Doxorubicin Hydrochloride

Doxorubicin Hydrochloride Manufacturers

• Sun Pharmaceutical Industries Limited
  

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  Doxorubicin Hydrochloride | Sun Pharmaceutical Industries Limited

  

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  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy:

  The recommended adult oral dosage of ondansetron is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of ondansetron 24 mg tablets has not been studied.

  Pediatric Use: There is no experience with the use of 24 mg ondansetron tablets in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use: The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day.

  For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use: There is no experience with the use of ondansetron tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia.

  Pediatric Use: There is no experience with the use of ondansetron tablets, in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use: The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Pfizer Laboratories Div Pfizer Inc.
  

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  Doxorubicin Hydrochloride | Pfizer Laboratories Div Pfizer Inc.

  

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  When possible, to reduce the risk of developing cardiotoxicity in patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, doxorubicin-based therapy should be delayed until the other agents have cleared from the circulation (see WARNINGSand PRECAUTIONS, General).

  Care in the administration of doxorubicin will reduce the chance of perivenous infiltration (see WARNINGS). It may also decrease the chance of local reactions such as urticaria and erythematous streaking. On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min. q.i.d. x 3 days may be useful. The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation are recommended. Blistering, ulceration, and/or persistent pain are indications for wide excision surgery, followed by split- thickness skin grafting.

  The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration.

  Doxorubicin has been used concurrently with other approved chemotherapeutic agents. Evidence is available that in some types of neoplastic disease, combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days.

  In a large randomized study (NSABP B-15) of patients with early breast cancer involving

  axillary lymph nodes (see CLINICAL PHARMACOLOGY, Clinical Studiesand ADVERSE REACTIONS, Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy), the combination dosage regimen of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) was administered intravenously on day 1 of each 21-day treatment cycle. Four cycles of treatment were administered.

  Dose Modifications

  Patients in the NSABP B-15 study could have dose modifications of AC to 75% of the starting doses for neutropenic fever/infection. When necessary, the next cycle of treatment cycle was delayed until the absolute neutrophil count (ANC) was ≥1000 cells/mm3 and the platelet count was ≥100,000 cells/mm3 and nonhematologic toxicities had resolved.

  Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

  Plasma bilirubin concentration (mg/dL)
  Dosage reduction (%)
  1.2-3.0
  50
  3.1-5.0
  75
  Reconstitution Directions

  It is recommended that doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly® needle inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. The rate of administration is dependent on the size of the vein, and the dosage. However, the dose should be administered in not less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration. A burning or stinging sensation may be indicative of perivenous infiltration and, if this occurs, the infusion should be immediately terminated and restarted in another vein. Perivenous infiltration may occur painlessly.

  Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Contact with alkaline solutions should be avoided since this can lead to hydrolysis of doxorubicin. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

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

  Handling and Disposal

  Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-4 There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate. However, given the toxic nature of this substance, the following protective recommendations are provided:

  Personnel should be trained in good technique for reconstitution and handling. Pregnant staff should be excluded from working with this drug. Personnel handling doxorubicin should wear protective clothing: goggles, gowns, and disposable gloves and masks. A designated area should be defined for reconstitution (preferably under a laminar flow system). The work surface should be protected by disposable, plastic-backed, absorbent paper. All items used for reconstitution, administration, or cleaning, including gloves,    should be placed in high-risk waste-disposal bags for high-temperature incineration. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All cleaning materials should be disposed of as indicated previously. In case of skin contact, thoroughly wash the affected area with soap and water or  sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with copious amounts of water for at least 15 minutes. Then seek medical evaluation by a physician. Always wash hands after removing gloves.

  Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

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• Pfizer Laboratories Div Pfizer Inc
  

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  Doxorubicin Hydrochloride | Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc

  

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  find right dose on chart below mL = milliliters; tsp = teaspoonful repeat dose every 4 hours do not give more than 6 times in 24 hours Age (yr) Dose (mL or tsp) under 4 years do not use 4 to 5 years 5 mL (1 tsp) 6 to 11 years 10 mL (2 tsp)

  Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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• Amneal-agila, Llc
  

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  Doxorubicin Hydrochloride | Amneal-agila, Llc

  

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  When possible, to reduce the risk of developing cardiotoxicity in patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, doxorubicin-based therapy should be delayed until the other agents have cleared from the circulation (See WARNINGS and PRECAUTIONS, General).

  Care in the administration of doxorubicin will reduce the chance of perivenous infiltration (see WARNINGS). It may also decrease the chance of local reactions such as urticaria and erythematous streaking. On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min. q.i.d. x 3 days may be useful. The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended. Blistering, ulceration, and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.

  The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration.

  Doxorubicin has been used concurrently with other approved chemotherapeutic agents. Evidence is available that in some types of neoplastic disease, combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days.

  In a large randomized study (NSABP B-15) of patients with early breast cancer involving axillary lymph nodes (see CLINICAL PHARMACOLOGY, Clinical Studies and ADVERSE REACTIONS, Adverse Reactions in Patients with Early
  Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy), the combination dosage regimen of AC (doxorubicin60 mg/m2 and cyclophosphamide 600 mg/m2) was administered intravenously on day 1 ofeach 21-day treatment cycle. Four cycles of treatment were administered.

  Dose Modifications

  Patients in the NSABP B-15 study could have dose modifications of AC to 75% of the starting doses for neutropenic fever/infection. When necessary, the next cycle of treatment cycle was delayed until the absolute neutrophil count (ANC) was ≥1000 cells/mm3 and the platelet count was ≥100,000 cells/mm3 and nonhematologic toxicities had resolved.

  Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

   Plasma bilirubin
  concentration (mg/dL)  Dosage reduction (%)  1.2 to 3  50  3.1 to 5  75

  Reconstitution Directions

  It is recommended that doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly® needle inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. The rate of administration is dependent on the size of the vein, and the dosage. However, the dose should be administered in not less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration. A burning or stinging sensation may be indicative of perivenous infiltration and, if this occurs the infusion should be immediately terminated and restarted in another vein. Perivenous infiltration may occur painlessly.

  Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form. Contact with alkaline solutions should be avoided since this can lead to hydrolysis of doxorubicin. Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

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

  Handling and Disposal

  Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-4 There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate. However, given the toxic nature of this substance, the following protective recommendations are provided:

  Personnel should be trained in good technique for reconstitution and handling. Pregnant staff should be excluded from working with this drug. Personnel handling doxorubicin should wear protective clothing: goggles, gowns, and disposable gloves and masks. A designated area should be defined for reconstitution (preferably under a laminar flow system). The work surface    should be protected by disposable, plastic-backed, absorbent paper. All items used for reconstitution, administration, or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high-temperature incineration. Spillage or leakage should be treated with dilute sodium    hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All cleaning materials should be disposed of as indicated   previously. In case of skin contact, thoroughly wash the affected area with soap and water or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with copious amounts of water for at least 15 minutes. Then seek medical evaluation by a physician. Always wash hands after removing gloves.

  Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

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• Fresenius Kabi Usa, Llc
  

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  Doxorubicin Hydrochloride | Fresenius Kabi Usa, Llc

  

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  When possible, to reduce the risk of developing cardiotoxicity in patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives sch as trastuzumab, doxorubicin-based therapy should be delayed until the other agents have cleared from the circulation (see WARNINGS  and PRECAUTIONS,  General).

  Care in the administration of doxorubicin will reduce the chance of perivenous infiltration (see WARNINGS).  It may also decrease the chance of local reactions such as urticaria and erythematous streaking.  On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle.  If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein.  If extravasation is suspected, intermittent application of ice to the site for 15 min. q.i.d. x 3 days may be useful.  The benefit of local administration of drugs has not been clearly established.  Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended.  Blistering, ulceration and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.

  The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals.  The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration.

  Doxorubicin has been used concurrently with other approved chemotherapeutic agents.  Evidence is available that in some types of neoplastic disease, combination chemotherapy is superior to single agents.  The benefits and risks of such therapy continue to be elucidated.  When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days.

  In a large randomized study (NSABP B-15) of patients with early breast cancer involving axillary lymph nodes (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES and ADVERSE REACTIONS, Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy), the combination dosage regimen of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) was administered intravenously on day 1 of each 21-day treatment cycle.  Four cycles of treatment were administered.

  Dose Modifications
  

  Patients in the NSABP B-15 study could have dose modifications of AC to 75% of the starting doses for neutropenic fever/infection.  When necessary, the next cycle of treatment cycle was delayed until the absolute neutrophil count (ANC) was ≥ 1000 cells/mm3 and the platelet count was ≥ 100,000 cells/mm3 and nonhematologic toxicities had resolved.

  Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

             Plasma bilirubin concentration (mg/dL)           
  

  Dosage reduction (%)

  1.2 to 3

  50

  3.1 to 5

  75

  
  Reconstitution Directions
  

  It is recommended that doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.  The tubing should be attached to a Butterfly® needle inserted preferably into a large vein.  If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.  The rate of administration is dependent on the size of the vein and the dosage.  However, the dose should be administered in not less than 3 to 5 minutes.  Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration.  A burning or stinging sensation may be indicative of perivenous infiltration and, if this occurs, the infusion should be immediately terminated and restarted in another vein.  Perivenous infiltration may occur painlessly.

  Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form.  Contact with alkaline solutions should be avoided since this can lead to hydrolysis of doxorubicin.  Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

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

  Handling and Disposal
  

  Procedures for proper handling and disposal of anti-cancer drugs should be considered.  Several guidelines on this subject have been published.1-4  There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.  However, given the toxic nature of this substance, the following protective recommendations are provided:

  Personnel should be trained in good technique for reconstitution and handling. Pregnant staff should be excluded from working with this drug. Personnel handling doxorubicin should wear protective clothing: goggles, gowns and disposable gloves and masks. A designated area should be defined for reconstitution (preferably under a laminar flow system).  The work surface should be protected by disposable, plastic-backed, absorbent paper. All items used for reconstitution, administration or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high-temperature incineration. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All cleaning materials should be disposed of as indicated previously. In case of skin contact, thoroughly wash the affected area with soap and water or sodium bicarbonate solution.  However, do not abrade the skin by using a scrub brush. In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with copious amounts of water for at least 15 minutes.  Then seek medical evaluation by a physician. Always wash hands after removing gloves.

  Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

  Dose Modifications
  

  Patients in the NSABP B-15 study could have dose modifications of AC to 75% of the starting doses for neutropenic fever/infection.  When necessary, the next cycle of treatment cycle was delayed until the absolute neutrophil count (ANC) was ≥ 1000 cells/mm3 and the platelet count was ≥ 100,000 cells/mm3 and nonhematologic toxicities had resolved.

  Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

             Plasma bilirubin concentration (mg/dL)           
  

  Dosage reduction (%)

  1.2 to 3

  50

  3.1 to 5

  75

  
  Reconstitution Directions
  

  It is recommended that doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.  The tubing should be attached to a Butterfly® needle inserted preferably into a large vein.  If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.  The rate of administration is dependent on the size of the vein and the dosage.  However, the dose should be administered in not less than 3 to 5 minutes.  Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration.  A burning or stinging sensation may be indicative of perivenous infiltration and, if this occurs, the infusion should be immediately terminated and restarted in another vein.  Perivenous infiltration may occur painlessly.

  Doxorubicin should not be mixed with heparin or fluorouracil since it has been reported that these drugs are incompatible to the extent that a precipitate may form.  Contact with alkaline solutions should be avoided since this can lead to hydrolysis of doxorubicin.  Until specific compatibility data are available, it is not recommended that doxorubicin be mixed with other drugs.

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

  Handling and Disposal
  

  Procedures for proper handling and disposal of anti-cancer drugs should be considered.  Several guidelines on this subject have been published.1-4  There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.  However, given the toxic nature of this substance, the following protective recommendations are provided:

  Personnel should be trained in good technique for reconstitution and handling. Pregnant staff should be excluded from working with this drug. Personnel handling doxorubicin should wear protective clothing: goggles, gowns and disposable gloves and masks. A designated area should be defined for reconstitution (preferably under a laminar flow system).  The work surface should be protected by disposable, plastic-backed, absorbent paper. All items used for reconstitution, administration or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high-temperature incineration. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All cleaning materials should be disposed of as indicated previously. In case of skin contact, thoroughly wash the affected area with soap and water or sodium bicarbonate solution.  However, do not abrade the skin by using a scrub brush. In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with copious amounts of water for at least 15 minutes.  Then seek medical evaluation by a physician. Always wash hands after removing gloves.

  Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’s urine and other body fluids for at least 5 days after each treatment.

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• Pfizer Laboratories Div Pfizer Inc
  

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  Doxorubicin Hydrochloride | Pfizer Laboratories Div Pfizer Inc

  

  ---

  2.1 Recommended Dose

  Adjuvant Breast Cancer

  The recommended dose of doxorubicin HCl is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma

  The recommended dose of doxorubicin HCl when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin HCl, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications

  Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin HCl is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5.0 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin HCl in patients with elevated serum total bilirubin concentrations as follows:

  Serum bilirubin concentration Doxorubicin HCl Dose reduction 1.2 – 3.0 mg/dL 50 % 3.1 – 5.0 mg/dL 75 % greater than 5.0 mg/dL Do not initiate doxorubicin HCl
  Discontinue doxorubicin HCl

  [see Warnings and Precautions (5.5) and Use in Specific Population (8.7)]

  2.3 Preparation and Administration

  Preparation of Doxorubicin HCl for injection

  Reconstitute doxorubicin hydrochloride for injection with 0.9% Sodium Chloride Injection, USP to obtain a final concentration of 2 mg per mL as follows:

  5 mL 0.9% Sodium Chloride Injection, USP to reconstitute 10 mg doxorubicin HCl vial 10 mL 0.9% Sodium Chloride Injection, USP to reconstitute 20 mg doxorubicin HCl vial 25 mL 0.9% Sodium Chloride Injection, USP to reconstitute 50 mg doxorubicin HCl vial 75 mL 0.9% Sodium Chloride Injection, USP to reconstitute 150 mg doxorubicin HCl vial

  Gently shake vial until the contents have dissolved.

  Protect reconstituted solution from light.

  Preparation for Continuous Intravenous Infusion

  Dilute doxorubicin HCl solution or reconstituted solution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Protect from light following preparation until completion of infusion.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of Doxorubicin HCl Injection or Doxorubicin HCl for Injection following reconstitution under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection:

  Administer doxorubicin HCl as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer doxorubicin HCl intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

  Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion.

  Management of Suspected Extravasation

  Discontinue doxorubicin HCl for burning or stinging sensation or other evidence indicating peri-venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

  Do not remove the needle until attempts are made to aspirate extravasated fluid. Do not flush the line. Avoid applying pressure to the site. Apply ice to the site intermittently for 15 min 4 times a day for 3 days. If the extravasation is in an extremity, elevate the extremity. In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)].

  Incompatibility with Other Drugs

  Do not admix doxorubicin HCl with other drugs. If doxorubicin HCl is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin HCl.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin HCl consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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• Teva Parenteral Medicines, Inc.
  

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  Doxorubicin Hydrochloride | Teva Parenteral Medicines, Inc.

  

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  2.1 Recommended Dose

  Adjuvant Breast Cancer

  The recommended dose of doxorubicin hydrochloride injection is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma

  The recommended dose of doxorubicin hydrochloride injection when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin hydrochloride injection, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications

  Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin hydrochloride injection is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin > 5 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin hydrochloride injection in patients with elevated serum total bilirubin concentrations as follows:

  Serum bilirubin concentration Doxorubicin HCl Dose reduction 1.2 to 3 mg/dL 50 % 3.1 to 5 mg/dL 75 % greater than 5 mg/dL

  Do not initiate doxorubicin HCl

  Discontinue doxorubicin HCl

  [see Warnings and Precautions (5.5) and Use in Specific Population (8.7)]

  2.3 Preparation and Administration

  Preparation for Continuous Intravenous Infusion

  Dilute doxorubicin hydrochloride injection solution or reconstituted solution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Protect from light following preparation until completion of infusion.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of doxorubicin hydrochloride injection following reconstitution under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection:

  Administer doxorubicin hydrochloride injection as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer doxorubicin hydrochloride injection intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin hydrochloride injection administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

   

  Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin hydrochloride injection administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion.

   

  Management of Suspected Extravasation

  Discontinue doxorubicin hydrochloride injection for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows: 

  Do not remove the needle until attempts are made to aspirate extravasated fluid. Do not flush the line. Avoid applying pressure to the site. Apply ice to the site intermittently for 15 min 4 times a day for 3 days. If the extravasation is in an extremity, elevate the extremity. In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)].

   

  Incompatibility with Other Drugs

  Do not admix doxorubicin hydrochloride injection with other drugs. If doxorubicin hydrochloride injection is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin hydrochloride injection.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin hydrochloride injection consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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  2.1 Recommended Dose

  Adjuvant Breast Cancer

  The recommended dose of doxorubicin HCl is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma

  The recommended dose of doxorubicin HCl when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin HCl, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications

  Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin HCl is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5.0 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin HCl in patients with elevated serum total bilirubin concentrations as follows:

  Serum bilirubin concentration Doxorubicin HCl Dose reduction 1.2 – 3.0 mg/dL 50 % 3.1 – 5.0 mg/dL 75 % greater than 5.0 mg/dL Do not initiate doxorubicin HCl
  Discontinue doxorubicin HCl

  [see Warnings and Precautions (5.5) and Use in Specific Population (8.7)]

  2.3 Preparation and Administration

  Preparation for Continuous Intravenous Infusion

  Dilute doxorubicin HCl solution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Protect from light following preparation until completion of infusion.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of Doxorubicin HCl Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection:

  Administer doxorubicin HCl as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer doxorubicin HCl intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

  Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion.

  Management of Suspected Extravasation

  Discontinue doxorubicin HCl for burning or stinging sensation or other evidence indicating peri-venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

  Do not remove the needle until attempts are made to aspirate extravasated fluid. Do not flush the line. Avoid applying pressure to the site. Apply ice to the site intermittently for 15 min 4 times a day for 3 days. If the extravasation is in an extremity, elevate the extremity. In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)].

  Incompatibility with Other Drugs

  Do not admix doxorubicin HCl with other drugs. If doxorubicin HCl is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin HCl.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin HCl consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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  2.1 Dosage for Postherpetic Neuralgia

  In adults with postherpetic neuralgia, gabapentin capsules may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.

  2.2 Dosage for Epilepsy with Partial Onset Seizures

  Patients 12 years of age and above
  
  The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin capsules is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin capsules three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours.
  
  Pediatric Patients Age 3 to 11 years
  
  The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin capsules in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin capsules in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

  2.3 Dosage Adjustment in Patients with Renal Impairment

  Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):

  TABLE1. Gabapentin capsules Dosage Based on Renal Funtion TID = Three times a day; BID = Two times a day; QD = Single daily dose
  a     For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
  b     Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
  Renal Function Creatinine Clearance (mL/min)
  Total Daily Dose Range (mg/day)
  Dose Regimen (mg)
  ≥ 60
  900 to 3600
  300 TID
  400 TID
  600 TID
  800 TID
  1200 TID
  >30 to 59
  400 to 1400
  200 BID
  300 BID
  400 BID
  500 BID
  700 BID
  >15 to 29
  200 to 700
  200 QD
  300 QD
  400 QD
  500 QD
  700 QD
  15a
  100 to 300
  100 QD
  125 QD
  150 QD
  200 QD
  300 QD
  Post-Hemodialysis Supplemental Dose (mg)b
  Hemodialysis
   
  125 b
  150 b
  200 b
  250 b
  350 b
  
  

  Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

  
  

  
  

  The use of gabapentin capsules in patients less than 12 years of age with compromised renal function has not been studied.

  2.4 Dosage in Elderly

  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

  2.5 Administration Information

  Administer gabapentin capsules orally with or without food.
  
  Gabapentin capsules should be swallowed whole with water.
  
  If the gabapentin capsules dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

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  2.1 Recommended Dose Adjuvant Breast Cancer

  The recommended dose of doxorubicin hydrochloride, USP is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma The recommended dose of doxorubicin hydrochloride, USP when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin hydrochloride, USP, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin hydrochloride, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5.0 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin hydrochloride, USP in patients with elevated serum total bilirubin concentrations as follows:

  Table Serum bilirubin concentration
  Doxorubicin hydrochloride, USP Dose reduction
  1.2 to 3 mg/dL
  50 %
  3.1 to 5 mg/dL
  75 %
  greater than 5 mg/dL
  Do not initiate doxorubicin hydrochloride, USP 
  Discontinue doxorubicin hydrochloride, USP
  

   [see Warnings and Precautions (5.5) and Use in Specific Populations (8.7)]

  2.3 Preparation and Administration Preparation for Continuous Intravenous Infusion

  Dilute doxorubicin hydrochloride, USP solution or reconstituted solution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.  Protect from light following preparation until completion of infusion.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of Doxorubicin hydrochloride injection, USP following reconstitution under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15  to 30 C (59  to 86 F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection

  Administer doxorubicin hydrochloride, USP as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer doxorubicin hydrochloride, USP intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin hydrochloride, USP administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

  Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin hydrochloride, USP administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion. Management of Suspected Extravasation

  Discontinue doxorubicin hydrochloride, USP for burning or stinging sensation or other evidence indicating peri venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

  Do not remove the needle until attempts are made to aspirate extravasated fluid. Do not flush the line. Avoid applying pressure to the site. Apply ice to the site intermittently for 15 min 4 times a day for 3 days. If the extravasation is in an extremity, elevate the extremity. In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)] . Incompatibility with Other Drugs

  Do not admix doxorubicin hydrochloride, USP with other drugs. If doxorubicin hydrochloride, USP is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin hydrochloride, USP.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin hydrochloride, USP consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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• Mylan Institutional Llc
  

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  Doxorubicin Hydrochloride | Mylan Institutional Llc

  

  ---

  2.1 Recommended Dose Adjuvant Breast Cancer

  The recommended dose of doxorubicin hydrochloride, USP is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma The recommended dose of doxorubicin hydrochloride, USP when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin hydrochloride, USP, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin hydrochloride, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5.0 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin hydrochloride, USP in patients with elevated serum total bilirubin concentrations as follows:

  Serum bilirubin concentration
  Doxorubicin hydrochloride, USP Dose reduction
  1.2 to 3 mg/dL
  50 %
  3.1 to 5 mg/dL
  75 %
  
  greater than 5 mg/dL
  Do not initiate doxorubicin hydrochloride, USP
  Discontinue doxorubicin hydrochloride, USP
  

   [see Warnings and Precautions (5.5) and Use in Specific Populations (8.7)]

  2.3 Preparation and Administration Preparation of Doxorubicin Hydrochloride for injection, USP

  Reconstitute doxorubicin hydrochloride for injection, USP with 0.9% Sodium Chloride Injection, USP to obtain a final concentration of 2 mg per mL as follows:

  5 mL 0.9% Sodium Chloride Injection, USP to reconstitute 10 mg doxorubicin hydrochloride, USP vial. 25 mL 0.9% Sodium Chloride Injection, USP to reconstitute 50 mg doxorubicin hydrochloride, USP vial.

  Gently shake vial until the contents have dissolved.

  Protect reconstituted solution from light.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of Doxorubicin hydrochloride for injection, USP following reconstitution under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [150 to 300 C (590 to 860F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection: Administer doxorubicin hydrochloride, USP as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. Administer doxorubicin hydrochloride, USP intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin hydrochloride, USP administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin hydrochloride, USP administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

  Protect from light from preparation for infusion until completion of infusion.

    Infuse only through a central catheter. Decrease the rate of doxorubicin hydrochloride, USP administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.   Protect from light from preparation for infusion until completion of infusion. Management of Suspected Extravasation

  Discontinue doxorubicin hydrochloride, USP for burning or stinging sensation or other evidence indicating peri venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

    Do not remove the needle until attempts are made to aspirate extravasated fluid.   Do not flush the line.   Avoid applying pressure to the site.   Apply ice to the site intermittently for 15 min 4 times a day for 3 days.   If the extravasation is in an extremity, elevate the extremity.   In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)] . Incompatibility with Other Drugs

  Do not admix doxorubicin hydrochloride, USP with other drugs. If doxorubicin hydrochloride, USP is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin hydrochloride, USP.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin hydrochloride, USP consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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