DRUGS & SUPPLEMENTS

Gepromi

advertisement
How is the drug helping you?

Gepromi uses


DESCRIPTION

Gepromi injection, a progestin, is a sterile solution of Gepromi in a suitable vegetable oil available for intramuscular use.

Gepromi occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils.

It has the following structural formula:

C21H30O2 M.W. 314.47

Pregn-4-ene-3, 20-dione

Each mL contains: Gepromi 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s.

Gepromi structural formula.

CLINICAL PHARMACOLOGY

Transforms proliferative endometrium into secretory endometrium.

Inhibits the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation.

Pharmacokinetics and Metabolism:

Absorption: After intramuscular administration of 10 mg of Gepromi in oil, maximum plasma concentrations (geometric mean of 7 ng/mL) were reached within approximately 8 hours after injection and plasma concentrations remained above baseline for about 24 hours after injection. Injection of 10, 25, and 50 mg resulted in geometric mean values for maximum plasma concentration (CMAX) of 7, 28, and 50 ng/mL, respectively.

Distribution: Gepromi is extensively bound to plasma proteins, primarily albumin (50-54%) and cortisol-binding protein (43-48%).

Metabolism: Gepromi is metabolized primarily in the liver by reduction to pregnanediol, pregnanetriol, and pregnanolone. Subsequent conjugation results in the formation of glucuronide and sulfate metabolites. The mean plasma metabolic clearance rate in cycling women is 2510 ± 135 (SEM) L/day.

Excretion: The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the urine and bile. Gepromi metabolites which are excreted in the bile may undergo enterohepatic recycling or may be excreted in the feces.

The pharmacokinetic data was determined in a small number of patients, limiting the precision in which population values may be estimated.

Special Populations:

Renal Insufficiency: The safety and effectiveness in patients with renal insufficiency have not been established. Since Gepromi metabolites are excreted mainly by the kidneys, Gepromi should be administered with caution and careful monitoring in this patient population.

Hepatic Insufficiency: The safety and effectiveness in patients with hepatic insufficiency have not been established. Since Gepromi is metabolized by the liver, use in patients with liver dysfunction or disease is contraindicated.

Drug Interactions:

The metabolism of Gepromi by human liver microsomes was inhibited by ketoconazole (IC50 < 01 μM). Ketoconazole is a known inhibitor of cytochrome P450 3A4 and these data suggest that ketoconazole or other known inhibitors of this enzyme may increase the bioavailability of Gepromi. The clinical relevance of the in vitro findings is unknown.

advertisement

INDICATIONS AND USAGE

This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

CONTRAINDICATIONS

  • Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.

  • Liver dysfunction or disease.

  • Known or suspected malignancy of breast or genital organs.

  • Undiagnosed vaginal bleeding.

  • Missed abortion.

  • Known sensitivity to Gepromi injection.

  • Known sensitivity to sesame oil/seeds.

WARNINGS

The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.

Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.

PRECAUTIONS

General

The pretreatment physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear.

Because progestational drugs may cause some degree of fluid retention, conditions which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac, or renal dysfunction, require careful observation.

In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken.

Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.

The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric.

The pathologist should be advised of progestin therapy when relevant specimens are submitted.

There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism. The dosage used may be important in minimizing these adverse effects.

A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term intramuscular administration of Medroxyprogesterone acetate has been shown to produce mammary tumors in beagle dogs. There is no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice.

Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.

Gepromi at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.

Geriatric Use:

The safety and effectiveness in geriatric patients (over age 65) have not been established.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Nursing Mothers:

Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined.

advertisement

ADVERSE REACTIONS

Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions; mental depression; pyrexia; insomnia; nausea; and somnolence.

A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.

The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness.

The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI and butanol extractable protein bound iodine, and decrease in T3 uptake values.

DOSAGE AND ADMINISTRATION

Gepromi is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection.

Amenorrhea: Five to 10 mg are given for six to eight consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding forty-eight to seventy-two hours after the last injection. This may be followed by spontaneous normal cycles.

Functional Uterine Bleeding: Five to 10 mg are given daily for six doses. Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of Gepromi is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of Gepromi, they are discontinued.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

advertisement

HOW SUPPLIED

Gepromi Injection USP, 500 mg/10 mL (50 mg/mL) is available in 10 mL multiple dose vials, individually boxed.

(NDC 0591-3128-79)

Store at 20°-25°C (68°-77°F).

Rx only

For all medical inquiries contact:

ACTAVIS

Medical Communications

Parsippany, NJ 07054

800-272-5525

Distributed By:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Manufactured By:

Hikma Farmacêutica

Fervença 2705-906 Terrugem SNT

Portugal

Content Updated: September 2014

PATIENT INFORMATION

FOR THE TREATMENT OF AMENORRHEA (ABSENCE OF MENSES IN WOMEN WHO HAVE PREVIOUSLY HAD A MENSTRUAL PERIOD) OR ABNORMAL UTERINE BLEEDING DUE TO HORMONAL IMBALANCE.

Please read this information carefully before you start to use Gepromi Injection and each time your prescription is renewed, in case anything has changed. This leaflet does not take the place of discussions with your doctor. If you still have any questions, ask your doctor or health-care provider.

About Gepromi Injection

Gepromi Injection is a sterile injectable solution containing the natural female hormone called Gepromi. Gepromi Injection is indicated for the treatment of amenorrhea and abnormal uterine bleeding due to Gepromi deficiency.

Understanding the role of Gepromi Injection in the treatment of your menstrual irregularities.

Gepromi is one of the hormones essential for regular menstrual periods. If your doctor has determined your body does not produce enough Gepromi on its own, Gepromi Injection may be prescribed to provide the Gepromi you need.

When you do not produce enough Gepromi, menstrual irregularities can occur. Gepromi Injection can provide you with the Gepromi needed during a normal menstrual cycle.

Possible side effects of Gepromi Injection

The following side effects have been reported with Gepromi Injection. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.

  • breakthrough bleeding

  • spotting

  • changes in menstrual flow

  • amenorrhea

  • change in weight (increase or decrease)

  • pain, irritation, swelling, and/or redness at the injection area

  • general swelling

  • vaginal discharge

  • yellow discoloration of skin or white of eyes

  • breast tenderness, discharge from the nipple

  • skin reactions including rash, hives, itching, and swelling

  • acne

  • hair loss or growth of new hair

  • mental depression

  • fever

  • insomnia or sleepiness*

  • nausea

  • anaphylactoid (life-threatening allergic) reaction with symptoms that may include a sense of uneasiness or apprehension; flushing; fast, throbbing heartbeat; itching; hives; difficult breathing; swelling of the throat; fainting; nausea; vomiting; or convulsions.

*If you experience sleepiness, do not drive or operate machinery.

When you should not use Gepromi Injection

  • If you are allergic to Gepromi, progesterone-like drugs, benzyl alcohol or sesame oil/seeds.

  • If you have unusual vaginal bleeding which has not been evaluated by your doctor.

  • If you have liver disease.

  • If you have known or suspected cancer of the breast or genital organs.

  • If you have a miscarriage and your physician suspects some tissue is still in the uterus.

  • If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.

Risks of Gepromi Injection

  • Abnormal blood clotting. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.

Precautions

Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Gepromi Injection, call your doctor immediately:

  • Abnormal bleeding from the vagina.

  • Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs.

  • Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye.

  • Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or health-care provider to show you how to examine your breasts monthly.)

  • Yellowing of the skin and/or white of the eyes indicating possible liver problems.

How Gepromi Injection works

Gepromi Injection is intended for administration by injection into a muscle mass. Following injection, the medication is absorbed into the bloodstream.

Other information

  • Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else.

  • This medication was prescribed for your particular medical condition. Do not use it for another condition.

  • Keep this and all drugs out of the reach of children.

How to use Gepromi Injection

Gepromi Injection will be administered to you by a health-care provider or your caregiver. Your doctor will provide instructions regarding the dose and manner in which the medication should be injected. Follow your doctor’s instructions closely. If you have any questions about product administration, ask your doctor or health-care provider.

How Supplied

Gepromi Injection, 500 mg/10 mL (50 mg/mL) is available in 10 mL multiple dose vials. Vials are individually boxed.

Gepromi Injection should be stored at 20°-25°C (68°-77°F).

Do not use Gepromi Injection after the expiration date which is printed on the vial label.

Rx only

For all medical inquiries contact:

ACTAVIS

Medical Communications

Parsippany, NJ 07054

800-272-5525

Distributed By:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Manufactured By:

Hikma Farmacêutica

Fervença 2705-906 Terrugem SNT

Portugal

Content Updated: September 2014

advertisement

Gepromi pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Gepromi available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Gepromi destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Gepromi Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Gepromi pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


advertisement

References

  1. Dailymed."PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PROGESTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "progesterone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Gepromi?

Depending on the reaction of the Gepromi after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Gepromi not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Gepromi addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sDrugs.com conducted a study on Gepromi, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Gepromi consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 21 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2019 "sDrugs.com". All Rights Reserved