Prometrium Micro 200mg Capsules

Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. It is essential for the development of decidual tissue and is necessary for the maintenance of pregnancy. Progesterone acts by binding to specific progesterone receptors in target tissues, leading to gene expression changes.

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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ 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
Respiratory 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 when passing urine
+ Frequent urination
Mood changes, such as:
+ Depression
+ Memory problems or loss

This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor. Additionally, 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

While many people may not experience side effects or only have mild symptoms, it is essential to be aware of the following possible side effects:

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

If any of these side effects or other symptoms bother you or persist, 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.

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 symptoms 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 is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any existing health problems

Your doctor will help you determine whether 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 first consulting your doctor.

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 undergoing certain types of surgery, and will instruct you on when to resume taking it after the procedure.

Until you are aware of how this medication affects you, avoid driving and engaging in activities that require alertness. 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 blood sugar levels.

Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed. 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 and may include heart attack, stroke, and clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Prolonged periods of immobility, such as long trips, bedrest after surgery, or illness, may increase your risk of blood clots, so discuss this with your doctor.

Certain side effects, including heart attack, stroke, 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. Discuss the benefits and risks of using this medication with your doctor.

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, consult with your doctor.

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

• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, St. John's Wort) - may decrease progesterone levels and efficacy.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase progesterone levels and adverse effects.

• Other CYP3A4 inducers/inhibitors (e.g., grapefruit juice, diltiazem, verapamil, erythromycin)
• Drugs that may be affected by progesterone's metabolism (e.g., cyclosporine - progesterone may inhibit its metabolism, leading to increased levels).

• Abnormal vaginal bleeding (spotting, breakthrough bleeding)
• Breast tenderness or pain
• Headache, migraine
• Dizziness, somnolence (especially after dosing)
• Nausea, abdominal pain
• Mood changes, depression
• Signs of thromboembolic events (e.g., leg pain/swelling, chest pain, shortness of breath, sudden severe headache, vision changes)
• Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)

Category B. While Prometrium is indicated for secondary amenorrhea and prevention of endometrial hyperplasia, it is also widely used off-label for luteal phase support in assisted reproductive technology (ART) and for prevention of preterm birth in certain high-risk pregnancies. The FDA label states Category B for its approved indications, meaning animal reproduction studies have shown an adverse effect but adequate and well-controlled studies in pregnant women have not shown a risk to the fetus in any trimester. However, its use in early pregnancy for ART is common and generally considered safe.

L3 (Moderately Safe). Progesterone is excreted in breast milk. While no adverse effects have been reported in breastfed infants, caution should be exercised. The decision to breastfeed should consider the potential benefits of breastfeeding and the potential risks to the infant.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

No specific dose adjustment is generally required based on age alone. However, caution should be exercised in elderly patients due to potential for increased sensitivity to adverse effects, especially those related to cardiovascular or hepatic function. The risks associated with hormone therapy (e.g., cardiovascular events, breast cancer) should be carefully considered, as these risks generally increase with age.

• Always take Prometrium at bedtime and with food to minimize side effects like dizziness and maximize absorption.
• Prometrium is micronized progesterone, which allows for better oral absorption compared to non-micronized forms.
• While Prometrium itself does not have a black box warning, it's crucial to differentiate its use from combined estrogen-progestin hormone therapy, which carries significant cardiovascular and cancer risks.
• Patients should be advised that drowsiness and dizziness are common side effects, especially at the beginning of therapy.
• For luteal phase support in ART, vaginal progesterone formulations (e.g., Endometrin, Crinone) are often preferred due to direct uterine delivery and potentially fewer systemic side effects, though oral Prometrium is also used.

• Medroxyprogesterone acetate (Provera) - synthetic progestin for secondary amenorrhea and endometrial protection.
• Norethindrone acetate (Aygestin) - synthetic progestin for secondary amenorrhea and endometriosis.
• Vaginal progesterone (e.g., Endometrin, Crinone) - for luteal phase support and prevention of preterm birth.
• Intramuscular progesterone (e.g., Progesterone in oil) - for luteal phase support and prevention of preterm birth.

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 this 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.