Tarina® 24 Fe

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg

Please see full Prescribing Information here.

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Tarina® 24 Fe is an AB-rated generic oral contraceptive

Compares to: Junel® Fe 24, Larin™ 24 Fe, Lomedia® 24 Fe, Blisovi™ 24 Fe, and Loestrin® 24 Fe
  • A progestin/estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 24 light yellow to yellow tablets, each containing 1 mg norethindrone acetate USP and 20 mcg ethinyl estradiol USP
    • 4 brown non-hormone containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack
Product Gallery
ndc # package size order numbers
50102-224-23 Carton Containing 3 Pouches
ndc # 50102-224-23
package size Carton Containing
3 Pouches
order numbers

ORDER Tarina® 24 Fe

ANDA

1-800-331-2632 (Ext. 74591)
www.andanet.com
329348

ASD Healthcare

1-800-746-6273
www.asdhealthcare.com
54137

Cardinal

1-800-326-6457
www.cardinal.com
5520002

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

Tarina 24 Fe is a progestin/estrogen combined oral contraceptive indicated for use by women to prevent pregnancy. The efficacy of Tarina 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.

WARNINGS:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Consult the Package Insert for Complete Prescribing Information

CONTRAINDICATIONS

Do not prescribe Tarina 24 Fe to women who currently have the following conditions:


  • A high risk of arterial or venous thrombotic disease
  • Breast cancer or other estrogen- or progestin-sensitive cancer
  • Undiagnosed abnormal uterine bleeding
  • Liver tumors or liver disease
  • Pregnancy
  • Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
  • Thrombotic disorders and other vascular problems—Stop Tarina 24 Fe if a thrombotic event occurs. Stop at least 4 weeks before and 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding.
  • Liver disease—Discontinue Tarina 24 Fe if jaundice occurs.
  • High blood pressure—If used in women with wellcontrolled hypertension, monitor blood pressure and stop Tarina 24 Fe if blood pressure rises significantly.
  • Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Tarina 24 Fe. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache—Evaluate significant change in headaches and discontinue Tarina 24 Fe if indicated.
  • Bleeding irregularities and amenorrhea—Evaluate irregular bleeding or amenorrhea

ADVERSE REACTIONS

The most common adverse reactions reported (greater than or equal to 2%) include headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain


Patients should be counseled that Tarina 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference:
Tarina® 24 Fe [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 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.