Miprogen SR 300mg Tablet 10’S

INTRODUCTION

MIPROGEN SR TABLET contains Progesterone which belongs to the group of medicines called Steroid hormones. It is used to treat disorders caused due to progesterone deficiency such as menopause (along with estrogen) to reduce the risk of cancer, premenopause, pre-menstrual syndrome (physical and psychological symptoms that females experience in the weeks before their period), menstrual irregularities, benign mastopathies (breast disease) and secondary amenorrhea (missed periods).

It can also be used to prevent endometrial thickness of uterus in non-hysterectomized postmenopausal women who are taking conjugated estrogens.

Before taking MIPROGEN SR TABLET inform your doctor if you have any liver, heart or kidney problems, diabetes, asthma, epilepsy or depression. Do not take MIPROGEN SR TABLET if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding or blood clots.

During treatment with MIPROGEN SR TABLET, your doctor will instruct you to have periodic blood tests and regular physical examination (breast and uterine examination) as a precaution.

MIPROGEN SR TABLET is not recommended for use in pregnant women or who might become pregnant. It is for use in postmenopausal women only. It is not recommended for use in breast-feeding women and in children and adolescents (below 18 years of age).

The most common side effects of taking MIPROGEN SR TABLET are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea and vomiting. Consult your doctor if any of the side effect worsens.

USES OF MIPROGEN SR TABLET
Treats disorders caused due to progesterone deficiency such as menopause (along with estrogen), premenopause, pre-menstrual syndrome, menstrual irregularities, benign mastopathies and secondary amenorrhea
Prevents endometrial thickness of uterus in non-hysterectomized postmenopausal women who are taking conjugated estrogens
HOW MIPROGEN SR TABLET WORKS

MIPROGEN SR TABLET can diffuse freely into cells, where it binds to the progesterone receptors and exerts its progestational activity. It acts by adjusting the hormonal balance in the body, which gets imbalanced as you get near to the menopause, during menopause, before you get your periods or during other menstrual conditions.

DIRECTIONS FOR USE

Take MIPROGEN SR TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you based upon your age, body weight and disease condition.

SIDE EFFECTS OF MIPROGEN SR TABLET
COMMON
Headache
Breast pain
Irregular vaginal bleeding or spotting
Stomach or abdominal cramps, bloating, nausea, vomiting
Hair loss
Fluid retention
Vaginal yeast infection
RARE

Stop taking MIPROGEN SR TABLET and contact your doctor immediately if you experience any of the following side effects:

Signs of liver disease (such as yellow skin or white of the eyes)
Severely high blood pressure (signs include headache, tiredness and dizziness)
Migraine-like headaches (happening for the first time)
Sudden or gradual, partial or complete loss of eyesight
Bulging of one or both eyes, double vision
Swelling of the optic nerve
Retinal vascular lesions (eye diseases)
Signs of blood clot (such as painful swelling and redness of the legs, sudden chest pain and trouble breathing)
HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.

Nausea or vomiting:

Take MIPROGEN SR TABLET with or just after meals. Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS
PREGNANCY

MIPROGEN SR TABLET is not recommended for use in pregnant women or who might become pregnant. It is for use in postmenopausal women only. Consult your doctor before taking MIPROGEN SR TABLET.

BREASTFEEDING

MIPROGEN SR TABLET is not recommended for use in breast-feeding women. Consult your doctor before taking MIPROGEN SR TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy or sleepy after taking MIPROGEN SR TABLET.

LIVER

MIPROGEN SR TABLET is not recommended for use in patients who had or have liver disease and with abnormal liver function test. It should be used with caution in patients with benign liver tumor. Consult your doctor before taking MIPROGEN SR TABLET.

ALLERGY

Do not take MIPROGEN SR TABLET if you are allergic to Progesterone or any other ingredients of this medicine or soya.  

LUNGS

MIPROGEN SR TABLET is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism). It should be used with caution in patients with asthma. Consult your doctor before taking MIPROGEN SR TABLET.

HEART DISEASE

MIPROGEN SR TABLET is not recommended for use in patients with recent heart attack or chest pain. It should be used with caution in patients with high blood pressure. Consult your doctor before taking MIPROGEN SR TABLET.

OTHERS

MIPROGEN SR TABLET is not recommended for use if you:

Have known or suspected cancer of the breast or womb lining (endometrium)
Have unusual vaginal bleeding
Had or have blood clots in the legs (deep venous thrombosis) or in the veins (thrombosis)
Have bleeding on the brain (cerebral hemorrhage) or stroke
Have blood clotting disorder (like protein C, protein S or antithrombin deficiency)
Have porphyria (rare genetic blood disorder)

Before taking MIPROGEN SR TABLET, inform your doctor if you:

Have problems in your uterus (such as fibroid growths or endometriosis (womb lining growth outside your womb)
Have a history of excessive womb lining growth (endometrial hyperplasia)
Have increased risk of blood clot formation (when you are unable to walk for long time after major surgery, injury or illness, obese and older age)
Have a family history of having breast cancer
Have diabetes
Have gallstones
Have migraine or severe headaches
Have systemic lupus erythematosus (an immune system disease that affects many organs of the body)
Have epilepsy (fits)
Have otosclerosis (disease affecting the eardrum and hearing)
Have ever had depression
Have skin sensitivity towards light

Use in pediatrics:

MIPROGEN SR TABLET is not recommended for use in children and adolescents (under 18 years of age). Consult your child’s doctor for advice.

Use in geriatrics:

MIPROGEN SR TABLET should be used with caution in elderly patients. Consult your doctor before taking MIPROGEN SR TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking MIPROGEN SR TABLET, inform your doctor if you are taking any of the following medicines:

Medicines used to treat epilepsy (Ex. carbamazepine, phenytoin, phenobarbital)
Medicines used to treat bacterial infections (Ex. rifampicin, rifabutin, ampicillin and tetracyclines such as doxycycline, minocycline)
Medicines used to treat HIV infection (Ex. nelfinavir, nevirapine, efavirenz, ritonavir)
St. john’s wort (used to treat depression)
Bromocriptine (used to stop breast milk production, treat infertility or parkinsonism)
Cyclosporine (used to prevent graft rejection)
Medicines used to treat fungal infections (Ex. griseofulvin, ketoconazole, terbinafine)
Spironolactone (used to treat fluid retention)
Other progesterone medicines used to treat hormonal problems (such as medroxyprogesterone acetate and megestrol)
Medicines used to prevent or treat blood clots (Ex. warfarin, phenindione)
Medicines used to treat diabetes (Ex. glimepiride, metformin)
Ulipristal (used to prevent pregnancy in emergencies)
Tizanidine (used to treat multiple sclerosis)

B. Drug–Food interactions:

Do not take MIPROGEN SR TABLET with food as it may increase the bioavailability of this medicine.

Overdosage:

If you or anyone else accidentally take too much of MIPROGEN SR TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are dizziness, tiredness, drowsiness or sleepiness.

SYNOPSIS
Drug :  

Progesterone

Pharmacological Category :  

Progestins (female hormones)

Therapeutic Indication :  

Various disorders due to progesterone deficiency, Prevents endometrial hyperplasia (together with estrogen)

Dosage Forms :  

Tablet, Soft gel Capsule, Pessaries, Injection, Vaginal Gel, Vaginal spray 

MORE INFORMATION
Keep MIPROGEN SR TABLET out of reach of children
Store MIPROGEN SR TABLET at room temperature
FAQs ABOUT MIPROGEN SR TABLET

Is MIPROGEN SR TABLET safe to use in patients with liver problems?

MIPROGEN SR TABLET is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism) and it should be used with caution in patients with asthma. Consult your doctor before taking MIPROGEN SR TABLET.

Does MIPROGEN SR TABLET make you feel tired?

Yes, MIPROGEN SR TABLET may cause tiredness in some individuals. To manage this, drink plenty of fluids and eat balanced diet and frequent meals. Get enough rest and follow regular sleep schedule.

What are the common side effects of MIPROGEN SR TABLET?

The most common side effects of taking MIPROGEN SR TABLET are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea, vomiting, irregular vaginal bleeding or spotting, fluid retention and vaginal yeast infection. Consult your doctor if any of the side effect worsens.

What to do if I forget to take a dose of MIPROGEN SR TABLET?

You should take MIPROGEN SR TABLET immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose. 

Why is MIPROGEN SR TABLET necessary for pregnancy?

MIPROGEN SR TABLET supplements your body with sufficient levels of progesterone that is required for a successful implantation of fertilized egg in the uterus and for the maintenance of an early pregnancy. It sustains pregnancy among infertile women and in women who face repeated/threatened abortions by increasing the thickness of uterine wall.

When is progesterone produced in the reproductive cycle?

The typical menstrual cycle takes approximately 28 to 32 days and is divided into three distinct phases namely the follicular phase, the ovulatory phase and the luteal phase. The luteal phase is the period when the body produces progesterone, the hormone that makes the uterus prepare its lining to receive the egg.

What precautions need to be followed while taking MIPROGEN SR TABLET?

Before taking MIPROGEN SR TABLET inform your doctor if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding, heart problems, blood clots, diabetes or asthma. Take MIPROGEN SR TABLET regularly as instructed by the physician without fail. Do not miss a dose of MIPROGEN SR TABLET to achieve maximum benefits.

REFERENCES

1. KD. Tripathi. Estrogens, Progestins, and Contraceptives. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 316.

2. Michaela Jewson, Prashant Purohit, Mary Ann Lumsden. Progesterone and abnormal uterine bleeding/menstrual disorders. ScienceDirect. November 2020. [Accessed on 22nd July 2022] https://www.sciencedirect.com/science/article/abs/pii/S152169342030081X

3. R Erny, A Pigne, C Prouvost, M Gamerre, C Malet, H Serment, J Barrat. The effects of oral administration of progesterone for premature labor. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 1986. [Accessed on 22nd July 2022] https://pubmed.ncbi.nlm.nih.gov/3513581

4. Cyndea Pharma. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 22nd July 2022] https://www.medicines.org.uk/emc/files/pil.352.pdf

5. Torrent Pharmaceuticals Ltd. herNMP SR (Progesterone Sustained Release Tablets). [Revised in July 2016] [Accessed on 22nd July 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2686.pdf

6. Catalent Pharma Solutions. U.S. Food & Drug Administration. [Accessed on 22nd July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf

USEFUL DIAGNOSTIC TESTS
Saline-infusion sonography
Ultrasound
Anti-mullerian hormone
Net Qty
1 N
Item Weight
17.5 g
Ingredient
PROGESTERONE 300MG
Hsn Code
30043919
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