Tyblume
Generic: LEVONORGESTREL AND ETHINYL ESTRADIOL
Basic Information
Manufacturer
Exeltis USA, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
b2482d51-d606-4aaa-8af4-19e4fe2f8872
Indications & Usage
1 INDICATIONS AND USAGE TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy.
TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
( 1 )
TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs are discussed elsewhere in labeling: Serious cardiovascular events [see Boxed Warning and Warnings and Precautions (5.1 and 5.4) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Gallbladder disease [see Warnings and Precautions (5.5) ] Adverse carbohydrate and lipid metabolic effects [see Warnings and Precautions (5.6) ] Headache [see Warnings and Precautions (5.7) ] Bleeding irregularities and amenorrhea [see Warnings and Precautions (5.8) ] Depression [see Warnings and Precautions (5.9) ] Cervical cancer [see Warnings and Precautions (5.10) ] Effect on binding globulins [see Warnings and Precautions (5.11) ] Hereditary angioedema [see Warnings and Precautions (5.12) ] Chloasma [see Warnings and Precautions (5.13) ] Risk of liver enzyme elevations with concomitant hepatitis C treatment [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site condition: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Psychiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma [see Warnings and Precautions (5.13) ] Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins Common adverse reactions are: headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc.
at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site condition: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Psychiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma [see Warnings and Precautions (5.13) ] Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins Common adverse reactions are: headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc.
at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.