Movisse Uses

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Movisse indications

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Movisse Tablets, USP

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

Uses of Movisse in details

Movisse 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.

Movisse description

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Movisse (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.

Movisse dosage

Movisse Tablets

Therapy with Movisse 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 Movisse 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 Movisse tablets therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Movisse tablets.

Endometriosis

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

Movisse interactions

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If a woman on Movisse takes a drug or herbal product that induces an enzyme(s) that metabolizes Movisse, 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 Movisse and may decrease the effectiveness of Movisse 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 Movisse, however the therapeutic effect of Movisse 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.

Movisse 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 Movisse based on the comprehensive assessment of the available adverse event information. A causal relationship with Movisse 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 Movisse was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Movisse 0.35 mg administered daily and 174 subjects participated in a clinical trial of Movisse 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Movisse-treated subjects are shown in the table.

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

Movisse contraindications

Hypersensitivity to any component of Movisse. 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: Movisse 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 Movisse:

Norethisterone in Canada.


Unit description / dosage (Manufacturer)Price, USD
Movisse tablet 0.35 mg (Mylan Pharmaceuticals Ulc (Canada))

List of Movisse substitutes (brand and generic names):

N-ETHI TABLET 1 strip / 10 tablets each (Goddres Pharmaceuticals Pvt Ltd)$ 1.99
Nc Norm P 5 mg Tablet (Unicure (India) Pvt.Ltd.)$ 0.04
NCNORM P 5 MG TABLET 1 strip / 10 tablets each (Unicure India Pvt Ltd)$ 0.42
NCNORM P 5 MG TABLET 1 strip / 6 tablets each (Unicure India Pvt Ltd)$ 0.40
NOORE 5MG TABLET 1 strip / 10 tablets each (Cure Quick Pharmaceuticals)$ 0.64
Norate 5mg TAB / 10 (Dewcare Concept)$ 0.54
5 mg x 10's (Dewcare Concept)$ 0.54
Norate 5 mg Tablet (Dewcare Concept)$ 0.05
NORATE tab 5 mg x 10's (Dewcare Concept)$ 0.54
Norate A 5 mg Tablet (Dewcare Concept)$ 0.06
Norate-A Norethisterone Acetate 5mg TAB / 10 (Dewcare)$ 0.63
5 mg x 10's (Dewcare)$ 0.63
NORATE-A tab 5 mg x 10's (Dewcare)$ 0.63
Tablet; Oral; Norethindrone 5 mg (Gedeon Richter)
Norcolut 5mg - 20 Tablets (Gedeon Richter)$ 9.40
Norcolut 5 mg x 20's (Gedeon Richter)$ 1.14
Norcolut 5 mg x 2 Blister x 10 Tablet (Gedeon Richter)
Norcolut 5 mg x 2 x 10's (Gedeon Richter)$ 42.00
Norcolut tab 5 mg 20's (Gedeon Richter)$ 4.30
Norcutin 5 mg x 1's
Norcutin 5 mg x 50 x 10's
Norcutin 5 mg x 500's
NORDART tab 5 mg x 10's (Intra (Intra Life))$ 0.61
Nordiropin Simplex 5mg INJ / 1.5ml (Novo Nordisk)
NORDIROPIN SIMPLEX inj 5 mg x 1.5ml (Novo Nordisk)
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))

Reviews

The results of a survey conducted on ndrugs.com for Movisse 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 Movisse. 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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