Skip to main content
MedicHelpLine
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsOralHigh Alert

SHAROBEL

NORETHINDRONE

Standard Dose
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, SHAROBEL™ must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
Max Dose
See official label
Primary Use
INDICATIONS AND USAGE 1.
Summary

Indications and usage INDICATIONS AND USAGE 1.

Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2.

Structured Monograph

Clinical summary

Indications and usage INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) No method4 85 85 Spermicides5 28 18 42 Fertility awareness-based methods Standard Days method6 TwoDay method6 Ovulation method6 Symptothermal method6 24 5 4 3 0.4 47 Withdrawal 22 4 46 Sponge Parous women Nulliparous women 24 12 20 9 36 Condom7 Female (fc) Male 21 18 5 2 41 43 Diaphragm8 12 6 57 Combined pill and progestin-only pill 9 0.3 67 Norelgestromin and ethinyl estradiol patch 9 0.3 67 NuvaRing 9 0.3 67 Depo-Provera 6 0.2 56 Intrauterine contraceptives ParaGard (copper T) Mirena (LNg) 0.8 0.2 0.6 0.2 78 80 Implanon 0.05 0.05 84 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Emergency Contraception: Emergency contraceptive pills or insertion of a copper intrauterine contraceptive after unprotected intercourse substantially reduces the risk of pregnancy. 9 (See Chapter 6.) Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 (See Chapter 18.) Source: Trussell J. Contraceptive Effi cacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Techology: Twentieth Revised Edition. New York NY: Ardent Media, 2011. Notes: 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. See the text for the derivation of the estimate for each method. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day. 7 Without spermicides. 8 With spermicidal cream or jelly. 9 ella, Plan B One-Step and Next Choice are the only dedicated products specifi cally marketed for emergency contraception. The label for Plan B One-Step (one dose is 1 white pill) says to take the pill within 72 hours after unprotected intercourse. Research has shown that all of the brands listed here are effective when used within 120 hours after unprotected sex. The label for Next Choice (one dose is 1 peach pill) says to take 1 pill within 72 hours after unprotected intercourse and another pill 12 hours later. Research has shown that both pills can be taken at the same time with no decrease in effi cacy or increase in side effects and that they are effective when used within 120 hours after unprotected sex. The FDA has in addition declared the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel (1 dose is 2 white pills), Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or Quasence (1 dose is 4 white pills), Jolessa, Portia, Seasonale or Triv

Monitoring

  • WARNINGS Cigarette smoking increases the risk of serious cardiovascular disease.
  • Women who use oral contraceptives should be strongly advised not to smoke.
  • SHAROBEL ™ does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs).
  • The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks.

Interaction Notes

  • Review official label interaction section.