progesterone intravaginal gel

Action and Spectrum

Actions and Spectrum 

The main purpose of intravaginal progesterone gel is to give women undergoing fertility therapy pharmacological support. A hormone called progesterone is crucial for maintaining a pregnancy and for the menstrual cycle.  

The range of activity or potency of intravaginal progesterone gel is referred to as its spectrum. The ability to sustain the growth of the embryo and the upkeep of the pregnancy would fall under the spectrum in this instance. 

Drug Interaction

Adverse Reaction

Frequency not defined  

Arthralgia 

General pruritus 

Ectopic pregnancy 

Jaundice 

Dysarthria 

Drunk feeling 

Bloating 

Vaginal candidiasis 

1-10% 

Irritability (8%) 

Constipation (<5%) 

Worry (8%) 

Cough (8%) 

Dizziness (5%) 

Vaginal discharge (10%) 

Chest pain (7%) 

Cholecystectomy (<5%) 

Fatigue (8%) 

Diarrhea (7-8%) 

Constipation (2-3%) 

>10% 

Breast enlargement (40%) 

Urinary difficulties (11%) 

Somnolence (27%) 

Mood swings (22-23%) 

Nausea (6-22%) 

Musculoskeletal pain (12%) 

Headache (13%) 

Dizziness (15-24%) 

Breast pain (13%) 

Abdominal pain (5-12%) 

Perineal pain (17%) 

Nervousness (16%) 

Sleep disorder (18%) 

Depression (11-19%) 

Breast tenderness (27%) 

Cramps (15-26%) 

Black Box Warning

Black Box Warning 

In the black box warning, it is stated that using intravaginal progesterone gel increases the risk of venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism. 

Contraindication / Caution

Contraindication/Caution: 

• Women who have a known hypersensitivity to progesterone or any of the other ingredients in the gel should not use intravaginal progesterone gel.  
• women who have a history of liver disease, depression, migraines, asthma, or seizures should use intravaginal progesterone gel with caution because it may make these conditions worse.  
• intravaginal progesterone gel should be used cautiously by women with a history of blood clots, stroke, or heart attacks as it may raise the risk of venous thromboembolism. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category
 

Pharmacology

Pharmacology 

progesterone, a female sex hormone produced by the ovaries, is supplemented in the pharmacology of intravaginal progesterone gel. 

progesterone is essential to the menstrual cycle because it helps the embryo grow and develop and prepare the uterus for pregnancy 

Pharmacodynamics 

The effects of intravaginal progesterone gel on the body’s hormone levels and reproductive system are part of its pharmacodynamics. A steroid hormone, progesterone, has impacts on the body by interacting with receptors. 

During fertility treatment, intravaginal progesterone gel helps the embryo’s growth and development by supplementing the body’s natural synthesis of progesterone. 

Pharmacokinetics 

Absorption   

progesterone gel used intravaginally is given directly to the vagina and then absorbed into the bloodstream. To improve its bioavailability and absorption, the progesterone in the gel has been formed into tiny particles known as micronized progesterone. 

Distribution 

progesterone is dispersed throughout the body after being absorbed into the bloodstream and binds to receptors in the reproductive system, including the uterus and ovaries. 

Metabolism 

The liver breaks down progesterone into metabolites that are eliminated through the urine and feces. It is crucial to raise any worries with your healthcare professional because some drugs and medical conditions can impact how progesterone is metabolized. 

Elimination and excretion 

Urine and feces are used by the body to expel progesterone and its metabolites. progesterone has a short elimination half-life, lasting only 20 to 30 minutes. 

Adminstartion

Administration:  

progesterone gel is normally injected intravaginally once a day, ideally at the same time each day. The applicator that comes with the gel is meant to be put into the vagina after being filled with the recommended amount of gel. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: progesterone intravaginal gel 

Why do we use progesterone intravaginal gel? 

To encourage embryo implantation and early pregnancy in women undergoing assisted reproductive technologies like in vitro fertilisation (IVF), progesterone intravaginal gel is generally used in fertility treatments.