Oncology

Oncology

Zitomycin Lyophilised

Zitomycin Lyophilised

Admin / March 01, 2018 / Photography, Video

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Composition

Each vial contains

Mitomycin IP 2mg/ 10 mg/40 mg

Mannitol IP q.s

Description

Mitomycin injection is a sterile bluish violet lyophilised mass. It contains mannitol, sodium hydroxide, water for injection as excipients. Mitomycin is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The molecular formula Is C15-H18-1,14-05 and its molecular weight Is 33433. Its structural formula is

Zitomycin

Mechanism of Action / Pharmacodynamics

Mitomycin injection IP selectively inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of Mitomycin Injection IP - Induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

Pharmacokinetics

In humans, Mitomycin Injection IP Is rapidly cleared from the serum after Intravenous administration. Time required to reduce the serum concentration by 50% after a 30 mg bolus injection is 17 minutes. After injection of 30 mg, 20 mg, or 10 mg I.V., the maximum serum concentrations 2.4 µg/ml, 1.7 µg/ml, and 0.52 µg / ml, respectively. Clearance is effected primarily by metabolism in the liver, but metabolism occurs in other tissues as well. The rate of clearance Is inversely proportional to the maximum serum concentration because, it is thought, of satisfaction of the degradative pathways.

Approximately 10% of a dose of Mitomycin injection IP is excreted unchanged in the urine. Since metabolic pathways are saturated at relatively low doses , the percent of dose excreted in Urine Increases with Increasing dose. In children, excretion of intravenously administered Mitomycin Injection IP is similar.

Indications

INDICATIONS

Mitomycin is not recommended as a single-agent, primary therapy.

It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/ or radiotherapy

Dosage & Administration

Mitomycin should be given intravenously only, using care to avoid extravasation of the compound. If extravasation of the compound. If extravasation occurs, cellulitis, ulceration and slough may result.

After full hematological recovery (see guide to dosage adjustment) from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals: 20mg/m2 intravenously as a single dose via a functioning intravenous catheter.

Because of cumulative myelosuppression, patients should be fully reevaluated after each course of Mitomycin Injection, IP and the dose reduced if the patient has experienced any toxicities. Doses greater than 20mg/m2 nave not been shown to be more effective, and are more toxic than lower doses.

Guide in dosage adjustment:

Nadir after prior dose Leucocyte/mm3

Platelets/mm3

Percentage of prior dose to be given

<4000

<100,000

100%

3000-3999

75,000-99999

100%

2000-2999

75,000-99999

70%

<2000

<25000

50%

No repeat dosage should be given until leucocyte count has returned to 4000/mm3 and a platelet count to 100,000/mm3. When Mitomycin Injection IP is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of Mitomycin Injection IP, the drug should be stopped since chances of response are minimal.

Reconstitution: Each vial contains Mitomycin 2mg , 10 mg, 40mg . To administer add Sterile Water for injection,4ml, 20ml, and 80ml respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained.

Warnings

Patients being treated with Mitomycin Injection IP must be observed carefully and frequently during and after therapy.

The use of mitomycin injection IP results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia. Therefore the following studies should be obtained repeatedly during therapy, platelet count, white blood cell count, differential, and haemoglobin. The occurrence of a platelet count below 100,0000/mm3 or a WBC below 4,000/mm3 or a progressive decline in either is an indication to withhold further therapy until blood count have recovered above these levels.

Patients should be advised of the potential toxicity of this drug, particularly bone marrow suppression. Deaths have been reported due to septicemia as a resullt of leukopenia due to the drug.

Patients receiving Mitomycin Injection IP should be observed for evidence of renal toxicity Mitomycin injection IP should not be given to patients with a serum creatinine greater than 1.7mg percents.

Usage In Pregnancy

Pregnancy Category D. Safe use of Mitomycin Injection IP in pregnant woman has not been established. Teratological changes have been noted in animal studies. The effect of Mitomycin lnjection IP on fertility is unknown.

Nursing Mothers

It is not known if mitomycin is excreted in human milk. Because many drugs excreted in human milk and because of the potential for serious adverse reactions in nursing infants from mitomycin, it Is recommended that nursing be discontinued when receiving mitomycin therapy.

Precautions

Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids in patients who had previously or simultaneously received Mitomycin Injection IP. The onset of this acute respiratory distress occured within minutes to hours after the vinca alkaloid injection. The total number of doses for each drug has varied considerably. Bronchodilators, steroids and/or oxygen have produced symptomatic relief.

A few cases of adult respiratory distress syndrome have been reported in patients receiving Mitomycin injection IP in combination with other chemotherapy and maintained at FIO2 concentrations greater than 50% perioperatively. Therefore, caution should be exercised using only enough oxygen to provide adequate arterial saturation since oxygen itself is toxic to lungs. Careful attention should be paid to fluid balance and overhydration should be avoided. Bladder fibrosis / contraction has been reported with intravesical administration not an approved route of administration), which in rare cases has required cystectomy.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions (Side Effects)

Bone Marrow Toxicity

This was the most common and most serious toxicity. Thrombocytopenia and / or leukopenia may occur anytime within 8 weeks after onset of therapy with an average time of 4 weeks. Recovery after cessation of therapy was within 10 weeks. Mitomycin lnjection IP produces cumulative myelosuppression.

Integument and Mucous Mambrane Toxicity

This had occured in approximately 4% of patients treated with Mitomycin Injection IP. Cellulitis at the injection site has been reported and is occasionally severe. Stomatitis and alopecia also occur frequently. Rashes are rarely reported. The most important dermatological problem with this drug, however is the necrosis and consequent sloughing of tissue which result If the drug is extravasated durig injection. Extravasation may occur with or without an accompanying stinging or burning sensation and even if there is adequate blood return when the injection needle is aspirated.

Renal Toxicity

Rise in creatinine.

Pulmonary Toxicity

This has occurred infrequently but can be severe and may be life threatening. Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative or Mitomycin Injection IP -induced pulmonary toxicity. If other etiologies are eliminated, Mitomycin Injection IP therapy should be discontinued. Steroids have been employed as treatment of this toxicity, but the therapeutic value has not been determined.

Hemolytic Uremic Syndrome (HUS)

This serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia(haematocrit < 25%), thrombocytopenia ( < 100,000/mm3) , and irreversible renal failure ( serum creatinine > 1.6 mg/dL) has been reported in patients receiving systematic Mitomycin Injection IP. Microangiopathic hemolysis with fragmented red blood cells on peripheral blood smears has occurred.

Other less frequent complications on the syndrome may include pulmonary edema, neurologic abnormalities and hypertension. Exacerbation of the symptoms associated with HUS has been reported in some patients receiving blood product transfusions. A high mortality rate has been associated with this syndrome.

The syndrome may occur at any time during systematic therapy with Mitomycin injection IP as a single agent or in combination with other cytotoxic drugs. Less frequently, HUS haS also been reported in patients receiving combinations of cytotoxic drugs not including mitomycin Injection IP. Patients develops the syndrome at total doses exceeding 60mg of Mitomycin injection IP Consequently, patients receiving >60 mg of Mitomycin injection IP should be monitored closely for unexplained anemia with fragmented cells on peripheral blood smear, thrombocytopenia, and decreased renal function.

The incidence of the syndrome has net been defined. Therapy for the syndrome is Investigational.

Cardiac Toxicity

Congestive heart failure, often treated effectively with diuretics and cardiac glycosides, has rarely been reported. Acute side effects due to Mitomycin Injection IP were fever, anorexia, nausea, and vomiting.

Other

Headache, blurring of vision, confusion, drowsiness, syncope, fatigue, edema, thrombophlebitis, hematemesis, diarrhea, and pain. These did not appear to be dose related and were not unequivocally drug related. They may have been due to the primary or metastatic disease processes.

Overdose & Contradiction

CONTRAINDICATIONS

Mitomycin injection IP is contraindicated In patients who have demonstrated a hypersensitive Of idiosyncratic reaction to it in the past.

Mitomycin Injection IP is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

Storage

Stability

1) Unreconstituted Mitomycin Injection IP stored at room temperature is stable for the lot life indicated on the package. Avoid excessive heat (over 40°C,104°F) .

2) Reconstituted with Sterile Water for injection to a concentration of 0.5 mg per ml MItomycin Injection IP is stable for 14 days refrigerated or 7 days at room temperature.

3) Diluted In various I.V. fluids at room temperature, to a concentration of 20 to 40 micrograms per ml:

I.V Fluid

Stability

5% Dextrose Injection

3 hours

0.9% Sodium Chloride Injection

12 hours

Sodium Lactate Injection

24 hours

4) The combination of Mitomycin injection IP (5Mg to 15mg) and heparin (1,000 units to 10,000 units) in 30mL of 0.9% Sodium Chloride Injection Is stable for 48 hours at morn temperature.

Store between 15°C to 30°C. Protect from light.

Presentation

ZITOMYCIN (Mitomycin Injection IP) is available in a vial containing Mitomycin IP 2mg / 10 mg/40mg.

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