Rx Item-Briellyn 0.4 0.035 Tab 3X28 by Glenmark Generics Gen Ovcon

BRIELLYN- norethindrone and ethinyl estradiol
Glenmark Pharmaceuticals Inc., USA

Rx only

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

DESCRIPTION

BRIELLYN 28-Day (norethindrone and ethinyl estradiol tablets USP) provide a continuous regimen for oral contraception derived from 21 light peach tablets composed of norethindrone USP and ethinyl estradiol USP to be followed by 7 white to off-white tablets of inert ingredients. The structural formulas are:

chemical structures
(click image for full-size original)


The light peach active tablets each contain 0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP, and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc. The white to off-white tablets in the 28-Day regimen contain only inert ingredients as follows: lactose monohydrate, magnesium stearate, pregelatinized starch and talc.

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).

INDICATIONS AND USAGE

Oral contraceptives are 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 1 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.

Briellyn 0.4 0.035 Tab 3X28 by
NDC No. 68462-0316-29 UPC/GTIN No. 3-68462-31629-8 MPN 31629 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

Briellyn 0.4 0.035 Tab 3X28 by
Glenmark Generics Inc.

NORETHINDRONE-ETHINYL EST
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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Briellyn 0.4 0.035 Tab 3X28 by
NDC No. 68462-0316-29 UPC/GTIN No. 3-68462-31629-8 MPN 31629 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

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