Introvale
Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more
Treatment
7 FDA approvals
20 Active Studies for Introvale
Treatment for
Endometrial Hyperplasia
What is Introvale
Levonorgestrel
The Generic name of this drug
Treatment Summary
Levonorgestrel (LNG), also known as Plan B, is a hormone used in contraception and hormone therapy. It can come in a single dose, an intrauterine device, or a subdermal implant. Levonorgestrel is the most widely used emergency contraceptive, and was approved by the FDA in 1982. It has been found to be highly effective with few estrogenic side effects compared to other emergency contraceptives.
Triphasil-21
is the brand name
Introvale 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 7 uses including Osteoporosis, Postmenopausal and Menopause .
Osteoporosis, Postmenopausal
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol
Postmenopausal Osteoporosis
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
moderate Menopausal Vasomotor Symptoms
Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol
Has had at least 1 child
Emergency Contraception
Hot flashes
Used to treat Menopause in combination with Estradiol
Effectiveness
How Introvale Affects Patients
Levonorgestrel is a type of contraceptive that works by preventing ovulation, fertilization, and implantation. As an emergency contraceptive pill it can prevent pregnancy up to 72 hours after intercourse, and its effectiveness is 89%. When used in intrauterine or implantable devices, levonorgestrel is more than 99% successful in preventing pregnancy. It can also be used as part of a hormonal therapy to reduce the risk of endometrial cancer caused by estrogen.
How Introvale works in the body
Levonorgestrel has multiple mechanisms of action. It suppresses ovulation by slowing the release of hormones from the hypothalamus that would normally cause the release of an egg. It also makes the cervical mucus thicker and harder for sperm to pass through, reducing the risk of fertilization. Finally, it can act as an anti-estrogen to reduce the risk of endometrial cancer in those taking estrogen-based hormone therapy.
When to interrupt dosage
The measurement of Introvale is based upon the determined illness, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage is contingent upon the technique of delivery outlined in the table below.
Condition
Dosage
Administration
Osteoporosis, Postmenopausal
, 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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
Menorrhagia
, 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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
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 - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant, Implant - Subcutaneous
Warnings
Introvale has forty-three contraindications, and its utilization should be avoided if any of the conditions in the subsequent table are present.
Introvale Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Levonorgestrel may interact with Pulse Frequency
Abortion, Septic
Do Not Combine
undiagnosed abnormal genital bleeding
Do Not Combine
Abortion, Spontaneous
Do Not Combine
HCG elevated
Do Not Combine
Pelvic Infection
Do Not Combine
Vaginitis
Do Not Combine
Acute Coryza
Do Not Combine
Breast Neoplasms
Do Not Combine
Uterine Cervicitis
Do Not Combine
Communicable Diseases
Do Not Combine
Gonorrhea
Do Not Combine
Breast Cancer
Do Not Combine
Intrauterine Devices
Do Not Combine
Liver Neoplasms
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
Endocarditis, Bacterial
Do Not Combine
Vaginosis, Bacterial
Do Not Combine
suspected pregnancy
Do Not Combine
Uterine Cervicitis
Do Not Combine
Uterine Neoplasms
Do Not Combine
Pelvic Inflammatory Disease
Do Not Combine
Breast Neoplasms
Do Not Combine
Uterine Cervical Neoplasms
Do Not Combine
Fibroid Tumor
Do Not Combine
Endometritis
Do Not Combine
chlamydial cervical infection
Do Not Combine
PAP Test Abnormalities
Do Not Combine
Liver Failure, Acute
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
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
Gonorrhea
Do Not Combine
There are 20 known major drug interactions with Introvale.
Common Introvale 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.
Introvale Toxicity & Overdose Risk
The lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000mg/kg. Overdosing on this drug may cause nausea and bleeding. People who overdose on levonorgestrel should receive supportive care and contact a local poison control center. There is no specific antidote for levonorgestrel overdose.
Introvale Novel Uses: Which Conditions Have a Clinical Trial Featuring Introvale?
99 active studies are in progress to evaluate the potential of Introvale for treating Postmenopausal Osteoporosis, Women who have had at least one child and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Endometriosis
30 Actively Recruiting
Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4
Hot flashes
19 Actively Recruiting
Not Applicable, Phase 2, Phase 4, Early Phase 1, Phase 3
Menorrhagia
3 Actively Recruiting
Phase 1, Phase 2, Not Applicable
Has had at least 1 child
0 Actively Recruiting
Endometrial Hyperplasia
3 Actively Recruiting
Not Applicable, Phase 2, Phase 3
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Menopause
0 Actively Recruiting
Osteoporosis, Postmenopausal
0 Actively Recruiting
Emergency Contraception
1 Actively Recruiting
Phase 4
Introvale Reviews: What are patients saying about Introvale?
5
Patient Review
11/14/2015
Introvale for Abnormally Long or Heavy Periods
5
Patient Review
7/12/2017
Introvale for Birth Control
4.7
Patient Review
10/11/2015
Introvale for Abnormally Long or Heavy Periods
4.3
Patient Review
5/4/2015
Introvale for Abnormally Long or Heavy Periods
3.7
Patient Review
7/11/2016
Introvale for Abnormally Long or Heavy Periods
3.7
Patient Review
8/9/2016
Introvale for Birth Control
3.7
Patient Review
5/20/2016
Introvale for Birth Control
3.3
Patient Review
10/8/2013
Introvale for Birth Control
3.3
Patient Review
4/24/2016
Introvale for Birth Control
3.3
Patient Review
3/22/2017
Introvale for Painful Periods
3
Patient Review
9/17/2013
Introvale for Birth Control
3
Patient Review
11/19/2019
Introvale for Birth Control
2.7
Patient Review
3/25/2017
Introvale for Abnormally Long or Heavy Periods
2.7
Patient Review
2/19/2018
Introvale for Acne
2.3
Patient Review
6/14/2020
Introvale for Birth Control
2
Patient Review
4/1/2019
Introvale for Birth Control
1
Patient Review
11/14/2017
Introvale for Abnormally Long or Heavy Periods
Patient Q&A Section about introvale
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Introvale generic for Seasonale?
"Sandoz has announced that the FDA has approved their generic equivalent of Duramed's Seasonale, Introvale (levonorgestrel and ethinyl estradiol tablets, USP)."
Answered by AI
What is Introvale medicine?
"Introvale is a prescription medicine used to prevent pregnancy by means of contraception. It may be used alone or with other medications, and is classified as an Estrogen/Progestin drug under the subcategory of Contraceptives, Oral. Its efficacy in children has not been established prior to menarche."
Answered by AI
Is Amethia and Ashlyna the same?
"The drug Amethia is used as a contraceptive to prevent pregnancy. The generic version of Amethia is Ethinyl Estradiol/Norethindrone."
Answered by AI
What is Introvale generic for?
"Introvale is a combined oral contraceptive that contains levonorgestrel and ethinyl estradiol. It is indicated for use by women to prevent pregnancy. Introvale is available in generic form."
Answered by AI