Nordiropin Simplex Uses

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Nordiropin Simplex indications

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Nordiropin Simplex Tablets, USP

Nordiropin Simplex 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. Nordiropin Simplex tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Uses of Nordiropin Simplex in details

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

High-strength tablets are sometimes used in some female cancers such as breast cancer.

Nordiropin Simplex description

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Nordiropin Simplex (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.

Nordiropin Simplex dosage

Nordiropin Simplex Tablets

Therapy with Nordiropin Simplex tablets must be adapted to the specific indications and therapeutic response of the individual patient.

Secondary Amenorrhea, Abnormal Uterine Bleeding due to Hormonal Imbalance in the Absence of Organic Pathology

2.5 to 10 mg Nordiropin Simplex tablets may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Nordiropin Simplex tablets therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Nordiropin Simplex tablets.

Endometriosis

Initial daily dosage of 5 mg Nordiropin Simplex tablets for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Nordiropin Simplex tablets is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

Nordiropin Simplex interactions

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If a woman on Nordiropin Simplex takes a drug or herbal product that induces an enzyme(s) that metabolizes Nordiropin Simplex, 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 Nordiropin Simplex and may decrease the effectiveness of Nordiropin Simplex 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 Nordiropin Simplex, however the therapeutic effect of Nordiropin Simplex 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: Not applicable.

Nordiropin Simplex side effects

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Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Nordiropin Simplex based on the comprehensive assessment of the available adverse event information. A causal relationship with Nordiropin Simplex 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 Nordiropin Simplex was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Nordiropin Simplex 0.35 mg administered daily and 174 subjects participated in a clinical trial of Nordiropin Simplex 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Nordiropin Simplex-treated subjects are shown in the table.

Adverse reactions reported by <1% of Nordiropin Simplex-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 Nordiropin Simplex 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 Nordiropin Simplex is stopped.

Nordiropin Simplex contraindications

Hypersensitivity to any component of Nordiropin Simplex. 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: Nordiropin Simplex 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.

Active ingredient matches for Nordiropin Simplex:

Norethisterone in India.


Unit description / dosage (Manufacturer)Price, USD
Nordiropin Simplex 5mg INJ / 1.5ml
NORDIROPIN SIMPLEX inj 5 mg x 1.5ml (Novo Nordisk)

List of Nordiropin Simplex substitutes (brand and generic names):

NORDART tab 5 mg x 10's (Intra (Intra Life))$ 0.61
Nordron 5 mg
Norelut 5 mg x 5 x 10's (Dexa Medica)$ 19.53
Noreta HRT 1mg TAB / 10 (German Remedies (Zydus Cadila Healthcare Ltd.))$ 0.17
1 mg x 10's (German Remedies (Zydus Cadila Healthcare Ltd.))$ 0.17
Noreta HRT 1 mg Tablet (German Remedies (Zydus Cadila Healthcare Ltd.))$ 0.01
NORETA-HRT tab 1 mg x 10's (Zydus (G.Rem))$ 0.17
Noreth 5 mg Tablet (Taurus Laboratories Pvt. Ltd.)$ 0.04
NORETHEA TABLET 1 strip / 10 tablets each (Orchid Chemicals & Pharmaceuticals Ltd)$ 0.59
Norethindrone Acetate tablet 5 mg/1 (Av Pak (US))
Tablet; Oral; Norethindrone 5 mg (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))
5 mg x 10's (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 0.48
Norethisterone 5 mg Tablet (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 0.05
Norethisterone 5mg TAB / 10 (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 0.48
NORETHISTERONE / ATOZ tab 5 mg x 10's (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 0.48
Ovcon-35 / 28 28 0.4-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 89.09
Ovcon-50 28 50-1 mcg-mg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 89.09
Loestrin 1.5/30 / 21 21 1.5-30 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 79.32
Loestrin 1/20 / 21 21 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 79.32
Loestrin Fe 1/20 28 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 79.32
Loestrin Fe 1.5/30 28 1.5-30 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 77.10
Loestrin 24 Fe 28 1-20 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 75.15
Nor-QD 28 0.35 mg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 65.87
Tri-Norinyl / 28 28 0.5/1/0.5-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 62.63
Ortho-Novum 10/11 / 28 28 35 mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 60.25
Modicon / 28 28 0.5-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 59.99
Norinyl 1+35 / 28 28 1-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 55.99
Ortho-Novum 1/35 / 28 28 1-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 55.99
Brevicon / 28 28 0.5-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 53.00
Norinyl 1+50 / 28 28 1-50 mg-mcg tablet 1 Disp Pack = 28 Pills (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 52.99
Necon 10/11 / 28 28 35 mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 35.99
Ortho-Novum 7/7/7 / 28 28 0.5/0.75/1-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 33.99
Necon 0.5/35 / 28 28 0.5-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 32.99
Necon 1/35 / 28 28 1-35 mg-mcg tablet Disp Pack (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 31.99
Loestrin fe 1-20 tablet (Atoz Pharmaceuticals (Zota Healthcare Pvt Ltd))$ 5.23

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The results of a survey conducted on ndrugs.com for Nordiropin Simplex are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Nordiropin Simplex. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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