Ifosfamide

Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.

Preparation for Intravenous Administration/ Stability

Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP

Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.

Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Ifosfamide for Injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days.  Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL).  In order to prevent bladder toxicity, Ifosfamide for Injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day.  A protector, such as mesna, should also be used to prevent hemorrhagic cystitis.  Ifosfamide for Injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes.  Although Ifosfamide for Injection has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of Ifosfamide for Injection in such patients have not been conducted.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve.  Use the quantity of diluent shown below to constitute the product:

Dosage

Strength

Quantity of

Diluent

Final

Concentration

1 gram

20 mL

50 mg/mL

3 grams

60 mL

50 mg/mL

Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

    5% Dextrose Injection, USP

    0.9% Sodium Chloride Injection, USP

    Lactated Ringer’s Injection, USP

    Sterile Water for Injection, USP

Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve.  Use the quantity of diluent shown below to constitute the product:

Dosage

Strength

Quantity of

Diluent

Final

Concentration

1 gram

20 mL

50 mg/mL

3 grams

60 mL

50 mg/mL

Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

    5% Dextrose Injection, USP

    0.9% Sodium Chloride Injection, USP

    Lactated Ringer’s Injection, USP

    Sterile Water for Injection, USP

Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days.  Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL).  In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day.  A protector, such as mesna, should also be used to prevent hemorrhagic cystitis.  Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes.  Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.

Preparation for Intravenous Administration/Stability

Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

5% Dextrose Injection, USP

0.9% Sodium Chloride Injection, USP

Lactated Ringer’s Injection, USP

Sterile Water for Injection, USP

Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Preparation for Intravenous Administration/Stability

Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

5% Dextrose Injection, USP

0.9% Sodium Chloride Injection, USP

Lactated Ringer’s Injection, USP

Sterile Water for Injection, USP

Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

2.1 General Instructions

For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.

Apply diclofenac sodium topical solution to clean, dry skin.

To avoid spillage, dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.

To treat the other knee, if symptomatic, repeat the procedure.

Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

2.2 Special Precautions

Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee.

Wash and dry hands after use.

Do not apply diclofenac sodium topical solution to open wounds.

Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes.

Do not apply external heat and/or occlusive dressings to treated knees.

Avoid wearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry.

Protect the treated knee(s) from sunlight.

Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution.

Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).

Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.

Preparation for Intravenous Administration/ Stability

Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP

Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.

Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Ifosfamide for Injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days.  Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥100,000/μL, WBC ≥4,000/μL).  In order to prevent bladder toxicity, Ifosfamide for Injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day.  A protector, such as mesna, should also be used to prevent hemorrhagic cystitis.  Ifosfamide for Injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes.  Although Ifosfamide for Injection has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of Ifosfamide for Injection in such patients have not been conducted.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve.  Use the quantity of diluent shown below to constitute the product:

Dosage

Strength

Quantity of

Diluent

Final

Concentration

1 gram

20 mL

50 mg/mL

3 grams

60 mL

50 mg/mL

Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

    5% Dextrose Injection, USP

    0.9% Sodium Chloride Injection, USP

    Lactated Ringer’s Injection, USP

    Sterile Water for Injection, USP

Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral use by adding Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve.  Use the quantity of diluent shown below to constitute the product:

Dosage

Strength

Quantity of

Diluent

Final

Concentration

1 gram

20 mL

50 mg/mL

3 grams

60 mL

50 mg/mL

Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

    5% Dextrose Injection, USP

    0.9% Sodium Chloride Injection, USP

    Lactated Ringer’s Injection, USP

    Sterile Water for Injection, USP

Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.

Constituted or constituted and further diluted solutions of Ifosfamide for Injection should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Ifosfamide injection should be administered intravenously at a dose of 1.2 g/m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL). In order to prevent bladder toxicity, ifosfamide should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although ifosfamide has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of ifosfamide in such patients have not been conducted.

Preparation for Intravenous Administration/ Stability

Ifosfamide injection may be diluted to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:

5% Dextrose injection, USP 0.9% sodium chloride injection, USP lactated Ringer's injection, USP sterile water for injection, USP

Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection), the use of large volume parenteral glass bottles, Viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (eg, 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.

Further diluted solutions of ifosfamide should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

The dose is one drop of dorzolamide hydrochloride-timolol maleate ophthalmic solution in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).