Proluton Depot 500mg/2 Ml Injection

PROLUTON DEPOT 500MG/2 ML INJECTION by GERMAN REMEDIES

• Name:

  • Brand Name: Proluton Depot 500mg/2ml Injection
  • Common Name: Hydroxyprogesterone Caproate Injection

• Composition:

  • Active Ingredient: Each 2 ml vial contains 500 mg of Hydroxyprogesterone Caproate (250mg/ml).
  • Other Ingredients: May also contain castor oil and benzyl benzoate.

• Uses: Proluton Depot is a synthetic progestin primarily used to:

  • Reduce the risk of premature birth (preterm labor) in pregnant women, particularly those with a history of previous preterm delivery. It is also prescribed for the treatment and prevention of conditions such as:
  • Menstrual abnormalities
  • Amenorrhea (absence of menstruation)
  • Abnormal uterine bleeding
  • Endometriosis
  • Recurrent miscarriages

• Dosage and Administration:

  • Proluton Depot is administered as an intramuscular (IM) or subcutaneous (SC) injection by a healthcare professional. It should not be self-administered.
  • For the prevention of preterm labor, it is typically initiated weekly between the 16th and 20th week of gestation and continued through the 37th week or until delivery, whichever comes first.
  • Dosage and duration will be determined by the doctor based on the patient's age, body weight, and medical condition.

• Side Effects: Common side effects may include:

  • Pain, swelling, itching, lumps, or redness at the injection site
  • Nausea
  • Diarrhea
  • Skin rash, red rashes, or itching of the skin
  • Tiredness or fatigue
  • Dizziness and fainting
  • Increased appetite
  • Fever Serious side effects, though rare, can include:
  • Anxiety
  • Chest pain and discomfort, fast heartbeat
  • Signs of depression
  • Blood clots (thrombotic or thromboembolic events)
  • Jaundice (yellowing of eyes or skin, dark urine)
  • Severe allergic reactions (e.g., swelling of the face, lips, mouth, throat, difficulty breathing)

• Precautions:

  • Contraindications: Not recommended for patients with liver tumors, active liver disease, cholestatic jaundice during pregnancy, blood clots or other blood clotting problems, uncontrolled high blood pressure, known or suspected breast cancer or other hormone-sensitive cancers, or undiagnosed abnormal vaginal bleeding.
  • Warnings: Use with caution in patients with asthma, seizure disorders, migraine, cardiac or renal impairment, diabetes or pre-diabetes, or a history of mental depression.
  • Pregnancy: Not for use in women pregnant with more than one baby (twins, triplets, etc.) or to stop active premature labor.
  • Interactions: May interact with anticonvulsants (e.g., carbamazepine, phenytoin), antituberculosis medicines (e.g., rifampicin), and antifungal medications (e.g., ketoconazole, itraconazole), affecting its effectiveness or metabolism.
  • Monitoring: Regular monitoring of blood sugar levels is advisable. Patients should be closely observed for signs and symptoms of thrombotic disorders. Inform your doctor immediately if you experience yellowing of eyes or skin, dark urine, stomach pain, sudden severe headache, vision changes, or signs of blood clots.

• Storage:

  • Store in a cool, dry place, protected from light.
  • Keep it in the original pack or container.
  • Store below 25°C, ideally between 15°C and 30°C (59°-86°F).
  • Keep out of the sight and reach of children.
  • Multidose vials should be used within 5 weeks after the first use.

PROLUTON DEPOT 500MG/2 ML INJECTION: Frequently Asked Questions

What is PROLUTON DEPOT used for?

PROLUTON DEPOT 500mg/2ml Injection is primarily used to reduce the risk of premature birth (preterm labor) in pregnant women who have a history of delivering a premature baby. It is also used in the management of menstrual abnormalities, amenorrhea (absence of menstruation), abnormal uterine bleeding, and endometriosis.

How does PROLUTON DEPOT work?

PROLUTON DEPOT contains hydroxyprogesterone caproate, a synthetic form of the female hormone progesterone. It works by enhancing progesterone levels in the body, which plays a crucial role in maintaining pregnancy by supporting the uterine lining and regulating hormonal balance. It helps the uterus grow during pregnancy and is believed to prevent contractions that could lead to miscarriage. The exact mechanism by which it prevents premature birth is not fully understood, but it is thought to modulate the immune response to prevent embryo rejection and facilitate its attachment to the uterus.

What is the usual dosage for PROLUTON DEPOT?

PROLUTON DEPOT 500mg/2ml Injection is administered by a doctor or trained nurse, usually as an intramuscular injection. For the prevention of preterm labor, it is typically given weekly between the 16th and 20th week of gestation and continued through week 37 or until delivery, whichever comes first. The specific dosage and duration are determined by the doctor based on the patient's medical condition and pregnancy stage.

What are the possible side effects of PROLUTON DEPOT?

Common side effects include pain, swelling, itching, or a hard lump at the injection site, headache, dizziness, fatigue, fever, skin rash, nausea, and diarrhea. Less common but more serious side effects can include signs of blood clots (e.g., leg swelling, redness, pain), severe allergic reactions (e.g., swelling of the face, lips, throat), jaundice (yellowing of skin/eyes), and high blood pressure. It is important to report any severe or persistent side effects to your doctor.

Is PROLUTON DEPOT safe during pregnancy or breastfeeding?

PROLUTON DEPOT is generally considered safe and is prescribed during pregnancy to reduce the risk of premature birth in women with a history of preterm delivery. However, it is not recommended for use in women pregnant with multiple babies (twins, triplets, etc.) or to stop active premature labor.

During breastfeeding, components of PROLUTON DEPOT pass into breastmilk in small amounts. While some sources suggest it is safe if prescribed, others recommend consulting a doctor as it may affect the infant and advise waiting at least 6 weeks after birth before use.

Can PROLUTON DEPOT be taken with other medications?

PROLUTON DEPOT may interact with other medicines. It's crucial to inform your doctor about all medications, supplements, or herbal preparations you are taking. Medicines like carbamazepine, phenytoin, phenobarbital (anticonvulsants), rifampicin, isoniazid (antituberculosis medicine), ketoconazole, and itraconazole (antifungal medications) may alter the effects of PROLUTON DEPOT.

What precautions should be taken with PROLUTON DEPOT?

Inform your doctor if you have a history of liver disease, hormone-dependent cancers (like breast cancer), blood clotting disorders, uncontrolled high blood pressure, diabetes, pre-diabetes, asthma, seizure disorders, migraine, cardiac or renal impairment, or depression. It is not recommended for patients with liver tumors, active liver disease, or undiagnosed abnormal vaginal bleeding. Avoid alcohol consumption as its interaction is unknown, and it may worsen dizziness.

What happens if a dose of PROLUTON DEPOT is missed?

If you miss a dose, contact your doctor as soon as you remember. Do not double the dose to make up for a missed one. Your doctor will advise on how to proceed.

How should PROLUTON DEPOT be stored?

PROLUTON DEPOT should be stored in a cool, dry place, typically at room temperature (15-30°C or 59-86°F), and kept in its original pack or container. Protect it from light and avoid excessive heat or cold. Keep the injection out of the sight and reach of children.