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.
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.
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.
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
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.
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)
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.
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 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
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.
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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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:
GI ulcers (gastric/duodenal)
abnormal renal function
elevated liver enzymes
increased bleeding time
injection site pain
Additional adverse experiences reported occasionally (<1% in patients taking Ketolas or other NSAIDs in clinical trials) include:
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
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.
The results of a survey conducted on ndrugs.com for Ketolas are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ketolas. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
Consumer reported age
No survey data has been collected yet
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology