Progesterone Micro 100mg Capsules

Manufacturer BIONPHARMA Active Ingredient Progesterone Capsules(proe JES ter one) Pronunciation proe JES ter one
WARNING: Do not use this drug with an estrogen to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, breast cancer, a blood clot, and dementia.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to lower the chance of endometrial changes after menopause in people who are getting estrogen therapy.It is used to treat people who do not have a monthly period cycle.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Progestin
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Pharmacologic Class
Progestin; Steroid hormone
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Pregnancy Category
Category B
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FDA Approved
May 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Progesterone is a natural female hormone important for regulating menstruation and supporting pregnancy. This medication helps to replace or supplement your body's natural progesterone, often used with estrogen in hormone therapy or to help with menstrual problems.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
If you are taking your medication once a day, take it at bedtime.
You can take your medication with or without food. However, if it causes stomach upset, take it with food.
Swallow your medication with a full glass of water.
If you have difficulty swallowing, consult your doctor for advice.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature, avoiding refrigeration or freezing.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of reach of children and pets.

What to Do If You Miss a Dose

If you forget to take a dose of your medication:

Take the missed dose as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take the capsule at bedtime, as it can cause drowsiness or dizziness.
  • Take with food to improve absorption and reduce stomach upset.
  • Avoid grapefruit juice, as it can increase progesterone levels.
  • Do not smoke, as smoking can increase the risk of blood clots, especially when combined with hormone therapy.
  • Report any unusual vaginal bleeding, breast changes, or signs of blood clots immediately to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: For prevention of endometrial hyperplasia in postmenopausal women receiving concomitant estrogen: 100 mg daily at bedtime, or 200 mg daily at bedtime for 12 sequential days per 28-day cycle. For treatment of secondary amenorrhea: 400 mg daily at bedtime for 10 days.
Dose Range: 100 - 400 mg

Condition-Specific Dosing:

endometrial_hyperplasia_prevention: 100 mg daily at bedtime (continuous) or 200 mg daily at bedtime for 12 sequential days per 28-day cycle.
secondary_amenorrhea: 400 mg daily at bedtime for 10 days.
luteal_phase_support_ART: Typically 100-200 mg 2-3 times daily (off-label for oral route, often vaginal/IM preferred for this indication).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (except for specific conditions like secondary amenorrhea in older adolescents, consult specialist)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, use with caution
Severe: No specific adjustment recommended, use with caution
Dialysis: Not available

Hepatic Impairment:

Mild: Use with caution
Moderate: Reduced dose may be necessary; use with caution
Severe: Contraindicated due to extensive hepatic metabolism
Confidence: Medium

Pharmacology

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Mechanism of Action

Progesterone is a naturally occurring steroid that induces secretory changes in the endometrium, preparing it for implantation of a fertilized ovum. It also inhibits the pituitary secretion of gonadotropins, which in turn prevents follicular maturation and ovulation. In estrogen-primed women, progesterone transforms the proliferative endometrium into a secretory endometrium.
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Pharmacokinetics

Absorption:

Bioavailability: <10% (due to extensive first-pass metabolism)
Tmax: 1.5-2 hours
FoodEffect: Food increases absorption

Distribution:

Vd: 2-4 L/kg
ProteinBinding: 96-99% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Yes (metabolites like allopregnanolone are neuroactive)

Elimination:

HalfLife: 25-50 hours (for metabolites; parent drug is shorter, ~5-9 hours)
Clearance: Not precisely quantified for oral route due to high first-pass
ExcretionRoute: Primarily renal (50-60%), also biliary/fecal (10%)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within hours (sedative effects); endometrial effects within days
PeakEffect: Related to steady-state plasma concentrations (achieved within days of regular dosing)
DurationOfAction: Dependent on dosing frequency (e.g., 24 hours for once-daily dosing)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Cardiovascular symptoms, including:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Mobility issues, such as trouble walking
Severe dizziness or fainting
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, such as:
+ Itching or discharge
+ Abnormal vaginal bleeding
Urinary symptoms, including:
+ Pain while urinating
+ Frequent urination
Mood changes, such as depression or memory problems

This medication may cause fluid retention, leading to swelling or weight gain. If you experience any of these symptoms, inform your doctor. Seek immediate medical attention if you notice signs of a blood clot, including:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

Dizziness, drowsiness, tiredness, or weakness
Headache
Gastrointestinal symptoms, including:
+ Constipation
+ Diarrhea
+ Vomiting
+ Upset stomach
Stomach pain or cramps
Bloating
Breast-related symptoms, such as:
+ Enlarged breasts
+ Tender breasts
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased interest in sex

This list is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden severe headache or migraine
  • Sudden vision changes (e.g., partial or complete loss of vision)
  • Sudden chest pain, shortness of breath, or coughing up blood
  • Pain, swelling, or warmth in one leg
  • Yellowing of the skin or eyes (jaundice)
  • Severe mood changes or depression
  • Unusual vaginal bleeding or spotting after menopause
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have a peanut allergy, as the capsules contain peanut oil.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other cancers
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that may be influenced by estrogen or progesterone
Unexplained vaginal bleeding
* If you are pregnant or think you may be pregnant. Do not take this medication during pregnancy unless your doctor advises you to do so.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and they will instruct you on when to resume taking it after the surgery or procedure.

Until you know how this medication affects you, avoid driving and other activities that require your full attention. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels.

Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your healthcare provider. This medication may interfere with certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.

There is a risk of blood clots associated with this medication, which can be life-threatening. Blood clots can manifest as heart attacks, strokes, or clots in the legs, lungs, or eyes. If you have a history of blood clots, inform your doctor. Prolonged periods of immobility, such as long trips, bed rest after surgery, or illness, may increase your risk of developing blood clots. Discuss this with your doctor if you anticipate being still for an extended period.

Certain side effects, including heart attacks, strokes, and breast cancer, have been reported in individuals taking estrogen with progestin. The risk of these side effects may vary depending on factors such as treatment duration, whether estrogen is taken with or without progestin, and other individual factors. Your doctor can help you understand the benefits and risks of using this medication.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not a form of birth control and will not prevent pregnancy. If you have questions or concerns, discuss them with your doctor.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Dizziness
  • Nausea
  • Vomiting
  • Fatigue

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive; there is no specific antidote.

Drug Interactions

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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, St. John's Wort) - may significantly decrease progesterone levels, reducing efficacy.
  • CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Grapefruit juice) - may significantly increase progesterone levels, increasing risk of adverse effects.
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Moderate Interactions

  • Cyclosporine - Progesterone may increase plasma concentrations of cyclosporine.
  • Insulin/Oral Hypoglycemics - Progesterone may decrease glucose tolerance, requiring adjustment of antidiabetic therapy.
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Minor Interactions

  • Thyroid hormones - Progesterone may decrease serum concentrations of thyroid-binding globulin, leading to decreased total T3 and T4 levels (free levels usually unchanged).

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: Progesterone is extensively metabolized by the liver; baseline assessment is important, especially given contraindication in severe hepatic impairment.

Timing: Prior to initiation of therapy

Blood Pressure

Rationale: Hormone therapy can affect blood pressure.

Timing: Prior to initiation of therapy

Lipid Profile

Rationale: Hormones can influence lipid metabolism.

Timing: Prior to initiation of therapy

Breast Examination & Mammography

Rationale: Part of routine health screening for women, especially those on hormone therapy.

Timing: Prior to initiation of therapy, as clinically indicated

Pelvic Examination & Pap Smear

Rationale: Part of routine gynecological health screening.

Timing: Prior to initiation of therapy, as clinically indicated

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Routine Monitoring

Blood Pressure

Frequency: Annually or as clinically indicated

Target: Normal limits

Action Threshold: Significant elevation requiring intervention

Lipid Profile

Frequency: Annually or as clinically indicated

Target: Normal limits

Action Threshold: Significant abnormalities requiring intervention

Breast Examination & Mammography

Frequency: Annually or as clinically indicated

Target: No new abnormalities

Action Threshold: New lumps, pain, or suspicious findings

Pelvic Examination

Frequency: Annually or as clinically indicated

Target: Normal findings

Action Threshold: Abnormal bleeding, pain, or suspicious findings

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Symptom Monitoring

  • Unusual vaginal bleeding or spotting
  • Breast tenderness or lumps
  • Mood changes, depression
  • Headache, migraine
  • Dizziness, drowsiness
  • Signs of thromboembolic events (e.g., sudden chest pain, shortness of breath, severe headache, vision changes, leg pain/swelling)
  • Signs of liver dysfunction (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Category B. While not indicated for use during pregnancy by the manufacturer for all uses, it is commonly used off-label for luteal phase support in assisted reproductive technologies (ART) and for prevention of preterm birth (though vaginal route is more common for the latter). Use only if clearly needed and potential benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Generally considered safe for specific indications (e.g., luteal phase support) under medical supervision. No increased risk of congenital anomalies observed in studies.
Second Trimester: No specific risks identified for continued use if indicated.
Third Trimester: No specific risks identified for continued use if indicated.
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Lactation

L3 (Moderately Safe). Small amounts of progesterone are excreted into breast milk. Generally considered compatible with breastfeeding, but caution is advised, and infant should be monitored for any adverse effects (e.g., drowsiness).

Infant Risk: Low; no significant adverse effects reported in breastfed infants.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended unless under specialist guidance for specific conditions (e.g., secondary amenorrhea in older adolescents).

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, geriatric patients may be more sensitive to the sedative effects and should be monitored for adverse reactions. Consider baseline health status and comorbidities.

Clinical Information

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Clinical Pearls

  • Oral micronized progesterone is often preferred over synthetic progestins due to its natural structure and potentially different side effect profile (e.g., less androgenic effects).
  • Taking progesterone at bedtime is crucial due to its common side effect of drowsiness and dizziness.
  • Food significantly increases the absorption of oral micronized progesterone; advise patients to take it with a meal.
  • Patients should be educated on the signs and symptoms of thromboembolic events, even though the risk with progesterone alone is lower than with combined estrogen-progestin therapy.
  • For luteal phase support in ART, vaginal or injectable formulations are often preferred due to higher local endometrial concentrations and avoidance of first-pass metabolism, though oral may be used as an adjunct or alternative in some protocols.
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Alternative Therapies

  • Other progestins (e.g., medroxyprogesterone acetate, norethindrone)
  • Vaginal progesterone (gel, suppositories, inserts) - often preferred for luteal phase support or preterm birth prevention due to local delivery and higher endometrial concentrations.
  • Injectable progesterone (e.g., progesterone in oil) - used for luteal phase support or prevention of preterm birth.
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Cost & Coverage

Average Cost: $20 - $100+ per 30 capsules (100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.