Vincristine Sulfate Injection

DRUG DESCRIPTION

Vincristine Sulfate Injection, USP (vincristine sulfate) is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn). Originally known as leurocristine, it has also been referred to as LCR and VCR. The molecular formula for Vincristine Sulfate, USP is C46H56N4O10H2SO4. It has a molecular weight of 923.04.

The structural formula is as follows:

Vincristine  Sulfate Structural Formula Illustration

Vincristine Sulfate, USP is a white to off-white powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, Vincristine Sulfate, USP has an ultraviolet spectrum with maxima at 221 nm (???+47,100).

Vincristine Sulfate Injection, USP (vincristine sulfate) is a sterile, preservative-free, single use only solution available for intravenous use in 2 mL (1 mg and 2 mg) vials. Each mL contains 1 mg Vincristine Sulfate, USP, 100 mg mannitol and Water for Injection, USP q.s. Sulfuric acid or sodium hydroxide have been added for pH control. The pH of Vincristine Sulfate Injection, USP (vincristine sulfate) ranges from 4.0 to 5.0. At the time of manufacture, the air in the containers is replaced by nitrogen.

What are the precautions when taking vincristine sulfate (Vincristine Sulfate Injection)?

Before using vincristine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current...

Read All Potential Precautions of Vincristine Sulfate Injection


Vincristine Sulfate Injection Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, weight loss, diarrhea, bloating, stomach/abdominal pain or cramps, mouth sores, dizziness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Vincristine may also affect the nerves in the intestines, causing gut movement to slow down. This effect can result in constipation, which in some cases may become serious. Consult your doctor or pharmacist about how you can prevent constipation (e.g., maintain a diet adequate in fiber, drink plenty of water, exercise, choose the right type of laxative with a stool softener, avoid bulk-forming laxatives). Tell your doctor or pharmacist promptly if you develop constipation.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication commonly affects the nerves and muscles in your body. Most of these side effects go away after this medication is stopped, however some effects may persist for a long time. Tell your doctor immediately if any of these serious side effects occur: painful/difficult urination, change in the amount of urine, pain (e.g., in the joints, back, muscles, jaw), numbness/tingling/pain of the arms/legs, weakness, difficulty walking, loss of coordination/balance, inability to move your muscles (e.g., muscles of the face, other parts of your body), drooping eyelids, hoarseness, trouble speaking, mental/mood changes (e.g., depression, hallucinations, confusion).

Tell your doctor right away if you have any other serious side effects, including: vision/hearing changes, seizures, unusual bleeding/bruising.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Trouble breathing may infrequently occur with vincristine treatment, especially when it is given with another chemotherapy drug, mitomycin-C. Patients with lung problems may be more sensitive to this side effect. Long-term treatment of this side effect may be required if it worsens. This effect may occur within minutes to several hours after vincristine is given and up to 2 weeks after the dose of mitomycin-C. Get medical help right away if you have shortness of breath or coughing. If you have this reaction, you should not receive vincristine again.

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), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using vincristine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of nerve/muscle disease (demyelinating form of Charcot-Marie-Tooth syndrome), radiation treatment to the liver.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other nerve/muscle problems (neuromuscular disease, neuropathy), liver disease, decreased bone marrow function, blood disorders, current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

Children may be more sensitive to the effects of this drug, especially slowed movement of the gut that may cause vomiting and constipation.

Elderly patients who also take drugs that may cause difficult urination as a side effect may be more sensitive to the effects of this drug on the kidneys (urinary retention). Consult your doctor for more details. See also Drug Interactions.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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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