Epirubicin hydrochloride for injection
Nombre del Producto:Epirubicin hydrochloride inyectable
Specification: 5ml 10mg 10ml 20mg 25ml 50mg
Standard: USP Currently
Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include sodium chloride, USP, and water for injection, USP. The pH of the solution has been adjusted to 3.0 with hydrochloric acid, NF. Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (8S-cis)-10[(3-amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12naphthacenedione hydrochloride. The active ingredient is a red-orange hygroscopic powder, with the empirical formula C27H29NO11HCl and a molecular weight of 579.95. The structural formula is as follows:
SIDE EFFECTS: See also Warning section.
Nausea, vomiting, diarrhea, abdominal pain, flushing, or skin/nail color changes may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause your urine to turn a reddish color. This is a normal, harmless effect of the drug that usually stops within 2 days after each dose and should not be mistaken for blood in your urine.
Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).
Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
Severe nausea, vomiting, and diarrhea may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.
Get medical help right away if you have any very serious side effects, including: chest pain, coughing up blood, sudden pain/swelling/redness usually in the leg.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist
Special warnings and precautions for use
Before using epirubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or to anthracenediones (e.g., mitoxantrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, recent heart attack, fast/slow/irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Before having surgery, tell your doctor or dentist that you are using this medication.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.
Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially effects on the heart.
This medication may affect the production of sperm in males, increasing the risk of fathering a child with birth defects. Therefore, men receiving treatment with this drug should use reliable forms of birth control (e.g., condoms). Consult your doctor for details and to discuss effective forms of birth control.
This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age and men using this medication should use reliable forms of birth control (such as birth control pills, condoms) to prevent pregnancy. Consult your doctor for details and to discuss effective forms of birth control.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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