Tulana

Norethindrone Tablets, USP 0.35 mg

Please see full Prescribing Information here.

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Tulana is an AB1-rated generic oral contraceptive

Compares to: Nor-QD®, Camila®, Heather®, and Incassia
  • A progestin-only oral contraceptive
  • Single-phase continuous administration regimen
    • 28 tablets of norethindrone in a 28-day tablet blister pack
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ndc # package size order numbers
50102-200-13 Carton Containing 3 Packages
ndc # 50102-200-13
package size Carton Containing
3 Packages
order numbers

ORDER Tulana

AmerisourceBergen

1-610-727-7000
www.amerisourcebergen.com
10187847

ANDA

1-800-331-2632 (Ext. 74591)
www.andanet.com
328268

Cardinal

1-800-326-6457
www.cardinal.com
5460522

R&S Northeast

1-800-262-7770
www.rsnortheast.com
020013

Seacoast Medical LLC

1-877-410-0811
www.seacoastmedical.com/afaxys
500042

Smith Medical Partners LLC

1-800-292-9653
340B 1-877-445-7970 www.smpspecialty.com
572-0941

Important Safety Information

INDICATION

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

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

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.

Consult the Package Insert for Complete Prescribing Information

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

1. ECTOPIC PREGNANCY
Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.

2. DELAYED FOLLICULAR ATRESIA/OVARIAN CYSTS
If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.

3. IRREGULAR GENITAL BLEEDING
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy, or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.

4. CARCINOMA OF THE BREAST AND REPRODUCTIVE ORGANS
Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives, and there is insufficient data to determine whether the use of POPs similarly increases the risk.

Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.

However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. HEPATIC NEOPLASIA
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

INFORMATION FOR THE PATIENT

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 spermicides 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.

Reference:
Tulana [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; March 2018.

Please see full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.