Drug Uses
Diflucan is indicated for the treatment of:
-Vaginal candidiasis (vaginal yeast infections due to Candida).
-Oropharyngeal and esophageal candidiasis.
-Cryptococcal meningitis.
Diflucan is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
How Taken
Diflucan comes as a tablet and liquid to take by mouth. It is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Diflucan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Shake the liquid well before each use to mix the medication evenly. Continue to take Diflucan even if you feel well. Do not stop taking Diflucan without talking to your doctor.
Warnings/Precautions
Do not take Diflucan if you are taking cisapride (Propulsid). Combined with cisapride (Propulsid), Diflucan could cause serious, even fatal, heart problems.
Before taking Diflucan, tell your doctor if you have any other medical conditions, especially kidney disease, or if you take other medicines. You may not be able to take Diflucan, or you may require a dosage adjustment or special monitoring during your treatment.
Diflucan is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take Diflucan without first talking to your doctor if you are pregnant or could become pregnant during treatment.
Diflucan passes into breast milk and may be harmful to a nursing baby. For this reason, Diflucan should not be taken by nursing mothers. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
Missed Dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Possible Side Effects
If you experience any of the following serious side effects, stop taking Diflucan and seek emergency medical attention or contact your doctor immediately: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); liver damage (pale stools, yellowing of the skin or eyes, abdominal pain, unusual fatigue, or dark urine); or
a rash.
Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue taking Diflucan and talk to your doctor: nausea, vomiting, or abdominal pain; diarrhea; headache; dizziness; fatigue; or itching.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Storage
Store tablets below 86°F (30°C). Protect from freezing. Diflucan injections in Viaflex Plus plastic containers are available in both sodium chloride and dextrose diluents. Store between 77°F (25°C) and 41°F (5°C). Brief exposure up to 104°F (40°C) does not adversely affect the product. Protect from freezing.
Overdose
Seek emergency medical attention if an overdose is suspected. Symptoms of a Diflucan overdose include confusion, hallucinations, paranoia, decreased movement, decreased breathing, tearing eyes, drooling, urinary incontinence, seizures, and death.
More Information
Avoid alcohol or use it in moderation while taking Diflucan. Alcohol and Diflucan can both affect the liver.
Use caution when driving or performing other hazardous activities. Diflucan may cause dizziness. If you experience dizziness, avoid these activities.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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July 24, 2007 -- An expert panel gave its OK for expanded use of the osteoporosis drug Evista Tuesday, telling the FDA that the drug appears effective in preventing some breast cancer.
If the agency follows the panel's advice, it would clear the way for the drug, also called raloxifene, to be legally sold as a cancer prevention agent to millions of women.
It would also position the drug as an alternative to the anti-estrogen drug tamoxifen, which has long been used to help fight breast cancer's return. In 1998, the FDA approved tamoxifen for use by women who hadn't had breast cancer but were at high risk of developing the disease.
Breast cancer is the second leading cause of cancer death among women, and about 40,500 American women will die from breast cancer in 2007, according to the American Cancer Society. About 13% of women are estimated to develop breast cancer in their lifetime, according to the National Cancer Institute.
"Postmenopausal women at high risk for invasive breast cancer, I think now should have a choice," says George Sledge, MD, a professor of medicine at Indiana University. Sledge is also a consultant for Eli Lilly & Co, the maker of Evista.
Experts voted 10-4, with one abstaining, to recommend that Lilly be allowed to market Evista's ability to cut the likelihood of breast cancer in postmenopausal women at high risk for tumors. A company study showed that raloxifene and tamoxifen are equally effective at reducing the risk of cancer in those women.
"I do believe raloxifene is effective in reducing breast cancer," says panelist Otis Brawley, MD, a professor of oncology at Emory University School of Medicine.
Close Decision
The panel voted 8 to 6, with one abstention, on whether Lilly should be allowed to promote Evista's possible cancer-fighting abilities to all postmenopausal women with osteoporosis.
Three studies filed by the company all showed that women who took Evista for up to five years developed fewer invasive breast cancers than women who took a placebo. But women who took the drug also had a higher risk of serious blood clots and fatal stroke.
An FDA analysis of the three studies was inconclusive as to whether Evista's potential benefits outweighed its risks. Agency officials said they were troubled because Lilly had not submitted any data showing whether women who take Evista actually live longer than those who don't.
"It is uncertain if the balance of benefits and risk factors for women at high risk is favorable because the magnitude of benefits is unknown," says Patricia Cortazar, MD, an FDA safety official.
Potential Risks
Several breast cancer advocacy groups opposed the approval. Carolina Hinestrosa, executive vice president of the Breast Cancer Coalition, says the government should boost efforts to find causes of breast cancer rather than approving drugs with relatively small benefits.
"Considering that most women will not develop breast cancer in their lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly to keep it out of the hands of women at risk for cardiovascular disease. One panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt D. Furburg, MD, a Wake Forest University professor of public health who voted to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally promoting Evista as a cancer-fighting drug. Critics said approving the new use for the drug would clear the way for the company to promote the drug with direct-to-consumer advertising.
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the company will "continue working with the FDA to make this important option a reality for patients."
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