VAGIFEM

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Generic Name for VAGIFEM

Estradiol (as hemihydrate) 10micrograms; vaginal tabs.

Legal Classification:

Rx

Pharmacological Class for VAGIFEM

Estrogen.

Manufacturer of VAGIFEM

Novo Nordisk

Indications for VAGIFEM

Atrophic vaginitis.

Adult dose for VAGIFEM

1 tab intravaginally once daily for 2 weeks, then 1 tab twice weekly. Reevaluate periodically.

Children's dosing for VAGIFEM

Not recommended.

Contraindications for VAGIFEM

Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI, DVT, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat.X).

Warnings/Precautions for VAGIFEM

See literature. Endometrial hyperplasia. Gallbladder disease. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Severely atrophic vaginal mucosa or other trauma risk. Familial hyperlipoproteinemia. Discontinue if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs, and 2 weeks before surgery associated with thromboembolism. Monitor thyroid function. Nursing mothers.

Interactions for VAGIFEM

May be antagonized by CYP3A4 inducers (eg, St. John's Wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice).

Adverse Reactions for VAGIFEM

See literature. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; increased risk of gallbladder disease, thromboembolic disorders.

How is VAGIFEM supplied?

Vaginal tabs—8, 18 (w. applicators)

Related Disease:

Menopausal disorders

Recent Updates

25microgram dosage discontinued.

Related Resources

FDA warns of unintentional exposure to estrogen with Evamist

July 29, 2010

The FDA has notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist (estradiol transdermal spray, from Ther-Rx) in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

Vagifem 25mcg to be discontinued

May 20, 2010

Novo Nordisk announced that Vagifem (estradiol hemihydrate vaginal tablets) 10mcg will become the only available formulation of Vagifem for the treatment of atrophic vaginitis.

FDA launches "Bad Ad Program" to detect misleading drug ads

May 11, 2010

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has launched the Bad Ad Program, designed to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.

Fast-Results! available soon for genital herpes symptom relief

March 23, 2010

Fast-Results! (benzalkonium chloride and allantoin topical spray, from Merix Pharmaceutical) will be made available soon over-the-counter for the treatment of genital herpes symptoms.

CitraNatal B-Calm prenatal vitamin available

March 01, 2010

Mission Pharmacal has expanded its CitraNatal product line with the addition of CitraNatal B-Calm prenatal vitamins.

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