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.
Nextstellis (Drospirenone and Estetrol)
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Product Details
Description
Nextstellis is a combination oral birth control pill that contains a progestin (drospirenone) and an estrogen (estetrol). Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.
Fact Table
Formula
C18H24O4
License
US FDA, EU EMA
Bioavailability
high
Legal status
Rx-Only
Chemical Name
Drospirenone/estetrol
Elimination half-life
24–27 h
Dosage (Strength)
3mg/14.2mg
Pregnancy
-
Brands
Nextstellis
Protein binding
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PubChem CID
27125
MedlinePlus
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ChEBI
142773
ATC code
G03AA18
DrugBank
DB01395
KEGG
D12047
Routes of administration
By mouth
Directions
Nexstellis is available in a tablet. You should receive a blister pack of 28 tablets with your prescription:
- 24 pink active tablets contain 3 mg of drospirenone and 14.2 mg of estetrol
- 4 white inactive tablets
Take one tablet by mouth once daily at the same time each day. Follow the instructions that come with your prescription. Talk to your doctor or pharmacist about any questions or concerns you may have.Ingredients
Each pink tablet contains drospirenone and estetrol.
Contraindications
- Do not take Nexstellis if you are older than 35 years old and you smoke.
- Do not take Nextstellis if you currently have or have had blood clots, uncontrolled high blood pressure, a heart attack, a stroke, or certain heart valve problems.
- Do not take Nextstelllis if you currently have or have had breast cancer or any other hormonally-sensitive cancer.
- Do not take Nexstellis if you have migraines with aura.
- Do not take Nexstellis if you have diabetes with high blood pressure or end-organ damage or if you have had diabetes for more than 20 years.
- Do not take Nextstellis if you have a liver tumor, liver cancer, acute hepatitis, or decompensated liver cirrhosis.
- Do not take Nextstellis with hepatitis C medications that contain ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
- Do not take Nexstellis if you have unexplained vaginal bleeding.
- Do not take Nextstellis if you have kidney problems.
- Do not take Nexstellis if you have adrenal insufficiency.
Cautions
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
- Females over 35 years old who smoke should not use NEXTSTELLIS
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
- Before you start taking Nextstellis, tell your doctor:
- About all the medications you take, including prescription, nonprescription, vitamins, and herbal supplements
- About your allergies
- About your health conditions
- If you are pregnant, think you may be pregnant, or have plans to become pregnant
- If you are breastfeeding or have plans to breastfeed
- Nextstellis can increase your risk for blood clots, a heart attack, or a stroke. Cardiovascular risk factors should be considered before starting Nextstellis.
- Nextstellis can cause high potassium levels in your blood. Your potassium levels should be checked regularly. Call your doctor right away if you develop muscle fatigue, weakness, irregular heart rhythms, nausea, or paralysis.
- Nextstellis can cause high blood pressure. You should periodically check your blood pressure.
- Nexstellis can cause migraines that may become severe or won't go away.
- Nexstellis can cause liver problems.
- Nextstellis can increase your risk for hormonally-sensitive cancers such as breast cancer.
- Nexstellis can decrease glucose intolerance in women who have prediabetes or diabetes.
- Nexstellis can increase triglyceride levels in women who have elevated triglyceride levels or have a family history of elevated triglyceride levels. This can lead to pancreatitis.
- Nextstellis can cause gallbladder problems and cholestasis.
- Nextstellis can cause irregular vaginal bleeding or no menstruation.
Side Effects
The most common side effects caused by Nextstellis include abnormal vaginal bleeding, mood changes, headache, acne, weight gain, painful periods, breast tenderness, and decreased sex drive.
These are not all of the possible side effects of Nextstellis. Contact your doctor right away if you experience side effects that become bothersome or won't go away.
References:
- Nexstellis. Greenville, NC: Mayne Pharma; 2021.
- Nextstellis (drospirenone and estetrol tablets) 3 mg/14.2 mg. Accessed February 9, 2022.
- High potassium (hyperkalemia). Mayo Clinic. November 14, 2020. Accessed February 9, 2022.
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 : 13640
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