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Doxorubicin

Structure

Doxorubicin 10
Vial contains sterile mixture of Doxorubicin Hydrochloride and Lactose.

Doxorubicin 50
Vial contains sterile mixture of Doxorubicin Hydrochloride and Lactose.

No Prescription

Doxorubicin is prescribed for:
Doxorubicin is prescribed to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilm’s tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.

Dosage

Care in the administration of Doxorubicin will reduce the chance of perivenous infiltration.
It may also decrease the change 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. for 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 prescribed dose schedule when prescribed as a single agent is 60 to 75 /m 2 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 prescribed 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 prescribed in combination with other chemotherapy drugs, the most commonly prescribed dosage of doxorubicin is 40 to 60 /m 2 given as a single intravenous injection every 21 to 28 days.
Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows:

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

Reconstitution Directions
Doxorubicin 10 and 50 mg vials should be reconstituted with 5 mL and 25 mL respectively, of Sterile water for Injection IP, to give a final concentration of 2 mg/mL of doxorubicin hydrochloride.
An appropriate volume of air should be withdrawn from the vial during reconstitution to avoid excessive pressure buildup.
Bacteriostatic diluents are not recommended.
After adding the diluent, the vial should be shaken and the contents allowed to dissolve.
The reconstituted solution is stable for 7 days at room temperature and under normal room light and 15 days under refrigeration (2° to 8°C).
It should be protected from exposure to sunlight.

Discard any of the unused solution from the 50 single dose vials.
Unused solutions of the multiple dose vial remaining beyond the recommended storage times should be discarded.
It is recommended that Doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, IP, or 5% Dextrose Injection, IP.
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 doxorubicin.
Red blood cell and platelet levels should also be monitored since they may also be depressed.
Hematologic toxicity may require dose reduction or suspension or delay of doxorubicin therapy.
Persistent severe myelosuppression may result in superinfection or hemorrhage.
Doxorubicin may potentiate the toxicity of other anticancer therapies.
Exacerbation of cyclophosphamide induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported.
Radiation induced toxicity to the myocardium, mucosae, skin and liver have been reported to be increased by the administration of doxorubicin Pediatric may be indicative of too rapid an administration.
A burning or stinging sensation may be indicative of perivenous infiltration and 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.
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
Skin reactions associated with doxorubicin have been reported.
Skin accidentally exposed to doxorubicin should be rinsed copiously with soap and warm water, and if the eyes are involved, standard irrigation techniques should be prescribed immediately.
The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.
Procedures for proper handling and disposal of anti-cancer drugs should be considered.
Caregivers of pediatric patients receiving doxorubicin should be counseled to take precautions (such as wearing latex gloves) to prevent contact with the patient’ urine and other body fluids for at least 5 days after each treatment.

Contraindications

Doxorubicin is contraindicated if you have any of the following conditions:
Doxorubicin therapy should not be started in patients who have marked myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy.
Doxorubicin treatment is contraindicated in patients who received previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenes.

Package

- Vial of 15 ml;
- Vial of 50 ml;
(c) 2017