EPIFASI 5000 IU ( Human Chorionic Gonadotrophin ) Ampoule

Composition   

Each lyophilized ampoule contains: 
Human Chorionic Gonadotrophin ........................ 5000 I.U.
Each solvent ampoule contains: 
Sodium chloride 0.9% ............................................ 1 ml
Inactive ingredients: 

Lactose, dipotassium hydrogen phosphate, potassium dihydrogen phosphate.                                                         

Indications                        

Women: 
Anovulatory infertility due to absent or low concentrations of gonadotrophins; to promote ovulation; where the cause of anovulation is not due to primary ovarian failure, and the women have been appropriately pre-treated with human menotrophins (EPIGONAL).
In combination with menotrophins as an adjunct to in-vitro fertilization procedures and other assisted conception techniques.

Men: 
To stimulate and maintain spermatogenesis in men with hpogonadotrophic hypogonadism.                                                           

Dosage and Administration                            

The solvent should be added to the lyophilized powder; the reconstituted solution of Epifasi should be immediately administered by intramuscular injection only. Any unused portion should be discarded.
Women: 
Induction of ovulation and pregnancy: 5000-10000 units one day following the last dose of menotrophins (EPIGONAL).

Men: 
Infertility: 5000 I.U. is administered by intramuscular injection to stimulate spermatogenesis 3 times/week for 4-6 months before administration of menotrophins (EPIGONAL).                                                                

Contraindications                  

Hypersensitivity to the drug.
Precocious puberty.
Prostatic carcinoma or other androgen-dependent neoplasms.
Breast, uterine, ovarian, and testicular tumours.
Hypothalamus, pituitary, thyroid, and adrenal gland tumours.                                                            

Warnings and Precautions                       

Combination therapy with EPIGONAL for infertility should be used only by physicians experienced with infertility problems.
Induction of androgens secretion by Epifasi may cause fluid retention; therefore Epifasi should be used with caution in patients with:
Epilepsy.
Migraine.
Asthma.
Heart disease.
Renal disorders.
Patients suspected to be susceptible to hypersensitivity reactions should be given skin tests before treatment.                                                             

Pregnancy and Lactation                        

Epifasi is contraindicated during pregnancy (Category X).
Epifasi should be used with caution during lactation.                                                            

Undesirable Effects                          

These depend on dosage, duration of therapy, and individual susceptibility. 

Possible side effects include: headache, irritability, tiredness, restlessness, oedema (especially in males), acute abdominal pain, ascites, pleural effusion, hypovolemia, premature epiphyseal closure or precocious puberty, gynecomastia, pain at injection site, aggressive behaviour, ovarian hyperstimulation syndrome, enlargement of preexisting ovarian cyst and possible rupture, arterial thromboembolism, and multiple births.
Hypersensitivity reactions both localized and systemic in nature including erythema, urticaria, rash, angiodema, dyspnoea have been reported.

Pharmacological Properties                           

Epifasi is a polypeptide hormone produced by the placenta and obtained from the urine of pregnant women.
Its effects are mainly those of the gonadotrophin, leutinizing hormone (which is secreted from the pituitary gland), and is responsible for triggering ovulation and formation of the corpus luteum which leads to the production of progesterone in women. It has a small degree of follicle stimulating hormone (FSH) activity.
In normal pregnancy, hCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone, and preventing menstruation.
In men: It stimulates and maintains spermatogenesis in men with hpogonadotrophic hypogonadism.
Pharmacokinetics: 
Following intramuscular administration, peak plasma concentrations are achieved within about 6 hours after a dose. It is distributed primarily to the gonads. Blood concentrations decline in a biphasic manner, with half-lives of about 6-11 hours and 23-38 hours respectively. Chorionic gonadotrophin is metabolised mainly in the kidneys. About 10-12% of a dose is excreted in urine within 24 hours.                                                      

Storage     

Store at a temperature 15°C - 30°C. After reconstitution, refrigerate the product at a temperature 2°C -  8°C, and use within 30 days.                                                       

Packaging        

Epifasi 5000 IU Injection: Box containing 1 lyophilized ampoule and 1 solvent ampoule of 0.9% sodium chloride.

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