Prolutex Injection 25 mg (Progesterone)

Adult administration

Administer subcutaneously once daily for 25 mg from the date of oocyte retrieval until 12 weeks of pregnancy. Inject in an appropriate subcutaneous area (thigh or abdomen), injecting slowly at a 45° to 90° angle to minimize the risk of localized skin tissue damage.

This medication should be used with caution for early manifestations of thromboembolic disorders or cardiovascular diseases such as myocardial infarction, and should be discontinued immediately if related symptoms appear. There is insufficient evidence that this medication prevents natural miscarriage, so it is important to identify the cause of infertility before use. Do not use if you have an allergy to this medication or have undiagnosed vaginal bleeding, breast cancer, or liver dysfunction. Patients with impaired liver function or histories of depression, asthma, diabetes, etc., should use this medication with caution, as their conditions may worsen; careful observation is necessary. During use, side effects such as pain or itching at the injection site, vaginal bleeding, headache, and uterine cramps may occur, and you should consult a doctor if any abnormal symptoms appear. This medication may increase the risk of thrombosis, so particular caution is necessary for patients over 35, smokers, or those at high risk for atherosclerosis. Patients with a history of depression should carefully monitor for worsening symptoms, and sudden discontinuation of the medication can cause anxiety or seizures, so caution is advised. Fluid retention may exacerbate existing conditions such as heart, kidney, liver, migraines, and asthma, so patients with these conditions should be managed carefully. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. It may interact with other medications, so especially if you are taking medications that promote or inhibit drug metabolism in the liver, you should consult a doctor or pharmacist. During pregnancy, the possibility of fetal malformations cannot be excluded, so caution is needed for early use in pregnancy; it is recommended not to use during breastfeeding. The safety of this medication has not been sufficiently studied in children or the elderly, so it should be used cautiously in these age groups. Overdosage may result in drowsiness, nausea, vomiting, dizziness, and specific detoxification agents are not available, so treatment should be provided based on the symptoms. This medication is used as a subcutaneous injection and should not be used if it has changed color or contains foreign substances; the syringe should not be reused after use. For storage, keep out of reach of children, avoid direct sunlight, and store at room temperature; refrigeration or freezing should not be done.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, cough with fever accompanied by respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output.

Mild side effects

Injection site reactions (pain, irritation, itching, swelling), vaginal bleeding, headache, uterine cramps, vaginal discharge, discomfort in the vulva (vulvar itching, inflammation), breast tenderness, chest pain, ovarian hyperstimulation syndrome (OHSS), breast enlargement, nipple enlargement and pain, injection site hematoma, injection site induration, fatigue, burning sensation, lethargy, mood changes, dizziness, drowsiness, intestinal gas, abdominal pain, nausea, vomiting, constipation, itching, redness, weight gain.

This medication is sensitive to light and should be stored in a sealed container that blocks light. It is also important to store it at a cool temperature between 15 and 25 degrees Celsius to maintain its efficacy.

Appearance

A clear colorless liquid in a colorless transparent vial for injection.

Package unit

1 vial (1.112 mL) X 7 vials