoriv 10 mg Tablet (East African (I) Remedies Pvt Ltd)$ 0.04
Ketoriv Skin 60 ml Shampoo (East African (I) Remedies Pvt Ltd)$ 1.27
Ketoro 0.5 % x 5 mL
KETOROCIN 0.5MG EYE DROPS 1 packet / 5 ML eye drop each (Appasamy Ocular Device Pvt Ltd)$ 0.57
Ketorocin 0.5% w/v Eye Drop (Appasamy Ocular Device Pvt Ltd)$ 0.57
Ketorocin-LS 4mg Eye Drop (Appasamy Ocular Device Pvt Ltd)$ 0.83
KETOROCINLS EYE DROPS 1 packet / 5 ML eye drop each (Appasamy Ocular Device Pvt Ltd)$ 0.83
Injectable; Injection; Ketorolac Tromethamine 30 mg / ml (Dr Reddy Laboratories Ltd)
Tablet, Film-Coated; Oral; Ketorolac Tromethamine 10 mg (Dr Reddy Laboratories Ltd)
Ketorol 10mg DT-TAB / 10 (Dr Reddy Laboratories Ltd)$ 0.57
Ketorol 30mg/ml AMP / 1 (Dr Reddy Laboratories Ltd)$ 0.24
Ketorol 10mg TAB / 10 (Dr Reddy Laboratories Ltd)$ 0.51
Ketorol 10 mg x 2 Blister x 10 Tablet (Dr Reddy Laboratories Ltd)

References

  1. PubChem. "ketorolac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "ketorolac". http://www.drugbank.ca/drugs/DB00465 (accessed September 17, 2018).
  3. MeSH. "Cyclooxygenase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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