Your session is about to expire
What is Balcoltra
LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel is a synthetic hormone used in contraception and hormone therapy. It is also known as Plan B and is used as an emergency contraceptive or as a hormonal contraceptive released from an intrauterine device. It can also be used as a long-term contraceptive, with some devices lasting up to three years. Levonorgestrel was approved by the FDA in 1982 and is the most commonly used emergency contraceptive. It is very effective and does not cause estrogenic side effects unlike other emergency contraceptives.
Triphasil-21is the brand name
Balcoltra Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Triphasil-21
Levonorgestrel
1984
243
Approved as Treatment by the FDA
Levonorgestrel, also known as Triphasil-21, is approved by the FDA for 6 uses including Emergency Contraception and moderate Menopausal Vasomotor Symptoms .Emergency Contraception
moderate Menopausal Vasomotor Symptoms
Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol
Postmenopausal Osteoporosis
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol
Has had at least 1 child
Hot flashes
Used to treat Menopause in combination with Estradiol
Effectiveness
How Balcoltra Affects PatientsLevonorgestrel is a type of emergency contraceptive used to prevent pregnancy. It can be taken as a pill up to 72 hours after intercourse, and is 89% effective. When used in intrauterine or implantable devices, levonorgestrel is more than 99% effective in preventing pregnancy. In addition, it can also be used as part of hormone therapy to help prevent endometrial cancer.
How Balcoltra works in the bodyLevonorgestrel works in different ways to prevent pregnancy. It stops the hypothalamus from releasing the hormones that trigger ovulation, which prevents the release of viable eggs from the ovaries. It also thickens cervical mucus, which makes it harder for sperm to get to the uterus and fertilize an egg. Finally, it changes the endometrium so that a fertilized egg is less likely to implant. When used together with estrogen, it reduces the possibility of endometrial cancer caused by unopposed estrogen.
When to interrupt dosage
The endorsed dosage of Balcoltra is contingent upon the diagnosed situation, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The measure of dosage likewise changes as per the technique of delivery noted in the table below.Condition
Dosage
Administration
Postmenopausal Osteoporosis
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Emergency Contraception
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Hypermenorrhea
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Menopause
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Hot flashes
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Has had at least 1 child
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Endometrial Hyperplasia
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Endometriosis
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
moderate Menopausal Vasomotor Symptoms
, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg
Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
Warnings
Balcoltra ContraindicationsCondition
Risk Level
Notes
Septic Abortion
Do Not Combine
undiagnosed abnormal genital bleeding
Do Not Combine
infected abortions
Do Not Combine
HCG elevated
Do Not Combine
Pelvic Infection
Do Not Combine
Vaginitis
Do Not Combine
Acute Coryza
Do Not Combine
presence or history of breast cancer
Do Not Combine
Uterine Cervicitis
Do Not Combine
Communicable Diseases
Do Not Combine
gonococcal cervical infection
Do Not Combine
Breast Cancer
Do Not Combine
Intrauterine Devices
Do Not Combine
Neoplasms, Hepatic
Do Not Combine
congenital or aquired uterine abnormality
Do Not Combine
Chlamydia Infections
Do Not Combine
Hypersensitivity
Do Not Combine
Emergency Contraception
Do Not Combine
Bacterial Endocarditis
Do Not Combine
lower genital tract infection
Do Not Combine
suspected pregnancy
Do Not Combine
Uterine Cervicitis
Do Not Combine
uterine neoplasia
Do Not Combine
Pelvic Inflammatory Disease
Do Not Combine
history of progestogen-sensitive breast cancer
Do Not Combine
Cervical Neoplasia
Do Not Combine
Fibroid Tumor
Do Not Combine
Postpartum Endometritis
Do Not Combine
chlamydial cervical infection
Do Not Combine
PAP Test Abnormalities
Do Not Combine
acute liver disease
Do Not Combine
Uterine anomaly distorting uterine cavity
Do Not Combine
Breast Cancer
Do Not Combine
Cervical Dysplasia
Do Not Combine
Thromboembolism
Do Not Combine
Bacterial Vaginosis
Do Not Combine
history of pelvic inflammatory disease
Do Not Combine
Breast
Do Not Combine
Vaginal Bleeding
Do Not Combine
Bacterial Vaginosis
Do Not Combine
Pelvic Inflammatory Disease
Do Not Combine
gonococcal cervical infection
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Levonorgestrel may interact with Pulse Frequency
Common Balcoltra Drug Interactions
Drug Name
Risk Level
Description
Astemizole
Major
The metabolism of Astemizole can be decreased when combined with Levonorgestrel.
Axitinib
Major
The metabolism of Axitinib can be decreased when combined with Levonorgestrel.
Cabazitaxel
Major
The metabolism of Cabazitaxel can be decreased when combined with Levonorgestrel.
Copanlisib
Major
The metabolism of Copanlisib can be decreased when combined with Levonorgestrel.
Crizotinib
Major
The metabolism of Crizotinib can be decreased when combined with Levonorgestrel.
Balcoltra Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000 mg/kg. Symptoms of a levonorgestrel overdose include nausea and bleeding, and should be treated with symptomatic care. In the case of an overdose, contact your local poison control center as there is no specific antidote.
Balcoltra Novel Uses: Which Conditions Have a Clinical Trial Featuring Balcoltra?
Condition
Clinical Trials
Trial Phases
Endometriosis
30 Actively Recruiting
Phase 3, Not Applicable, Early Phase 1, Phase 2, Phase 4, Phase 1
Menopause
0 Actively Recruiting
Hot flashes
22 Actively Recruiting
Phase 2, Not Applicable, Phase 1, Phase 4, Early Phase 1
Has had at least 1 child
0 Actively Recruiting
Emergency Contraception
1 Actively Recruiting
Phase 4
Endometrial Hyperplasia
9 Actively Recruiting
Phase 2, Not Applicable
Hypermenorrhea
0 Actively Recruiting
Postmenopausal Osteoporosis
3 Actively Recruiting
Not Applicable, Phase 4
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Balcoltra Reviews: What are patients saying about Balcoltra?
3.7Patient Review
5/8/2021 I was on Balcoltra for a while, but I didn't find that it did much to help with my spotting issue. It also was insanely expensive; however, there is a coupon on the Balcoltra website which lowers the cost to $21 per pack.
3.3Patient Review
8/27/2022 For the first three months, this pill shortened my periods. However, during that time I also experienced constant breakouts and acne flare-ups.
2.7Patient Review
10/12/2021 Balcoltra birth control pills. I bled for 18 days straight, was bloated and cramping the entire time I took this medicine, got migraines, and my nipples were very sore.
Patient Q&A Section about balcoltra
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.What kind of birth control is Balcoltra?
"Thispill prevents pregnancy by using 2 hormones, levonorgestrel and ethinyl estradiol. There is a small amount of iron in each of the 7 inactive tablets taken during the fourth week. These inactive pills do not contain any hormones."
Answered by AI
Does Balcoltra stop periods?
"If you takeBalcoltra, you may miss a period or have irregular vaginal bleeding or spotting, especially during the first few months. This is usually not serious. If the bleeding or spotting continues, especially after you have had regular menstrual cycles, you should call your doctor."
Answered by AI
Does Balcoltra make u gain weight?
"Some common side effects of taking Balcoltra may include acne, facial skin darkening, weight gain, or difficulties with contact lenses."
Answered by AI
Is Balcoltra birth control good?
"I have been taking Balcoltra for around a year as a form of birth control and it has been working very well for me. I had previously been taking Sprintec but it made me very depressed and moody. Balcoltra has helped clear up my acne and I only have a very short and light period now."
Answered by AI