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Cyclophosphamide (Cyclophosphamide)

Trade Name : Cyclophosphamide

West-Ward Pharmaceuticals Corp.

CAPSULE

Strength 25 mg/1

CYCLOPHOSPHAMIDE Alkylating Activity [MoA],Alkylating Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cyclophosphamide (Cyclophosphamide) which is also known as Cyclophosphamide and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 25 mg/1 per ml. Read more

Cyclophosphamide (Cyclophosphamide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • u00a0
  • Cyclophosphamide is an alkylating drug indicated for treatment of:
  • Limitations of Use:
  • Malignant Diseases
  • Minimal Change Nephrotic Syndrome in Pediatric Patientsn- Array
  • During or immediately after the administration, administer adequate amounts of fluid to reduce the risk of urinary tract toxicity ().
  • Malignant Diseases: Adult and Pediatric Patients
  • Minimal Change Nephrotic Syndrome in Pediatric Patients
  • Capsules:
  • Capsules: 25 mg and 50 mg ()
  • Cyclophosphamide Capsules are contraindicated in patients with:
  • No data
  • 5.7n- 8.1n- 8.3
  • Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or .
  • Cyclophosphamide is a pro-drug that is activated by cytochrome P450s .
  • An increase of the concentration of cytotoxic metabolites may occur with:
  • Combined or sequential use of cyclophosphamide and other agents with similar toxicities can potentiate toxicities.
  • Etanercept: In patients with Wegeneru2019s granulomatosis, the addition of etanercept to standard treatment, including cyclophosphamide, was associated with a higher incidence of non-cutaneous malignant solid tumors.
  • Metronidazole: Acute encephalopathy has been reported in a patient receiving cyclophosphamide and metronidazole. Causal association is unclear. In an animal study, the combination of cyclophosphamide with metronidazole was associated with increased cyclophosphamide toxicity.
  • Tamoxifen: Concomitant use of tamoxifen and chemotherapy may increase the risk of thromboembolic complications.
  • Coumarins: Both increased and decreased warfarin effect have been reported in patients receiving warfarin and cyclophosphamide.
  • Cyclosporine: Lower serum concentrations of cyclosporine have been observed in patients receiving a combination of cyclophosphamide and cyclosporine than in patients receiving only cyclosporine. This interaction may result in an increased incidence of graft-versus-host disease.
  • Depolarizing muscle relaxants: Cyclophosphamide treatment causes a marked and persistent inhibition of cholinesterase activity. Prolonged apnea may occur with concurrent depolarizing muscle relaxants (e.g., succinylcholine). If a patient has been treated with cyclophosphamide within 10 days of general anesthesia, alert the anesthesiologist.
  • No data
  • 8.6n- 12.3
  • No specific antidote for cyclophosphamide is known.
  • Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur.
  • Serious consequences of overdosage include manifestations of dose dependent toxicities such as myelosuppression, urotoxicity, cardiotoxicity (including cardiac failure), veno-occlusive hepatic disease, and stomatitis .
  • Patients who received an overdose should be closely monitored for the development of toxicities, and hematologic toxicity in particular.
  • Cyclophosphamide and its metabolites are dialyzable. Therefore, rapid hemodialysis is indicated when treating any suicidal or accidental overdose or intoxication.
  • Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with cyclophosphamide overdose.
  • Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:
  • Cyclophosphamide has a molecular formula CHClNOP u2022 HO and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline and ethanol.
  • Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: pregelatinized starch and sodium stearyl fumarate.
  • Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.
  • In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac.
  • No data
  • Cyclophosphamide administered by different routes, including intravenous, subcutaneous or intraperitoneal injection, or in drinking water, caused tumors in both mice and rats. In addition to leukemia and lymphoma, benign and malignant tumors were found at various tissue sites, including urinary bladder, mammary gland, lung, liver, and injection site .
  • Cyclophosphamide was mutagenic and clastogenic in multiple and genetic toxicology studies.
  • Cyclophosphamide is genotoxic in male and female germ cells. Animal data indicate that exposure of oocytes to cyclophosphamide during follicular development may result in a decreased rate of implantations and viable pregnancies, and in an increased risk of malformations. Male mice and rats treated with cyclophosphamide show alterations in male reproductive organs (e.g., decreased weights, atrophy, changes in spermatogenesis), and decreases in reproductive potential (e.g., decreased implantations and increased post-implantation loss) and increases in fetal malformations when mated with untreated females .
  • 1. OSHA Hazardous Drugs. . http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • Cyclophosphamide Capsules
  • 25 mg, supplied as a blue/blue opaque capsule with u201c54 006u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0382-13: Bottle of 30 Capsules
  • NDC 0054-0382-25: Bottle of 100 Capsules
  • 50 mg, supplied as a blue/blue opaque capsule with u201c54 881u201d printed in black ink on the cap and body, containing a white to off-white powder.
  • NDC 0054-0383-13: Bottle of 30 Capsules
  • NDC 0054-0383-25: Bottle of 100 Capsules
  • Storage
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); with excursions permitted between 15u00baC to 30u00baC (59u00b0F to 86u00b0F). [See USP Controlled Room Temperature.]
  • Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures.n
  • Advise the patient of the following:
  • Myelosuppression, Immunosuppression, and Infections
  • Urinary Tract and Renal Toxicity
  • Cardiotoxicity
  • Pulmonary Toxicity
  • Embryo-Fetal Toxicity
  • Lactation
  • Infertility
  • Hydration and Important Administration Instructions
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10008219/04
  • Revised September 2019
  • No data
  • No data

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