RVP

Drug Catalog - Product Detail

MONO-LINYAH 35MCG-0.25MG TAB 6 X 28

NDC Mfr Size Str Form
16714-0360-04 NORTHSTAR RX 28 0.25-35MG-MCG TABLET
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PACKAGE FILES

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Generic Name
NORGESTIMATE AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA090523
Description
11 DESCRIPTION Mono-Linyah is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 3
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Mono-Linyah Tablets are available in a compact blister card (NDC 16714-360-01) containing 28 tablets in the following order: 21 blue, biconvex, round, coated tablets with "C3" debossed on one side containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol, and 7 white, biconvex, round, coated tablets with "P" debossed on one side and the " N " debossed on the other side containing inert ingredients. Mono-Linyah Tablets are available in the following configurations: Carton of 1 blister card NDC 16714-360-02 Carton of 3 blister cards NDC 16714-360-03 Carton of 6 blister cards NDC 16714-360-04 Keep out of reach of children. 16.2 Storage Conditions Store at 20° to 25℃ (68° to 77ºF), [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Mono-Linyah is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day (2.2) Take tablets in the order directed on the blister pack (2.2) Do not skip or delay tablet intake. (2.2) 2.1 How to Start Mono-Linyah Mono-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling ( 16 )]. Mono-Linyah may be started using either a Day 1 start or a Sunday start (see Table 1). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are available. For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Mono-Linyah Starting Mono-Linyah after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Mono-Linyah may be started immediately. An additional method of contraception is not needed if Mono-Linyah is started immediately. If Mono-Linyah is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Mono-Linyah. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Mono-Linyah, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Mono-Linyah. [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and FDA-Approved Patient Labeling .] Starting Mono-Linyah after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Mono-Linyah following the instructions in Table 1 for women not currently using hormonal contraception. Mono-Linyah is not recommended for use in lactating women [see Use in Specific Populations ( 8.3 )] . If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Mono-Linyah. [See Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 and 8.3 ), and FDA-Approved Patient Labeling ]. Compact Blister Dispenser If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the blister foil. If the patient will start pill-taking on "Day 1", place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill. Remove the first active pill at the top of the dispenser (Day 1) by pressing the pill through the blister foil. 2.3 Missed Tablets 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling ] . 1 2