levonorgestrel oral/ferrous bisglycinate/ ethinylestradiol

Action and Spectrum

Actions and Spectrum 

levonorgestrel oral/ethinylestradiol both are synthetic progestin hormone, and they work primarily by preventing ovulation, making it more difficult for sperm to reach the egg, and altering the uterine lining to reduce the chance of implantation. 

ferrous bisglycinate is a form of iron supplement and it provides iron, an essential mineral required to produce hemoglobin, which carries oxygen in the blood.

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

Nausea (7%) 

Amenorrhea (2%) 

Vaginal moniliasis (2%) 

Breast pain (4%) 

Emotional lability (3%) 

Acne (3%) 

Depression (2%) 

Abdominal pain (4%) 

Metrorrhagia (8%) 

Dysmenorrhea (7%) 

<1% 

Hypertension 

Dysmenorrhea 

Flatulence 

Weight gain 

Hypercholesterolemia 

>10% 

Headache (14%) 

Post marketing Reports 

Musculoskeletal and connective-tissue disorders: back pain, muscle spasm, Pain in extremity, arthralgia 

Immune system disorders: including pruritus, rash, urticaria, erythema, hypersensitivity reactions 

Respiratory, thoracic, and mediastinal disorders: cough, Nasopharyngitis 

Psychiatric disorders: Depression, anxiety, insomnia 

Vascular disorders: Deep vein thrombosis, pulmonary embolism 

Gastrointestinal disorders: vomiting, diarrhea, abdominal pain, nausea 

Cardiac disorder: Chest pain, palpitations, dyspnea 

Sleep disorders: Somnolence 

Black Box Warning

Black Box Warning 

Cigarette smoking will raise the threat of great cardiovascular occasions from blended hormonal contraceptive (CHC) use.  

This threat will increase with age, in girls aged ≥35 year, and with the wide variety of cigarettes smoked. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Women with a history of blood clots or certain clotting disorders may be contraindicated from using levonorgestrel oral/ethinylestradiol as combined oral contraceptives.  
• Allergy or sensitivity to iron or ferrous bisglycinate components of the supplement. 

Caution: 

• Women with a history of severe migraines or migraines with aura should be cautious when using levonorgestrel oral/ethinylestradiol as combined oral contraceptives. 
• ferrous bisglycinate in form of Iron supplements may cause gastrointestinal side effects, and caution should be taken in individuals with conditions like inflammatory bowel disease.

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: levonorgestrel oral/ethinylestradiol are present in human milk 

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

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 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  

levonorgestrel oral/ethinylestradiol both are synthetic progestin, a type of female sex hormone. It acts by binding to progesterone receptors in the body.  

levonorgestrel oral/ethinylestradiol they prevent pregnancy by inhibiting ovulation (release of an egg from the ovaries), thickening cervical mucus thus making it harder for sperm to reach the egg also reduces the risk of breakthrough bleeding, and enhances the contraceptive efficacy of combined drug. 

ferrous bisglycinate is a form of iron supplement used to treat or prevent iron deficiency anemia. It contains iron, an essential mineral required to produce hemoglobin, which carries oxygen in the blood.  

Pharmacodynamics 

levonorgestrel oral/ethinylestradiol both exerts its effects by binding to progesterone receptors in target tissues, including the hypothalamus, pituitary gland, and reproductive organs. 

ferrous bisglycinate provides supplemental iron, which is necessary to treat or prevent iron deficiency anemia. 

Pharmacokinetics 

Absorption   

levonorgestrel oral/ethinylestradiol both well absorbed after oral administration.  

ferrous bisglycinate is a form of iron supplement shows high bioavailability and better absorption. 

Distribution 

levonorgestrel oral/ethinylestradiol both extensively bound to plasma proteins. 

ferrous bisglycinate is distributed throughout the body. 

Metabolism 

levonorgestrel oral/ethinylestradiol both undergoes metabolism mainly in the liver. 

ferrous bisglycinate as iron is not significantly metabolized in the body. 

Elimination and excretion 

levonorgestrel oral/ethinylestradiol are excreted in urine around 40 to 68% and in feces 16 to 48%. 

iron supplements are primarily excreted through feces and sweat. 

Adminstartion

Administration 

Oral contraceptive containing levonorgestrel /ethinylestradiol are usually taken orally in form of tablets.  

ferrous bisglycinate, as an iron supplement is taken orally and available in various forms such as tablets and capsules. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: levonorgestrel oral/ferrous bisglycinate/ethinylestradiol         

Why do we use levonorgestrel oral/ferrous bisglycinate/ethinylestradiol? 

levonorgestrel oral/ethinylestradiol are commonly used for birth control to prevent pregnancy as combined oral contraceptives.   

ferrous bisglycinate is a form of iron supplement used to treat iron deficiency. 

Iron supplements like ferrous bisglycinate help increase iron levels in the body and improve red blood cell production.