Crinone Vaginal gel, is it safe ? side effects, how to use

What is Crinone

Crinone gel is a branded formulation which is a bioadhesive vaginal gel containing micronised progesterone. This medicine is generally prescribed for the treatment of Secondary amenorrhea and ART treatment for infertility in women.

 

  1. What are the Generic Name(s)
  2. How does it work ?
  3. What are it’s uses ?
  4. How effective is this medicine ?
  5. What are the Side Effects ?
  6. What is the Dosage ?
  7. What are the precautions I need to take ?
  8. Is it safe to take If I am pregnant ?
  9. Is it safe to take if I am breast feeding ?
  10. Can this medicine be given to Children and Infants ?
  11. Is Crinone available as over the counter (OTC) product?
  12. Frequently asked questions
  13. Reference
Crinone Vaginal gel, uses, side effects, how to use

Crinone Vaginal gel, uses, side effects, how to use


What are the Generic Name(s)

The generic name of Crinone is Progesterone, Each applicator delivers 1.125 grams of Crinone gel containing either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, light mineral oil, polycarbophil, carbomer homopolymer Type B, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide.

How does it work ?

Crinone contains Progesterone, which is a type of female hormone (progestin) and is similar to the hormone that your body naturally makes. Progesterone stimulates luteal actions, changes in uterus and vagina as seen in early pregnancy.

What are it’s uses ?

Crinone vagina gel is normally prescribed for the treatment of secondary amenorrhea and infertility in women caused by the deficiency of progesterone.

How effective is this medicine ?

Efficacy of Crinone  for luteal support in frozen embryo transfer cycles is reportedly 60.5% (n=238) while intramuscular progesterone is 61.7% (n=682).

Efficacy of this gel in donor oocyte cycles , measuring clinical pregnancy rates for women who received this vaginal gel or intramuscular progesterone within a donor oocyte program,  is 58% and intramuscular progesterone is 53%

What are the Side Effects ?

Common side effects include :

  • abdominal pain
  • perineal pain (the perineum is the area between the avinga and the rectum)
  • cramps
  • bloating
  • headache
  • fatigue
  • increase appetite
  • constipation
  • diarrhea
  • nausea
  • joint pain
  • depression
  • mood swings
  • sleep disorder
  • nervousness
  • decreased libido
  • breast enlargement
  • excessive urination at night
  • vaginal discharge
  • upper respiratory tract infection

Some of the Serious side effects include :

  • Blood clots, Progestational drug products may increase your chance of having blood clots in your blood vessels. Blood clots can cause :
    •  blood vessel problems (thrombophlebitis)
    • stroke
    • loss of your arm or leg
    • blood clot in your lungs (pulmonary embolus)
    • heart attack
    • death
  • Birth defects. Abdominal wall defect and cleft palate have been reported with Crinone use in early pregnancy. It is not known if these defects were caused by this medicine

Seek emergency medical help or consult a doctor immediately if you get any of the following signs or any other unusual symptoms that concern you:

  • 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 arm or leg indicating possible clots in the brain or eye.

What is the Dosage ?

Assisted Reproductive Technology

Progesterone 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation.Progesterone 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.

Secondary Amenorrhea

Progesterone 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Progesterone 8% every other day up to a total of six doses may be instituted.

It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed.

What are the precautions I need to take ?

  • Take this medicine only if prescribed by the doctor
  • Take full course of treatment
  • Do not take this medicine, If you are allergic allergic to any of the ingredients of this medicine or any of their excipients
  • Do not take this medicine after the expiry date stated on the carton package
  • Tell your doctor if you are taking any medicine
  • Tell your doctor if you are suffering from any disease
  • Keep this medicine out of the reach of children
  • Seek emergency medical help or consult a doctor immediately, If the side effects persist or if you observe any of the serious side effects

Crinone should not be used in individuals with any of the following conditions:

  1. Known sensitivity to progesterone or any of the other ingredients
  2. Undiagnosed vaginal bleeding
  3. Liver dysfunction or disease
  4. Known or suspected malignancy of the breast or genital organs
  5. Missed abortion
  6. Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders

Is it safe to take If I am pregnant ?

Crinone is classified as Pregnancy category B by FDA, Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Is it safe to take if I am breast feeding ?

Progesterone is reported to affect the quality of the breast milk, so it is suggested that this drug may administered to nursing mothers only when clearly necessary and the potential benefits from administering this drug outweighs the potential risks to the infant.

Can this medicine be given to Children and Infants ?

This drug should be kept out of sight and reach of children and infants.

 

Is Crinone available as over the counter (OTC) product?

This medicine is available as both over the counter product and on prescription.

Frequently asked questions

I am taking edoxaban, can I use this medicine ?

No, Progesterone may increase the blood levels of edoxaban, consult a doctor before taking this medicine.

Can Progesterone increase breast size ?

Progesterone has a side effect of causing breast tenderness, discomfort and increase in breast size.

Can this medicine prevent preterm birth ?

Vaginally dosed progesterone is being investigated as potentially beneficial in preventing preterm birth in women at risk for preterm birth. The initial study by Fonseca suggested that vaginal progesterone could prevent preterm birth in women with a history of preterm birth

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