Prinagel

Indications

Prinagel is prescribed for:

• Maintaining pregnancy in cases of threatened or recurrent abortion.
• Providing luteal support during in vitro fertilization (IVF) and assisted reproductive technology (ART).
• Offering luteal support for confirmed luteal phase insufficiency.
• Addressing secondary amenorrhea.
• Managing dysfunctional uterine bleeding (DUB).

Consult a registered physician before using this medication.

Pharmacology

Prinagel contains micronized progesterone, which is structurally and biologically identical to the natural progesterone produced in the body. This hormone is secreted by the ovaries, placenta, and adrenal glands. In conjunction with adequate estrogen levels, progesterone converts a proliferative endometrium into a secretory endometrium, enhancing endometrial receptivity for embryo implantation. Once implantation occurs, progesterone is crucial for maintaining the pregnancy and reduces circulating gonadotropin levels.

Dosage

Route of Administration: Vaginal Application

• For Maintenance of Pregnancy in Threatened/Recurrent Abortion: Administer 90 mg of Progesterone Micronized (8% gel) vaginally once daily.
• For Reproductive Failure and IVF Treatment: Start treatment with 90 mg of Progesterone Micronized within 4 days (preferably 2 days) after administering hCG (human chorionic gonadotropin). Apply 90 mg (8% gel) vaginally once or twice daily. Most women will respond to a daily dose, though some may require administration twice daily. Continue treatment for up to 10 to 12 weeks if pregnancy is confirmed.
• For Secondary Amenorrhea: Apply 90 mg of Progesterone Micronized (8% gel) once daily for six days, every other day.
• Use in Children and Adolescents: Not indicated for pediatric use.
  Consult a registered physician before using this medication.

Administration

One application (using the provided applicator) contains 1.125 grams of Progesterone Micronized, equating to 90 mg of progesterone.

Steps for Application:

1. Remove the cap from the tube, invert it, and use the sharp point to open the tube.
2. Pull the plunger up to the ring mark and attach it to the tube’s opening.
3. Squeeze the tube gently to fill the applicator up to the ring mark.
4. Remove the tube.
5. To apply the gel, lie down and insert the applicator deeply into the vagina.
6. Push the plunger in slowly until the applicator is empty.
7. After use, pull the plunger out beyond the point of resistance and clean both parts with warm, soapy water (avoid detergents). Rinse thoroughly and allow to dry. Do not expose the applicator to hot or boiling water.

Consult a registered physician before using this medication.

Interactions

No significant drug interactions have been reported; however, concurrent use with other vaginal preparations is not recommended.

Contraindications

Prinagel is contraindicated in patients with:

• Known or suspected malignancies of the breast or genital organs.
• Missed abortions.
• Undiagnosed uterine bleeding.
• Liver dysfunction or disease.
• Known hypersensitivity to any component of the formulation.
• Known or suspected progesterone-dependent neoplasia.
• Active thrombophlebitis or thromboembolic disorders, including a history of hormone-associated thromboembolic events.
• Acute porphyria.

Side Effects

Common Side Effects:
Abdominal pain, perineal discomfort, constipation, nausea, diarrhea, vomiting, breast enlargement, dyspareunia, depression, decreased libido, nervousness, somnolence, intermenstrual spotting, and vaginal irritation.

Rare Side Effects:
Cerebrovascular disorders, pulmonary embolism.

Pregnancy & Lactation

Pregnancy Category A. Proven effective for supporting embryo implantation and maintaining pregnancies. Not recommended during lactation, as detectable levels of progestogens have been found in breast milk, and their effects on nursing infants are unknown.

Precautions & Warnings

Discontinue use immediately if cerebrovascular disorders, pulmonary embolism, or retinal thrombosis occur. Stop treatment if liver function tests become abnormal or cholestatic jaundice develops. Patients with a history of depression should be monitored closely, and treatment should be stopped if severe depression recurs. Prinagel should not be used alongside other vaginal therapies.

Overdose Effects

Acute overdose with Prinagel is unlikely due to the limited absorption rate of progesterone via the vaginal epithelium and the formulation’s extended-release characteristics. However, in the event of an overdose, discontinue Prinagel and provide symptomatic treatment.

Therapeutic Class

Drugs for Infertility.

Storage Conditions

Store below 25°C in a dry place, protected from light. Keep all medications out of reach of children.