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Adriamycin
Overview
What is Adriamycin?
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of var.. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Chemically, doxorubicin hydrochloride is (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-a-L-lyxo-hexopyranosyl)-oxy]-8-glycoloyl-7,8,9,10-tetrahydro-
6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The structural formula is as follows:
Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic, but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins.
It is supplied in the hydrochloride form as a sterile red-orange lyophilized powder containing lactose and as a sterile parenteral, isotonic solution with sodium chloride for intravenous use only.
Adriamycin (DOXOrubicin HCl) for Injection, USP:
Each 10 mg lyophilized vial contains 10 mg of Doxorubicin Hydrochloride, USP and 50 mg of Lactose Monohydrate, NF.
Each 50 mg lyophilized vial contains 50 mg of Doxorubicin Hydrochloride, USP and 250 mg of Lactose Monohydrate, NF.
What does Adriamycin look like?
What are the available doses of Adriamycin?
Adriamycin (DOXOrubicin HCl) for Injection, USP: Vials contain 10 mg and 50 mg doxorubicin hydrochloride as a red-orange lyophilized powder.
What should I talk to my health care provider before I take Adriamycin?
How should I use Adriamycin?
Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer
Adjuvant Breast Cancer
The recommended dose of doxorubicin is 60 mg/madministered as an intravenous bolus on day 1 of each 21 day treatment cycle, in combination with cyclophosphamide, for a total of four cycles
Metastatic Disease, Leukemia, or Lymphoma
What interacts with Adriamycin?
Sorry No Records found
What are the warnings of Adriamycin?
Sorry No Records found
What are the precautions of Adriamycin?
Sorry No Records found
What are the side effects of Adriamycin?
Sorry No records found
What should I look out for while using Adriamycin?
Doxorubicin is contraindicated in patients with:
What might happen if I take too much Adriamycin?
Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin (300 mg/m) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4-7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.
How should I store and handle Adriamycin?
Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs. Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:NDC 0143-9275-01NDC 0143-9277-01Store all vials at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.Reconstituted Solution StabilityAfter 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 (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.Handling and Disposal Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The cytotoxic effect of doxorubicin on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin cytocidal activity.
Non-Clinical Toxicology
Doxorubicin is contraindicated in patients with:Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clearance is altered by another drug resulting in increased or decreased serum theophylline concentrations. Theophylline only rarely alters the pharmacokinetics of other drugs.
The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with theophylline. The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state theophylline regimen. If theophylline is being initiated in a patient who is already taking a drug that inhibits theophylline clearance (e.g., cimetidine, erythromycin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be smaller. Conversely, if theophylline is being initiated in a patient who is already taking a drug that enhances theophylline clearance (e.g., rifampin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be larger. Discontinuation of a concomitant drug that increases theophylline clearance will result in accumulation of theophylline to potentially toxic levels, unless the theophylline dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits theophylline clearance will result in decreased serum theophylline concentrations, unless the theophylline dose is appropriately increased.
The drugs listed in Table III have either been documented not to interact with theophylline or do not produce a clinically significant interaction (i.e., <15% change in theophylline clearance).
The listing of drugs in Tables II and III are current as of February 9, 1995. New interactions are continuously being reported for theophylline, especially with new chemical entities. Before addition of a newly available drug in a patient receiving theophylline, the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and theophylline has been reported.
Cardiomyopathy
Doxorubicin can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative exposure. Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for doxorubicin. Cardiomyopathy may develop during treatment or up to several years after completion of treatment and can include decrease in LVEF and signs and symptoms of congestive heart failure (CHF). The probability of developing cardiomyopathy is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m of doxorubicin, 3 to 5% at a dose of 400 mg/m, 5 to 8% at a dose of 450 mg/m, and 6 to 20% at a dose of 500 mg/m, when doxorubicin is administered every 3 weeks. There is an additive or potentially synergistic increase in the risk of cardiomyopathy in patients who have received radiotherapy to the mediastinum or concomitant therapy with other known cardiotoxic agents such as cyclophosphamide and trastuzumab.
Pericarditis and myocarditis have also been reported during or following doxorubicin treatment.
Assess left ventricular cardiac function (e.g., MUGA or echocardiogram) prior to initiation of doxorubicin, during treatment to detect acute changes, and after treatment to detect delayed cardiotoxicity. Increase the frequency of assessments as the cumulative dose exceeds 300 mg/m. Use the same method of assessment of LVEF at all time points .
Consider the use of dexrazoxane to reduce the incidence and severity of cardiomyopathy due to doxorubicin administration in patients who have received a cumulative doxorubicin dose of 300 mg/mand who will continue to receive doxorubicin.
Arrhythmias
Doxorubicin can result in arrhythmias, including life-threatening arrhythmias, during or within a few hours after doxorubicin administration and at any time point during treatment. Tachyarrhythmias, including sinus tachycardia, premature ventricular contractions, and ventricular tachycardia, as well as bradycardia may occur. Electrocardiographic changes including non-specific ST-T wave changes, atrioventricular and bundle-branch block can also occur. These electrocardiographic changes may be transient and self-limited and may not require dose-modifications of doxorubicin.
The following adverse reactions are discussed in more detail in other sections of the labeling.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).