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Rx Item-Viorele 21 5 Tab 3X28 By Glenmark Generics

NDC 68462-0318-29 UPC/GTIN No.3-68462-31829-4 Mfg.Part No.31829BRAND: VIORELE NDC: 68462-0318-29,68462031829 UPC: 3-68462-31829-4,368462318294 Glenmark Generics Inc.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 scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.AzuretteKariva

Rx Item-Viorele 21 5 Tab 3X28 By Glenmark Generics

$179.94$51.42

Item No.:RX195154/a, Item No. RX195154, 195154, NDC No.: 68462-0318-29, 68462-318-29, 6846231829, 68462031829, 0318-29, 031829 UPC No. 3-68462-31829-4, 368462-318294, 368462318294, Rx Item-Viorele 21 5 Tab 3X28 By Glenmark Generics Only Physician, Pharmacy Or Licensed Facility Can purchase this RX Item Brand/Generic: , Drug Category: Contraceptives-HormonalDrug Class: 68120000 Contraceptives

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VIORELE, KARIVA,AZURETTE- desogestrel and ethinyl estradiol and ethinyl estradiol
Glenmark Generics Inc., USA
Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION



VIORELE (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include vitamin E, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2 inert green, round tablets with the following inactive ingredients: lactose, starch, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow, FD&C blue No. 2 indigo carmine aluminum lake. VIORELE also contains 5 yellow, round tablets containing 0.01 mg ethinyl estradiol USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which include vitamin E, lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow. The molecular weights for desogestrel and ethinyl estradiol USP are 310.48 and 296.40 respectively
CLINICAL PHARMACOLOGY

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Receptor binding studies, as well as studies in animals, have shown that etonogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity (91, 92). The relevance of this latter finding in humans is unknown.
INDICATIONS AND USAGE

VIORELE (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
he use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the authors" permission). For further information, the reader is referred to a text on epidemiologic methods.
DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, VIORELE (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. VIORELE may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each cycle pack blister card is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different "day label strips" are provided with each cycle pack blister card in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of VIORELE should be considered.

The use of VIORELE for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers").

If the patient starts on VIORELE postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days.
Storage

Store at 20� to 25�C (68� to 77�F). [See USP Controlled Room Temperature].

NDC 68462-0318-29 UPC/GTIN No.3-68462-31829-4 Mfg.Part No.31829
RX ITEM-Viorele 21 5 Tab 3X28 By Glenmar
NDC 68462-0318-29 UPC/GTIN No.3-68462-31829-4 Mfg.Part No.31829

BRAND: VIORELE NDC: 68462-0318-29,68462031829 UPC: 3-68462-31829-4,368462318294 Glenmark Generics Inc.
Viorele 21 5 Tab 3X28 By Glenmark Generi
BRAND: VIORELE NDC: 68462-0318-29,68462031829 UPC: 3-68462-31829-4,368462318294 Glenmark Generics Inc.

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
DESOG-E.ESTRADIOL/E.ESTRA
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

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