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  • ALL
  • COMBINED ORAL CONTRACEPTIVES
  • PROGESTIN-ONLY ORAL CONTRACEPTIVES
  • EMERGENCY CONTRACEPTIVES
Econtra

EContra One-Step

(Levonorgestrel) Tablet, 1.5 mg

distributor product number:

AmerisourceBergen: 10186363
ANDA: 328092
Cardinal: 5439013
Morris & Dickson: 246314
R&S Northeast: 021116
Seacoast Medical LLC: 500041
Smith Medical Partners LLC:
571-2369
View full Product Information here

ella

ella®

ulipristal acetate tablet 30 mg

distributor product number:

AmerisourceBergen: 10153832
ANDA: 50102091101
Cardinal: 5029780
McKesson: 3470556
Morris & Dickson: 602680
R&S Northeast: 091101
Seacoast Medical LLC: 500033
Smith Medical Partners LLC:
5264-882
View full Prescribing Information here

Aubra

Aubra EQ

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg

distributor product number:

AmerisourceBergen: 10189389
ANDA: 50102022023
Cardinal: 5478490
Morris & Dickson: 392407
R&S Northeast: 0220230
Seacoast Medical LLC: 500043
Smith Medical Partners LLC:
5728597
View full Prescribing Information, including Boxed Warning, here

Chateal

Chateal EQ

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg

distributor product number:

AmerisourceBergen: 10189487
ANDA: 50102023023
Cardinal: 5478508
Morris & Dickson: 392530
R&S Northeast: 023023
Seacoast Medical LLC: 500044
Smith Medical Partners LLC:
5728605
View full Prescribing Information, including Boxed Warning, here

Cyred

Cyred EQ

Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg

distributor product number:

AmerisourceBergen: 10189510
ANDA: 50102025423
Cardinal: 5478516
Morris & Dickson: 392514
R&S Northeast: 025423
Seacoast Medical LLC: 500046
Smith Medical Partners LLC:
5728621
View full Prescribing Information, including Boxed Warning, here

tulana

Tulana

Norethindrone Tablets USP 0.35 mg

distributor product number:

AmerisourceBergen: 10187847
ANDA: 328268
Cardinal: 5460522
Morris & Dickson: 269902
R&S Northeast: 020013
Seacoast Medical LLC: 500042
Smith Medical Partners LLC:
572-0941
View full Prescribing Information here

Tarina

Tarina Fe 1/20 EQ

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg

distributor product number:

AmerisourceBergen: 10189488
ANDA: 50102022823
Cardinal: 5478524
Morris & Dickson: 392795
R&S Northeast: 022823
Seacoast Medical LLC: 500045
Smith Medical Partners LLC:
5728613
View full Prescribing Information, including Boxed Warning, here

VyLibra

VyLibra®

Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg

distributor product number:

AmerisourceBergen: 10185558
ANDA: 328025
Cardinal: 5423173
Morris & Dickson: 225870
R&S Northeast: 023513
Seacoast Medical LLC: 112406
Smith Medical Partners LLC:
570-7401
View full Prescribing Information, including Boxed Warning, here

Tri-VyLibra

Tri-VyLibra®

Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg

distributor product number:

AmerisourceBergen: 10185559
ANDA: 328026
Cardinal: 5423181
Morris & Dickson: 225896
R&S Northeast: 023313
Seacoast Medical LLC: 112407
Smith Medical Partners LLC:
570-7294
View full Prescribing Information, including Boxed Warning, here

IMPORTANT SAFETY INFORMATION FOR THE COMBINED ORAL CONTRACEPTIVES (COCS)

Chateal EQ (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Aubra EQ (levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg), Tarina Fe 1/20 EQ (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Cyred EQ (desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.25/0.035 mg) and Tri-VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg).

Indication and Usage of Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ and VyLibra

Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ and VyLibra are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Tri-VyLibra is indicated for use by women to prevent pregnancy and is also indicated to treat moderate acne in women 15 years of age and older who also wish to use oral contraception.

IMPORTANT SAFETY INFORMATION about Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra, and Tri-VyLibra including Boxed Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra and Tri-VyLibra should not be used by women who are over 35 years of age who smoke.

Consult the Package Insert for Complete Prescribing Information for each combined oral contraceptive product

Contraindications

Do not prescribe combined oral contraceptives to women who currently have the following conditions:

  • A high risk of arterial or venous thrombotic disease including women who are known to smoke if over age 35; have a current or past history of deep vein thrombosis, pulmonary embolism, thrombophlebitis, thrombophilic conditions, or thromboembolic disorders; have cerebrovascular or coronary artery disease(current or history); have valvular heart disease with complications; have persistent blood pressure values of greater than or equal to 160 mm Hg systolic or greater than or equal to 100 mm Hg diastolic; have headache with focal neurologic symptoms; or have diabetes with vascular involvement
  • Major surgery with prolonged immobilization
  • Known or suspected carcinoma of breast or personal history of breast cancer, carcinoma of the endometrium, or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Acute or chronic hepatocellular disease with abnormal liver function or hepatic adenomas or carcinomas
  • Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of the oral contraceptive pills
  • 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 and other vascular events—Stop combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (evaluate for retinal thrombosis immediately). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast and cervix—Women with current or past history of breast cancer should not use COCs.
  • Liver Disease—Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (>8 years use) are associated with COC use. Do not use in women receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
  • High Blood pressure—Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs.
  • Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.
ADVERSE REACTIONS

The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference: Chateal EQ, Aubra EQ, Tarina Fe 1/20 EQ, Cyred EQ, VyLibra®, and Tri-VyLibra® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; 2018.

Please see full Prescribing Information for Chateal EQ here.
Please see full Prescribing Information for Aubra EQ here.
Please see full Prescribing Information for Tarina Fe 1/20 EQ here.
Please see full Prescribing Information for Cyred EQ here.
Please see full Prescribing Information for VyLibra® here.
Please see full Prescribing Information for Tri-VyLibra® here.


Important Safety Information for Tulana (Norethindrone 0.35 mg tablet USP)

INDICATIONS: Progestin only oral contraceptives are indicated for the prevention of pregnancy.
CONTRAINDICATIONS include known or suspected pregnancy, known or suspected carcinoma of the breast, undiagnosed abnormal genital bleeding, benign or malignant liver tumors or active liver disease and hypersensitivity to any components of the pills.
WARNINGS include ectopic pregnancy considerations, delayed follicular atresia/ovarian cysts, irregular genital bleeding, carcinoma of the breast and reproductive organs, and hepatic neoplasias.
PRECAUTIONS include carbohydrate and lipid metabolism, drug interactions, interactions with laboratory tests, pregnancy, nursing mothers, pediatric use, fertility following discontinuation and headache.
ADVERSE REACTIONS reported with progestin only pills include menstrual irregularities, headache, breast tenderness, nausea and dizziness. Androgenic side effects such as acne, hirsuitism and weight gain occur rarely.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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

Please see full Prescribing Information for Tulana here.


ella® (ulipristal acetate 30 mg tablet) Important Safety Information

The most common side effects of ella (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella, therefore, a reliable barrier method of contraception should be used with subsequent acts of intercourse in that same menstrual cycle. Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effectiveness. After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella. Repeated use of ella within the same menstrual cycle is not recommended. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella. ella does not protect against STI/HIV.

Reference: ella® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; May 2018.

Please see full Prescribing Information for ella® here.


EContra One-Step Product Information

Usage
EContra One-Step (Levonorgestrel 1.5 mg tablet) is a progestin-only emergency contraceptive pill indicated for use in women to reduce the chance of pregnancy after unprotected sex (if contraceptive failed or birth control not used). EContra One-Step is not intended to be used in place of routine birth control.

Who Should Not Use EContra One-Step

  • Women who are known to be pregnant as it will not work. However, EContra One-Step will not harm an existing pregnancy.
  • Women known to be allergic to Levonorgestrel.

Women should ask a doctor or pharmacist before using EContra One-Step if taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Side effects may include menstrual changes, abdominal pain, nausea, vomiting, tiredness, headache, dizziness, or breast pain.

Reference: EContra One-Step [product information]. Charleston, SC, Afaxys Pharma, LLC; November 2017.

Please see full Product Information for EContra One-Step here.