Manotropin (hcg) 5000iu
Product Description
A purified preparation of human gonadotropins; in women, produces ovarian follicular growth; when followed by administration of HCG, produces ovulation; used with HCG for at least 3 mo to induce spermatogenesis in men with primary or secondary pituitary hypofunction who have previously achieved adequate masculinization with HCG administration.
Indications:
Women: Given with HCG sequentially to induce ovulation and pregnancy in anovulatory infertile patients without primary ovarian failure. Used with HCG to stimulate multiple follicles for in vitro fertilization programs.
Men: With concomitant HCG therapy to stimulate spermatogenesis in men with primary hypogonadotropic hypogonadism due to a congenital factor or prepubertal hypophysectomy and in men with secondary hypogonadotropic hypogonadism due to hypophysectomy, craniopharyngioma, cerebral aneurysm, or chromophobe adenoma.
Contraindications/cautions:
Known sensitivity to menotropins; high gonadotropin levels, indicating primary ovarian failure; overt thyroid or adrenal dysfunction, abnormal bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovary syndrome, intracranial lesion, such as pituitary tumor, pregnancy (women); normal gonadotropin levels, indicating pituitary function; elevated gonadotropin levels, indicating primary testicular failure; infertility disorders other than hypogonadotropin hypogonadism (men).
Dosage:
Available Forms:
Powder for injection--75 IU FSH/75 IU LH, 150 IU FSH/150 IU LH
Women:
To achieve ovulation, HCG must be given following menotropins when clinical assessment indicates sufficient follicular maturation as indicated by urinary excretion of estrogens; initial dose is 5 IU FSH/75 IU LH/d IM for 9---12 d. Follow administration with 10,000 IU HCG 1 d after the last dose of menotropins. Do not administer for longer than 12 d. Treat until estrogen levels are normal or slightly higher than normal. When urinary estrogen excretion is < 100 µg/24 h, and urinary estriol excretion is < 50 µg/24 h prior to HCG administration, there is less risk of ovarian overstimulation. Do not administer if urinary excretion exceeds these values. Couple should engage in intercourse daily beginning on the day prior to the HCG administration and until ovulation occurs. If there is evidence of ovulation but pregnancy does not occur, repeat regimen for at least 2 more courses before increasing dose to 150 IU FSH/150 IU LH/d IM for 9---12 d followed by 10,000 IU HCG 1 d after the last dose of menotropins. If there is evidence of ovulation but pregnancy does not occur, repeat this regimen twice more. Larger doses are not recommended.
Men:
Pretreat with HCG (5,000 IU three times per week) until serum testosterone levels are within a normal range and masculinization has occurred. Pretreatment may take 4---6 mo. Then give 1 amp (75 IU FSH/75 IU LH) menotropins IM 3× per wk and HCG 2,000 IU twice a wk. Continue for a minimum of 4 mo. If increased spermatogenesis has not occurred at the end of 4 mo, continue treatment with 1 amp menotropins three times per week or 2 amps (dose of 150 IU FSH/150 IU LH) menotropins three times per week with the HCG dose unchanged.
Pharmacokinetics:
Route Onset Peak Duration
IM Slow Weeks Months
Metabolism: T½: unknown
Distribution: Crosses placenta
Excretion: Urine
Adverse Effects:
Women:
CV: Arterial thromboembolism
GU: Ovarian enlargement, hyperstimulation syndrome, hemoperitoneum
Hypersensitivity: Hypersensitivity reactions
Other: Febrile reactions; birth defects in resulting pregnancies, multiple pregnancies
Men:
Endocrine: Gynecomastia
Nursing Considerations:
Assessment:
History:
Sensitivity to menotropins; high gonadotropin levels; overt thyroid or adrenal dysfunction, abnormal bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovary syndrome, intracranial lesion (women); normal gonadotropin levels; elevated gonadotropin levels; infertility disorders other than hypogonadotropin hypogonadism (men)
Physical:
T; masculinization (men); abdominal exam, pelvic exam; testicular exam; serum gonadotropin levels; 24 h urinary estrogens and estriol excretion (women); serum testosterone levels (men)
Implementation:
Dissolve contents of 1 amp in 1---2 ml of Sterile Saline. Administer IM immediately. Discard any unused portion.
Store ampules at room temperature or in refrigerator; do not freeze.
Monitor women at least every other day during treatment and for 2 wk after treatment for any sign of ovarian enlargement.
Discontinue drug at any sign of ovarian overstimulation, and arrange to have patient admitted to the hospital for observation and supportive measures. Do not attempt to remove ascitic fluid because of the risk of injury to the ovaries. Have the patient refrain from intercourse if ovarian enlargement occurs.
Provide women with calendar of treatment days and explanations about what signs of estrogen and progesterone activity to watch for. Caution patient that 24-h urine collections will be needed periodically, that HCG also must be given to induce ovulation, and that daily intercourse should begin 1 d prior to HCG administration and until ovulation occurs.
Alert patient to risks and hazards of multiple births.
Provide support and encouragement to the male patient, explaining the need for long-term treatment, regular sperm counts, and masculinizing effects of HCG.
Drug-specific teaching points:
Prepare a calendar showing the treatment schedule; drug can only be given IM and must be used with HCG to achieve the desired effects.
Have intercourse daily beginning on the day prior to HCG therapy until ovulation occurs.
The following may occur: breast enlargement (men); ovarian enlargement, abdominal discomfort, fever, multiple births (women).
Report pain at injection site, severe abdominal or lower back pain, fever, fluid in the abdomen.
Adverse effects in Italic are most common; those in Bold are life-threatening.
A purified preparation of human gonadotropins; in women, produces ovarian follicular growth; when followed by administration of HCG, produces ovulation; used with HCG for at least 3 mo to induce spermatogenesis in men with primary or secondary pituitary hypofunction who have previously achieved adequate masculinization with HCG administration.
Indications:
Women: Given with HCG sequentially to induce ovulation and pregnancy in anovulatory infertile patients without primary ovarian failure. Used with HCG to stimulate multiple follicles for in vitro fertilization programs.
Men: With concomitant HCG therapy to stimulate spermatogenesis in men with primary hypogonadotropic hypogonadism due to a congenital factor or prepubertal hypophysectomy and in men with secondary hypogonadotropic hypogonadism due to hypophysectomy, craniopharyngioma, cerebral aneurysm, or chromophobe adenoma.
Contraindications/cautions:
Known sensitivity to menotropins; high gonadotropin levels, indicating primary ovarian failure; overt thyroid or adrenal dysfunction, abnormal bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovary syndrome, intracranial lesion, such as pituitary tumor, pregnancy (women); normal gonadotropin levels, indicating pituitary function; elevated gonadotropin levels, indicating primary testicular failure; infertility disorders other than hypogonadotropin hypogonadism (men).
Dosage:
Available Forms:
Powder for injection--75 IU FSH/75 IU LH, 150 IU FSH/150 IU LH
Women:
To achieve ovulation, HCG must be given following menotropins when clinical assessment indicates sufficient follicular maturation as indicated by urinary excretion of estrogens; initial dose is 5 IU FSH/75 IU LH/d IM for 9---12 d. Follow administration with 10,000 IU HCG 1 d after the last dose of menotropins. Do not administer for longer than 12 d. Treat until estrogen levels are normal or slightly higher than normal. When urinary estrogen excretion is < 100 µg/24 h, and urinary estriol excretion is < 50 µg/24 h prior to HCG administration, there is less risk of ovarian overstimulation. Do not administer if urinary excretion exceeds these values. Couple should engage in intercourse daily beginning on the day prior to the HCG administration and until ovulation occurs. If there is evidence of ovulation but pregnancy does not occur, repeat regimen for at least 2 more courses before increasing dose to 150 IU FSH/150 IU LH/d IM for 9---12 d followed by 10,000 IU HCG 1 d after the last dose of menotropins. If there is evidence of ovulation but pregnancy does not occur, repeat this regimen twice more. Larger doses are not recommended.
Men:
Pretreat with HCG (5,000 IU three times per week) until serum testosterone levels are within a normal range and masculinization has occurred. Pretreatment may take 4---6 mo. Then give 1 amp (75 IU FSH/75 IU LH) menotropins IM 3× per wk and HCG 2,000 IU twice a wk. Continue for a minimum of 4 mo. If increased spermatogenesis has not occurred at the end of 4 mo, continue treatment with 1 amp menotropins three times per week or 2 amps (dose of 150 IU FSH/150 IU LH) menotropins three times per week with the HCG dose unchanged.
Pharmacokinetics:
Route Onset Peak Duration
IM Slow Weeks Months
Metabolism: T½: unknown
Distribution: Crosses placenta
Excretion: Urine
Adverse Effects:
Women:
CV: Arterial thromboembolism
GU: Ovarian enlargement, hyperstimulation syndrome, hemoperitoneum
Hypersensitivity: Hypersensitivity reactions
Other: Febrile reactions; birth defects in resulting pregnancies, multiple pregnancies
Men:
Endocrine: Gynecomastia
Nursing Considerations:
Assessment:
History:
Sensitivity to menotropins; high gonadotropin levels; overt thyroid or adrenal dysfunction, abnormal bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovary syndrome, intracranial lesion (women); normal gonadotropin levels; elevated gonadotropin levels; infertility disorders other than hypogonadotropin hypogonadism (men)
Physical:
T; masculinization (men); abdominal exam, pelvic exam; testicular exam; serum gonadotropin levels; 24 h urinary estrogens and estriol excretion (women); serum testosterone levels (men)
Implementation:
Dissolve contents of 1 amp in 1---2 ml of Sterile Saline. Administer IM immediately. Discard any unused portion.
Store ampules at room temperature or in refrigerator; do not freeze.
Monitor women at least every other day during treatment and for 2 wk after treatment for any sign of ovarian enlargement.
Discontinue drug at any sign of ovarian overstimulation, and arrange to have patient admitted to the hospital for observation and supportive measures. Do not attempt to remove ascitic fluid because of the risk of injury to the ovaries. Have the patient refrain from intercourse if ovarian enlargement occurs.
Provide women with calendar of treatment days and explanations about what signs of estrogen and progesterone activity to watch for. Caution patient that 24-h urine collections will be needed periodically, that HCG also must be given to induce ovulation, and that daily intercourse should begin 1 d prior to HCG administration and until ovulation occurs.
Alert patient to risks and hazards of multiple births.
Provide support and encouragement to the male patient, explaining the need for long-term treatment, regular sperm counts, and masculinizing effects of HCG.
Drug-specific teaching points:
Prepare a calendar showing the treatment schedule; drug can only be given IM and must be used with HCG to achieve the desired effects.
Have intercourse daily beginning on the day prior to HCG therapy until ovulation occurs.
The following may occur: breast enlargement (men); ovarian enlargement, abdominal discomfort, fever, multiple births (women).
Report pain at injection site, severe abdominal or lower back pain, fever, fluid in the abdomen.
Adverse effects in Italic are most common; those in Bold are life-threatening.
