New Release: Alpha testing version has been released.

Norgestrel

G03C - Estrogens ATC G03CA53 Small molecule approved 1968 Oral Natural product

JFDA label: PROGYLUTON Tab

Mechanism of Action

Agonist of Progesterone receptor — Progesterone receptor agonist

TargetActionGene / class
Progesterone receptor efficacy AGONIST PGR

Indications

Approved

  • Hemorrhage — hemorrhage

Off-label

  • Endometrial Neoplasms

Dosing

Source: openFDA

Directions • take 1 tablet at the same time every day • this product will work best to prevent pregnancy when taken exactly as directed • you can start on any day of the month • use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start working See the enclosed leaflet for more information on how to switch from another contraceptive method. • never skip your daily tablet • to prevent pregnancy, take this product every day, even when you bleed or have spotting • when you finish this pack, start the next one the following day without a break • if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days: • take 1 tablet immediately, as soon as you remember that you missed it • then go back to taking your daily tablet at your usual time • use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again • if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed • you should continue to see your healthcare provider(s) for routine healthcare visits When to use a condom (or another barrier method) • every time you have sex for the next 2 days (48 hours): • after you start your first pack of this product • if you take a tablet more than 3 hours late or miss a tablet on 1 or more days • if you vomit or have a severe diarrhea within 4 hours of taking a tablet

Warnings & Precautions

Source: openFDA

Warnings & Precautions

Warnings Allergy alert: Do not use if you are allergic to this product or any of its ingredients, such as FD&C yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy too. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs. Do not use • if you have or ever had breast cancer • if you are already pregnant or think you may be pregnant • together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) • as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex • if you are male Ask a doctor before use if • you currently have vaginal bleeding between your periods and you have not already talked to a doctor • you have liver problems • you have or ever had any cancer Ask doctor or pharmacist before use if • you are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension • you are taking a supplement containing St John’s Wort (an herbal ingredient) • if you have taken ulipristal acetate (an emergency contraceptive, or morning after pill) in the past 5 days See the enclosed leaflet for a detailed list of medicines that may interact with this product. When using this product • you are likely to experience changes in your menstrual periods, such as irregular periods, spotting or bleeding between your periods, or you may stop having periods. To prevent pregnancy, keep taking the product. • you may experience headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating • talk to a doctor (but continue taking every day) if • you have repeated vaginal bleeding brought on by sex • you start having periods that last more than 8 days or are unusually heavy • you start having migraines with aura (headaches that start with changes in vision) or your migraine headaches get worse • take a pregnancy test or talk to a doctor if • your period is late after missing any tablets in the last month • you have not had a period for 2 months or think you may be pregnant Seek medical help right away if • you have sudden or severe persistent pain in your lower belly mostly on one side (you could have an ectopic pregnancy) • you develop yellowing of your skin or whi

Pregnancy & Lactation

Lactation

Caution Hale L3

This record contains information specific to the levonorgestrel implant, which is not available in the United States.

Chemistry & Properties

2D structure
FormulaC21H28O2
Molecular weight312.45 g/mol
IUPAC name(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
CAS797-63-7
PubChem CID13109
InChIKeyWWYNJERNGUHSAO-CULCCENASA-N
logP3.88 (XLogP 3.3)
Polar surface area37.3 Ų
H-bond acceptors / donors2 / 1
Drug-likeness (QED)0.75
Lipinski violations0
SMILESC#CC1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21CC

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP1A2Substrate
CYP2B6Inhibitor
CYP2C19Inhibitor
CYP2C19Substrate
CYP2C8Inhibitor
CYP3A4Substrate

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Drug–drug interactions (100+, DDInter)

Interacting drugSeverityManagement
Acitretin major
Bexarotene major
Brigatinib major
Carfilzomib major
Dabrafenib major
Encorafenib major
Griseofulvin major
Lumacaftor major
Mycophenolic acid major
Sugammadex major
Tranexamic acid major
Acarbose moderate
Adalimumab moderate
Albiglutide moderate
Alefacept moderate
Alogliptin moderate
Aminophylline moderate
Anakinra moderate
Apalutamide moderate
Aprepitant moderate
Artemether moderate
Asparaginase Escherichia coli moderate
Canagliflozin moderate
Canakinumab moderate
Certolizumab pegol moderate
Chlorpropamide moderate
Cladribine moderate
Clarithromycin moderate
Clotrimazole moderate
Cobicistat moderate
Cyclosporine moderate
Dapagliflozin moderate
Dasatinib moderate
Deferasirox moderate
Dulaglutide moderate
Elagolix moderate
Emapalumab moderate
Empagliflozin moderate
Enasidenib moderate
Entrectinib moderate

Showing 40 of 100+.

Registered Products (2)

BrandForm / strengthPackAgentCitizen (JOD)
OVRAL TABS Tablet 50 mcg, 500 mcg 21 tab Arab Company for Medical & Agricultural Products 1.290
PROGYLUTON Tab Tablet 0.5 mg, 2 mg 21 tab The Jordan Drugstore Co 1.520