VyLibra® is an AB-rated generic oral contraceptive.
Estarylla™, Mili®, Mono-Linyah™, MonoNessa®, Ortho-Cyclen®, Previfem®, and Sprintec®
The Product Information Sheet features a summary of all relevant product information including VyLibra® (norgestimate and ethinyl estradiol tablets, USP) 0.250 mg/0.035 mg product details, product description, NDC number, and product features.Download Now
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on combination oral contraceptives (COCs), especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent.
The most common adverse reactions associated with VyLibra include headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, and rash.
Use of COCs increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.View Full Prescribing Information, Including Boxed Warning
Package Size: A Carton Containing 3 Packages
|ANDA||1-800-331-2632 (Ext. 74591)||andanet.com||328025|
|Morris & Dickson||1-888-376-7409||morrisdickson.com||225870|
|R & S Northeast||1-800-262-7770||rsnortheast.com||023513|