Susten 100 (1 Ml Ampoule)

SUSTEN 100 (1 ML AMPOULE)

SUSTEN 100 (1 ML AMPOULE) is a medical product manufactured by Sun Pharmaceutical Industries Ltd., primarily used to manage conditions related to female reproductive health.

• Name:

  • Brand Name: SustEN 100 Injection, Susten 100 Injection.
  • Common Name: Progesterone Injection.

• Composition:

  • Active Ingredient: Natural Micronised Progesterone (100 mg/ml).
  • Other Ingredients: Benzyl Alcohol (200 mg) as a preservative.

• Uses: SUSTEN 100 is prescribed for various gynecological and fertility-related conditions due to progesterone deficiency:

  • Female Infertility: Used as part of fertility treatments, including assisted reproductive technologies (ART) like in vitro fertilization (IVF) or gamete intra-fallopian transfer (GIFT), to support the luteal phase and enhance implantation of a fertilized egg.
  • Maintenance of Early Pregnancy: Especially in women with a history of repeated miscarriages due to luteal phase defect, or to prevent premature labor.
  • Hormone Replacement Therapy (HRT): Often prescribed along with estrogen to reduce menopausal symptoms and prevent endometrial hyperplasia.
  • Secondary Amenorrhea: To restore menstrual periods in women who have not reached menopause but are not menstruating due to a lack of natural progesterone.
  • Dysfunctional Uterine Bleeding: To manage abnormal vaginal bleeding caused by hormonal imbalances.
  • Threatened Abortion: To help prevent miscarriage.
  • Premenstrual Syndrome (PMS): To relieve associated symptoms.

• Dosage and Administration:

  • SUSTEN 100 is administered as an injection by a qualified healthcare professional, typically into the muscles (intramuscular) or under the skin (subcutaneous).
  • Self-administration is not recommended.
  • The dosage and duration of treatment are determined by the doctor based on the patient's age, weight, and specific medical condition. It is crucial to follow the prescribed schedule and not exceed the recommended dose.

• Side Effects:

  • Common Side Effects: Headache, back pain, dizziness, weight gain, vaginal discharge, stomach cramps, abdominal discomfort, nausea, breast pain or tenderness, pelvic pain, fatigue, mood changes, injection site reactions (pain, swelling, redness), decreased libido, insomnia, flushing, irregular uterine bleeding, leg cramps, vaginal inflammation, edema, and painful periods.
  • Serious Side Effects (rare): Severe allergic reactions, swelling, painful urination, depression, memory loss, breast lumps, dark patches on the skin, vomiting, blood clots (e.g., in legs, eyes, or leading to stroke/heart attack), severe headache, bulging eyes, vision alterations, and jaundice. Seek immediate medical attention if these occur.

• Precautions:

  • Inform your doctor about any allergies to progesterone or similar drugs.
  • Not recommended for individuals with a history of breast cancer, unusual vaginal bleeding (undiagnosed), severe liver disease, blood clots (thrombophlebitis, thromboembolic disorder, stroke), porphyria, certain types of cancer (breast, ovarian, uterine), ectopic pregnancy, idiopathic jaundice, severe itching or pemphigoid gestationis during previous pregnancies.
  • Caution is advised for patients with kidney problems, heart problems, diabetes, asthma, epilepsy, or migraine, and closer monitoring may be required.
  • Limited information is available on alcohol interaction; generally, it is advisable to limit or avoid alcohol and consult a doctor.
  • If pregnant or planning to conceive, discuss with your doctor. It is generally considered safe during the first trimester if prescribed for pregnancy maintenance.
  • While human studies suggest the drug does not pass into breastmilk in significant amounts and is not expected to cause toxicity to the baby, one source indicates it is contraindicated for breastfeeding women. Always consult your doctor for personalized advice.
  • This medicine may cause dizziness, sleepiness, or decreased alertness; exercise caution when driving or operating machinery.
  • Do not stop taking the medicine abruptly unless instructed by your doctor, as discontinuing it suddenly may cause symptoms to return.
  • SUSTEN 100 is intended for use in female patients only and is not recommended for men or children below 18 years of age.

• Storage:

  • Store below 30°C, in a cool and dry place.
  • Keep away from moisture, heat, and direct sunlight.
  • Do not freeze the ampoules.
  • Keep out of sight and reach of children and pets.

Here are some frequently asked questions about SUSTEN 100 (1 ML AMPOULE):

What is SUSTEN 100 used for?

SUSTEN 100 (1 ML AMPOULE) is primarily used to manage conditions related to female reproductive health where there is a deficiency of progesterone, a vital hormone. It is prescribed for hormone replacement therapy (HRT), to regulate irregular menstrual cycles (e.g., amenorrhea), and to treat abnormal uterine bleeding. It is also used to support pregnancy, prevent premature labor, and in assisted reproductive technology (ART) cycles to aid luteal phase support and enhance successful implantation of a fertilized egg.

How does SUSTEN 100 work?

SUSTEN 100 contains natural micronized progesterone. It works by mimicking the action of naturally produced progesterone in the body. Progesterone plays a key role in preparing the endometrium (uterine lining) for the implantation of a fertilized egg and maintaining the uterine lining during pregnancy. It also helps inhibit uterine contractions that could lead to preterm labor and regulates the menstrual cycle by counteracting the proliferative effects of estrogen on the endometrium.

What is the usual dosage for SUSTEN 100?

SUSTEN 100 (1 ML AMPOULE) is an injection that should be administered into the muscle by a qualified healthcare professional. The exact dosage and frequency will depend on the specific condition being treated, as well as factors like age, weight, and medical history. It is crucial to follow the doctor's prescribed schedule strictly and not to exceed the recommended dose.

What are the possible side effects of SUSTEN 100?

Common side effects of SUSTEN 100 can include headache, nausea, vomiting, bloating, abdominal cramps or pain, vaginal discharge, mood swings, breast pain or tenderness, dizziness, and fatigue or drowsiness. More serious, though rare, side effects can include allergic reactions, swelling, painful urination, depression, memory loss, breast lumps, dark patches on the skin, and blood clots. Seek immediate medical attention if you experience severe symptoms like chest pain, breathlessness, severe headache, or vision changes.

Is SUSTEN 100 safe during pregnancy or breastfeeding?

SUSTEN 100 can be used during the first three months of pregnancy, especially for maintaining early pregnancy, preventing threatened abortion, or in cases of repeated miscarriages due to luteal phase defect, if prescribed by a doctor. However, it should not be used in women with ectopic pregnancy or a history of certain skin problems during previous pregnancies.

For breastfeeding, there is limited information, and it is advised to consult a doctor. While some studies suggest the drug may not pass into breastmilk in significant amounts, it is generally contraindicated or advised to be used with caution, and the effects on infants are not fully known.

Can SUSTEN 100 be taken with other medications?

SUSTEN 100 can interact with certain medications. Hepatic enzyme inducers like carbamazepine and phenytoin can reduce its effectiveness by decreasing progesterone levels. Antifungal medications like ketoconazole and immunosuppressants like cyclosporine can potentially increase progesterone levels when taken alongside this injection. It is crucial to inform your doctor about all prescription, over-the-counter, nutritional, vitamin supplements, and herbal products you are taking to avoid potential interactions.

What precautions should be taken with SUSTEN 100?

Before using SUSTEN 100, inform your doctor if you have a history of breast cancer, unusual vaginal bleeding, liver disease, blood clotting disorders (e.g., thromboembolism or stroke), heart problems, kidney problems, diabetes, or asthma. Caution is advised for older patients, especially those above 70 years old, due to potential liver and kidney issues. This medicine may cause dizziness, sleepiness, or decreased alertness, so driving or operating machinery should be avoided if these symptoms occur.

What happens if a dose of SUSTEN 100 is missed?

If a dose of SUSTEN 100 is missed, take it as soon as you remember, unless it is almost time for the next scheduled dose. In that case, skip the missed dose and continue with your regular schedule. Do not take a double dose to compensate for the missed one. If you miss more than one dose, or are concerned, contact your doctor for advice.

How should SUSTEN 100 be stored?

SUSTEN 100 (1 ML AMPOULE) should be stored at controlled room temperature, ideally between 20°C to 25°C (68°F to 77°F), or below 30°C. It should be kept in a cool, dry place, away from direct sunlight and moisture. Do not freeze the medicine. Keep it out of sight and reach of children and pets, and ensure it is used before its expiration date.