NOR-QD SUMMARY
WatsonPharma
13536-2
Physician Labeling
Nor-QD® Tablets
(norethindrone 0.35 mg tablets, USP)
Rx only
Each yellow NOR-QD® tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include D&C Yellow No. 10, FD&C Yellow No. 6, lactose, magnesium stearate, povidone, and starch.
1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills.
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NEWS HIGHLIGHTSMedia Articles Related to Nor-QD (Norethindrone)
Give Teens Access to Emergency Contraception, Pediatricians Say
Source: MedicineNet Miscarriage Specialty [2012.11.26]
Title: Give Teens Access to Emergency Contraception, Pediatricians Say
Category: Health News
Created: 11/26/2012 10:35:00 AM
Last Editorial Review: 11/26/2012 12:00:00 AM
Plan B: Obama Administration to Drop Age Limits on OTC Sales
Source: MedPage Today OB/Gyn [2013.06.10]
WASHINGTON (MedPage Today) -- The Obama administration signaled its intent late Monday to stand down in the emergency contraception fray, announcing that it was dropping plans to appeal a Federal judge's decision to allow broad access to Plan B One-Step.
Published Studies Related to Nor-QD (Norethindrone)
Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. [2011.05]
OBJECTIVE: To evaluate the efficacy and safety of low-dose oral contraceptives (IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with primary dysmenorrhea...
[Influence of estradiol administration mode on plasma insulin-like growth factor-I (IGF-I) and its binding proteins 1 and 3 concentration in postmenopausal women treated with norethisterone acetate]. [2011.03]
CONCLUSION: Mode of administration of estradiol did not influenced the plasma levels of IGF-I, IGFBP-1, IGFBP-3 in postmenopausal women treated with norethisterone acetate.
Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a
placebo-controlled, double-blind, randomized trial. [2011]
OBJECTIVE: To evaluate the efficacy and safety of low-dose oral contraceptives
(IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with
primary dysmenorrhea... CONCLUSION(S): IKH-01 could be used as a single agent or in combination with
analgesics for treatment of primary dysmenorrhea.
Pharmacokinetics of once- versus twice-daily tacrolimus formulations in kidney transplant patients receiving expanded criteria deceased donor organs: a single-center, randomized study. [2010.10]
BACKGROUND: Noncompliance to immunosuppressive treatment is 1 of the risk factors for kidney graft loss. The once-daily, prolonged-release tacrolimus formulation may improve treatment adherence. We sought to compare the pharmacokinetics of both tacrolimus formulations in older de novo recipients of a cadaveric renal transplant from an expanded-criteria donor... CONCLUSION: For older de novo recipients of kidneys from expanded criteria donors tacrolimus QD is comparable to the same dose in the BID formulation with similar at least short-term transplant outcomes. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Effect of the bile acid sequestrant colesevelam on the pharmacokinetics of pioglitazone, repaglinide, estrogen estradiol, norethindrone, levothyroxine, and glyburide. [2010.05]
The purpose of this study was to assess effects of colesevelam on the pharmacokinetics of glyburide, levothyroxine, estrogen estradiol (EE), norethindrone (NET), pioglitazone, and repaglinide in healthy volunteers. Six drugs with a potential to interact with colesevelam were studied in open-label, randomized clinical studies.
Clinical Trials Related to Nor-QD (Norethindrone)
The Effect of Atazanavir and Ritonavir on the Pharmacokinetics of Oral Norethindrone [Recruiting]
The purpose of this study is to learn if women taking the atazanavir and ritonavir have
lower levels of a birth control medication called norethindrone. Norethindrone (also called
the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth
control pill used to prevent pregnancy. Norethindrone is the standard medication used in
women who take the progestin only pill to prevent pregnancy. There are other birth control
pills which contain different medications. The investigators want to learn if HIV
medications (atazanavir and ritonavir) make the blood level of this birth control pill
higher or lower. If the levels of norethindrone are too low it may not work to prevent
pregnancy. The investigators also hope to learn about changes in the vaginal fluids and
cervical fluids when women are taking this birth control pill.
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding [Recruiting]
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side
effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of
heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and
severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may
effectively slough the endometrium prior to insertion of the LNG IUS.
Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Recruiting]
(A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist
(Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the
two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor:
1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis
that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine
whether quality of life, assessed by questionnaire, is better in patients assigned to NA
than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than
GnRH agonist.
Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate for 12 Months [Recruiting]
This study is conducted in Europe. The primary aim of this observational study is to
investigate the occurrence of bleeding in women taking 0. 5 mg estradiol and 0. 1 mg
norethisterone acetate for 12 months.
A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen [Recruiting]
The purpose of this study is to investigate the effect of steady-state concentrations of
TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol
and norethindrone (administered once a day) and on the levels of progesterone, luteinizing
hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol
and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.
Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen
will be studied. Steady-state is a term that means that the drug has been given long enough
so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is
being investigated for the treatment of chronic hepatitis C virus (HCV) infection.
Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in
the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.
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