I-Dox


Doxorubicin Hydrochloride Liposome Injection (As Pegylated Liposome)

Prescribing Information :

Material Safety Data Sheet :

Doxorubicin-Hydrochloride-Liposome-Injection-I-Dox-20mg

Strength:

20mg/10ml

Description:

Single use vial

Pack Size:

1 Vial

Storage Conditions:

Store between 2°- 8°C (36°-46°F) in a refrigerator. Do not freeze.

Doxorubicin-Hydrochloride-Liposome-Injection-I-Dox-50mg

Strength:

50mg/25ml

Description:

Single use vial

Pack Size:

1 Vial

Storage Conditions:

Store between 2°- 8°C (36°-46°F) in a refrigerator. Do not freeze.

Approved Indications of I-Dox



  • Metastatic Carcinoma of the Ovary whose disease has progressed or recurred after platinum-based chemotherapy

  • Metastatic Breast Cancer patients with increased cardiac risk.

  • Multiple Myeloma in combination with Bortezomib in patients





Product Information



Getwell Pharmaceuticals is a leading manufacturer and supplier of Pegylated Liposomal Doxorubicin Injection: I-Dox at a cost effective price in India. We have a range of complex generics and drug delivery based formulations.



Dosage of Pegylated Liposomal Doxorubicin Injection



Each 10 ml & 30 ml vials contains 20 mg & 50 mg of Doxorubicin HCl respectively at a concentration of 2 mg/ml.



Preparation for Intravenous Administration:



A maximum dose of 90 mg diluted in 250 ml of 5 % Dextrose injection IP / USP prior to administration is the most appropriate dose of i-Dox.



Side effects



Body as a whole: Allergic reaction, chills, infection, chest pain, back pain, abdomen enlarged and malaise. Cellulites, anaphylactoid reaction, ascites, flu syndrome, neck pain, moniliasis, injection site pain, face edema, chills, fever, pelvic pain, chest pain Substernal and injection site inflammation may have incidence ratio less than 1%.



Digestive system: Dyspepsia, oral moniliasis, mouth ulceration, esophagitis and dysphasia. Lesser than 1 % incidence of gingivitis, eructation, increased salivation, Melina, gastrointestinal hemorrhage, proctitis, jaundice, ileus, periodontal abscess, flatulence, aphthous stomatitis, gastritis, glossitis and gum hemorrhage may be seen



Contraindications



I-Dox (Doxorubicin HCl liposome injection) is contraindicated in patients who have a history of hypersensitivity reactions to conventional Doxorubicin HCl formulation or the ® components of i-Dox. ® I-Dox is contraindicated in nursing mothers.


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