HCG 10000 IU/vial (IM/SC Injection)

Indications

• Ovulation induction in infertility due to anovulation or impaired follicle-ripening (female)
• Preparation of follicles for puncture in controlled ovarian hyperstimulation programs (ART) (female)
• Luteal phase support (female)
• Threatened and habitual abortion (female)
• Hypogonadotropic hypogonadism (male)
• Delayed puberty associated with insufficient gonadotropic pituitary function (male)
• Cryptorchidism (not due to anatomical obstruction) (male)
• Treatment of oligospermia (male)

Pharmacology

• LH activity
• Gonadal steroid production
• Substitute for the endogenous mid-cycle LH surge (female)
• Substitute for endogenous LH during the luteal phase (female)
• Stimulation of Leydig cells to promote testosterone production (male)
• Maximal plasma levels reached approximately six hours after a single injection
• 80 percent metabolized, predominantly in the kidneys
• Elimination half-life of about 2 days

Dosage & Administration

• Reconstituted solution administered intramuscularly
• Ovulation induction and preparation of follicles: Usually one injection of 5000-10000IU
• Luteal phase support: Two repeat injections of 2500 to 5000IU
• Threatened & habitual abortion: 5000IU deep intramuscular injection twice weekly
• Hypogonadotropic hypogonadism: 2500 to 5000 IU, two times per week

Interaction

• No interactions of clinical relevance are known

Contraindications

• Known or suspected androgen-dependent tumours e.g., prostatic carcinoma or breast carcinoma (male)

Side Effects

• Allergic reactions including pain and rash at injection site
• Generalized reactions such as rash and fever
• Unwanted ovarian hyperstimulation syndrome (female)
• Water and sodium retention leading to excessive androgen production (male)
• Aggravation or recurrence in patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine

Pregnancy & Lactation

• Pregnancy Category X
• Contraindicated in pregnant women
• Contraindicated during lactation

Precautions & Warnings

• Increased risk of multiple births in pregnancies after induction of ovulation with gonadotropic preparations
• Unwanted ovarian hyperstimulation due to FSH-containing preparation
• Ultrasound assessment and estrogen level monitoring recommended prior to FSH-treatment
• Discontinue FSH-containing preparation immediately in case of unwanted ovarian hyperstimulation
• HCG must not be given in case of unwanted ovarian hyperstimulation
• HCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development
• Regular monitoring of skeletal maturation in prepubertal boys

Use in Special Populations

• Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients
• Discontinue therapy if signs of precocious puberty occur
• Clinical studies did not include subjects aged 65 and over

Overdose Effects

• Very low acute toxicity of urinary gonadotropin preparations
• No symptoms of an acute parenteral overdose known in humans

Therapeutic Class

• Female Sex hormones

Storage Conditions

• Store at 2°C-8°C in refrigerator; do not freeze
• Store below 25°C for a single period of not more than 3 months
• Protect from light and keep in a dry place

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