Prontogest

Drugs , Obstetrics and Gynaecology / October 21, 2016

Class: Obsterics & Gynaecology
Dosage Form: Pessaries
Description: Progesterone vaginal pessaries
Stock: Available
Manufacturer: Marcryl Pharma

Composition:

Progesterone……………200, 400 mg

Properties:

Pharmacodynamics
Prontogest
(progesterone) is a natural progestogen. Progesterone released during the luteal phase of the menstrual cycle leads to the development of a secretory endometrium. Abrupt decline in the release of progesterone from the corpus luteum at the end of the cycle is the main determinant of the onset of menstruation. If the duration of the luteal phase is artificially lengthened either by sustaining luteal function of by treatment with progesterone, decidual changes in the endometrial stroma similar to those seen in early pregnancy can be induced. Progesterone is important for the maintenance of pregnancy as it suppresses menstruation and uterine contractility.

Pharmacokinetics
Absorption
Progesterone is rapidly absorbed following vaginal administration. The time to peak plasma level varies depending on the individual and the dose administered. In general peak plasma levels are reached within 3-8 hours with a decrease in levels over 24 hours.
Distribution
Progesterone is extensively protein bound (96-99%) principally to serum albumin and corticosteroid binding globulin.
Metabolism
progesterone is extensively metabolized by the liver. Prolonged serum levels results from vaginal administration because absorption and action occur. Biotarnsformation of it is by the liver.
Excretion
Progesterone is primarily excreted renally (50-60%) with minimal 10% biliary and fecal excretion.

Indications:

Prontogest is indicated:

  • For the supplementation of insufficient secretion of progesterone in women participating in fertilisation programs
  • In recurrent miscarriages, it is advisable to begin administration of Prontogest from the very beginning of gestation with the dosage of 200-400 mg per day
  • In surgery during pregnancy, 200-400 mg a day or as otherwise medically prescribed

Contraindicatons:

Prontogest is contraindicated in:

  • Undiagonsed vaginal bleeding
  • A history of thrombo-embolic disorders

Side Effects:

Side effects of progesterone may include gastrointestinal disturbances, acne, fluid retention, or edema, mass gain, allergic skin rashes or urticaria, mental depression, breast changes including discomfort or less frequently gynaecomastia and changes in libido. Alterations in liver function tests have been reported and jaundice has been reported less frequently.

Dosage and Administration:

The following is generally recommended:

  • 200 mg inserted into the vagina or rectal daily
  • It can be increased up to 400 mg twice daily

Overdosage:

Overdosage may produce euphoria or dysmenorrhea.
Treatment is symptomatic and supportive.

Warnings:

Progesterone is metabolised in the liver and should be used with caution in patients with hepatic dysfunction. Prontogest contains the hormone progesterone which is present in significant concentrations in women during the second half of the menstrual cycle and during pregnancy. This should be borne in mind when treating patients with conditions that may be hormone-sensitive. Unless progestogens are being used as part of the management of breast carcinoma, they should not be given to patients with these conditions.
Progesterones, in general, should be used with caution in patients with cardiovascular or renal impairment, daibetes mellitus, asthma, epilepsy, migraine or other conditions which may be aggravated by fluid retention. The should be uesd with care in persons with history of mental depression.

Packaging:

6 strips containing 5 vaginal off-white pessaries.

Storage:

Store at room temperature, below 25°C.

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