Hetero Drugs Ltd.,

Hetero Drugs Ltd., Drugs

• Levetiracetam
  

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  Levetiracetam

  

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  Levetiracetam Tablet isindicated as adjunctive treatment of partial onset seizures in adults andchildren 4 years of age and older with epilepsy.

  Levetiracetam Tablet isindicated as adjunctive therapy in the treatment of myoclonic seizures inadults and adolescents 12 years of age and older with juvenile myoclonicepilepsy.

  Levetiracetam Tablet is indicated as adjunctive therapy in the treatment ofprimary generalized tonic-clonic seizures in adults and children 6 years of ageand older with idiopathic generalized epilepsy.

  Partial Onset Seizures

  Adults 16 Years And Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

   Levetiracetam is given orally with or without food.

  Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children

  Patient Weight Daily Dose  20 mg/kg/day(BID dosing) 40 mg/kg/day(BID dosing) 60 mg/kg/day(BID dosing) 20.1 to 40 kg      500 mg/day(1 x 250 mgtablet BID)      1000 mg/day(1 x 500 mgtablet BID)       1500 mg/day(1 x 750 mgtablet BID)               >40 kg       1000 mg/day(1 x 500 mgtablet BID)      2000 mg/day(2 x 500 mgtablets BID)       3000 mg/day(2 x 750 mgtablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or  60 mg/kg/day:

  Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg)         

                                                                    100 mg/mL

   A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  Treatment should beinitiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID).Dosage should be increased by 1000 mg/day every 2 weeks to the recommended dailydose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not beenstudied.

   

  Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 To <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. See Table 14 for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Adult Patients With Impaired Renal Function

  Levetiracetam dosing must beindividualized according to the patient's renal function status. Recommendeddoses and adjustment for dose for adults are shown in Table 16. To use thisdosing table, an estimate of the patient's creatinine clearance (CLcr) inmL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL)determination using the following formula:

   

                [140-age(years)] x weight (kg) CLcr = ———————————————— (x 0.85 for female patients)                 72x serum creatinine (mg/dL)

  Table 16: Dosing Adjustment Regimen For AdultPatients With  Impaired Renal Function

          Group Creatinine Clearance (mL/min) Dosage (mg) Frequency         Normal > 80 500 to 1,500 Every 12 h         Mild 50 to 80 500 to 1,000 Every 12 h         Moderate 30 to 50 250 to 750 Every 12 h         Severe < 30 250 to 500 Every 12 h      ESRD patients   using dialysis ---- 500 to 1,000 1Every 24 h

  1Following dialysis, a 250 to 500 mg supplementaldose is recommended.

   

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• Indomethacin
  

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  Indomethacin

  

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  Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).   After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.   Indomethacin is available as 25 mg and 50 mg capsules.   Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient. Pediatric Use   Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).   Adult Use   Dosage Recommendations for Active Stages of the Following:   1.   Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis. Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG. In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY. If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued. Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions. As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).   2.  Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg  to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days   3.  Acute gouty arthritis.   Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.

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