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Arsenic Trioxide information from DrugsUpdate  

See Available Brands of Arsenic Trioxide in India

P - Contraindicated in Pregnancy
L - Contraindicated in lactation
LI - Lab *

Arsenic trioxide, an inorganic compound, interrupts with cell division process as a cytostatic compound and inhibits progression of malignant cells by induction of apoptosis. Arsenic trioxide is prescribed for the treatment of acute promyelocytic leukaemia (APL).

Pharmacodynamics

The pharmacodynamic action of arsenic trioxide is not fully studied. Arsenic trioxide induces structural changes in the cell that causes DNA fragmentation in apoptosed, malignant cells. Arsenic trioxide induces damage of fusion malignant protein PML/RAR-alpha.

Pharmacokinetics

After intravenous administration, the peak plasma concentration is absorbed after 2 hours of infusion. The mean elimination half-life of arsenic trioxide is 10-14 hours with a rapid distribution phase and slow elimination phase. The terminal half life of arsenic trioxide metabolites such as MMA and DMA are 32 and 72 hours, respectively. The Vss of arsenic trioxide depends on body weight. Arsenic trioxide is mostly distributed as methylated form and distributed as less cytotoxic forms such as MMA and DMA via non-enzymatic and enzymatic processes. Most of the administered dose is excreted via the urine as unchanged arsenic trioxide with a clearance rate of 49 L/hr.

Arsenic Trioxide Indications / Arsenic Trioxide Uses

In Acute promyelocytic leukaemia (Intravenously).

Arsenic Trioxide Adverse Reactions / Arsenic Trioxide Side Effects

Arsenic trioxide can cause cough, painful breathing, shortness of breath, fever, weight gain, fatigue, edema in the ankles or feet, easy bruising, hypokalemia, dry skin, weight loss, increased micturition, sore throat, hyperglycemia, constipation, diarrhoea, mild rashes, joints pain, myalgia, constipation, troubled sleeping and vomiting.

Precautions

Arsenic trioxide is contraindicated in patients with renal disease, liver disease, electrolyte imbalance, heart rhythm disorders including QT prolongation.

Special Precautions

Renal impairment; APL differential syndrome; cardiac diseases; co-administration of other medications that can prolong the QT interval or lead to electrolyte abnormalities. Monitor 12-lead ECA; serum electrolytes and creatinine to be monitored before initiating therapy; ECG once weekly; electrolytes, blood count, and coagulation twice wkly during induction and at least once wkly during consolidation.

Other Drug Interactions

Arsenic trioxide may interact narcotics, ondansetron, clarithromycin, diuretics, anti-depressants, anti-malarial drugs, anti-arrhythmic drugs, sumatriptan, chlorpromazine and droperidol.

Dosage

Acute Promyelocytic Leukemia (Adults):
The induction treatment schedule should start with 0.15 mg/kg, IV (over 1-2 hours), daily dose until the development of bone marrow remission. The maximum total induction dose should not exceed 60 doses.
After 3-6 weeks (post-induction treatment), the consolidation treatment schedule should be started with 0.15 mg/kg, IV, daily doses, up to 25 doses. The treatment should be continued up to 5 weeks.

Food(before/after)

Information Not Available

List of Contraindications

Arsenic Trioxide and Pregnancy

USFDA pregnancy category D. Arsenic trioxide can harm the unborn fetus. Perform pregnancy tests before using Arsenic trioxide. Use effective contraceptive modes to prevent unintended pregnancies while taking Arsenic trioxide.

Arsenic Trioxide and Lactation

Nursing mothers should consult the healthcare provider before Arsenic trioxide treatment.

Arsenic Trioxide and Children

Information Not Available

Arsenic Trioxide and Geriatic

Information Not Available

Arsenic Trioxide and Other Contraindications

Pregnancy; lactation; hypersensitivity

Storage

Store at 20-25°C.

Lab interference

Store at 20-25°C.

Arsenic Trioxide brands in India:

Arsenox Arsikem Arsitri Riflux Tab

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