Prontogest 100mg/1ml solution for injection 1 vial (unlicensed)

Brand Name: Prontogest^�® injections contain the active ingredient progesterone, which is a naturally occurring female sex hormone. It is used in the treatment of menstrual disorders, and in IVF/assisted reproduction and to help maintain early pregnancy in women who have had recurrent miscarriages. It is commonly prescribed in the United Kingdom under the brand name Gestone.

Generic Name: Progesterone in oil

ACTIVE INGREDIENTS:
Progesterone

Excipients:
Benzyl alcohol, ethyl oleate q.b.

Prontogest Ampoules of a sterile straw-coloured solution of Progesterone BP 100mg per ml in ethyl oleate for injection containing 10% v/v benzyl alcohol.
Uses

Prontogest is indicated for the treatment of dysfunctional uterine bleeding.

It is also indicated for the maintenance of early pregnancy in cases of documented history of repeated miscarriages due to luteal phase defect and in selected cases as an adjunct to successful treatment of infertility with techniques such as In-Vitro Ferilisation (IVF) or Gamete Intra-Fallopian Transfer (GIFT) in order to facilitate uterine implantation of the fertilised ovum.
Dosage and Administration

Prontogest is given by intra-muscular injection. It should be injected deep into the buttock, rather than the thigh or deltoid, using a 1.5 inch (3.8 cm) needle. This site has ample fat cells where a depot of progesterone can be formed for slow release.

Dysfunctional uterine bleeding
5-10mg daily for 5-10 days until 2 days before anticipated onset of menstruation.
Maintenance of pregnancy
Twice weekly of more frequent (maximum: daily) injections of 25-100mg from approximately day 15, or day of transfer of embryo or gametes usually until 8-16 weeks of pregnancy when secretion of progesterone from the placenta should be established.

Daily dosage can be increased to 200mg at the discretion of the physician.

As the indications for Prontogest are restricted to women of childbearing age, dosage recommendations for children and the elderly are not appropriate.
Contra-indications, Warnings etc.
Contra-Indications:

Hypersensitivity to progestins, undiagnosed vaginal bleeding, missed or incomplete abortion, history of thrombo-embolism, mammary or genital tract carcinoma, thrombo-phlebitis, cerebral haemorrhage, marked hepatic dysfunction. Contra-indicated as a diagnostic test for pregnancy.
Interactions:

Prontogest may interfere with the effects of bromocriptine. Prontogest may affect the results of laboratory tests of hepatic and/or endocrine functions.

Prontogest may affect the results of laboratory tests of hepatic and/or endocrine functions.

Prontogest may raise the plasma concentration of cyclosporin.
Effects on Ability to Drive and to Use Machines

No known effect.
Other Undesirable Effects:

Breakthrough bleeding, change in menstrual flow, amenorrhoea, changes in cervical erosion and secretions, breast changes, oedema, weight gain, catabolism, cholestatic jaundice, allergic reactions and rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism, local reactions at site of injection.
Use in Pregnancy and Lactation

Prontogest may be used to maintain pregnancy where there is deficient production of endogenous progesterone from the corpus luteum. It should not be necessary to administer Prontogest once there is adequate secretion of placental progesterone. Prontogest contains progesterone itself, the same as the naturally secreted hormone, and is not associated with masculinization of a female foetus as are synthetic progestins.

Detectable amounts of progesterone enter the breast milk. As the effect on the suckling infant has not been determined, the use of Prontogest during lactation is not recommended.
Other Special Warnings and Precautions:

Prontogest should be used cautiously in patients with conditions that might be aggravated by fluid retention (eg hypertension, cardiac disease, renal disease, epilepsy), with a history of mental depression, diabetes, mild to moderate hepatic dysfunction, acute intermittent porphyria, migraine or photosensitivity.

If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.
Overdosage

This is unlikely and is not expected to produce any adverse effects. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
Pharmaceutical Precautions

Store in a cool place protected from light. On storage, solid matter may separate and this should be redissolved by warming before use.

SHELF LIFE AND STORAGE OF RULES:
At room temperature. Validity
60 months.