SUSTEN GEL 8%

Name

Brand Name: Susten Gel 8% (also known as Susten 8% Gel 1's) Common Name: Progesterone Vaginal Gel

Composition

Susten Gel 8% contains Progesterone (Natural Micronized) at 8% w/w as its active ingredient.

Uses

Susten Gel 8% is primarily used in women to address various conditions related to progesterone deficiency and support reproductive health. It is prescribed for:

• Female Infertility: Used as a hormone replacement therapy, particularly in women undergoing assisted reproductive technology (ART) procedures like IVF, by preparing the uterine lining for embryo implantation and supporting early pregnancy.
• Regulation of Menstrual Cycles: Helps regulate ovulation and menstruation in women experiencing irregular periods or secondary amenorrhea (absence of menstrual periods).
• Luteal Phase Support: Provides progesterone to support the luteal phase during fertility treatments.
• Endometrial Preparation: Aids in preparing the endometrium for implantation during fertility treatments, ensuring an optimal environment for a fertilized egg.
• Hormone Replacement Therapy (HRT): Can alleviate menopausal symptoms like hot flushes, night sweats, mood swings, and vaginal dryness, often alongside estrogen.

Dosage and Administration

Susten Gel 8% is for vaginal use only. It is typically administered using a pre-filled applicator directly into the vagina, usually once a day, either in the morning or at bedtime. The exact dosage and duration of treatment should be strictly followed as prescribed by a doctor, based on the individual's condition. It is crucial not to use more or less than advised and not to use it for longer than recommended. Hands should be washed thoroughly before and after application. Do not use tampons or other vaginal products for at least 6 hours before and 6 hours after using Susten 8% Gel.

Side Effects

While generally safe, Susten Gel 8% may cause side effects, which are often temporary. Common Side Effects:

• Vaginal bleeding, discharge, irritation, or itching
• Abdominal pain, cramps, bloating, or constipation
• Headache, dizziness, or drowsiness
• Breast pain, tenderness, or enlargement
• Nausea
• Low sex drive
• Fatigue
• Fluid retention, edema Serious Side Effects (seek immediate medical attention if experienced):
• Allergic reactions (severe skin rashes, swelling of face, lips, tongue, throat causing breathing difficulties)
• Depression
• Breast lumps
• Loss of vision or blurred vision (potential retinal thrombosis)
• Unexpected vaginal bleeding
• Convulsions (seizures)
• Chest pain and discomfort, fever and chills

Precautions

Before using Susten Gel 8%, inform your healthcare provider about your complete medical history and any other medications you are taking to prevent potential adverse effects or interactions.

• Contraindications: Not recommended for use if you have unexplained vaginal bleeding, porphyria, suspected breast or reproductive organ cancers, a history of blood clots (thrombophlebitis, thromboembolic disorder), stroke, or missed abortion/miscarriage.
• Medical Conditions: Use with caution if you have liver disease, kidney problems, heart issues, diabetes, asthma, epilepsy, migraine, or a history of depression. Liver dysfunction is a particular concern as progesterone is metabolized by the liver.
• Pregnancy and Breastfeeding: It is generally not recommended during pregnancy unless prescribed to support an ongoing pregnancy, especially if it was used to help achieve conception. It is not recommended for breastfeeding women as its safety is not established for nursing infants.
• Interactions: Avoid using other vaginal products or creams simultaneously with Susten Gel 8% as they may interfere with its effects. Inform your doctor about all medicines, herbal products, and supplements you are taking. Specific drug interactions may include Carbamazepine, Ketoconazole, Insulin, Phenobarbital, Venetoclax, and Edoxaban.
• Driving: Susten Gel 8% may cause dizziness or drowsiness; caution is advised when driving or operating machinery.
• Age: Not recommended for individuals below 18 years of age.

Storage

Store Susten Gel 8% in a cool and dry place, away from direct sunlight and heat. Do not refrigerate or freeze the gel. Keep it out of sight and reach of children and pets. Ensure to use the gel before the expiry date mentioned on the packaging.

What is SUSTEN GEL 8% used for?

SUSTEN GEL 8% is primarily used to address hormonal imbalances in women. It is prescribed for female infertility, particularly to support women undergoing Assisted Reproductive Technology (ART) procedures by supplementing or replacing progesterone. It also helps manage secondary amenorrhoea, which is the absence of menstrual periods, by re-establishing regular menstrual cycles. In some cases, it may be used to support early pregnancy when prescribed by a doctor.

How does SUSTEN GEL 8% work?

SUSTEN GEL 8% contains natural micronized progesterone. When inserted vaginally, it slowly releases progesterone, which mimics the actions of the naturally occurring female hormone. Progesterone prepares the lining of the uterus (endometrium) to receive and sustain a fertilized egg, converting it to a secretory state receptive to embryo implantation. It also helps inhibit uterine contractions, which is crucial for supporting early pregnancy.

What is the usual dosage and how is it applied?

The exact dosage of SUSTEN GEL 8% is determined by your doctor based on your specific condition. It is applied directly into the vagina using a pre-filled disposable applicator, usually once or twice daily. For fertility treatments, it may be continued for up to 10-12 weeks if pregnancy occurs. It is crucial to follow your doctor's instructions carefully and not exceed the prescribed amount. Wash your hands thoroughly before and after application.

What are the possible side effects of SUSTEN GEL 8%?

Common side effects can include vaginal discharge or irritation, breast tenderness or pain, nausea, headache, bloating or abdominal cramps, drowsiness, fatigue, and changes in sexual desire. If these symptoms persist or worsen, you should consult your doctor. More serious, though rare, side effects that require immediate medical attention include allergic reactions (skin rash, swelling), severe depression, or signs of a blood clot (e.g., sudden severe headache, chest pain, shortness of breath, pain/swelling in the leg).

Is SUSTEN GEL 8% safe during pregnancy or breastfeeding?

During Pregnancy: SUSTEN GEL 8% is widely used and considered safe to support early pregnancy, especially when prescribed as part of fertility treatment. Your doctor may advise continuing its use for a certain period after confirming pregnancy.

During Breastfeeding: While some sources suggest it is considered safe due to low systemic absorption when applied vaginally, others advise against its use or recommend consulting your doctor. It is best to consult your healthcare provider before using this medicine while breastfeeding.

Can SUSTEN GEL 8% be taken with other medications?

SUSTEN GEL 8% can interact with certain medications. For example, anticonvulsants (like phenytoin or carbamazepine) and antibiotics like rifampin may reduce its effectiveness. The herbal supplement St. John's Wort can also interfere with its efficacy. Conversely, antifungals like ketoconazole may increase progesterone levels. It is important to inform your doctor about all prescription, over-the-counter medications, vitamins, nutritional supplements, and herbal products you are taking to prevent potential interactions. Do not use other vaginal products without consulting your doctor, and if advised, separate the doses by at least 6 hours.

What precautions should be taken while using SUSTEN GEL 8%?

Inform your doctor about your complete medical history before using this gel, especially if you have liver or kidney problems, heart conditions, diabetes, asthma, epilepsy, migraines, a history of depression, unexplained vaginal bleeding, porphyria, or a history of blood clots or breast/genital tract malignancies. It is intended for intra-vaginal use only. Do not use tampons or other vaginal products for at least 6 hours before and after applying the gel.

What happens if a dose of SUSTEN GEL 8% is missed?

If you forget to apply a dose, do so as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one unless specifically instructed by your doctor.

How should SUSTEN GEL 8% be stored?

SUSTEN GEL 8% should be stored in a cool, dry place, away from direct sunlight and heat. Do not refrigerate or freeze it. Ensure it is kept out of the sight and reach of children. Always check the expiry date on the packaging and do not use the gel beyond this date.