Mesna

Mesna Manufacturers

• App Pharmaceuticals, Llc
  

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  Mesna | Cardinal Health

  

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  ■ adults and children 12 years and over:
  take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

  ■ children under 12 years: consult a doctor

  ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
  
  

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• Teva Parenteral Medicines, Inc
  

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  Mesna | Woonsocket Prescription Center,incorporated

  

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  do not take more than directed (see overdose warning) adults and children 12 years and over: 2 tablets every 6 hours while symptoms persist. Do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor

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• Baxter Healthcare Corporation
  

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  Mesna | Smiths Medical Asd, Inc.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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• Sagent Pharmaceuticals
  

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  Mesna | Tya Pharmaceuticals

  

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  There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.

  To determine the initial dosage, consideration should be given to the patient’s age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.

  Clinical experience suggests the following recommendations:

  Oral Administration Inital Dosage Range Adults

  Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d.

  Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d.

  To achieve prompt control, higher doses may be required in some cases.

  Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d.

  Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d.

  Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently haloperidol has been used in doses above 100 mg for severely resistant patients; however the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

  Children

  The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.)

  The total dose may be divided, to be given b.i.d. or t.i.d.

  Psychotic Disorders - 0.05 mg/kg/day to 0.15 mg/kg/day

  Nonpsychotic Behavior Disorders and Tourette's Disorder - 0.05 mg/kg/day to 0.075 mg/kg/day

  Severely disturbed psychotic children may require higher doses. In severely disturbed, non-psychotic children or in hyperactive children with accompanying conduct disorders, who have failed to respond to psychotherapy or medications other than antipsychotics, it should be noted that since these behaviors may be short lived, short term administration of haloperidol may suffice. There is no evidence establishing a maximum effective dosage. There is little evidence that behavior improvement is further enhanced in dosages beyond 6 mg per day.

  Maintenance Dosage

  Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.

  Switchover Procedure

  The oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.

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• Sagent Pharmaceuticals
  

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  Mesna | Mylan Institutional Llc

  

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  Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER INTRAVENOUSLY.

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

  Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy. These patients should be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate, USP. Furthermore, it is recommended that patients being considered for haloperidol decanoate, USP therapy have been treated with, and tolerate well, short-acting haloperidol, USP in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol, USP. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection. During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate, USP therapy can be supplemented with short-acting forms of haloperidol, USP.

  The dose of haloperidol decanoate injection, 50 mg/mL or haloperidol decanoate injection, 100 mg/mL should be expressed in terms of its haloperidol, USP content. The starting dose of haloperidol decanoate, USP should be based on the patient's age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate, USP be 10 to 15 times the previous daily dose in oral haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate.

  Initial Therapy

  Conversion from oral haloperidol to haloperidol decanoate, USP can be achieved by using an initial dose of haloperidol decanoate, USP that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.

  In patients who are elderly, debilitated, or stable on low doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol), a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents is appropriate for initial conversion.

  In patients previously maintained on higher doses of antipsychotics for whom a low dose approach risks recurrence of psychiatric decompensation and in patients whose long-term use of haloperidol, USP has resulted in a tolerance to the drug, 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections.

  The initial dose of haloperidol decanoate, USP should not exceed 100 mg regardless of previous antipsychotic dose requirements. If, therefore, conversion requires more than 100 mg of haloperidol decanoate, USP as an initial dose, that dose should be administered in two injections, i.e. a maximum of 100 mg initially followed by the balance in 3 to 7 days.

  Maintenance Therapy

  The maintenance dosage of haloperidol decanoate, USP must be individualized with titration upward or downward based on therapeutic response. The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient.

  HALOPERIDOL DECANOATE, USP DOSING RECOMMENDATIONS Patients
  Monthly
  1st Month
  Maintenance
  Stabilized on low daily oral doses (up to 10 mg/day)
  Elderly or Debilitated 
  10-15 x Daily Oral Dose
  10-15 x Previous Daily Oral Dose
  High dose
  Dose Risk of relapse Tolerant to oral haloperidol 
  
  20 x Daily Oral Dose
  10-15 x Previous Daily Oral Dose
  

  Close clinical supervision is required during initiation and stabilization of haloperidol decanoate, USP therapy. Haloperidol decanoate, USP is usually administered monthly or every 4 weeks. However, variation in patient response may dictate a need for adjustment of the dosing interval as well as the dose (See CLINICAL PHARMACOLOGY).

  Clinical experience with haloperidol decanoate, USP at doses greater than 450 mg per month has been limited.

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• Mylan Institutional Llc
  

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  Mesna | Mylan Institutional Llc

  

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  2.1 Intravenous Dosing

  Mesna injection may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

  Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna injection is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.

  Table 1: Recommended Intravenous Dosing Schedule * The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.

  0 Hours

  4 Hours

  8 Hours

  Ifosfamide

  1.2 g/m2

  --

  --

  Mesna Injection*

  240 mg/m2

  240 mg/m2

  240 mg/m2

  2.3 Monitoring for Hematuria

  Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when mesna injection is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

  2.4 Preparation for Intravenous Administration and Stability Preparation

  Determine the volume of mesna injection for the intended dose.

  Dilute the volume of mesna injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:

  • 5% Dextrose Injection, USP • 5% Dextrose and 0.2% Sodium Chloride Injection, USP • 5% Dextrose and 0.33% Sodium Chloride Injection, USP • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 0.9% Sodium Chloride Injection, USP • Lactated Ringer’s Injection, USP Stability

  The mesna injection multidose vials may be stored and used for up to 8 days after initial puncture.

  Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.

  Do not mix mesna injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.

  The benzyl alcohol contained in mesna injection vials can reduce the stability of ifosfamide. Ifosfamide and mesna injection may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with mesna injection and may reduce the stability of ifosfamide.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

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• Agila Specialties Private Limited
  

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  Mesna | Agila Specialties Private Limited

  

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  2.1 Intravenous Dosing

  Mesna may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

  Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.

  Table1. Recommended Intravenous Dosing Schedule

  1The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.
  

   
  0 Hours
  4 Hours
  8 Hours
  Ifosfamide
  1.2 g/m2
  –
  –
  Mesna  injection1
  240 mg/m2
  240 mg/m2
  240 mg/m2
  2.2 Intravenous and Oral Dosing

  Mesna may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of mesna tablets as outlined below.

  Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. Mesna tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.

  Table 2. Recommended Intravenous and Oral Dosing Schedule

  1The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of mesna to ifosfamide should be maintained.
  

   
  0 Hours
  2 Hours
  6 Hours
  Ifosfamide
  1.2 g/m2
  –
  –
  Mesna injection1
  240 mg/m2
  –
  –
  Mesna tablets
  –
  480 mg/m2
  480 mg/m2
  

  The efficacy and safety of this ratio of intravenous and oral mesna has not been established as being effective for daily doses of ifosfamide higher than 2 g/m2.

  Patients who vomit within two hours of taking oral mesna should repeat the dose or receive intravenous mesna.

  2.3 Monitoring for Hematuria

  Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when mesna is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

  2.4 Preparation for Intravenous Administration and Stability

  Preparation 

  Determine the volume of mesna injection for the intended dose.

  Dilute the volume of mesna injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:

    5% Dextrose Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   5% Dextrose and 0.33% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   0.9% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP

  Stability 

  The mesna injection multidose vials may be stored and used for up to 8 days after initial puncture.

  Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.

  Do not mix mesna injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.

  The benzyl alcohol contained in mesna injection vials can reduce the stability of ifosfamide. Ifosfamide and mesna may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with mesna and may reduce the stability of ifosfamide.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

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