What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Twirla (Levonogestrel and Ethinyl Estradiol)
Prescription Required
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Product Details
Description
Twirla contains two drugs: levonorgestrel, a progestin, and ethinyl estradiol, and estrogen. Twirla (levonorgestrel and ethinyl estradiol) is used to prevent pregnancy in women who have a body mass index (BMI) that is less than 30 kg/m2.
Fact Table
Formula
C21H28O2, C20H24O2
License
US DailyMed, US FDA, EU EMA
Bioavailability
38% - 48%
Legal status
Rx-Only
Chemical Name
Levonogestrel and Ethinyl Estradiol
Elimination half-life
7–36 hours
Dosage (Strength)
120mcg/30mcg
Pregnancy
-
Brands
Twirla
Protein binding
97–98%
PubChem CID
13109, 5991
MedlinePlus
a610021, a604032
ChEBI
6443, 4903
ATC code
G03AC03, G03CA01
DrugBank
DB00367
KEGG
D00950, D00554
Routes of administration
Patches
Directions
Twirla is available as a transdermal patch for use on the skin only. Follow the instructions that come with your prescription. If you have any questions, talk to your doctor or pharmacist.
The dose is to apply one patch to clean, dry, and intact skin every week for three consecutive weeks.
Apply the patch to the abdomen, buttock, or upper torso. Do not apply the patch to the breasts. Do not cut the patch. Do not wear the patch during the fourth week.
Each patch delivers 120 mcg/day of levonorgestrel and 30 mcg/day of ethinyl estradiol.
Ingredients
The active ingredients in Twirla include levonorgestrel and ethinyl estradiol.
Contraindications
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI = 30 KG/M2 See full prescribing information for complete boxed warning.
- TWIRLA is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use.
- TWIRLA is contraindicated in women with a BMI = 30 KG/m2. Compared to women with a lower BMI, women with a BMI = 30 KGg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events.
- Do not use Twirla if you have or have ever had blood clots, a heart attack, or a stroke, uncontrolled high blood pressure, certain heart valve problems, a condition that makes your blood clot more than normal, or if you smoke and are older than 35 years old.
- Do not use Twirla if your body mass index is 30 kg/m2 or more.
- Do not use Twirla if you have or have had breast cancer or other hormonally-sensitive cancer.
- Do not use Twirla if you have liver tumors, acute viral hepatitis, or decompensated liver cirrhosis.
- Do not use Twirla if you have migraines with aura, if you are older than 35 years old and have migraines with or without aura, or if you have headaches with focal neurological symptoms.
- Do not use Twirla if you have undiagnosed abnormal bleeding from the vagina.
- Do not use Twirla if you are pregnant.
- Do not use Twirla if you are allergic to levonorgestrel, ethinyl estradiol, or any of its other ingredients.
- Do not use Twirla if you take hepatitis C drugs that contain ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Cautions
- Prior to using Twirla transdermal system, tell your doctor:
- About all the medications you take, including prescription, over-the-counter, vitamins, and herbal supplements
- About your allergies
- About your health conditions
- About any planned surgeries
- If you are pregnant or have plans to become pregnant
- If you are breastfeeding or have plans to breastfeed
- Twirla can increase your risk for blood clots, a heart attack, or a stroke. Cardiovascular risk factors should be considered before starting Twirla.
- Twirla can cause liver problems.
- Twirla can cause high blood pressure. Your blood pressure should be checked periodically.
- Twirla can cause or worsen existing gallbladder disease.
- Twirla can decrease glucose intolerance in women who are prediabetic or diabetic.
- Twirla can increase triglyceride levels, which can lead to pancreatitis.
- Twirla can cause headaches that may become severe or persistent.
- Twirla can cause abnormal vaginal bleeding or no menstruation.
Side Effects
The most common side effects of Twirla include application site reactions, nausea, headache, abnormal vaginal bleeding, and weight gain.
These are not all the possible side effects that can be caused by Twirla. Call your doctor right away if you develop side effects that become bothersome or won't go away.
Reference:
Twirla. Grand Rapids, MI: Corium International, Inc.; 2020.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13643
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