Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 28 March 2017

Indication(s)

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 0.5 %.

However, the typical failure rate is estimated to be closer to 5 %, due to late or omitted pills.

Table 1 lists the pregnancy rates for users of all major methods of contraception.

SHAROBEL ™ Tablets have not been studied for and are not indicated for use in emergency contraception.

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Advisory information

contraindications
CONTRAINDICATIONS Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease
Special warnings and precautions

PRECAUTIONS 1.

General Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

2.

Physical Examination and Follow-up It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations.

The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.

3.

Carbohydrate and Lipid Metabolism Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements.

Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased.

There is usually no effect on total cholesterol, HDL3, LDL, or VLDL. 4.

Drug Interactions The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin.

No significant interaction has been found with broad-spectrum antibiotics.

Herbal products containing St. John 's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

This may also result in breakthrough bleeding.

Concurrent use of bosentan and norethindrone containing products may result in decreased concentrations of these contraceptive hormones thereby increasing the risk of unintended pregnancy and unscheduled bleeding.

5.

Interactions with Laboratory Tests The following endocrine tests may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin (SHBG) concentrations may be decreased.

Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).

6.

Carcinogenesis See WARNINGS.

7.

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.

It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.

8.

Nursing Mothers In general, no adverse effects have been found on breastfeeding performance or on the health, growth or development of the infant.

However, isolated post-marketing cases of decreased milk production have been reported.

Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.

9.

Pediatric Use Safety and efficacy of

Norethindrone 0.35 mg

Tablets have been established in women of reproductive age.

Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older.

Use of this product before menarche is not indicated.

10.

Fertility Following Discontinuation The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

11.

Headache The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.

INFORMATION FOR THE PATIENT 1.

See " Detailed Patient Labeling " for detailed information.

2.

Counseling issues The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives: The necessity of taking pills at the same time every day, including throughout all bleeding episodes.

The need to use a backup method such as condoms and spermicide for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.

The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.

The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.

The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

Adverse reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC.

Toll-Free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse reactions reported with the use of POPs include: Menstrual irregularity is the most frequently reported side effect.

Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.

Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.

Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal Disorders: vomiting, abdominal pain; General Disorders and Administration Site Conditions: fatigue, edema; Psychiatric Disorders: depression, nervousness; Musculoskeletal and Connective Tissue Disorders: pain in extremity; Reproductive

System and Breast Disorders: genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped; Immune System Disorders: anaphylactic/anaphylactoid reaction, hypersensitivity; Hepatobiliary Disorders: hepatitis, jaundice cholestatic; Skin and Subcutaneous Tissue Disorders: alopecia, rash, rash pruritic.

Usage information

Dosing and administration
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.

More information

Category Value
Authorisation number ANDA200961
Orphan designation No
Product NDC 16714-441
Date Last Revised 23-05-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1539955
Marketing authorisation holder Northstar Rx LLC
Warnings WARNING Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.