Progesterone/oil 50mg/ml Mdv 10ml

Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. It binds to intracellular progesterone receptors, leading to gene expression changes. It transforms the proliferative endometrium into a secretory endometrium, which is essential for the implantation of a fertilized ovum and the maintenance of pregnancy. It also inhibits gonadotropin secretion and uterine contractions.

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 immediate medical attention:

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance or coordination
+ Drooping on one side of the face or blurred vision
Respiratory issues, including:
+ Shortness of breath
+ Sudden weight gain or swelling in the arms or legs
Mobility problems, such as trouble walking
Severe dizziness or fainting
Vision 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 problems, including:
+ Pain while urinating
+ Frequent urination
Mood changes, such as depression or memory problems

This medication may cause fluid retention or swelling in the body. If you experience swelling, weight gain, or difficulty breathing, 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 changes, or pain in a leg or arm
Difficulty speaking or swallowing

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dizziness, drowsiness, fatigue, or weakness
Headache
Gastrointestinal issues, such as:
+ Constipation
+ Diarrhea
+ Vomiting or upset stomach
+ Stomach pain or cramps
+ Bloating
Breast-related symptoms, including:
+ Enlarged breasts
+ Tender breasts
Muscle pain or weight gain
Vaginal bleeding or spotting
Decreased interest in sex
Irritation at the site of application

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
A recent miscarriage

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 first consulting your doctor.

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your surgery or procedure.

Precautions and Warnings

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

Regular Health Check-Ups

It is essential to have regular breast exams and gynecology check-ups while taking this medication. You should also perform breast self-exams as instructed by your healthcare provider.

Lab Tests and Blood Clots

This medication may affect certain laboratory tests, so inform all of your healthcare providers and lab personnel that you are taking this medication. There is a risk of blood clots associated with this medication, which can be life-threatening. Blood clots can occur in the form of heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, discuss this with your doctor. Prolonged periods of immobility, such as long trips, bedrest after surgery, or illness, may increase your risk of blood clots. Talk to your doctor if you will be stationary for an extended period.

Potential Side Effects and Risks

Certain side effects, including heart attack, stroke, breast cancer, and others, have been reported in people 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.

Special Considerations

If you are 65 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, consult your doctor.

Respiratory Complications

A type of pneumonia has been associated with this medication. Seek immediate medical attention if you experience shortness of breath, difficulty breathing, cough, or fever.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of using this medication during pregnancy or breastfeeding.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease progesterone levels, reducing efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice): May increase progesterone levels, increasing risk of side effects.
• Insulin/Oral Hypoglycemics: Progesterone may decrease glucose tolerance, requiring adjustment of antidiabetic medication.

• Corticosteroids: Progesterone may increase plasma concentrations of corticosteroids by competing for protein binding sites.

• Injection site pain, swelling, or irritation
• Breast tenderness or swelling
• Headache
• Dizziness or lightheadedness
• Nausea, abdominal pain, bloating
• Mood changes, depression, irritability
• Fatigue
• Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
• Signs of blood clot (sudden severe headache, vision changes, slurred speech, weakness/numbness in an arm or leg, chest pain, shortness of breath, pain/swelling/redness in a leg)
• Jaundice (yellowing of skin or eyes)

Progesterone injection is commonly used to support the luteal phase in assisted reproductive technology (ART) cycles and to prevent preterm birth in certain high-risk pregnancies. Its use in pregnancy is well-established for these specific indications.

Progesterone is excreted in breast milk in small amounts. However, it is generally considered compatible with breastfeeding (LactMed rating L2 - Safer). No adverse effects on the breastfed infant have been reported.

Generally not indicated for routine pediatric use. Limited data on safety and efficacy in pediatric populations, except for specific conditions like primary amenorrhea under specialist guidance.

Use with caution in elderly patients. While progesterone itself is generally well-tolerated, older women using hormone replacement therapy (which may include progesterone) have an increased risk of cardiovascular events and breast cancer. Individual risk-benefit assessment is crucial.

• Progesterone in oil is typically administered via intramuscular (IM) injection, which can be painful. Advise patients to rotate injection sites (e.g., upper outer quadrant of the buttock) and apply warm compresses after injection to help with absorption and reduce discomfort.
• This formulation is crucial for luteal phase support in IVF and other assisted reproductive technologies, as it helps prepare and maintain the uterine lining for embryo implantation.
• Patients should be educated on the signs and symptoms of potential side effects, particularly those related to thromboembolic events, and instructed to seek immediate medical attention if they occur.
• Ensure patients understand the importance of consistent daily dosing for optimal therapeutic effect, especially in fertility treatments.
• The oil base provides a sustained release of progesterone, leading to more stable serum levels compared to some other formulations.

• Vaginal progesterone (e.g., Crinone gel, Endometrin inserts, progesterone suppositories): Often preferred for luteal phase support due to local endometrial effects and fewer systemic side effects, though absorption can be variable.
• Oral micronized progesterone (e.g., Prometrium): Used for luteal phase support, secondary amenorrhea, and hormone replacement therapy, but has significant first-pass metabolism leading to lower bioavailability and different metabolite profiles compared to IM or vaginal routes.
• Other progestins (synthetic): While not direct alternatives for all indications of natural progesterone, synthetic progestins (e.g., medroxyprogesterone acetate, norethindrone) are used in contraception, HRT, and for managing abnormal uterine bleeding.

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.