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INTRODUCTION BIOSTERONE DEPOT 250 INJECTION contains Hydroxyprogesterone which belongs to the group of medicines called Progestin hormones. It is used to lower the preterm birth risk in women with a singleton pregnancy having a history of preterm delivery. It is also used to prevent premature...
BIOSTERONE DEPOT 250 INJECTION contains Hydroxyprogesterone which belongs to the group of medicines called Progestin hormones. It is used to lower the preterm birth risk in women with a singleton pregnancy having a history of preterm delivery. It is also used to prevent premature labor and miscarriage in pregnant women.
Preterm delivery is a condition in which the baby is born too early that is before the completion of 37 weeks with early symptoms such as frequent sensation of womb contractions, constant backache, feeling of pressure in abdomen, light bleeding or change in vaginal discharge.
Miscarriage is the sudden and early loss of pregnancy before the 20th week of gestation. It is characterized by symptoms such as vaginal bleeding or spotting, pain or cramps in the abdomen or back or fluid/tissue coming out of vagina. Your doctor may monitor your blood sugar levels while using this medicine if you are diabetic or pre-diabetic.
BIOSTERONE DEPOT 250 INJECTION is not recommended for use in patients with liver tumours, any active liver disease, thrombosis/thromboembolic disorders (formation of clots in the blood vessels), known or suspected breast cancer/other hormone-sensitive cancers and uncontrolled high blood pressure.
BIOSTERONE DEPOT 250 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 and it should be used with caution in breastfeeding women.
It is not recommended for use in girls (aged below 16 years). The common side effects associated with the use of BIOSTERONE DEPOT 250 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.
BIOSTERONE DEPOT 250 INJECTION helps in lowering the chances of preterm birth where hydroxyprogesterone is a synthetic preparation of progesterone hormone works by regulating the female reproductive system and plays a vital role in implanting the embryo successfully in the womb. It also induces anti-inflammatory response that can initiate pre-term labour.
BIOSTERONE DEPOT 250 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 dose and duration for you depending upon your age, body weight and disease condition.
Stop receiving BIOSTERONE DEPOT 250 INJECTION and contact your doctor if you experience any of the following side effects:
Diarrhoea:
Drink lot of fluids such as water to keep yourself hydrated. Try to avoid receiving any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.
Nausea:
Stick to simple meals while receiving this medicine. Avoid eating oily, fried or spicy foods. Consult your doctor if the symptom gets worse.
Itching:
Tap or pat your skin upon itching. Try not to scratch the skin. Take cool or warm bath and place cool damp towel on the skin. Wear loose cotton clothes. Avoid using perfumed moisturizers, deodorants or soaps. Consult your doctor if the symptom gets worse.
BIOSTERONE DEPOT 250 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 BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION should be used cautiously in breastfeeding mothers. Consult your doctor before receiving it.
BIOSTERONE DEPOT 250 INJECTION should be used with caution in patients with kidney problems. Consult your doctor before receiving BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION 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 BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION should be used with caution in patients allergic to hydroxyprogesterone caproate, castor oil or any other ingredients of this medicine. Consult your doctor before receiving BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION should be used with caution in patients with lung problems such as asthma. Consult your doctor before receiving BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION should be used with caution in patients with heart problems. Consult your doctor before receiving BIOSTERONE DEPOT 250 INJECTION.
BIOSTERONE DEPOT 250 INJECTION is not recommended for use if you:
Before receiving BIOSTERONE DEPOT 250 INJECTION, inform your doctor if you:
Use in Paediatrics:
BIOSTERONE DEPOT 250 INJECTION is not recommended for use in girls (below 16 years). Consult your doctor before receiving it.
Use in Geriatrics:
BIOSTERONE DEPOT 250 INJECTION should be used with caution in elderly patients. Consult your doctor before receiving it.
A. Drug-Drug Interactions:
Before receiving BIOSTERONE DEPOT 250 INJECTION, inform your doctor, if you are taking any of the medicines including prescription and over-the-counter medicines, vitamins and herbal supplements.
Overdosage:
BIOSTERONE DEPOT 250 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.
| Drug | : | Hydroxyprogesterone |
| Pharmacological Category | : | Progestin hormone |
| Therapeutic Indication | : | Reduce the risk of preterm birth, premature labor and miscarriage in pregnant women |
| Dosage Forms | : | Injection |
Q: What is BIOSTERONE DEPOT 250 INJECTION used for?
A: BIOSTERONE DEPOT 250 INJECTION is used to lower the preterm birth risk in women with a singleton pregnancy having a history of preterm delivery. It is also used to prevent premature labor and miscarriage in pregnant women.
Q: What side effects are seen with BIOSTERONE DEPOT 250 INJECTION?
A: The common side effects associated with the use of BIOSTERONE DEPOT 250 INJECTION are pain, swelling, itching or a hard bump at the injection site, raised red rashes, itching, nausea, diarrhoea, increased pain with time and oozing out of blood or fluid. Inform your doctor if any of the side effect worsens or prolong.
Q: Who should avoid receiving BIOSTERONE DEPOT 250 INJECTION?
A: BIOSTERONE DEPOT 250 INJECTION is not recommended for use in patients with liver tumours, cholestatic jaundice (stopping or slowing of bile flow causing yellowing of skin) of 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 and uncontrolled hypertension (high blood pressure). Consult your doctor before receiving it.
Q: What medical conditions should be informed to doctor before receiving BIOSTERONE DEPOT 250 INJECTION?
A: Before receiving BIOSTERONE DEPOT 250 INJECTION, inform your doctor if you have diabetes or pre-diabetes, epilepsy (condition causing recurrent seizures), migraine (a type of severe headache), depression and preeclampsia (a complication of pregnancy).
Q: What is method of receiving BIOSTERONE DEPOT 250 INJECTION?
A: BIOSTERONE DEPOT 250 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 your muscle as an intramuscular injection. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Q: Can BIOSTERONE DEPOT 250 INJECTION be given to patients with liver problems?
A: BIOSTERONE DEPOT 250 INJECTION 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 skin) of pregnancy or any other active liver disease. It should be used with caution in patients with liver impairment. Consult your doctor before receiving BIOSTERONE DEPOT 250 INJECTION.
Q: When should I stop receiving BIOSTERONE DEPOT 250 INJECTION during pregnancy?
A: BIOSTERONE DEPOT 250 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 a history of preterm delivery. Consult your doctor before receiving it.
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 9th July 2022] 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 9th July 2022] 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 9th July 2022] 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 9th July 2022] 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 9th July 2022] https://www.biobrickpharma.com/product/harogest-500/
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 12 Jan 2023 | 02:33 PM(IST)