 Home / Antibiotics / Mitomycin-C, mitomycin |
 |
||||||||||||||
 Buy Mitomycin-C, mitomycinBuy Mitomycin-C to treat upper gastrointestinal cancer, breast cancer, and superficial bladder tumors. It is an aziridine-containing DNA crosslinker that is taken intravenously.Contraindications: Consult a doctor before taking Mitomycin-C if you have an allergy to mitomycin, if you are taking any other medications, if you are receiving tumor reduction or prevention treatment, if you suffer from impaired liver or kidney function, if you are pregnant or breastfeeding a baby, or if you are on a low-sodium diet. Avoid prolonged use, as Mitomycin-C causes delayed bone marrow toxicity. To read more about Mitomycin-C side effects, Mitomycin-C dosage, and for more useful information about Mitomycin-C (mitomycin), please click the product information link below.  PRODUCT INFORMATION |
||||||||||||||
|
||||||||||||||
Other name(s): Mutamycin, Ametycine, Mitem |
||||||||||||||
Often prescribed for cancer, gastrointestinal cancer, breast cancer, bladder cancer |
||||||||||||||
READ MORE ABOUT ANTIBIOTICS
Mitomycin-C, mitomycinOther names: Mutamycin
1. What Mitomycin-C 10 mg Is And What It Is Used For
Mitomycin belongs to a group of medications called other cytotoxic antibiotics, specifically the mitomycin subgroup.
Mitomycin is indicated in the treatment of alterations caused by the growth of some cells in certain parts of the body.
2. Before You Use Mitomycin-C (Mutamycin)
Do not use Mitomycin-C 10 mg:
If you are allergic (hypersensitive) to mitomycin or any of the other ingredients of Mitomycin-C.
The use of Mitomycin is contraindicated in patients with a low platelet count (thrombocytopenia), coagulation disorder and an increase in bleeding tendency due to other causes and in patients with impaired renal function.
Take special care with Mitomycin (Mutamycin):
Mitomycin-C should be administered under the supervision of an experienced physician.
The frequency of administration will depend on your age.
Local ulceration and cellulitis may be caused by tissue extravasation during intravenous injection and utmost care should be taken in administration so as to avoid this. Mitomycin-C should not be allowed to come into contact with your eyes or skin. If it does, appropriate treatment should be instituted immediately. The person that administers mitomycin should avoid the powder or solution coming into contact with the skin. Hand creams or other similar products should not be used as they may assist the penetration of the drug into the skin.
Using other medicines:
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Mitomycin should be administered with care in patients receiving another treatment for tumor prevention or reduction.
There have been reports of cardiac toxicity in some patients who received prior doxorubicin therapy.
With vinca alkaloids (Vinblastine) adverse reactions of contraction of the smooth muscle of the bronchi (bronchospasm) have been reported. There have also been reports of a greater risk of rapid decrease in platelet count, destruction of red blood cells and renal failure (Hemolytic Uremic Syndrome) in patients concomitanly taking Fluorouracil or Tamoxifen.
Patients with renal insufficiency:
Renal function should be evaluated before starting treatment with Mitomycin-C 10 mg. as it is contraindicated (see 4.3) in patients with renal insufficiency.
Patients with hepatic insufficiency:
Mitomycin-C 10 mg is not recommended in patients with hepatic insufficiency due to the lack of experience and information regarding the safety and efficacy of this medication in this group of patients.
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before you take any medication.
Pregnancy
Mitomycin-C 10 mg should not be administered to patients who are pregnant. Animal studies have shown a possible risk of abnormalities in the developing fetus.
The effect of mitomycin (Mutamycin) on fertility is unknown. Women in fertile age on treatment with mitomycin should use an adequate contraceptive.
Lactation
It is not known if mitomcyin is excreted in human milk. It is recommended that women receiving mitomycin not breast feed because of the potential for serious adverse reactions from mitomycin in nursing infants.
Driving and using machines:
The influence of Mitomycin-C 10 mg on the ability to drive or operate dangerous machinery is moderate.
Generalised weakness and somnolence have been reported on rare occasions. If you feel weak or suffer somnolence you should not drive or use dangerous machinery or tools.
Important information about some of the ingredients of Mitomycin
This medication contains 9.5 mg sodium per milligram of mitomcyin; this should be taken into consideration by patients on a low-sodium diet.
3. How To Use Mitomycin (Mutamycin)
Follow these instructions unless your doctor has given you other indications.
Remember to take your medication.
Mitomycin-C 10 mg should be given intravenously.
This medication should be administered by a health care provider. The precise dosage, frequency of administration and duration of treatment with Mitomycin-C varies depending on your weight and medical condition.
Your doctor will indicate the duration of your treatment with Mitomycin-C 10 mg.
If you have been administered more Mitomycin-C 10 mg. than you require:
If you have been administered more Mitomycin-C 10 mg. than you require, consult your doctor immediately.
In the event of overdose an increase in the more common side effects should be expected, such as fever, nausea, vomiting and myelosuppression.
In the case of overdose or accidental ingestion, consult your local poison control centre
4. Possible Side Effects
Like all medicines, Mitomycin-C 10 mg can cause side effects however not all patients experience them.
If you have the impression that the effect of Mitomycin is too strong or too weak, talk to your doctor or pharmacist.
The frequency of the side effects has been classified as follows: Very common (at least 1 in 10 patients); common (at least 1 in 100 patients); uncommon (at least 1 in 1.000 patients); rare (at least 1 in 10.000 patients); very rare (less than 1 in 10.000 patients). The side effects of mitomycin are usually frequent and moderately important. The side effects are more frequent with total doses of more than 50 mg. / m2. The most characteristic are:
Immune system disorders:
Common: fever and itching (pruritus).
Skin and subcutaneous tissue disorders:
Common: Hair loss, itching (pruritus), tissue death (necrosis) and pain at the injection site.
Vascular disorders:
Common: An inflammation of the vein with blood clots (thrombophlebitis).
Gastrointestinal disorders:
Very common: nausea (10 - 25%) and vomiting (14%).
Common: anorexia, mouth ulcers.
Nausea and vomiting are sometimes experienced immediately after treatment, but these are usually mild and of short duration.
Renal and urinary disorders:
Common: increase in serum creatinine and/or increase of value of blood ureic nitrogen.
Severe renal toxicity has occasionally been reported after treatment and renal function should be monitored before starting treatment and again after each course.
Nervous system disorders:
Common: sensation of tingling or numbness (paraesthesia).
Respiratory, thoracic and mediastinal disorders:
Uncommon or rare (<1%): the expectoration (coughing up) of blood (hemoptysis), difficulty in breathing (dyspnea), cough and pneumonia.
There have been reports of pulmonary toxicity (dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates) and fever.
Blood and lymphatic system disorders:
Very common: low blood cell count (aplastic anemia) (64%) 2 Ð 4 weeks from the start: a low platelet count (thrombocytopenia) (40%) and a decrease in the number of leukocytes (leucopenia) (<4.000 / mm3) (50%).
Uncommon or rare (<1%): anemia.
Since the most common toxicity of mitomycin is bone marrow suppression, and as a result of this, a low platelet count (thrombocytopenia) and a low number of leukocytes (leukopenia), the patients should be carefully monitored during each course of treatment and particular attention should be paid to peripheral blood count including platelet count. No repeat dosage should be given unless leukocyte count is above 3,0 x 109 / litre or more and the platelet count is 90,0 x 109 / litre or more.
The nadir is usually around four weeks after treatment and toxicity is usually cumulative, with increasing risk after each course of treatment. If disease progression continues after two courses of treatment, the drug should be stopped since the chances of response are minimal.
General disorders and administration site conditions:
Local ulceration and cellulitis may be caused by tissue extravasation during intravenous injection and utmost care should be taken in administration.
Bleeding, rashes and mouth ulcers have been reported. On rare occasions, there have been reports of general weakness and deep and continuous sleep.
There have also been reports of Hemolytic Uremic Syndrome: consisting of the decrease of red blood cells caused by the premature destruction of these due to coagualtion alteration (microangiopathic hemolytic anemia) (hematocrit or the percentage volume of red blood cells to whole <25%), a low platelet count (thrombocytopenia) (<100.000/mm3), irreversible renal failure, fluid accumulation in the lungs (pulmonary edema) and hypertension, with high mortality rate (52%).
Other reactions reported are: an inflammation of the mucous lining of any of the structures in the mouth (stomatitis), inflammation of the lungs (interstitial pneumonia), scarring throughout the lungs (pulmonary fibrosis), headache, blurred vision, confusion, somnolence, sudden loss of consciousness and sensibility (syncope), fatigue, the vomiting of blood (hematemesis) and diarrhea.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How To Store Mitomycin-C 10 mg
Keep this medication out of the reach and sight of children.
This product does not require any special storage conditions.
Store in the original package.
Do not use this medication after the expiry date indicated on the pack after Cad. The expiry date is the last day of the month indicated.
Should it be necessary to store the reconstituted solution of Mitomycin-C 10 mg, it should be protected from light and stored in a cool place. Do not refrigerate. After reconstitution, the solution should be disposed of after 12 hours if it has not been used.
From a microbiological point of view, the product should be used immediately after reconstituted.
Do not use Mitomycin if you notice any change in the way the product looks.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the boxes and medicines no longer required. These measures will help to protect the environment.
6. Further Information
Contents of Mitomycin-C 10 mg
- The active ingredient is mitomycin.
- The other ingredients are: Sodium chloride.
What the product looks like and contents of the pack
Mitomycin (Mutamycin) is a powder solution for injection that comes in a box containing 1 vial. Before reconstitution it is a blue-purple crystalline powder.
Information for the health care professional
The contents of the vial should be reconstituted with Water for Injection or solution of dextrose 20%, at least 10 ml for each 10 mg. vial.
Aseptic technique must be used during reconstitution and it is recommended that the solution be used immediately. Should it be necessary to store the reconstituted solution of Mitomycin-C 10 mg, it should be protected from light and stored in a cool place. Do not refrigerate. After reconstitution, the solution should be disposed of after 12 hours if it has not been used.
When the reconstituted solution is added to solutions for infusion, particularly if they contain dextrose, the resulting solution should be used immediately.
Once the product has been reconstituted the solution is a blue-purple crystalline color.
Mitomycin should be administered by a physician experienced in cytotoxic cancer chemotherapy. The equipment and medicine that is necessary for monitoring must be available. The doctor should take the necessary precautions so as to avoid intravascular injection and must receive appropriate formation and be familiar with the diagnosis and treatment of side effects, systemic toxicity and other complications.
If tissue extravasation during intravenous injection occurs, it is recommended that the area is immediately infiltrated with sodium bicarbonate 8.4% solution, followed by an injection of 4 mg. dexamethasone. A systemic injection of 200 mg of Vitamin B6 may be of some value in promoting the regrowth of tissues that have been damaged.
The product should not be allowed to come into contact with the skin. The person that administers mitomycin injection should avoid the powder or solution from coming into contact with the skin. If it does, hands should be washed several times with 8.4% sodium bicarbonate solution, followed by soap and water. Hand creams or other emollients should not be used as they may assist the penetration of mitomycin into the epidermal tissue.
In the event of contact with the eye, it should be rinsed several times with sodium bicarbonate eye lotion. It should then be observed for several days for evidence of corneal damage. If necessary, appropriate treatment should be instituted.
Dosage
Parenteral use
Intravenous administration
Intravenously, the dose should be given as slowly as possible and with great care in order to avoid extravasation.
The usual dose is in the range of 5 to 10 mg/m2 given at 1 to 6 weekly intervals depending on the therapeutic regime used.
Dose reductions
Cumulative myelosuppression has been reported. Toxicity should be evaluated and control of hemogram should take place before each course of treatment and the dose reduced if the patient has experienced any moderate-severe toxic effects.
In the treatment of superficial bladder tumors
In the treatment of superficial bladder tumours the usual dose is 10 to 40 mg (0.15 - 0.6 mg/ kg) dissolved in 20 to 40 ml of Water for Injection, instilled into the bladder through a urethral catheter, once or three times a week for a total of 20 doses. The dose should be retained by the patient for a minimum of one hour. During this one-hour period the patient should be rotated every 15 minutes to ensure that the product comes into contact with all areas of the bladder urothelium. When the bladder is emptied in the voiding process, care must be taken to ensure that no contamination occurs locally in the groin or genitalia areas.
In the prevention of recurrent superficial bladder tumors, the usual dose is equivalent to the strength of 4 to 10 mg (0.06 to 0.15 mg/kg) instilled into the bladder through a urethral catheter once or three times a week. The dose should be adjusted in accordance with the age and condition of the patient.
Administration in children
Mitomycin-C (Mutamycin) is not recommended in children due to the lack of experience and information regarding the safety and efficacy of this medication in this group of patients.
In any case, and taking into consideration that the posology should be calculated depending on various factors, it is advised that you consult the information provided in the Technical Specifications before you use this medication.
All medications must be kept out of the reach and sight of children.
|
