Menor - N

Menor - N (INN, BAN), also known as Norethindrone (USAN), is a synthetic progestational hormone with actions similar to those of progesterone but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for contraception.

Menor - N Tablets, USP

Menor - N tablets, USP are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Menor - N tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Effectiveness of

Oral Contraceptive: When used perfectly, without missing any pills, the chance of becoming pregnant is 0.5% (5 pregnancies per 1000 women per year of use). Typical failure rates are actually 5% in the 1st year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

Dosage: To achieve the maximum contraceptive effectiveness Menor - N tablets must be taken at exactly the same time each day. One tablet is taken without interruption for 28 days. After 28 tablets have been taken, a tablet from a new package is then taken the next day.

For the initial cycle of therapy, treatment should commence from day 1 up to and including day 5 of the menstrual cycle: One tablet daily with water at the same time of the day for 28 days. If this procedure is correctly followed, Menor - N provides protection against pregnancy starting from the 1st day of intake.

Missed Dose(s): If 1 tablet has been missed or there is a delay of >3 hrs in taking the tablet, the missed tablet should be taken as soon as it is remembered. The next tablet should be taken at the usual time, even if that means taking 2 tablets in 1 day. Whenever a progestin-only oral contraceptive tablet is taken ≥3 hrs late, a reliable supplementary non-hormonal contraceptive method should be used for the next 48 hrs.

Switching from Another

Oral Contraceptive: For a switch-over from a combination oral contraceptive (COC), treatment with Menor - N should begin on the 1st day following the last active tablet from the previous combination oral contraceptive cycle. For a switch-over from another brand of POPs, Menor - N can be started at any time, but no later than 24 hrs after the last active tablet.

Use After Childbirth: Women who elect not to breastfeed may start progestin-only oral contraceptive therapy immediately after childbirth. Women who are breastfeeding should start Menor - N 6 weeks after delivery. However, in non-fully breastfeeding women (women who are supplementing with some formula or food) fertility may return as soon as 4 weeks postpartum, therefore, the possibility of pregnancy must be considered when Menor - N is started after 4 weeks postpartum.

Use After Abortion or Miscarriage: After an abortion or miscarriage progestin-only oral contraceptives can be started as soon as the next day. Since fertility can return as early as 10 days post-abortion or miscarriage, the possibility of pregnancy must be considered when starting Menor - N later than 10 days following an abortion or miscarriage.

Breakthrough Bleeding or Spotting: In the event of breakthrough bleeding or spotting, treatment should be continued. Breakthrough bleeding is common among women using progestin-only oral contraceptives. If breakthrough bleeding persists or is accompanied by abdominal pain, additional medical evaluation should be considered.

In Case of Vomiting and Diarrhea: If vomiting occurs within 2 hrs of pill intake or if severe diarrhea lasting for >24 hrs occurs, the effectiveness of the contraception may be diminished. Patients should continue taking the pills on schedule if possible. An additional non-hormonal method of contraception during the time of illness and for an additional 48 hrs following the illness should be used.

Special Populations: Children (≤16 years): Safety and efficacy of Menor - N tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <16 years and for users ≥16 years. Use of Menor - N before menarche is not indicated.

Elderly: Use of Menor - N is not indicated in post-menopausal women.

Administration: For oral administration.

Hypersensitivity to any component of Menor - N. Known or suspected carcinoma of the breast; benign or malignant liver tumor; acute or chronic hepatocellular disease with abnormal liver function; undiagnosed abnormal genital bleeding.

Use in pregnancy: Menor - N is contraindicated during pregnancy.

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. Suspected pregnancy should be ruled out before initiating any hormonal contraceptive use.

Menor - N is a man-made form of progesterone, a naturally occurring female sex hormone. It has a number of uses:

• Low-strength progesterone is used in oral contraceptive pill to prevent pregnancy.
• Medium-strength progesterone is used, to treat irregular, painful or heavy periods, to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found), to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT), to delay periods.

If a woman on Menor - N takes a drug or herbal product that induces an enzyme(s) that metabolizes Menor - N, particularly CYP3A4, the patient should be counseled to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of Menor - N and may decrease the effectiveness of Menor - N or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: Some anti-epileptics (eg, carbamazepine, phenytoin), (fos)aprepitant, barbiturates, bosentan, griseofulvin, some (combinations of) HIV protease inhibitors (eg, nelfinavir, some ritonavir-boosted protease inhibitors), some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), rifampin and rifabutin, St. John's Wort.

In vitro studies suggest that activated charcoal binds to Menor - N, however the therapeutic effect of Menor - N is not affected when activated charcoal is administered 3 hrs after the previous dose or 12 hrs before the next dose.

Physicians are advised to consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations and the possible need to adjust dosages.

Laboratory Tests: Certain endocrine and liver function tests and blood components may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin concentrations may be decreased; thyroxine concentrations may be decreased, due to a decrease in thyroxine binding globulin.

Incompatibilities:

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Menor - N based on the comprehensive assessment of the available adverse event information. A causal relationship with Menor - N usually cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trial Data: The safety of Menor - N was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Menor - N 0.35 mg administered daily and 174 subjects participated in a clinical trial of Menor - N 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Menor - N-treated subjects are shown in the table.

Adverse reactions reported by <1% of Menor - N-treated subjects (N=3099) in the previously stated clinical trials are as follows: Psychiatric Disorders: Depression, nervousness. Gastrointestinal Disorders: Gastrointestinal disorder. Skin and Subcutaneous Tissue Disorders: Acne, hirsutism. Musculoskeletal and Connective Tissue Disorders: Pain in extremity. Reproductive System and Breast Disorders: Genital discharge. General Disorders and Administration Site Conditions: Edema.

Post-Marketing Data: Adverse reactions 1st identified during post-marketing experience with Menor - N are included as follows. The frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000, <1/1000; very rare <1/10,000, including isolated reports; unknown (cannot be estimated from the available data).

Adverse reactions are presented by frequency category based on spontaneous reporting rates.

Immune System Disorders: Very rare: Anaphylactic/anaphylactoid reaction, hypersensitivity.

Gastrointestinal Disorders: Very rare: Abdominal pain.

Hepatobiliary Disorders: Very rare: Hepatitis, cholestatic jaundice.

Skin and Subcutaneous Tissue Disorders: Very rare: Alopecia, rash, pruritic rash.

Pregnancy, Puerperium and Perinatal Conditions: Very rare: Ectopic pregnancy.

Reproductive System and Breast Disorders: Very rare: Breast pain, delayed menstruation, irregular menstruation, ovarian cyst, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleeding when Menor - N is stopped.