Adriamycin CS

Adriamycin CS Dosage/Direction for Use

doxorubicin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Care in the administration of ADRIAMYCIN will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. The recommended dosage schedule is 60-75 mg/m2 as a single intravenous injection administered at 21-day intervals. The lower dose should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration. An alternative dose schedule is 30 mg/m2 on each of three successive days repeated every 4 weeks. The adult dosage regimens may be suitable for paediatric cases. The recommended lifetime cumulative dose limit is 550 mg doxorubicin/m2 body surface area. ADRIAMYCIN has been administered as an intra-arterial infusion for 1-3 days at doses of 45-100 mg/m2. It is recommended that the total cumulative dose of doxorubicin for adults aged 70 or older be restricted to 450 mg/m2 body surface area.
Doxorubicin dosage must be reduced if hepatic function is impaired according to the following table: (See Table 2.)

Click on icon to see table/diagram/image

ADRIAMYCIN Injection is supplied as 10 mg and 50 mg doxorubicin hydrochloride in 5 and 25 mL vials, respectively (doxorubicin concentration 2 mg/mL).
ADRIAMYCIN Injection must be handled with care. If contact with the skin occurs, wash thoroughly with soap and water. The product contains no antimicrobial preservative. The single dose vials should be used in one patient on one occasion only. Discard any residue. The solution is to be stored under refrigeration (2°C to 8°C) and should be protected from sunlight and retained in the carton until time of use.
Storage of ADRIAMYCIN Injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after two to a maximum of four hours equilibration at room temperature (15°C to 25°C).
It is recommended that ADRIAMYCIN be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection or 5% Glucose Injection. The tubing should be attached to a butterfly needle inserted preferably into a large vein. 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 3-5 minutes. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration.
Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid administration. A burning or stinging sensation may be indicative of perivenous infiltration and the infusion should be immediately terminated and restarted in another vein.
Until specific compatibility data are available, it is not recommended that ADRIAMYCIN be mixed with other drugs. Contact with alkaline solutions should be avoided since this can lead to hydrolysis of doxorubicin. ADRIAMYCIN should not be mixed with heparin due to chemical incompatibility that may lead to precipitation.
Doxorubicin should not be mixed with fluorouracil (e.g., in the same IV infusion bag or at the Y-site of an IV infusion line) since it has been reported that these drugs are incompatible to the extent that a precipitate might form. If concomitant therapy with doxorubicin and fluorouracil is required, it is recommended that the IV line be flushed between the administration of these drugs.
ADRIAMYCIN has been used in combination with other approved chemotherapeutic agents.
Though evidence is available that at least in some types of neoplastic disease combination chemotherapy is superior to single agents the benefits and risks of such therapy have not yet been fully elucidated.
Intravesical Administration: The following procedure is recommended: The bladder should be catheterised and emptied.
Dilute ADRIAMYCIN to a final concentration of 80 mg in 100 mL of normal saline and instill via the catheter into the bladder.
The catheter should be removed and the patient instructed to be on one side. At 15-minute intervals the patient should alternate to the opposite side over a 1-hour period.
The patient should be requested not to urinate for 1-hour, after which the bladder should be emptied of solution.
The procedure should be repeated at monthly intervals.
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