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Balcoltra
Balcoltra is a combination oral contraceptive pill (OCP) used to prevent pregnancy. It contains two active ingredients: levonorgestrel, a progestin, and ethinyl estradiol, an estrogen. These hormones work together to inhibit ovulation, alter the cervical mucus to prevent sperm from reaching the egg, and change the lining of the uterus to prevent attachment of a fertilized egg. Balcoltra is also used to regulate menstrual cycles, reduce the risk of ovarian cysts, and decrease the severity of menstrual cramps.
Drug Availability and Controlled Substance Status
Balcoltra is available by prescription only and is not classified as a controlled substance. It is provided in a 28-day pack that contains 21 active pills (each containing levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg) and 7 inactive (placebo) pills.
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Frequently Asked Questions
How long does it take for Balcoltra to start working?
When starting Balcoltra on the first day of the menstrual cycle (Day 1 start), it is effective immediately. If started at any other time, additional non-hormonal contraception (e.g., condoms) should be used for the first 7 days.
Can I skip the placebo pills to avoid having a period?
Yes, some women choose to skip the placebo pills and start a new pack immediately to avoid menstruation. However, you should consult your healthcare provider before doing this to ensure it is safe for you.
What should I do if I miss a dose of Balcoltra?
If you miss one active pill, take it as soon as you remember and take the next pill at the usual time (this may mean taking two pills in one day). If you miss two or more active pills, follow the instructions provided in the package insert, which may include using backup contraception for a short period.
Is Balcoltra safe to use during breastfeeding?
Balcoltra is not typically recommended during breastfeeding, as the estrogen component can reduce milk supply. Progestin-only contraceptives are generally preferred for breastfeeding mothers.
Can Balcoltra cause weight gain?
Some women may experience weight changes while taking Balcoltra, although significant weight gain is uncommon. If you are concerned about weight changes, discuss this with your healthcare provider.
Does Balcoltra protect against sexually transmitted infections (STIs)?
No, Balcoltra does not protect against STIs. It is solely intended for contraception. For protection against STIs, consider using a barrier method, such as condoms, in conjunction with Balcoltra.
Comprehensive Drug Guide
How Does Balcoltra Work?
Balcoltra works by combining the effects of levonorgestrel and ethinyl estradiol:
- Levonorgestrel (Progestin): Suppresses ovulation by inhibiting the luteinizing hormone (LH) surge, thickens cervical mucus to hinder sperm penetration, and alters the endometrial lining to prevent implantation.
- Ethinyl Estradiol (Estrogen): Inhibits follicle-stimulating hormone (FSH) to prevent the maturation of eggs, stabilizes the endometrial lining to reduce breakthrough bleeding, and enhances the contraceptive effects of progestin.
What is Balcoltra Used For?
- Prevention of Pregnancy: As a contraceptive method to prevent unintended pregnancies.
- Regulation of Menstrual Cycles: In women with irregular periods.
- Reduction of Menstrual-Related Symptoms: Such as cramps, heavy bleeding, and menstrual-related acne.
Common Dosages
- Administration: Balcoltra should be taken at the same time each day to maintain consistent hormone levels and maximize its effectiveness. The tablets should be swallowed whole, with or without food. If a dose is missed, the specific instructions for missed doses should be followed to reduce the risk of pregnancy.
- Starting Balcoltra: It can be started on the first day of the menstrual cycle (Day 1 start) or on the first Sunday after the onset of menstruation (Sunday start). Additional non-hormonal contraception (e.g., condoms) should be used for the first 7 days if starting on any day other than the first day of the period.
Typical Dosing
FDA Approved Indications
Balcoltra is typically taken as follows:
- Standard Dosage: One active tablet (containing levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg) is taken once daily for 21 days, followed by one inactive tablet daily for 7 days. This 28-day cycle is repeated continuously, with menstruation typically occurring during the 7 days of inactive pills.
Off-Label Uses
Who Shouldn't Take Balcoltra?
Balcoltra is contraindicated in patients with:
- History of thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism).
- History of stroke or myocardial infarction.
- Known or suspected breast cancer or other estrogen- or progestin-sensitive cancers.
- Liver disease, including liver tumors or active hepatitis.
- Uncontrolled hypertension.
- Migraines with aura.
- Known hypersensitivity to levonorgestrel, ethinyl estradiol, or any component of the product.
- Pregnancy.
Advice From The Pharmacist
Patients using Balcoltra should be advised to:
- Take the pill at the same time every day to maintain its effectiveness and reduce the risk of missing doses.
- Be aware of potential side effects, such as nausea, breast tenderness, or mood changes, especially during the first few months of use.
- Use additional contraception (e.g., condoms) if they miss a dose or if they experience vomiting or severe diarrhea within a few hours of taking the pill, as these can reduce its effectiveness.
- Inform their healthcare provider if they experience any unusual symptoms, such as severe headaches, vision changes, or signs of a blood clot (e.g., sudden leg pain, chest pain, or difficulty breathing).
- Avoid smoking, especially if over the age of 35, as smoking increases the risk of serious cardiovascular side effects associated with hormonal contraceptives.
- Consult their healthcare provider before starting any new medications, including over-the-counter drugs and supplements, as some medications can reduce the effectiveness of oral contraceptives.
Side Effects of Balcoltra
Common Side Effects
Common side effects of Balcoltra may include:
- Nausea or vomiting
- Breast tenderness or enlargement
- Headache
- Weight changes
- Mood changes or depression
- Spotting or breakthrough bleeding between periods
- Decreased libido
Uncommon/Severe Side Effects
Serious side effects can include:
- Thromboembolic Events: Such as deep vein thrombosis, pulmonary embolism, stroke, or heart attack.
- Hypertension: Especially in patients with pre-existing high blood pressure.
- Liver Problems: Including liver tumors or jaundice.
- Severe Allergic Reactions: Such as rash, itching, swelling, or difficulty breathing.
Patients should seek immediate medical attention if they experience severe or persistent side effects, especially symptoms indicative of a blood clot or stroke.
Risks and Warnings of Balcoltra
- Increased Risk of Blood Clots: Balcoltra, like all combined oral contraceptives, increases the risk of venous thromboembolism (VTE), particularly in women who smoke, are over the age of 35, or have a history of clotting disorders. Patients should be informed of the signs of blood clots and advised to stop the medication and seek medical attention if they experience symptoms like leg pain, chest pain, or difficulty breathing.
- Cardiovascular Risks: The risk of cardiovascular events, such as heart attack or stroke, is higher in women who smoke and use combined oral contraceptives. Smoking cessation is strongly recommended for women using Balcoltra, particularly those over 35 years of age.
- Liver Disease: Combined oral contraceptives can exacerbate liver conditions or cause liver tumors. Regular monitoring of liver function may be necessary for some patients.
Interactions with Balcoltra
Common Drug Interactions
Balcoltra may interact with other medications, including:
- Antibiotics: Certain antibiotics, such as rifampin, can decrease the effectiveness of Balcoltra.
- Anticonvulsants: Medications like phenytoin and carbamazepine can reduce the contraceptive efficacy of Balcoltra.
- HIV Medications: Some antiretroviral drugs may interact with hormonal contraceptives.
- St. John’s Wort: An herbal supplement that can reduce the effectiveness of Balcoltra by increasing the metabolism of the hormones.
Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions and discuss the need for backup contraception if necessary.
Alternatives to Balcoltra
Alternative contraceptive methods include:
- Other Combined Oral Contraceptives (COCs): Such as Yaz, Yasmin, or Loestrin, which contain different combinations or dosages of hormones.
- Progestin-Only Pills: An option for women who cannot take estrogen-containing contraceptives.
- Long-Acting Reversible Contraceptives (LARCs): Such as intrauterine devices (IUDs) or contraceptive implants, which provide long-term contraception without the need for daily pills.
- Barrier Methods: Such as condoms or diaphragms, which can be used in combination with hormonal contraceptives or alone.
- Non-Hormonal Methods: Such as copper IUDs or fertility awareness-based methods.
The choice of contraception depends on individual preferences, health status, and lifestyle considerations.