• Email:sales@AmericanPharmaWholesale.com
  • Site Map




Please email us at Sales@AmericanPharmaWholesale.com with our item No, NDC#, UPC# or best is product link. We are located in Oceanside, California. Search over 100,000 items by Name, Item No., NDC, UPC (without dashes) or by Mfg.Name.


Menu

Rx Item-IMVEXXY estradiol VAGINAL INSERT 4 MCG KIT 8

RX762146Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-IMVEXXY estradiol VAGINAL INSERT 4 MCG KIT 8

$216.00$194.99

NDC No.50261-104-08 50261-0104-08 5026110408 50261010408 UPC/GTIN No.3-50261-10408-6 350261104086 350261-104086 MPN No.110408 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

Have a question?

For: Dyspareunia

Imvexxy (estradiol) is a bio-identical 17?-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause. hese highlights do not include all the information needed to use IMVEXXY safely and effectively. See full prescribing information for IMVEXXY. IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol. Each insert is imprinted in white ink on one side with 04 or 10 corresponding to the insert's dosage strengths.

IMVEXXY (estradiol vaginal inserts), 4 mcg and 10 mcg, are provided in opaque push-through blisters and are packaged in cartons containing either 18 inserts for the starter pack or 8 inserts for the maintenance pack.
IMVEXXY 4 mcg 8 inserts NDC 50261-104-08
IMVEXXY 4 mcg 18 inserts NDC 50261-104-18
IMVEXXY 10 mcg 8 inserts NDC 50261-110-08
IMVEXXY 10 mcg 18 inserts NDC 50261-110-18

Keep out of reach of children. Packages are not child-resistant.

16.2 Storage and Handling

Store at 20C to 25C (68F to 77F), excursions permitted to 15C to 30C (59F to 86F). [See USP Controlled Room Temperature.]


IMVEXXY (estradiol vaginal inserts)
Initial U.S. Approval: 1975
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.3)
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.2)
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

Estrogen Plus Progestin Therapy

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI) (5.2)
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.3)
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.4)

INDICATIONS AND USAGE

IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1)
DOSAGE AND ADMINISTRATION

IMVEXXY should be administered intravaginally:

1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Monday and Thursday). (2.1)
DOSAGE FORMS AND STRENGTHS

IMVEXXY vaginal inserts contain 4 mcg or 10 mcg estradiol. (3)
CONTRAINDICATIONS

Undiagnosed abnormal genital bleeding (4)
Known, suspected, or history of breast cancer (4, 5.3)
Known or suspected estrogen-dependent neoplasia (4, 5.3)
Active DVT, PE, or history of these conditions (4, 5.2)
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.2)
Known anaphylactic reaction or angioedema with IMVEXXY (4)
Known liver impairment or disease (4, 5.11)
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4)

WARNINGS AND PRECAUTIONS

Estrogens increase the risk of gallbladder disease (5.5)
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs (5.6, 5.7, 5.10, 5.11)
Monitor thyroid function in women on thyroid replacement hormone therapy (5.12, 5.19)

ADVERSE REACTIONS

In a single, prospective, randomized, placebo-controlled, double-blind trial, the most common adverse reaction with IMVEXXY (incidence ?3 percent and greater than placebo) was headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact TherapeuticsMD, Inc. at 1-888-228-0150 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration (7.1)
USE IN SPECIFIC POPULATIONS

Geriatric use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (5.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2019

RX762146
Rx Item-IMVEXXY estradiol VAGINAL INSERT
RX762146

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-IMVEXXY estradiol VAGINAL INSERT
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop