Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Indications for Drugs ::

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.

 

Indications Treatment of amenorrhea and functional uterine bleeding; intrauterine contraception in women who have had at least one child. Unlabeled use(s): Treatment of PMS (suppository), premature labor in late stages of pregnancy and menorrhagia (intrauterine).

 

Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Drug Dose ::

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.

 

Indications Treatment of amenorrhea and functional uterine bleeding; intrauterine contraception in women who have had at least one child. Unlabeled use(s): Treatment of PMS (suppository), premature labor in late stages of pregnancy and menorrhagia (intrauterine).

 

Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Contraindication ::

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.

 

Indications Treatment of amenorrhea and functional uterine bleeding; intrauterine contraception in women who have had at least one child. Unlabeled use(s): Treatment of PMS (suppository), premature labor in late stages of pregnancy and menorrhagia (intrauterine).

 

Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Drug Precautions ::

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.

 

Indications Treatment of amenorrhea and functional uterine bleeding; intrauterine contraception in women who have had at least one child. Unlabeled use(s): Treatment of PMS (suppository), premature labor in late stages of pregnancy and menorrhagia (intrauterine).

 

Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Drug Side Effects ::

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.

 

Indications Treatment of amenorrhea and functional uterine bleeding; intrauterine contraception in women who have had at least one child. Unlabeled use(s): Treatment of PMS (suppository), premature labor in late stages of pregnancy and menorrhagia (intrauterine).

 

Contraindications

IM, suppository, intrauterine: Hypersensitivity to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage (or history of these disorders); impaired liver function; breast cancer; undiagnosed vaginal bleeding; missed abortion; diagnostic test for pregnancy; pregnancy or suspected pregnancy. Intrauterine: Previous ectopic pregnancy; presence or history of PID; IV drug abuse.

 

Route/Dosage

Amenorrhea

IM 5 to 10 mg daily for 6 to 8 days.

Functional Uterine Bleeding

IM 5 to 10 mg daily for 6 days.

Contraceptive

Intrauterine 1 intrauterine system inserted into uterine cavity once yearly.

PMS

Intravaginal/PR Insert suppository 200 to 400 mg bid.

 

Interactions

Anticoagulants: Use intrauterine system with caution in patients receiving anticoagulant therapy.

 

Lab Test Interferences Altered metyrapone test.

 

Adverse Reactions

CNS: Depression; headache; migraine; fatigue; nervousness; dizziness; insomnia. DERM: Rash; acne; melasma; chloasma; photosensitivity. GI: Abdominal pain or discomfort; nausea. GU: Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; vaginal candidiasis; pruritus vulvae; changes in cervical erosion and secretions. Intrauterine:Endometritis; spontaneous abortion; pelvic infection. HEPA: Cholestatic jaundice. OTHER: Pain at injection site; breast tenderness; masculinization of female fetus; edema; weight changes; decreased libido.

 

Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk. Depression: Carefully observe patients with history of depression. Embedment: Partial penetration or lodging of intrauterine system in endometrium can result in difficult removal. Fluid retention: Use cautiously when conditions that might be affected by this factor are present (eg, asthma, cardiac or renal dysfunction, epilepsy). Intrauterine system: Postpone insertion in patients who have cervicitis or vaginitis. Do not insert postpartum or postabortion until involution of uterus is complete. Use with caution in patients who have anemia or history of menorrhagia. Bleeding and cramps may occur during first few weeks after insertion. Prophylactic antibiotics may be considered prior to insertion to decrease risk of PID. Ophthalmic effects: Discontinue medication if there are any sudden changes in vision or other serious ophthalmic effects. Pelvic infection: Increased risk of PID with intrauterine devices has been reported. Perforation: Partial or total perforation of uterine wall or cervix may occur. Thrombotic disorders: Discontinue if these conditions occur or are suspected.

PATIENT CARE CONSIDERATIONS

 

Administration/Storage

• When progesterone is used with estrogen, begin progesterone 2 wk after estrogen therapy.
• When progesterone is used for functional uterine bleeding, discontinue therapy when menstrual flow begins.
• Parenteral form is for IM use only. Inject into large muscle.
• Rotate injection sites.
• Store parenteral preparation at room temperature. Avoid freezing.

 

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Perform thorough physical assessment prior to therapy. Include breasts and pelvic organs and Pap smear at 6 to 12 mo intervals while patient is undergoing therapy.
• Before insertion of IUD be certain that gonorrhea and chlamydia cultures and other tests for STDs are completed and that sounding of uterus is done.
• Assess for breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, cholestatic jaundice or rash, and report to physician.
• Monitor I&O and patient’s weight.
• Observe for signs of fluid retention (especially in patients with epilepsy, migraine, asthma, cardiac or renal dysfunction) and report to physician.
• Notify physician of signs of suspected thrombophlebitis, cerebrovascular disorders, retinal thrombosis, or pulmonary embolism.
• Notify physician in cases of sudden, painful or complete loss of vision or if there is sudden onset of diplopia, proptosis or migraine.
• Assess for signs of depression (especially in patients with prior history of depression) and report to physician.
• Assess diabetic patients for possible reduction in glucose tolerance.

 

Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Tell patient to take oral forms with food if GI distress occurs.
• Advise diabetic patients that glucose tolerance may decrease and to monitor blood or urine sugars closely, reporting abnormalities to physician.
• Instruct patient not to smoke. Offer information on smoking cessation programs.
• Teach patients with IUD to recognize symptoms of pelvic inflammatory disease and ectopic pregnancy and to report these symptoms to physician.
• Advise patients with IUD that displacement can occur.
• Teach patients with IUD to check after each menstrual period for string protruding from uterus and to contact physician if it cannot be located.
• Instruct patient to report the following symptoms to physician immediately: Pain in calves with swelling, warmth and redness or sudden severe headache, visual disturbance or numbness in arm or leg.
• Tell patient to report the following symptoms to physician: Depression, steady weight gain, edema, decreased libido, breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, breast changes, jaundice or rash.
• Caution patient to avoid exposure to sunlight and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.

Drug Mode of Action ::  

(pro-JESS-ter-ohn)

Crinone, Prometrium, Progesterone in Oil

Class: Progestin

 

Action Inhibits secretion of pituitary gonadotropins, thereby preventing follicular maturation and ovulation (contraceptive effect); inhibits spontaneous uterine contraction; transforms proliferative endometrium into secretory endometrium.