DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Celdaz for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, Celdaz for Injection, USP is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
Celdaz for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Hemopoietic depression is the most common toxicity with Celdaz for Injection and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with Celdaz for Injection.
Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when Celdaz for Injection has been administered concomitantly with other anti-neoplastic drugs: however, it has also been reported in some patients treated with Celdaz for Injection alone.
Anaphylaxis can occur following the administration of Celdaz for Injection.
Hospitalization is not always necessary but adequate laboratory study capability must be available. Extravasation of the drug subcutaneously during intravenous administration may result in tissue damage and severe pain. Local pain, burning sensation and irritation at the site of injection may be relieved by locally applied hot packs.
Carcinogenicity of Celdaz was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by Celdaz in rats. In mice, administration of Celdaz resulted in the induction of angiosarcomas of the spleen.
USAGE IN PREGNANCY
Pregnancy Category C: Celdaz for Injection has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. Celdaz when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, Celdaz daily dose 7 times the human daily dose given on Days 6 to 15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well controlled studies in pregnant women. Celdaz for Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for Celdaz for Injection in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Symptoms of anorexia, nausea and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1 to 12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with Celdaz for Injection. Rarely, Celdaz for Injection has caused diarrhea. Some helpful suggestions include restricting the patient's oral intake of food for 4 to 6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days.
There are a number of minor toxicities that are infrequently noted. Patients have experienced an influenza-like syndrome of fever to 39°C, myalgias and malaise. These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments.
Alopecia has been noted as has facial flushing and facial paresthesia. There have been few reports of significant liver or renal function test abnormalities in man. However, these abnormalities have been observed more frequently in animal studies.
Erythematous and urticarial rashes have been observed infrequently after administration of Celdaz for Injection. Rarely, photosensitivity reactions may occur.
Give supportive treatment and monitor blood cell counts.
DOSAGE AND ADMINISTRATION
Malignant Melanoma: The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals.
An alternate recommended dosage is 250 mg/square meter body surface/day IV for 5 days. Treatment may be repeated every 3 weeks.
Hodgkin's Disease: The recommended dosage of Celdaz for Injection in the treatment of Hodgkin's disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days.
Celdaz for Injection 200 mg/vial is reconstituted with 19.7 mL of Sterile Water for Injection, USP. The resulting solution contains 10 mg/mL of Celdaz having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously.
The reconstituted solution may be further diluted with 5% dextrose injection, USP or sodium chloride injection, USP and administered as an intravenous infusion.
After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection, USP or sodium chloride injection, USP, the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-7. There is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.
NDC 61703-327-22, 200 mg of Celdaz for Injection, USP per vial as sterile Celdaz packaged in individual cartons.
Store in a refrigerator 2°C to 8°C (36°F to 46°F).
Mfd by: Zydus Hospira
Oncology Private Ltd., Gujarat, India
Dist. by: Hospira, Inc.
Lake Forest, IL 60045 USA
Product of India
Celdaz for Injection, USP
prepared as the citrate salt
For Intravenous Use Only
Caution: Cytotoxic Agent
CA-3359Carton NDC 61703-327-22
Celdaz pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Celdaz available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Celdaz destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Celdaz Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Celdaz pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Celdaz?
Depending on the reaction of the Celdaz after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Celdaz not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Celdaz addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Celdaz, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Celdaz consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
The information was verified by Dr. Arunabha Ray, MD Pharmacology