New Revised MRP, 100% GST benefit passed Proluton 500mg Injection(Depot) 2ml
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Introduction About PROLUTON 500MG INJECTION(DEPOT)
PROLUTON 500MG INJECTION(DEPOT) contains Hydroxyprogesterone which belongs to the group of medicines called Progestin hormones. It is used to lower the risk of preterm births among women who have a previous history of pre-term delivery.
Preterm delivery is a condition in which the baby is born too early that is before the completion of 37 weeks due to maternal complications.
PROLUTON 500MG INJECTION(DEPOT) is not recommended for use in patients with liver tumours, any active liver disease, blood clots in the body, known or suspected breast cancer/other hormone-sensitive cancers and uncontrolled high blood pressure.
PROLUTON INJECTION should be used with caution in patients with asthma, kidney or heart problems, diabetes or pre-diabetes, epilepsy and migraine. It is not recommended for use in pregnant women with cholestatic jaundice.
PROLUTON INJECTION is not recommended for use in girls (aged below 16 years). The common side effects associated with the use of PROLUTON INJECTION are pain, swelling, itching or a hard bump at the injection site, raised red rashes, itching, nausea and diarrhoea. Inform your doctor if any of the side effect worsens or prolong.
Uses Of PROLUTON 500MG INJECTION(DEPOT)
- Lowers the risk of preterm births among women who have a previous history of pre-term delivery
How PROLUTON 500MG INJECTION(DEPOT) Works
PROLUTON INJECTION contains a medicine called hydroxyprogesterone which is a synthetic form of naturally occurring female hormone called progesterone. It works by regulating the female reproductive system and by assisting successful implantation of embryo within the uterus. It also induces anti-inflammatory response that can initiate pre-term labour.
How to use PROLUTON 500MG INJECTION(DEPOT)
PROLUTON INJECTION will be given to you only by a doctor or a nurse in the back of your upper arm subcutaneously (under the skin) or in the muscle as an intramuscular injection. Your doctor will decide the correct Proluton dosage and duration depending upon your age, body weight and disease condition.
Side Effects Of PROLUTON 500MG INJECTION(DEPOT)
Common
- pain, swelling, itching, raised hard tissue at the injected site
- raised red rashes
- nausea
- diarrhoea
- increased pain with time
- oozing out of blood or fluid
- preeclampsia (high blood pressure and high protein level in urine)
- gestational hypertension or diabetes
Stop receiving Proluton Depot injection and contact your doctor if you experience any of the following side effects:
- signs of arterial or deep venous thrombotic or thromboembolic event such as leg swelling, redness in your leg, a spot on your leg that is warm to the touch and leg pain that gets worse when you bend your foot
- signs of allergic reactions such as raised red rashes, itching and angioedema (swelling on face, mouth and throat)
- decrease in glucose tolerance (raised blood glucose levels)
- fluid retention
- depression
- jaundice (a liver disorder causing yellowing of skin and mucous membranes)
- high blood pressure
How To Manage Side Effects
Diarrhea
Drink plenty of fluids like water, clear broths, or oral rehydration solutions to manage dehydration. Avoid caffeinated and alcoholic beverages, as they can worsen dehydration. Gradually reintroduce easily digestible foods like bananas, rice, applesauce, and toast (BRAT diet). Probiotics may also help restore the balance of gut bacteria. If diarrhea persists or is accompanied by severe symptoms such as dehydration, high fever, or bloody stools, seek medical attention promptly.
Nausea And Vomiting
It's essential to stay hydrated and take steps to alleviate symptoms. Start by sipping clear fluids like water, ginger tea, or electrolyte solutions. Eating small, bland meals throughout the day, such as crackers or toast, can also help. Avoid spicy, greasy, or strong-smelling foods. Ginger, whether in the form of tea or ginger candies, is known for its anti-nausea properties. Rest in a comfortable position and avoid sudden movements. If vomiting is persistent or accompanied by severe symptoms like dehydration, high fever, or abdominal pain, it's crucial to seek medical attention promptly
Warning & Precautions
Pregnancy
Consult your doctorProluton Depot injection is not recommended for use in pregnant women with cholestatic jaundice, undiagnosed abnormal vaginal bleeding that is unrelated to pregnancy. It should be used cautiously in pregnant women with a singleton pregnancy having history of preterm delivery. Consult your doctor before receiving Proluton Depot injection.
Breastfeeding
Use with CautionProluton Depot injection should be used cautiously in breastfeeding mothers. Consult your doctor before receiving it.
Kidney
Use with CautionProluton Depot injection should be used cautiously in breastfeeding mothers. Consult your doctor before receiving it.
Liver
Consult your doctorPROLUTON 500MG INJECTION(DEPOT) is not recommended for use in patients with liver problems such as liver tumours or any other active liver disease. It should be used with caution in patients with liver impairment. Consult your doctor before receiving Proluton Depot 500mg.
Allergy
ContraindicatedDo not receive Proluton Depot Injection if you are allergic to hydroxyprogesterone caproate, castor oil or any other ingredients of this medicine. Consult your doctor before receiving Proluton Depot.
Lungs
Use with CautionProluton Depot 500mg Injection should be used with caution in patients with lung problems such as asthma. Consult your doctor before receiving Proluton Depot.
Heart Disease
Use with CautionProluton Depot 500mg Injection should be used with caution in patients with heart problems. Consult your doctor before receiving Proluton Depot.
Use In Pediatrics
ContraindicatedPROLUTON 500MG INJECTION(DEPOT) is not recommended for use in girls (below 16 years). Consult your doctor before receiving it.
Use In Geriatrics
Use with CautionProluton Depot should be used with caution in elderly patients. Consult your doctor before receiving it.
Others
Proluton Depot 500mg Injection is not recommended for use if you:
- have or had thrombosis or thromboembolic disorders (formation of clots in the blood vessels)
- have or had known or suspected breast cancer or other hormone-sensitive cancers now or in the past
- have uncontrolled hypertension (high blood pressure)
Before receiving Proluton Depot inform your doctor if you:
- have diabetes or pre-diabetes
- have epilepsy (condition causing recurrent seizures)
- have migraine (a type of severe headache)
- high blood pressure
- have depression
- had preeclampsia (potentially dangerous complication of pregnancy)
Interactions
A. Drug-Drug Interactions:
Before receiving Proluton Depot 500 injection, inform your doctor, if you are taking any of the medicines including prescription and over-the-counter medicines, vitamins and herbal supplements.
Overdosage:
Proluton Depot 500 injection will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Hydroxyprogesterone |
| Pharmacological Category | : | Progestin hormone |
| Therapeutic Indication | : | Reduce the risk of preterm birth |
| Dosage Forms | : | Injection |
More Information
Storage
- Store Proluton Depot 500 at room temperature
- Keep Proluton Depot 500 out of reach and sight of children
FAQs About PROLUTON 500MG INJECTION(DEPOT)
Q: What is PROLUTON 500MG INJECTION(DEPOT) used for?
A: PROLUTON 500MG INJECTION(DEPOT) is used to lower the risk of preterm births among women who have a previous history of pre-term delivery.
Q: What are the side effects of PROLUTON 500MG INJECTION(DEPOT)?
A: Pain, swelling, itching, or a hard bump formation at the area of injection are some of the most common side effects observed in patients. Others include raised red rashes, itching, nausea, diarrhea, increased pain with time, and oozing out of blood or fluid. Inform your doctor if any of the side effects worsen or persist.
Q: Why is PROLUTON 500MG INJECTION(DEPOT) used during pregnancy?
A: PROLUTON 500MG INJECTION(DEPOT) benefits women who have a previous history of pre-term delivery by reducing the risk of the onset of early labour.
Q: How does PROLUTON 500MG INJECTION(DEPOT) help reduce the risk of pre-term labour?
A: PROLUTON 500MG INJECTION(DEPOT) works by regulating the female reproductive system and by assisting the successful implantation of an embryo within the uterus. It also induces an anti-inflammatory response that can initiate pre-term labour.
Q: Who should avoid receiving PROLUTON 500MG INJECTION(DEPOT)?
A: PROLUTON 500MG INJECTION(DEPOT) is not recommended for use in patients with liver tumours, cholestatic jaundice (stopping or slowing of bile flow causing yellowing of the skin) during pregnancy, any other active liver disease, thrombosis or thromboembolic disorders (formation of clots in the blood vessels), known or suspected breast cancer or other hormone-sensitive cancers, or uncontrolled hypertension (high blood pressure). Consult your doctor before receiving it.
Q: Is PROLUTON 500MG INJECTION(DEPOT) safe during pregnancy?
A: PROLUTON 500MG INJECTION(DEPOT) is not recommended for use in pregnant women with cholestatic jaundice or undiagnosed abnormal vaginal bleeding that is unrelated to pregnancy. It should be used cautiously in pregnant women with a singleton pregnancy and a history of preterm delivery. Consult your doctor before receiving PROLUTON 500MG INJECTION(DEPOT).
Q: What medical conditions should be communicated to the doctor before receiving PROLUTON 500MG INJECTION(DEPOT)?
A: Before receiving PROLUTON 500MG INJECTION(DEPOT), inform your doctor if you have liver, kidney, or lung problems such as asthma, heart problems, diabetes or pre-diabetes, epilepsy (a condition causing recurrent seizures), migraine (a type of severe headache), depression, or preeclampsia (a complication of pregnancy).
Q: How do you use PROLUTON 500MG INJECTION(DEPOT)?
A: PROLUTON 500MG INJECTION(DEPOT) will be given to you only by a doctor or a nurse in the back of your upper arm subcutaneously (under the skin) or in your muscle as an intramuscular injection. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.
Q: Can PROLUTON 500MG INJECTION(DEPOT) be given to patients with liver problems?
A: PROLUTON 500MG INJECTION(DEPOT) is not recommended for use in patients with liver problems such as liver tumours, cholestatic jaundice (stopping or slowing of bile flow causing yellowing of the skin), pregnancy, or any other active liver disease. It should be used with caution in patients with liver impairment. Consult your doctor before receiving PROLUTON 500MG INJECTION(DEPOT).
Q: Who should avoid using PROLUTON 500MG INJECTION(DEPOT)?
A: PROLUTON 500MG INJECTION(DEPOT) is not recommended for use if you are allergic to hydroxyprogesterone caproate, castor oil, or have liver problems such as liver tumours or any other active liver disease, blood clots in the body, known or suspected breast cancer or other hormone-sensitive cancers, or uncontrolled high blood pressure.
Q: Is PROLUTON 500MG INJECTION(DEPOT) hormone therapy?
A: PROLUTON 500MG INJECTION(DEPOT) is a hormonal medicine that contains hydroxyprogesterone, a synthetic form of the naturally occurring female sex hormone called progesterone.
Q: Can I buy PROLUTON 500MG INJECTION(DEPOT) from Netmeds, an online pharmacy?
A: Yes, you can purchase PROLUTON 500MG INJECTION(DEPOT) from Netmeds, a reputable online pharmacy. Simply visit their website, search for the medication, and place your order. It's important to ensure that you provide accurate prescription details and follow their purchasing guidelines. Additionally, always consult with your healthcare provider before purchasing or taking any medication.
References
1. KD. Tripathi. Estrogens, Progestins and Contraceptives. Essentials of medical pharmacology. Seventh edition. 2013. Page – 318.
2. AMAG Pharmaceuticals, Inc. Study Assessing Injection Pain of Makena (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women. NIH U.S National Library of Medicine. ClinicalTrials.gov. April 2022. [Accessed on 12th April 2024] https://clinicaltrials.gov/ct2/show/NCT02937766
3. Katarzyna J. Siemienowicz, Yili Wang, Magda Mareckova, Junko Nio-Kobayashi, Paul A. Fowler, Mick T. Rae W. Colin Duncan. Early pregnancy maternal progesterone administration alters pituitary and testis function and steroid profile in male fetuses. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. December 2020. [Accessed on 12th April 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736841/
4. AMAG Pharmaceuticals, Inc. U.S. Food & Drug Administration (FDA). [Revised in February 2018] [Accessed on 12th April 2024] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021945s012lbl.pdf
5. Sun Pharmaceutical Industries Ltd. Hydroxyprogesterone Caproate Injection USP. [Revised in March 2019] [Accessed on 12th April 2024] https://sunpharma.com/usa/wp-content/uploads/sites/2/2020/12/280-hydroxyprogesterone-caproate-inj-pil-208381.pdf
6. Biobrick Pharma. Hydroxyprogesterone Caproate Injection. [Accessed on 12th April 2024] https://www.biobrickpharma.com/product/harogest-500/
Useful Diagnostic Tests
- Early Pregnancy Checkup
- Basic Female Hormones
- Female Extended Package
- Basic Female Health Checkup
- Cancer Screening Package For Female
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