Indications And Usage

Ketotifen is a type of asthma medication which, when taken every day and used along with other antiasthma medications, may reduce the frequency, severity, and duration of asthma symptoms or attacks in children. It may also lead to a reduction in daily requirements of other antiasthma medications. Ketotifen is not effective for the prevention or treatment of acute asthma attacks. Ketotifen works by inhibiting certain substances in the body that are known to cause inflammation and symptoms of asthma.

Administration

For asthma:

Adults and children 3 years of age and older—The usual dose is 1 milligram (mg) (1 tablet or 5 milliliters [mL] of syrup) twice daily, once in the morning and once in the evening.

Infants and children from 6 months to 3 years of age—Dose is based on body weight and must be determined by the doctor. It is usually 0.25 mL (50 mcg or 0.05 mg) of syrup per kilogram (kg) (110 micrograms [mcg] or 0.110 mg per pound) of body weight twice daily, once in the morning and once in the evening.

Contraindications

persons with known hypersensivity to any component of this product.

Precautions

Ketotifen may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to ketotifen before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Ketotifen may cause some people to become excited, irritable, or nervous or to have trouble in sleeping. These are symptoms of central nervous system stimulation and are especially likely to occur in children.

For patients with diabetes:

The syrup form of ketotifen may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Adverse Reactions

Weight gain

Pregnancy and lactation

Pregnancy category: C

Renal and liver Impairment

-

Laboratory Tests

Indications And Usage

Acute Pain in Adult Patients:

Ketorolax 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.

The total combined duration of use of Ketorolax and oral ketorolac tromethamine 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 Ketorolax therapy is not to exceed 5 days.

Ketorolax 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 Ketorolax dosage range with low doses of narcotics prn, unless otherwise contraindicated.

Ketorolax and narcotics should not be administered in the same syringe .

Administration

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 Ketorolax and oral ketorolac tromethamine is not to exceed 5 days.

KETOROLAC TROMETHAMINE INJECTION:

Ketorolax may be used as a single or multiple dose on a regular or "as needed" 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 Ketorolax.

Patients should be switched to alternative analgesics as soon as possible, but Ketorolax therapy is not to exceed 5 days.

When administering Ketorolax, 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 Ketorolax 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 Ketorolax every 6 hours. The maximum daily dose for these populations should not exceed 60 mg

Contraindications

Ketorolax is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.

Ketorolax 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.

Ketorolax 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

Ketorolax is contraindicated as prophylactic analgesic before any major surgery.

In the setting of coronary artery bypass graft (CABG) surgery.

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

Ketorolax 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.

Ketorolax 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.

Ketorolax 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 Ketorolax and probenecid is contraindicated.

The concomitant use of Ketorolax and pentoxifylline is contraindicated.

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

Precautions

Ketorolax cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of Ketorolax in reducing inflammation may diminish the utility of this diagnostic sign in detecting complications of presumed noninfectious, painful conditions.

Adverse Reactions

Adverse reaction rates increase with higher doses of Ketorolax.

Practitioners should be alert for the severe complications of treatment with Ketorolax, 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 Ketorolax is indicated, especially when the drug is used inappropriately.

Pregnancy and lactation

There are no adequate and well-controlled studies of Ketorolax in pregnant women. Ketorolax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Renal and liver Impairment

Ketorolax should be used with caution in patients with impaired hepatic function or a history of liver disease.

If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ketorolax should be discontinued.

Laboratory Tests