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RX ITEM-Tri-Legest Fe 5 7 9 7 Tab 5X28 By Teva Pharma

NDC 00555-9032-70 UPC/GTIN No.3-05559-03270-1 Mfg.Part No.903270 NORETHINDRONE-E.ESTRADIOLBRAND: TRI-LEGEST FE NDC: 00555-9032-70,555903270 UPC: 3-05559-03270-1,305559032701 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.

RX ITEM-Tri-Legest Fe 5 7 9 7 Tab 5X28 By Teva Pharma

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Item No.: RX657116 NDC No.555903270 UPC No.:305559032701 NDC No.00555-9032-70 UPC/GTIN No.3-05559-03270-1 MPN 903270 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx657116 Tri-Legest Fe 5/7/9/7 Tab 5X28 by Teva Pharma Item No.3657116 NDC No.00555903270 UPC No.305559032701 Other Name Tri-Legest Fe

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TRI-LEGEST FE 28 DAY- norethindrone acetate and ethinyl estradiol
Barr Laboratories Inc.

Tri-Legest � 21

21 Tablets: (Each light pink tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol.)



Tri-Legest � Fe 28

28 Tablets: (Each light pink tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol; each brown tablet contains 75 mg ferrous fumarate.)

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

DESCRIPTION

Tri-Legest � (norethindrone acetate and ethinyl estradiol tablets, USP) is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen.

Tri-Legest � 21 provides for a 21-day dosage regimen of oral contraceptive tablets.

Tri-Legest � Fe 28 provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.

Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: calcium stearate, FD&C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: calcium stearate, D&C yellow no.10 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

Each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light blue tablet contains the following inactive ingredients: calcium stearate, FD&C blue no. 2 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

Each brown tablet contains crospovidone, ferrous fumarate, hydrogenated vegetable oil, and microcrystalline cellulose.
Each Tri-Legest � 21 tablet dispenser contains five light pink tablets, seven light yellow tablets, and nine light blue tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, followed by one light yellow tablet each day for seven days, and then one light blue tablet each day for nine days.

Each Tri-Legest � Fe 28 tablet dispenser contains five light pink tablets, seven light yellow tablets, nine light blue tablets, and seven brown tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light blue tablet each day for nine days, and then one brown tablet each day for seven days.

CLINICAL PHARMACOLOGY

Oral Contraception
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).

In vitro and animal studies have shown that norethindrone combines high progestational activity with low intrinsic androgenicity. In humans, norethindrone acetate in combination with ethinyl estradiol does not counteract estrogen-induced increases in sex hormone binding globulin (SHBG). Following multiple-dose administration of norethindrone acetate and ethinyl estradiol, serum SHBG concentrations increase two- to three-fold and free testosterone concentrations decrease by 47% to 64%, indicating minimal androgenic activity.

Acne
Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of norethindrone acetate and ethinyl estradiol increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.
INDICATIONS AND USAGE

Tri-Legest � (norethindrone acetate and ethinyl estradiol tablets, USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Tri-Legest � is indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest � should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay onit for at least 6 months.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 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 methods can result in lower failure rates.
DOSAGE AND ADMINISTRATION

The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.

Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different days of the week stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days.

Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.

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

Dosage and Administration for 21-Day Dosage Regimen
To achieve maximum contraceptive effectiveness, Tri-Legest � 21 (norethindrone acetate and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. Tri-Legest � 21 provides the patient with a convenient tablet schedule of "3 weeks on - 1 week off." Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day-1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets.

A. Sunday-Start Regimen: The patient begins taking tablets from the top row on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first tablet is taken on the same day. The last tablet in the dispenser will then be taken on a Saturday, followed by no tablets for a week (7 days). For all subsequent cycles, the patient then begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen of 21 days on-7 days off, the patient will start all subsequent cycles on a Sunday.

B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one tablet daily, beginning with the first tablet in the top row. The patient completes her 21-tablet regimen when she has taken the last tablet in the tablet dispenser. She will then take no tablets for a week (7 days). For all subsequent cycles, the patient begins a new 21-tablet regimen on the eighth day after taking her last tablet, again starting with the first tablet in the top row after placing the appropriate days of the week sticker over the preprinted days on the tablet dispenser. Following this regimen of 21 days on-7 days off, the patient will start all subsequent cycles on the same day of the week as the first course. Likewise, the interval of no tablets will always start on the same day of the week.

Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.

NDC 00555-9032-70 UPC/GTIN No.3-05559-03270-1 Mfg.Part No.903270 NORETHINDRONE-E.ESTRADIOL
RX ITEM-Tri-Legest Fe 5 7 9 7 Tab 5X28 B
NDC 00555-9032-70 UPC/GTIN No.3-05559-03270-1 Mfg.Part No.903270 NORETHINDRONE-E.ESTRADIOL

BRAND: TRI-LEGEST FE NDC: 00555-9032-70,555903270 UPC: 3-05559-03270-1,305559032701
Tri-Legest Fe 5 7 9 7 Tab 5X28 By Teva P
BRAND: TRI-LEGEST FE NDC: 00555-9032-70,555903270 UPC: 3-05559-03270-1,305559032701

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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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

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.