Ketoral 10 mg Film Coated Tablets

Composition

Each Film Coated Tablet Contains: Ketorolac Tromethamine 10 mg

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of Ketoral Tablets and other treatment options before deciding to use Ketoral Tablets.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

Ketoral Tablets are indicated for the short-term (s 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 IV or IM dosing of Ketoral and Ketoral Tablets are to be used only as continuation treatment, if necessary.

The total combined duration of use of KetoralIV/IM and Ketoral tablets 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 Ketoral tablet therapy is not to exceed 5 days.

Ketoral 10 mg Tablets – FAQs

What is the drug ketorolac (sold as Ketoral) used for?

Ketorolac is used for short term treatment of moderate to severe pain. Ketoral is usually used before or after medical procedures or after surgery to reduce pain and help you feel comfortable so that you can return to normal daily activities.

Ketoral belongs to a class of medicines called analgesics and non-steroidal anti-inflammatory drugs. It works by blocking the body’s production of certain natural substances that cause inflammation. This effect helps reduce swelling, pain, or fever.

Ketoral should not be used for mild or moderate pain, and should not be used long-term (do not use for more than 5 consecutive days). Ketorolac avialable as injection (I.M. / I.V) & oral tablets.  Ketoral Injection can be given by injection into a muscle or into a vein as directed by your doctor.

Is ketorolac stronger than ibuprofen?

There is no significant difference between ketorolac (sold as :Ketoral) and Ibuprofen (sold as : Advil or Brufen). Both will relieve pain equally effectively. Both medicines belong to the same class of medicines called NSAIDs .

The main difference between both medicines is the cases targeted by treatment and the duration of treatment.

Ketoral should not be used for more than 5 days, while ibuprofen can be used for a longer period. Ketoral is indicated in cases of severe and moderate pain, while ibuprofen can be prescribed in cases of mild, moderate and severe pain.

Is ketorolac same as tramadol?

Ketoral is not the same as tramadol. Both belong to a different class of drugs.

Ketoral belongs to a class of medications called NSAIDs , it works by blocking the production of prostaglandins that cause pain.

Tramadol belongs to a class of medications called opioid pain relievers, and works by blocking pain messages from the brain and nervous system.

What is the ketorolac side effects?

Common side effects (may affect between 1 and 10 in every 100 patient treated with Ketoral):

  • stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, wind, loss of appetite;
  • headache, dizziness;
  • Rash or spots on the skin.
  • High levels of liver enzymes in the blood.

Warnings

The most serious risks associated with Ketoral is Gastrointestinal Effects-Risk of Ulceration, Bleeding, and Perforation.

Ketoral is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding.

Ketoral can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with Ketoral.

Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy.

The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with, Ketoral. Do not use Ketoral for more than five days. However, even short-term therapy is not without risk.

In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include:

  • concomitant use of oral corticosteroids, or anticoagulants,
  • longer duration of NSAID therapy,
  • smoking,
  • use of alcohol,
  • older age,
  • poor general health status.

Most spontaneous reports of fatal Gl events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse Gl event, the lowest effective dose should be used for the shortest possible duration.

Patients and physicians should remain alert for signs and symptoms of Gl ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious Gl adverse event is suspected.  This should include discontinuation of Ketoral until a serious Gl adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

NSAIDS should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.

Ketorolac Tromethamine
Ketorolac Tromethamine

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of Ketoral tablets and other treatment options before deciding to use Ketoral tablets.

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 Ketoral and Ketoral tablets is not to exceed 5 days.

In adults, the use of Ketoral tablets is only indicated as continuation therapy to IV or IM dosing of Ketoral.

Transition from IV or IM dosing of Ketoral (single- or multiple-dose) to multiple-dose Ketoral tablets:

Patients age 17 to 64: 20 mg by mouth once followed by 10 mg each 4 to 6 hours as needed – do not exceed 40 mg/day.

Patient’s age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg by mouth once followed by 10 mg each 4 to 6 hours as needed – do not exceed 40 mg/day.

Note

  • Oral formulation should not be given as an initial dose.
  • Use minimum effective dose for the individual patient.
  • Do not shorten dosing interval of 4 to 6 hours.
  • Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of Ketoral and Ketoral tablets is not to exceed 5 days.

The following table summarizes Ketoral tablet dosing instructions in terms of age group:

Patient Population Ketoral Tablets (following IV or IM dosing of Ketoral)
Age < 17 years Oral not approved
Adult Age 17 to 64 years 20 mg once, then 10 mg each 4 to 6 hours as needed – do not exceed 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg each 4 to 6 hours as needed – do not exceed 40 mg/day

Ketoral is alternative to the brand Ketolac

You can read Ketolac Patient Information Leaflet (AR & EN) from the link here.

Ketolac 10 mg tablets
Ketoral 10 mg tablets

Product reference code:  M01AB15 .