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Nortrel 7 / 7 / 7 (Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol) - Summary

 

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BOX WARNING

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.

 

SUMMARY

Nortrel™ 7/7/7
(norethindrone and ethinyl estradiol tablets, USP
0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg)

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

COMBINATION ORAL CONTRACEPTIVES:

Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen): Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include D&C yellow #10, lactose monohydrate, magnesium stearate and pregelatinized starch. Each blue tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C blue no. 1 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C yellow no. 6 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each white tablet in the (28) package contains only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized starch.

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

NEWS HIGHLIGHTS RELATED TO NORTREL 7 / 7 / 7

Media Articles Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

Online Learning Supports GP Contraception Advice, Royal Australian College Of General Practitioners
Source: IT / Internet / E-mail News From Medical News Today [2008.10.09]

Pope Benedict Reiterates Church's Opposition To Contraception Use
Source: Sexual Health / STDs News From Medical News Today [2008.10.07]

'Extended Cycle' Contraception Garners More Interest
Source: MedicineNet Birth Control Specialty [2008.08.25]

Male Contraception: Progress Slow but Steady
Source: MedicineNet Vasectomy Specialty [2008.04.14]

Availability Of EC For Teens Declines At NYC Health Clinics, Report Says
Source: Health News from Medical News Today [2008.10.09]

more>>

Published Studies Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

Combined continuous ethinyl estradiol/norethindrone acetate does not improve forearm blood flow in postmenopausal women at risk for cardiovascular events: a pilot study. [2007.09]

HT update: spotlight on estradiol/norethindrone acetate combination therapy. [2008]

A multicenter, open-label study to evaluate satisfaction and menopausal quality of life in women using transdermal estradiol/norethindrone acetate therapy for the management of menopausal signs and symptoms. [2005]

Pharmacokinetic interaction between nevirapine and ethinyl estradiol/norethindrone when administered concurrently to HIV-infected women. [2002.04.15]

more>>

Clinical Trials Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills) [Active, not recruiting]

Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women [Not yet recruiting]

Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women [Active, not recruiting]

A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers [Active, not recruiting]

Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study [Active, not recruiting]

more>>

Page last updated: 2008-10-09

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