Ingredients In Plan B

Ingredients In Plan B
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May 23, 2022 Each Plan B tablet contains 0.75 mg of a single active steroid ingredient , levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)- (-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate.
May 31, 2022 Each Plan B tablet contains 0.75 mg of a single active steroid ingredient , levonorgestrel [18,19Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)- (-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate.
The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side. 4 CONTRAINDICATIONS Plan B One-Step is contraindicated for...
Each Plan B tablet contains 0.75 mg of a single active steroid ingredient , levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)- (-)-], a totally synthetic progestogen ... 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action - Emergency contraceptive pills are not effective if a woman is already pregnant.
Nov 22, 2021 Inactive ingredients : colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate 1-800-330-1271 www.PlanBOneStep.com If you are sexually active, you should see a healthcare provider for routine checkups.
Plan B (0.75mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) Tablets Information Plan B and Plan B One Step are emergency contraceptives intended to reduce the possibility of...
Apr 15, 2021 It helps prevent pregnancy by using a bigger dose of levonorgestrel, the synthetic hormone found in birth control pills. This mimics the natural hormone, progesterone, delaying the release of an...
Nov 8, 2021 Plan B is the EC pill that's talked about most often. It contains a synthetic version of the progestin hormone called levonorgestrel, which temporarily prevents an ovary from releasing an egg. The...
Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription 3. How does Plan B work? Plan B ...
Ingredients Active Ingredient - Levonorgestrel 1.5mg; Purpose - Emergency Contraceptive. Inactive Ingredients : Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Potato Starch, Talc. Other Information Store at 68-77°F (20-25°C) Directions Plan B One-Step is a single tablet you take by mouth.
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Label: PLAN B- levonorgestrel tablet

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These highlights do not include all the information needed to use Plan B safely and effectively. See full prescribing information for Plan B.

Plan B (levonorgestrel) tablets, 0.75mg, for oral ...
These highlights do not include all the information needed to use Plan B safely and effectively. See full prescribing information for Plan B.
Plan B (levonorgestrel) tablets, 0.75mg, for oral use
Initial U.S. Approval: 1982

Ectopic Pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Plan B should be evaluated for ectopic pregnancy. ( 5.1 )
Plan B is not effective in terminating an existing pregnancy. ( 5.2 )
Effect on menses: Plan B may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. ( 5.3 )
STI/HIV: Plan B does not protect against STI/HIV. ( 5.4 )

Nursing Mothers: Small amounts of progestin pass into the breast milk of nursing women taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. ( 8.3 )
Plan B is not intended for use in pediatric (premenarcheal) ( 8.4 ) or postmenopausal women ( 8.5 ).
Clinical trials demonstrated a higher pregnancy rate in the Chinese population. ( 8.6 )

Plan B® is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal ...
Take one tablet of Plan B orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon ...
Each Plan B tablet is supplied as a white, round tablet containing 0.75 mg of levonorgestrel and is marked with INOR on one side.
Plan B is contraindicated for use in the case of known or suspected pregnancy.
5.1 Ectopic Pregnancy
- Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only ...
6.1 Clinical Trial Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of ...
8.1 Pregnancy
- Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and ...
Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B.
There are no data on overdosage of Plan B, although the common adverse event of nausea and associated vomiting may be anticipated.
Each Plan B tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)-(-)-], a totally synthetic progestogen ...
12.1 Mechanism of Action
- Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B is believed to act as an emergency contraceptive principally by preventing ...
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
- Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in ...
A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women (mean age 27) compared the efficacy and safety of Plan B (one 0.75 mg tablet of levonorgestrel taken ...
Plan B (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. The tablet is white, round and marked INOR on ...
17.1 Information for Patients
-
Take Plan B as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
If you vomit within two ...
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
- for Duramed Pharmaceuticals, Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970
- Phone: 1-800-330-1271 Website ...
NDC 54868-4894-0
- Plan B®

(LEVONORGESTREL)
tablets 0.75 mg
-
Emergency Contraceptive
-
2 Levonorgestrel Tablets
- 0.75 mg each
-
The sooner you take the first tablet, the better Plan B® will ...

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PLAN B- levonorgestrel tablet
Number of versions: 1

PLAN B- levonorgestrel tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

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this version.
Plan B is a progestin-only emergency contraceptive, indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Plan B is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Plan B is not intended for routine use as a contraceptive. ( 1 )
The first tablet is taken orally as soon as possible within 72 hours after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Efficacy is better if Plan B is taken as soon as possible after unprotected intercourse. ( 2 )
A total of two 0.75 mg tablets taken 12 hours apart as a single course of treatment ( 3 )
Known or suspected pregnancy. ( 4 )
The most common adverse reactions (≥ 10%) in the clinical trial included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%) and breast tenderness (11%). ( 6.1 )

To report SUSPECTED ADVERSE REACTIONS, contact Barr Laboratories at 1-800-330-1271 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills. ( 7 )
See 17 for PATIENT COUNSELING INFORMATION.
Plan B® is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later.
Plan B is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Plan B is not indicated for routine use as a contraceptive.
Take one tablet of Plan B orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Plan B can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
Each Plan B tablet is supplied as a white, round tablet containing 0.75 mg of levonorgestrel and is marked with INOR on one side.
Plan B is contraindicated for use in the case of known or suspected pregnancy.
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B.
Plan B is not effective in terminating an existing pregnancy.
Some women may experience spotting a few days after taking Plan B. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.
Plan B does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
A physical examination is not required prior to prescribing Plan B. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status
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Ingredients In Plan B

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