Endogest Sr 300 Mg Tablet (10 Tab)

ENDOGEST SR 300 MG TABLET (10 TAB) by CIPLA LTD.

Name:

• Brand Name: ENDOGEST SR 300 MG TABLET
• Common Name: Progesterone (Natural Micronized)

Composition: Each sustained-release tablet contains Progesterone (Natural Micronized) 300 mg. Progesterone is a steroid hormone that functions similarly to the endogenous female sex hormone, playing a crucial role in regulating the menstrual cycle and supporting pregnancy.

Uses: ENDOGEST SR 300 MG TABLET is primarily used to treat various hormonal imbalances and gynecological conditions in women. These include:

• Hormone Replacement Therapy (HRT): To manage menopausal symptoms and prevent endometrial hyperplasia (thickening of the uterus lining) when used with estrogen.
• Menstrual Disorders: Treatment of amenorrhea (absence of menstrual periods), irregular menstruation, and dysfunctional uterine bleeding.
• Fertility and Pregnancy Support: Supports the luteal phase during assisted reproductive technologies (e.g., IVF), aids in endometrial preparation for implantation, maintains early pregnancy, and helps prevent threatened abortion and preterm labor.
• Premenstrual Syndrome (PMS): Management of symptoms.

Dosage and Administration: This medicine is typically taken orally, with or without food, around the same time daily for optimal results. Some sources specifically recommend taking it with food. The tablet should be swallowed whole and not chewed, crushed, or broken. The dosage and duration of treatment are determined by a healthcare professional based on the individual's medical condition.

Side Effects:

• Common Side Effects: Drowsiness, dizziness, headache, mood changes, breast tenderness or pain, nausea, bloating, abdominal pain or cramps, diarrhea, constipation, vaginal discharge, hot flashes, irregular vaginal bleeding or spotting, hair loss, and fatigue. These often resolve as the body adjusts to the medication.
• Serious Side Effects (less common): Chest pain, difficulty in passing urine, breast lumps, fever, chills, blurred or loss of vision, and convulsions. Seek immediate medical attention if these occur.

Precautions:

• Contraindications: Do not take if allergic to progesterone or soy, or if you have a history of breast cancer, uterine cancer, unexplained vaginal bleeding, blood clots, liver disease, porphyria, or cerebral hemorrhage.
• Warnings: Caution is advised for individuals with kidney disease, diabetes, high blood pressure, migraine, asthma, epilepsy, systemic lupus erythematosus, or a history of depression. Inform your doctor about all existing medical conditions and current medications.
• Driving/Operating Machinery: May cause drowsiness or dizziness; avoid these activities if affected.
• Pregnancy/Breastfeeding: Can be used during pregnancy if prescribed by a doctor, especially for support, but consult a doctor. It is generally not recommended during breastfeeding.
• Alcohol: Caution with alcohol consumption as it may increase dizziness and drowsiness; avoid alcohol during pregnancy.
• Regular medical examinations, including breast and uterine checks, may be advised during treatment.

Storage: Store in a cool and dry place, away from direct sunlight. Keep the medicine out of reach and sight of children. Recommended storage temperature is below 25°C or below 30°C.

What is ENDOGEST SR 300 MG TABLET used for?

ENDOGEST SR 300 MG TABLET is primarily used to manage conditions related to progesterone deficiency and hormonal imbalances in women. This includes treating female infertility and supporting pregnancy, particularly in cases of threatened abortion, recurrent miscarriages, and to prevent preterm labor. It is also prescribed for menstrual disorders such as amenorrhoea (absence of menstrual periods), irregular menstruation, and dysfunctional uterine bleeding. Additionally, it is used as part of Hormone Replacement Therapy (HRT) to alleviate menopausal symptoms and prevent endometrial hyperplasia (thickening of the uterus lining). It may also be used to support the luteal phase during assisted reproductive technologies like IVF and manage premenstrual syndrome (PMS).

How does ENDOGEST SR 300 MG TABLET work?

ENDOGEST SR 300 MG TABLET contains natural micronized progesterone. It works by supplementing or replacing the progesterone hormone levels in the body, which are vital for regulating the menstrual cycle and maintaining pregnancy. Progesterone helps prepare the lining of the uterus (endometrium) for the implantation of a fertilized egg and supports its development throughout pregnancy by maintaining the uterine environment and inhibiting excessive uterine contractions. In hormone replacement therapy, it helps balance hormonal changes and protects the uterus from risks associated with estrogen-only therapy.

What is the usual dosage for ENDOGEST SR 300 MG TABLET?

The dosage of ENDOGEST SR 300 MG TABLET is determined by your doctor based on your specific medical condition. Generally, it is taken orally, once daily in the evening or at bedtime. For optimal results and consistent hormone levels, it is advised to take the tablet around the same time each day. It can often be taken with or without food, though taking it with food may help reduce nausea. The tablet should be swallowed whole and not crushed or chewed. The duration of treatment can vary, typically ranging from 10-12 days a month to 25 days a month, depending on your health condition.

What are the possible side effects of ENDOGEST SR 300 MG TABLET?

Common side effects may include headache, breast tenderness or pain, nausea, bloating, dizziness, drowsiness, fatigue, irregular vaginal bleeding or spotting, vaginal discharge, and mood changes. Other reported side effects include abdominal cramps or pain, constipation, hot flashes, hair loss, fluid retention, joint pain, edema, rash, increased appetite, decreased libido, short menstrual cycle, flatulence, and vaginal yeast infection. Most of these side effects are usually temporary and resolve on their own. If you experience dizziness or drowsiness, avoid driving or operating heavy machinery. Consult your doctor if any side effects worsen or persist. More serious, though less common, side effects include chest pain, difficulty breathing, breast lumps, blurred vision, convulsions, and severe swelling of the face, lips, tongue, hands, or feet, which require immediate medical attention.

Is ENDOGEST SR 300 MG TABLET safe during pregnancy or breastfeeding?

During pregnancy, ENDOGEST SR 300 MG TABLET may be prescribed by a doctor during the early stages to support fetal growth, maintain pregnancy, and help prevent threatened abortions, recurrent miscarriages, or preterm labor. However, some sources suggest avoiding it if pregnant as it may harm the unborn baby or list it as contraindicated in pregnancy, or mention moderate side effects. Therefore, it is crucial to consult your doctor before taking this medicine if you are pregnant or planning a pregnancy, and only use it if specifically prescribed.

For breastfeeding women, ENDOGEST SR 300 MG TABLET is generally not recommended or considered contraindicated. Components of the medicine may pass into breast milk, and its effects on breastfed infants are unknown. Always consult your doctor before using this medicine while breastfeeding.

Can ENDOGEST SR 300 MG TABLET be taken with other medications?

ENDOGEST SR 300 MG TABLET can interact with several medications. Inform your doctor about all prescription, over-the-counter, and herbal medicines you are currently taking.

Key interactions include:

• Hepatic enzyme inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): These can speed up the liver's processing of medications, potentially lowering progesterone levels.
• CYP3A4 inhibitors (e.g., ketoconazole): These can slow down the breakdown of progesterone, leading to higher progesterone levels.
• Immunosuppressants (e.g., cyclosporine): Progesterone may increase their levels.
• Antidiabetic agents (e.g., metformin, insulin): Progesterone may affect blood sugar control.
• Certain anti-HIV medications (e.g., nelfinavir, nevirapine, efavirenz, ritonavir).
• St. John's Wort (an herbal remedy for depression).
• Bromocriptine (used to stop breast milk production, manage infertility, or Parkinsonism).
• Bosentan and Venetoclax are noted for severe interactions.

What precautions should be taken while using ENDOGEST SR 300 MG TABLET?

Before taking ENDOGEST SR 300 MG TABLET, inform your doctor if you have any pre-existing medical conditions or allergies. Do not take this medicine if you have:

• A known allergy to progesterone or any other ingredient in the tablet.
• Current or suspected breast cancer or uterine cancer.
• Unexplained vaginal bleeding.
• A history of blood clots, blood clotting disorders, recent heart attack, stroke, or bleeding in the brain.
• Liver disease or abnormal liver function.
• Porphyria (a rare blood disorder).

Use with caution and inform your doctor if you have a history of kidney disease, diabetes, high blood pressure, migraine or severe headaches, gallstones, asthma, epilepsy (fits), systemic lupus erythematosus, depression, fibroid growths or endometriosis, or a family history of breast cancer. Since this medicine may cause dizziness or drowsiness, avoid driving or operating machinery if you experience these effects. Avoid exceeding the recommended dose. Your doctor may recommend regular physical examinations (including breast and uterine exams) and blood tests as a precaution during treatment. If you are not trying to conceive, use effective birth control methods while taking this medicine. Caution is advised with alcohol consumption, as it may increase dizziness and drowsiness.

What happens if a dose of ENDOGEST SR 300 MG TABLET is missed?

If you miss a dose of ENDOGEST SR 300 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should ENDOGEST SR 300 MG TABLET be stored?

ENDOGEST SR 300 MG TABLET should be stored in a cool and dry place, away from direct sunlight. Keep it out of the reach and sight of children and pets. The recommended storage temperature is typically below 30°C or between 10°C to 25°C.