Neoclomide 200 mg/vial (IV Infusion)

Title and Categories

• Neoclomide
• Cytotoxic Chemotherapy

Dimensions

• N/A

Color Options

• N/A

Functions

• Antineoplastic drug therapy
• Biotransformation in the liver to active alkylating metabolites
• Interference with the growth of susceptible rapidly proliferating malignant cells
• Cross-linking of tumor cell DNA
• Treatment of malignant diseases
• Treatment of nonmalignant diseases

Materials

• N/A

Technical Specifications

• Bioavailability greater than 75%
• Elimination half-life of 3 to 12 hours
• Elimination primarily in the form of metabolites
• Plasma protein binding of unchanged drug is low
• No specific antidote for overdose
• Temperature not exceeding 25°C for storage
• Protect from light and moisture during storage
• Do not freeze during storage

Design Elements

• Intravenous and oral administration
• Dialyzable drug
• Pharmacokinetic parameters influenced by compromised renal function
• Oral dose recommendation for minimal change nephrotic syndrome in children
• Potential for serious adverse reactions in breast milk

Usability Features

• Adjusting dosages in response to antitumor activity and/or leukopenia
• Cautious dose selection for elderly patients

Indications

• Malignant lymphomas susceptible to treatment
• Hodgkin’s disease treatment
• Treatment of various types of leukemia
• Multiple myeloma treatment
• Advanced mycosis fungoides treatment
• Treatment of neuroblastoma (disseminated disease)
• Treatment of adenocarcinoma of the ovary
• Treatment of retinoblastoma
• Treatment of carcinoma of the breast
• Use in carefully selected cases of biopsy-proven 'minimal change' nephrotic syndrome in children

Pharmacology

• Biotransformation in the liver to active alkylating metabolites
• Mechanism of action involving cross-linking of tumor cell DNA
• Plasma protein binding of metabolites
• Cytotoxic and noncytotoxic metabolites identified in urine and plasma

Dosage & Administration

• Intravenous and oral dosing regimens
• Adjustment of dosages based on leukocyte count
• Dialyzable drug
• Pharmacokinetic parameter changes in compromised renal function
• Oral dose recommendation for minimal change nephrotic syndrome in children
• Adrenocorticosteroid therapy adjustment during cyclophosphamide therapy
• Potential for sterility with prolonged treatment duration

Interaction

• Increased metabolism and leukopenic activity with chronic administration of high doses of phenobarbital
• Alertness for combined drug actions

Contraindications

• Severely depressed bone marrow function
• Previous hypersensitivity to cyclophosphamide

Side Effects

• Nausea, vomiting, anorexia, abdominal discomfort, diarrhea
• Hemorrhagic colitis, oral mucosal ulceration, jaundice
• Alopecia, skin rash, pigmentation changes, nail changes
• Leukopenia, neutropenia, thrombocytopenia, anemia
• Hemorrhagic ureteritis, renal tubular necrosis
• Interstitial pneumonitis, interstitial pulmonary fibrosis
• Anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis
• SAIDH (syndrome of inappropriate ADH secretion)
• Malaise, asthenia

Pregnancy & Lactation

• Pregnancy Category D
• Excretion in breast milk
• Potential for tumorigenicity in humans

Precautions & Warnings

• Leukopenia, thrombocytopenia, tumor cell infiltration of bone marrow, previous X-ray therapy, previous therapy with other cytotoxic agents, impaired hepatic function, impaired renal function

Use in Special Populations

• Safety profile in pediatric patients similar to adults
• Elderly patients may be more susceptible to toxicities

Overdose Effects

• No specific antidote known
• Supportive measures for managing overdosage

Storage Conditions

• Temperature not exceeding 25°C
• Protection from light and moisture
• Avoid freezing

Therapeutic Class

• Cytotoxic Chemotherapy

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