Mini-Pill indications
Mini-Pill Acetate Tablets, USP
Mini-Pill Acetate 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. Mini-Pill Acetate tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
Uses of Mini-Pill in details
Mini-Pill 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.
Mini-Pill description
Mini-Pill (INN, BAN), also known as Mini-Pill (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.
Mini-Pill dosage
Mini-Pill Acetate Tablets
Therapy with Mini-Pill Acetate 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 Mini-Pill Acetate 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 Mini-Pill Acetate tablets therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Mini-Pill Acetate tablets.
Endometriosis
Initial daily dosage of 5 mg Mini-Pill Acetate tablets for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Mini-Pill Acetate tablets is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Mini-Pill interactions
If a woman on Mini-Pill takes a drug or herbal product that induces an enzyme(s) that metabolizes Mini-Pill, 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 Mini-Pill and may decrease the effectiveness of Mini-Pill 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 Mini-Pill, however the therapeutic effect of Mini-Pill 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:
Mini-Pill side effects
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Mini-Pill based on the comprehensive assessment of the available adverse event information. A causal relationship with Mini-Pill 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 Mini-Pill was evaluated in 3099 subjects in 2 clinical trials. Of these, 2925 subjects participated in a clinical trial of Mini-Pill 0.35 mg administered daily and 174 subjects participated in a clinical trial of Mini-Pill 0.35 mg/day administered on 21 days/cycle. Adverse reactions reported for ≥1% of Mini-Pill-treated subjects are shown in the table.
Adverse reactions reported by <1% of Mini-Pill-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 Mini-Pill 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 Mini-Pill is stopped.
Mini-Pill contraindications
Hypersensitivity to any component of Mini-Pill. 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: Mini-Pill 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 Mini-Pill:
Norethisterone in Finland.
List of Mini-Pill substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Mini-Pe (Denmark, Sweden) | |
| Movisse (Canada) | |
| Movisse tablet 0.35 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| N-ETHI | |
| N-ETHI TABLET | |
| N-ETHI TABLET 1 strip / 10 tablets each (Goddres Pharmaceuticals Pvt Ltd) | $ 1.99 |
| Nc Norm P | |
| Nc Norm P 5 mg Tablet (Unicure (India) Pvt.Ltd.) | $ 0.04 |
| NCNORM P | |
| 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 |
| NET (India) | |
| Net 150mg x 2mL INJ / 2ml (Divine Savior) | $ 1.19 |
| NET inj 150 mg x 2 mL x 2ml (Divine Savior) | $ 1.19 |
| Net 150mg x 2mL INJ / 2ml (Divine Savior) | $ 1.19 |
| Nodiol | |
| NOORE | |
| NOORE 5MG TABLET 1 strip / 10 tablets each (Cure Quick Pharmaceuticals) | $ 0.64 |
| Nor-Q.D. (United States) | |
| Nor-QD | |
| Tablet; Oral-28; Norethindrone 0.35 mg (Watson) | |
| Nora-BE | |
| Noraethisteronum | |
| Noralutin | |
| Norate (India) | |
| 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 | |
| Norate A 5 mg Tablet (Dewcare Concept) | $ 0.06 |
| Norate-A (India) | |
| 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 |
| Norclut (Malaysia) | |
| Norcolut (Bangladesh, Georgia, Hong Kong, Hungary, Lithuania, Singapore, Vietnam) | |
| 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 |
| Norcolut 5 | |
| Norcolut 5 mg (Hungary) | |
| Norcutin (Bangladesh) | |
| Norcutin 5 mg x 1's | |
| Norcutin 5 mg x 50 x 10's | |
| Norcutin 5 mg x 500's | |
| NORDART (India) | |
| NORDART tab 5 mg x 10's (Intra (Intra Life)) | $ 0.61 |
| Nordiropin Simplex (India) | |
| Nordiropin Simplex 5mg INJ / 1.5ml (Novo Nordisk) | |
| NORDIROPIN SIMPLEX inj 5 mg x 1.5ml (Novo Nordisk) | |
| Nordron (Taiwan) | |
| Nordron 5 mg | |
| Noregyna (Brazil) | |
See 726 substitutes for Mini-Pill | |
References
- DailyMed. "NORETHINDRONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "norethindrone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "norethindrone". http://www.drugbank.ca/drugs/DB00717 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Mini-Pill 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 Mini-Pill. 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.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology
