GRAVIBINON INJECTION – IS IT SAFE? USES, DOSAGE

WHAT IS GRAVIBINON INJECTION?

Gravibinon injection is a combination of estrogen and progesterone medication used in the treatment of threatened miscarriage including the other indications of habitual or multiple abortions in women. This is only used as an intramuscular injection. It is manufactured by Bayer Schering Pharma AG.

GRAVIBINON INJECTION – IS IT SAFE? USES, DOSAGE

What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
How effective is this medicine?
Is it addictive?
What is the dosage?
What if I miss a dose?
What to do in case of overdosage?
What to do in case of allergic reactions?
What are the side effects?
Does this medicine have any drug interactions?
Precautions
Can it be taken with alcohol?
Is it safe to use if I am breastfeeding?
CAN THIS MEDICINE BE USED FOR CHILDREN AND INFANTS?
IS THIS MEDICINE AVAILABLE AS THE OVER THE COUNTER(OTC) PRODUCT?
FREQUENTLY ASKED QUESTIONS
Reference

WHAT IS THE GENERIC NAME(S)?

The generic name of Gravibinon injection is:

• Estradiol Valerate[1] (EV)
• Hydroxyprogesterone Caproate[2](OHPC)

WHAT IS ITS COMPOSITION?

The Gravibinon injection is a non-pyrogenic clear solution with the combination of active ingredients like:

For 1ml:

•  Estradiol Valerate 5 mg
• Hydroxyprogesterone[3] 250 mg

For 2ml:

• Estradiol Valerate 10 mg
• Hydroxyprogesterone 500 mg

Inactive ingredients for the solution of the injection are:

• castor oil[4]
• sesame oil[5]
• Benzyl benzoate[6]

The composition of the ingredients increases with the strength of the medicine.

HOW DOES IT WORK?

1. Gravibinon injection fixes the progesterone receptors in the ovaries[7], uterus[8], breasts[9], and in the central nervous system[10] by modulating gonadotropins[11], and follicle stimulating hormone.
2. It starts to work from the 5th week of pregnancy[12] and continues till to the 20th week of pregnancy by attaching the progesterone receptors in the uterus which helps in the sustaining of pregnancy.
3. This injection helps in the strengthening of the uterus walls, growing of the breast tissue, and making sure that the body of the patient does not make milk until the delivery of the baby.
4. It works to balance the level of estradiol and progesterone of the women during pregnancy when the body is not making enough of any of the two hormones.
5. In amenorrhea[13], it restores the normal menstrual cycle which has been stopped for a long time by providing adequate estrogen to the body.
6. It works as good hormonal therapy and maintaining the pregnancy after conceiving in the patients with a high risk of spontaneous abortion[14] in the 1st trimester by providing adequate progesterone to the body.
7. As a result, the women who are suffering from multiple abortions can improve the prognosis for the continuation of the pregnancy after the 12th week of gestation.

WHAT ARE THE USES?

This is an intramuscular injection used for the control, treatment, and the development of the diseases like:

1. The prevention of preterm births.
2. The vasomotor symptoms associated with the Menopause[15] like hot flashes, severe dryness, burning, and itching sensation inside and outside of the vagina.
3. Adverse androgen-dependent prostate cancer(for palliation only)
4. The Vaginal Atrophy
5. Hypoestrogenism conditions
6. Vulvar Atrophy
7. Castration or primary ovarian failure
8. In the treatment of uncontrolled bleeding from the uterus due to the low level of hormones.

HOW EFFECTIVE IS THIS MEDICINE?

The effectiveness of the Gavibinon Injection depends upon the proportion of women who delivered less than 37 weeks of gestation.

It works effectively:

• to reduce the chances of preterm birth in women who have a history of singleton spontaneous preterm birth.
• for the women suffering from PCO syndrome and had a history of anovulation or corpus luteum insufficiency.
• as a mean of hormonal breast enlargement.
• in the treatment of Osteopenia due to hypogonadism
• as induction of feminization in delayed puberty
• termination of pregnancy owing to chromosomal anomalies.

IS IT ADDICTIVE?

As per research, there is no ingredient found in this medicine which can be addictive or habit forming.

WHAT IS THE DOSAGE?

Though we are giving you the dosage instructions of this injection it is strictly recommended to take the help of a practitioner to inject under the supervision of a doctor. Don’t inject this medicine on your own. It may be risky for you.

The dosages of this medicine are different for the treatment of each disease such as: 

• FOR MODERATE TO SEVERE VASOMETER SYMPTOMS

1. 10 to 20mg of Gravibinon injection once in every 4 weeks
2. discontinuation of the medication must be made at 3- month to 6- months of intervals.

• FOR ADVANCED ANDROGEN DEPENDENT CARCINOMA OF THE PROSTATE, FOR PALLIATION ONLY

1. 30mg or more once every week or in 2 weeks

• FOR FEMALE HYPOESTROGENISM

1. 10 to 20mg in once in every 4 weeks

Again it is strictly recommended to you not to take the risk of own medication of this medicine without consulting the doctor or without the supervision of the doctor.

WHAT IF I MISS A DOSE?

Gravibinon injection is such a term of medication that it will be dangerous or ineffective for you if missed any of the doses without the instructions of the doctor.

If in case, you have missed a dose it is advised to contact your doctor immediately as soon as you remember about the missed one.

Your doctor will suggest you the further step or schedule of the medication of this medicine.

Therefore, it is recommended not to miss a single dose of this medicine to keep your treatment effective.

WHAT TO DO IN CASE OF OVERDOSAGE?

It is strictly recommended to be careful about dosages while taking hormonal medicines or injections. Gravibinon is and hormonal injection whose overdosage may be extremely risky an sometimes fatal for you.

The major symptoms of the overdosage of this injection are vomiting, nausea, severe dizziness, excess vaginal bleeding, and sometimes fainting also.

If it happens immediately contact your doctor or rush to the nearby hospital for emergency hospitalization.

It is also recommended to contact your doctor immediately if you have taken an overdosage of this medication to avoid any adverse effects.

It is advised not to give this injection for the usage of other people without the prescription of a doctor.

WHAT TO DO IF THERE IS AN ALLERGIC REACTION?

It is advised to report your doctor immediately if you experience some allergic reactions after taking this injection like:

1. Urticaria
2. Pruritus
3. Angioedema
4. Swelling of face, tongue, throat, and lips
5. severe itchiness or rash
6. Hives

It may happen due to the allergic reaction of any of the ingredients Gravibinon contains.

WHAT ARE THE SIDE-EFFECTS?

You may go through some side-effects of Gravibinon injection are:

Rare But Serious Side-Effects

1. Breast cancer
2. Uterus cancer
3. Ovarian cancer
4. Heart Attack
5. Hematoma
6. Gall bladder disease
7. dementia
8. Dysmenorrhea
9. Discharge from the nipples
10. enlargement of breasts with tenderness
11. vaginitis
12. vaginal candidiasis
13. endometrial hypoplasia
14. gastrointestinal disorders
15. Frequent and painful urination
16. Dark patches on the face
17. Dark urine
18. Yellowing skin or eye

Common Side-Effects

1. Anxiety
2. Lumps at the injection area
3. Nausea and vomiting
4. A Headache
5. Pain in the Breasts
6. Bloating
7. Abdominal cramps
8. Irregular menstrual bleeding/spotting
9. Hair loss
10. Vaginal Yeast infection
11. Edema
12. Pulmonary Embolism
13. Increase in heartbeat
14. Redness on the face and neck
15. Pain, itching, an swelling at the injection area
16. Increases appetite
17. Polymenorrhea
18. Obesity
19. Aggravation of porphyria
20. Reduced tolerance to carbohydrates
21. Hypocalcemia
22. High Blood [Pressure (180/110)
23. Diarrhoea
24. Depression
25. Vaginal discharge

Some Warning Signs of The Serious Side-Effects

1. Shortness of breath
2. Verbal changes in speech
3. Uncontrolled vaginal bleeding
4. Prolonged Dizziness and getting fainted
5. Severe chest pain
6. Multiple lumps in the breasts
7. A severe Headache
8. Blurred vision
9. Retinal thrombosis
10. Intolerance to contact lenses
11. Muscular cramps in the legs
12. Nonstop vomiting
13. skin diseases like melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption.

We have given all these side-effects of this medicine after thorough research from different sources. It is recommended to you not to be panic about all these because they may or may not occur with everyone.

DOES THIS MEDICINE HAS ANY DRUG INTERACTIONS?

Gravibinon injection may have some drug interactions like:

• Erythromycin
• Clarithromycin
• Itraconazole
• Ritonavir
• Ketoconazole
• Nizoral
• Extina
• Kuric
• Zolegel
• Rifampin
• any type of Vitamins
• herbal supplements
• nonprescription medicines
• Grapefruit juice

PRECAUTIONS

Before the medication of this injection, it is recommended to inform your doctor about all the past, present, and suspective diseases in brief such as if you have:

• an active or history of Thromboembolic disorders or Thrombosis.
• active or past liver diseases like liver tumor whether it may be benign or malignant
• suspected or known hormone-related cancer.
• suspected or known breast cancer
• abnormal vaginal bleeding without pregnancy
• Severe hypertension
• cholestatic jaundice of pregnancy
• Uterus cancer
• active or history of Hematoma or blood clot
• allergic to Estradiol Valerate
• any upcoming or history of surgery
• a migraine
• endometriosis
• epilepsy or seizures
• asthma
• wheezing
• lupus
• cardiovascular problems like myocardial infarctions, heart stroke, and venous embolism
• thyroid
• kidney-related disorders
• elevated blood pressure
• hypertriglyceridemia
• hypocalcemia
• arterial vascular diseases like hypertension, diabetes mellitus, hypercholesterolemia
• bone metastases
• 6 weeks of postpartum
• Surgery with prolonged immobilization
• Active Hepatitis
• Nephritis
• Diabetes for more than 20 years
• Retinopathy
• Nephropathy
• Neuropathy

We have given you the list of precautions you have to take before the medication of this medicine after thorough research from different sources.

CAN I CONSUME ALCOHOL WHILE USING IT?

Alcohol has an additive effect on the ingredients of this injection for which you should not take alcohol during this medication. It may create some dangerous after-effects like:

• blood vomiting
• severe abdominal pain
• a sudden increase in blood pressure which may lead to brain stroke
• severe anxiety which may lead to a heart stroke
• Excess sweating
• Severe dizziness

It is recommended not to take alcohol during the whole medication period.

IS IT SAFE TO USE IF I AM BREASTFEEDING?

Gravibinon injection is not recommended if you are breastfeeding. There are proofs of the passing of the hormones into the baby through the breast milk while taking this injection.

You must inform your doctor about this if the medication of Gravibinon injection is necessary for you. The doctor may prescribe the perfect dosage for you as per your need.

CAN THIS MEDICINE BE USED FOR CHILDREN AND INFANTS?

Gravibinon injection is not at all recommended for the infants and the children under 16 years of age.

We have given this report after searching from different sources. It is suggested to consult your doctor about the medication of this injection for children.

Never self-medicate this for your own without the consultation, prescription, and the supervision of a doctor. It may be risky for your child.

IS THIS MEDICINE AVAILABLE AS THE OVER THE COUNTER(OTC) PRODUCT?

This medicine is used as a contraceptive formula with the combination of some other medicines as per the doctor’s prescription.

Otherwise, it is not available as an over the counter medicine for any other diseases.

FREQUENTLY ASKED QUESTIONS

• How I can store this medicine?

Ans – The storage of this medicine is very important. Follow the rules of storage that:

1. do not refrigerate this medicine.
2. Keep it between the room temperature of 20 to 25 degrees.
3. do not expose this to sunlight.
4. Keep it reach of pets an children.

• Can I stop this medicine on my own?

Ans –  Do not self-medicate or stop this medicine on your own without the instructions of the doctor. It may be risky or ineffective for you.

• Can I drive after taking this medicine?

Ans – You can feel severe dizziness and sleepy after this medication. So it is suggested not to drive or not to do any of the heavy machinery works after this injection.

• Can I use an expired injection of only before a week?

Ans – It is not at all advisable to take a single dose of the expired medicine whether it is of 2 days or 7 days. It will create lots of adverse effects after the usage. Therefore, it will be best for you to consult your doctor about the expired dose of the injection for your safe side.

• Can I take a substitute for this medicine due to the unavailability in my area?

Ans – No, do not go for a substitute for this injection without informing your doctor. It will be better to call your doctor if it is not available in your area to get a suggestion for the further medication.

• How much time does this medicine take to show the improvements?

Ans – Actually, the symptoms of the improvement of the medicine depends upon the severity of the disease. But generally, it takes an approximate time of 3 months to show the symptoms of improvement after the medication.

• Can I take this injection in an empty stomach or with the food?

Ans – The food has no specific role with the medication of this injection.

• How could I know that the medicine is working for me?

Ans – Only your doctor can tell you about your development after the regular gynaecological check-ups. If in case, you are wondering if this treatment helps you or not it is advised to consult your gynaecologist.

Reference

Wikipedia page on Gynaecology

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