Ethinyl estradiol and norgestimate (Ortho Tri-Cyclen Lo) is a combination of two hormonal medicines used primarily for contraception to prevent pregnancy.
Ethinyl estradiol and norgestimate (Ortho Tri-Cyclen Lo) Uses:
-
Acne vulgaris:
- Used for the treatment of moderate acne vulgaris in females at least 15 years of age
- Limitations of use:
- When used for acne, use only in females of 15 years or more than of age who achieved menarche, who also desire combination hormonal contraceptive therapy, and have no contraindications to combination hormonal contraceptive use Contraception: Prevention of pregnancy.
-
Off Label Use of Ethinyl estradiol and norgestimate in Adults:
- Used for abnormal uterine bleeding
- Used for dysmenorrhea
- Used for hirsutism
- Used for menstrual bleeding (menorrhagia)
- Used for polycystic ovary syndrome (PCOS) in women with menstrual irregularities and hirsutism/acne
Ethinyl estradiol and norgestimate dose in Females:
Acne (Ortho Tri-Cyclen, Tri-Estarylla, TriNessa, Tri-Previfem, Tri-Sprintec):
- Oral: Refer to dosing for contraception
Contraception:
- Oral: 1 tablet once in a day.
-
Schedule 1 (Sunday starter):
- Dose begins on the first Sunday after the onset of menstruation;
- if the menstrual period starts on Sunday, take the first tablet that very same day.
- With a Sunday start, an additional method of contraception should be used until after the first weak of consecutive administration.
-
Schedule 2 (Day 1 starter):
- Dose starts on the first day of the menstrual cycle taking 1 tablet once in a day.
-
Additional contraceptive dosing considerations:
-
Switching from a different contraceptive:
- Oral contraceptive:
- Start on the same day that a new pack of the previous oral contraceptive would have been taken.
- Transdermal patch, vaginal ring, injection:
- Start on the day the next dose would have been due.
- IUD or implant:
- Start on the day of removal. A backup method of contraception should be used for the first 7 days if IUD is not removed on the first day of the menstrual cycle.
- Oral contraceptive:
- Use after first-trimester abortion or miscarriage:
- Therapy may be started immediately. If not started within 5 days, a back-up method of contraception should be used for the first weak.
- Use after childbirth (in women who are not breast-feeding) or after a second trimester abortion or miscarriage:
- Therapy may be started ≥4 weeks postpartum.
- Pregnancy should be considered prior to treatment if menstrual periods have not restarted.
- An additional method of contraception (nonhormonal) should be used until after the first weak of consecutive administration.
-
-
Missed or late doses:
- If one dose is late ( less than 24 hours since the dose should have been taken) or if one dose is missed (24 to <48 hours since the dose should have been taken):
- Take dose as soon as possible.
- Continue remaining doses at the usual time (even if that means 2 doses on the same day).
- If ≥2 consecutive doses are missed (≥48 hours since dose should have been taken):
- Take the most recently missed dose as soon as possible, discard any other missed doses.
- Continue remaining doses at the usual time (even if that means taking 2 doses on the same day); use back-up contraception until hormonal pills have been taken for 7 consecutive days.
- If doses were missed during the last week of hormonal (active) tablets (eg, days 15 to 21 of a 28-day pack), omit the hormone-free interval by finishing the current pack and starting a new pack.
- If unable to start a new pack immediately, back up contraception is needed until hormonal pills from a new pack have been taken for 7 consecutive days.
- Consider the use of emergency contraception in some situations (refer to guidelines for details).
- Also, refer to the package insert for product specific information.
- If one dose is late ( less than 24 hours since the dose should have been taken) or if one dose is missed (24 to <48 hours since the dose should have been taken):
Ethinyl estradiol and norgestimate (Ortho Tri-Cyclen Lo) Dose in Children:
Females:
Acne: Oral:
- Adolescents of 15 years or more than 15 years;
- refer to adult dosing for contraception; not to be used prior to menarche.
Contraception:
- Oral: Refer to adult dosing;
- not to be used prior to menarche.
Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo) Pregnancy Risk Category: X
- Pregnant women should not use it.
- To prevent pregnancy, combination hormonal contraceptives can be used. If pregnancy does occur, treatment should be stopped.
- Combination hormonal contraceptives are generally not associated with any adverse effects on the fetus or mother if used inadvertently early in pregnancy.
- According to the manufacturer, combination hormonal contraceptives should be stopped for at least 4 weeks. This is especially true for women who have chosen not to breastfeed.
- Combination hormonal contraceptives should be stopped for less than 21 days after delivery due to increased risk of venous embolism (VTE).
- Postpartum day 42 sees a decrease in the risk to baseline.
- Combination hormonal contraceptives should be used in women aged between 21 and 42 after delivery. Women who use combination hormonal contraceptives between 21-42 days after delivery must consider the risk factors for VTE (eg., age >=35, previous VTEs, transfusion at birth, thrombophilia or immobility, preeclampsia/cesarean delivery, peripartum cardiacmyopathy, postpartum hemorhage, smoking, BMI>=30 kg/m2).
Use of ethinyl estradiol or norgestimate during breastfeeding
- Breast milk may contain contraceptive steroids.
- Breastfeeding mothers who use combination hormonal contraceptives have not reported any adverse health effects or persistent effects on infant growth.
- The manufacturer suggests that contraceptives containing estrogen may decrease milk production.
- Breastfeeding women should not start combination hormonal contraceptives less than 21 days after delivery due to increased risk of venous embolism (VTE).
- Postpartum day 42 sees a decrease in the risk to baseline.
- Combination hormonal contraceptives should be used in women aged between 21 and 42 after delivery. Women who use combination hormonal contraceptives must take into account the risk factors for VTE.
- When starting treatment for breastfeeding women, it is important to consider the risks and benefits of combination hormonal contraception.
- Pregnant women should not use it.
- To prevent pregnancy, combination hormonal contraceptives can be used. If pregnancy does occur, treatment should be stopped.
- Combination hormonal contraceptives are generally not associated with any adverse effects on the fetus or mother if used inadvertently early in pregnancy.
- According to the manufacturer, combination hormonal contraceptives should be stopped for at least 4 weeks. This is especially true for women who have chosen not to breastfeed.
- Combination hormonal contraceptives should be stopped for less than 21 days after delivery due to increased risk of venous embolism (VTE).
- Postpartum day 42 sees a decrease in the risk to baseline.
- Combination hormonal contraceptives should be used in women aged between 21 and 42 after delivery. Women who use combination hormonal contraceptives between 21-42 days after delivery must consider the risk factors for VTE (eg., age >=35, previous VTEs, transfusion at birth, thrombophilia or immobility, preeclampsia/cesarean delivery, peripartum cardiacmyopathy, postpartum hemorhage, smoking, BMI>=30 kg/m2).
Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo) Dose in Kidney Disease:
Manufacturer's labeling doesn't provide any dosage adjustments (has not been studied); use with caution and monitor blood pressure closely.
Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo) Dose in Liver disease:
Its use is contraindicated in patients with hepatic impairment.
Common Side Effects of Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo):
-
Central Nervous System:
- Headache
- Migraine
-
Gastrointestinal:
- Nausea
- Vomiting
-
Genitourinary:
- Breakthrough Bleeding
Less Common Side Effects Of Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo):
-
Central Nervous System:
- Mood Disorder
- Nervousness
- Fatigue
- Nipple Pain
- Depression
- Emotional Lability
- Mood Changes
-
Dermatologic:
- Acne Vulgaris
- Skin Rash
-
Endocrine & Metabolic:
- Weight Changes
- Weight Gain
- Weight Loss
- Menstrual Disease
-
Gastrointestinal:
- Gastrointestinal Pain
- Abdominal Distention
- Flatulence
- Abdominal Pain
-
Genitourinary:
- Breast Cyst
- Vulvovaginal Infection
- Breast Hypertrophy
- Breast Swelling
- Breast Tenderness
- Mastalgia
- Nipple Discharge
- Dysmenorrhea
- Vaginal Infection
- Genital Discharge
Side effects of Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo) (Frequency Not Defined):
-
Cardiovascular:
- Hypertension
- Venous Thromboembolism
-
Central Nervous System:
- Irritability
-
Endocrine & Metabolic:
- Amenorrhea
- Premenstrual Syndrome
-
Genitourinary:
- Cervical Carcinoma
- Cervical Dyspenia
- Abnormal Uterine Bleeding
Contraindications to Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo):
- Breast cancer and other estrogen-, progestin-dependent Neoplasms (currently or in the past).
- Hepatic tumors (benign and malignant) or hepatic diseases.
- pregnancy,
- Undiagnosed abnormal uterine bleeding
- concomitant use of hepatitis C drug combinations containing ombitasvir/ritonavir, with or without dasabuvir.
Women at high risk for arterial or venous embolisms, such as women with:
- Cerebrovascular Disease
- Coronary artery disease
- Diabetes mellitus and vascular disease
- DVT or PE (current and/or historical of),
- Hypercoagulopathies (inherited and acquired)
- hypertension (uncontrolled),
- Headaches with focal neurological symptoms
- Migraine headaches with aura and migraine headaches in people over 35 years old
- Thrombogenic valvular and rhythm diseases of heart (eg subacute bacteria endocarditis or atrial fibrillation)
- Women over 35 who smoke.
Canadian labeling: Additional contraindications not in the US labeling
- Hypersensitivity to Ethinyl estradiol or norgestimate, and any component of the formulation
- Myocardial Infarction (current and/or history of);
- Persistent blood pressure >=160mm Hg systolic, or >=100mm Hg diastolic
- Ocular lesions caused by ophthalmic vessels disease, including partial or total loss of vision and defect in the visual fields.
- steroid-dependent jaundice, jaundice cholestatica or history of jaundice during pregnancy
- Pancreatitis in association with severe hypertriglyceridemia (current and/or history of);
- severe dyslipoproteinemia;
- Extended immobilization and major surgery are associated with a higher risk of postoperative hemombolism.
- Thrombophlebitis, thromboembolic conditions, or thrombophilic disorders (current or historical);
- Prodromi of thrombosis: (eg, TIA or angina pectoris; history or current of)
- Predispositions to arterial or venous thrombosis may be hereditary or acquired.
- Factor V Leiden mutation, activated protein C (APC) resistance
- Antithrombin-III deficiencies
- protein C deficiency,
- protein S deficiency,
- Hyperhomocysteinemia (eg due to MTHFR C677T and A1298 mutations),
- Prothrombin mutation G20210A
- Antiphospholipid Antibodies (Anticardiolipin Anticoagulant, Lupus Anticoagulant)
- coadministration with ombitasvir, paritaprevir, ritonavir (with or without dasabuvir).
Warnings and precautions
-
Breast cancer
- Women with breast cancer history or who have had it are advised to not use this product.
- Breast cancer is a hormone sensitive tumor. Women with a history of breast cancer or a recent diagnosis may have a worse prognosis if they use combination hormonal contraceptives.
- Combination hormonal contraceptives have not been proven to reduce breast cancer risk in women who are at high risk due to their family history or susceptibility genes (BRCA1, BRCA2).
-
Cervical cancer:
- Theoretically, it may influence the prognosis for existing diseases.
- Combination hormonal contraceptives may be used by women who are awaiting treatment for cervical carcinoma.
- Combination hormonal contraceptives have been linked to a slight increase in cervical cancer risk. However, the evidence is inconsistent and could be due to other risk factors.
-
Chloasma
- Treatment should be avoided for women who are susceptible to chloasma and other risk factors.
- Combination hormonal contraceptives as well as sun exposure, pregnancy and sun exposure are all triggers for chloasma.
-
Cholestasis:
- Cholesteasis risk may increase if there has been a history of cholestasis in pregnancy, or with previous oral contraceptive use.
-
The Lipid Effects
- Combination hormonal contraceptives can increase the risk of pancreatitis in women with hypertriglyceridemia and a family history.
- Women with uncontrolled dyslipidemia should consider alternative contraception.
- Combination hormonal contraceptives can adversely affect lipid levels, especially serum triglycerides.
-
Retinal vascular embolism:
- If you experience an undiagnosed loss of vision, proptosis or diplopia, or retinal vessels lesions, discontinue use immediately and get checked for retinal vein embolism.
-
Thromboembolic disorders
- If you experience an arterial or vein thrombotic event, discontinue using combination hormonal contraceptives.
- Women who use combined hormonal contraceptives for longer periods of time, such as 35 and older, are more likely to experience thrombotic events.
- Combination hormonal contraceptives can also increase the risk for arterial thrombosis (eg MI, stroke). Women with a history or ischemic heart disease should not use them.
- The risk of venous embolism may be increased by oral contraceptives (risk is highest in the first year and lower than that associated with pregnancy).
- Studies have shown that this risk is higher for preparations containing third- or fourth-generation progestins, and/or high dose Ethinylestradiol.
- Women who have inherited thrombophilias, such as protein C or S deficiency and factor V Leiden mutation, antithrombin deficiencies, and prothrombin mutations, may be at greater risk for venous thromboembolism.
- Combination hormonal contraceptives are not recommended for women at high risk of venous or arterial thrombotic diseases.
-
Vaginal bleeding
- In the initial 3 months of therapy, it is possible to experience intra-cyclic bleeding or breakthrough.
- Unresolved vaginal bleeding is a sign of malignancy and pregnancy.
- Combination hormonal contraceptives may cause amenorrhea and oligomenorrhea, particularly if the condition was not present previously.
- There may be occasional missed periods.
-
Cardiovascular disease
- Women at high risk for venous or arterial thrombotic disease are not advised to use it.
- Patients with high risk factors for cardiovascular disease (eg hypertension, high blood pressure, high cholesterol, older age, high LDL, diabetes and women who smoke) should be cautious.
- Combination hormonal contraceptives can increase your risk of developing cardiovascular disease.
-
Depression
- Patients with a history or depression should be cautious; discontinue use if severe depression recurs.
-
Diabetes:
- Combination oral contraceptives have a limited effect on insulin requirements and do not have long-term consequences for diabetes control in women who are not suffering from nonvascular diseases.
- Women with diabetes and prediabetes should be cautious about using oral contraceptives.
- Contraceptive use should not be used in women who have concomitant neuropathy, retinopathy or nephropathy.
- Women with diabetes mellitus or vascular disease should not use this medication.
-
Endometrial and ovarian cancers:
- Women with BRCA1 or BRCA2 mutations may have to use oral contraceptives to lower their risk of developing ovarian cancer.
- Combination hormonal contraceptives reduce the risk of ovarian or endometrial cancer.
- Combination hormonal contraceptives may be used by women awaiting treatment for ovarian or endometrial cancer.
-
Gallbladder disease
- Combining hormonal contraceptives can increase the risk of gallbladder diseases or worsen existing gallbladder diseases.
-
Hepatic adenomas and carcinomas
- A higher risk of developing hepatocellular carcinoma in the long term (rare)
- Preexisting hepatic cancers are not recommended for use.
- Combination hormonal contraceptives can cause hepatic tumors (rare), and rupture could lead to fatal intra-abdominal bleeding.
-
Hepatic impairment
- Women with hepatic diseases should not use it.
- Combination hormonal contraceptives can be used for women with mild (compensated), but not severe (decompensated), cirrhosis.
- Women with impaired liver function may not be able to process hormonal contraceptives in combination.
- If jaundice occurs during treatment or if the liver function is abnormal, discontinue use.
-
Hepatitis
- Combination hormonal contraceptives are not recommended for women suffering from acute viral hepatitis, flares, or other severe conditions.
- Women with chronic hepatitis have not been shown to experience an increase in the severity or rate of cirrhotic fibrisis.
- It has been proven that continued use of a drug by women who are carriers does not cause liver disease or severe hepatic dysfunction.
-
Hereditary angioedema:
- Women with hereditary angioedema may be affected by estrogens.
-
Hypertension:
- When prescribing contraceptives, it is important to consider other risk factors such as smoking, diabetes, and older age.
- The manufacturer warns against use in women with uncontrolled hypertension. They recommend monitoring women with well-controlled hypertension. Stop taking the medication if your blood pressure increases significantly.
- Hypertension risk may increase with age, dosage, and length of use.
- Women with hypertension or vascular disease or persistent blood pressure levels >=160mm Hg Systolic or >=100mm Hg Diastolic should not use combination hormonal contraceptives.
- Women with mild hypertension (140-159 mmHg systolic, 90-99 mmHg diastolic) and women with moderate hypertension (140-159 mmHg systolic; or hypertension controlled to an acceptable level) may not be at risk.
-
Migraine
- Women with migraines without aura, including menstrual migraines, may consider using combination hormonal contraceptives.
- If you are over 35 years old, it is not recommended to be used in women suffering from migraine headaches or focal neurological symptoms.
- Assess new, persistent, severe or recurring headaches.
-
Transplantation of solid-organs:
- Although the data is not complete, serious medical complications have been reported in women who received complicated organ transplants (eg graft failures, vasculopathy rejections, rejections, and cardiac allografts).
- Combination hormonal contraceptives are not recommended for women who have had multiple organ transplants.
-
Systemic lupus, erythematosus
- Women with SLE should not use combination hormonal contraceptives if they have antiphospholipid antibodies. This is because there is a greater risk of arterial or venous embolism.
- Systemic lupus is a condition in which women with SLE are more at risk of heart disease, stroke, or VTE.
Ethinyl estradiol and norgestimate: Drug Interaction
|
Risk Factor C (Monitor therapy) |
|
|
Ajmaline |
Estrogen Derivatives may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. |
|
Anthrax Immune Globulin (Human) |
Estrogen Derivatives may enhance the thrombogenic effect of Anthrax Immune Globulin (Human). |
|
Antidiabetic Agents |
Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. |
|
Ascorbic Acid |
May increase the serum concentration of Estrogen Derivatives. |
|
C1 inhibitors |
Estrogen Derivatives may enhance the thrombogenic effect of C1 inhibitors. |
|
C1 inhibitors |
Progestins may enhance the thrombogenic effect of C1 inhibitors. |
|
Chenodiol |
Estrogen Derivatives may diminish the therapeutic effect of Chenodiol. Management: Monitor clinical response to chenodiol closely when used together with any estrogen derivative. |
|
CloZAPine |
CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
|
Corticosteroids (Systemic) |
Estrogen Derivatives may increase the serum concentration of Corticosteroids (Systemic). |
|
CYP3A4 Inducers (Moderate) |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
CYP3A4 Inhibitors (Moderate) |
May increase the serum concentration of Estrogen Derivatives. |
|
CYP3A4 Inhibitors (Strong) |
May increase the serum concentration of Estrogen Derivatives. |
|
Dantrolene |
Estrogen Derivatives may enhance the hepatotoxic effect of Dantrolene. |
|
Deferasirox |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Erdafitinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Flibanserin |
Estrogen Derivatives (Contraceptive) may increase the serum concentration of Flibanserin. |
|
Flibanserin |
Progestins (Contraceptive) may increase the serum concentration of Flibanserin. |
|
Guanethidine |
Estrogen Derivatives (Contraceptive) may diminish the therapeutic effect of Guanethidine. |
|
Herbs (Estrogenic Properties) |
May enhance the adverse/toxic effect of Estrogen Derivatives. |
|
Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca) |
May enhance the adverse/toxic effect of Progestins. |
|
Immune Globulin |
Estrogen Derivatives may enhance the thrombogenic effect of Immune Globulin. |
|
Lenalidomide |
Estrogen Derivatives may enhance the thrombogenic effect of Lenalidomide. |
|
Metreleptin |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Metreleptin may increase the serum concentration of Estrogen Derivatives (Contraceptive). |
|
Metreleptin |
May decrease the serum concentration of Progestins (Contraceptive). Metreleptin may increase the serum concentration of Progestins (Contraceptive). |
|
Mivacurium |
Estrogen Derivatives may increase the serum concentration of Mivacurium. |
|
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) |
May enhance the thrombogenic effect of Estrogen Derivatives. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Estrogen Derivatives. |
|
Proguanil |
Ethinyl Estradiol may diminish the therapeutic effect of Proguanil. |
|
ROPINIRole |
Estrogen Derivatives may increase the serum concentration of ROPINIRole. |
|
Sarilumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Selegiline |
Estrogen Derivatives (Contraceptive) may increase the serum concentration of Selegiline. |
|
Selegiline |
Progestins (Contraceptive) may increase the serum concentration of Selegiline. |
|
Siltuximab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Succinylcholine |
Estrogen Derivatives may increase the serum concentration of Succinylcholine. |
|
Thalidomide |
Estrogen Derivatives (Contraceptive) may enhance the thrombogenic effect of Thalidomide. |
|
Thalidomide |
Progestins (Contraceptive) may enhance the thrombogenic effect of Thalidomide. |
|
Thalidomide |
Estrogen Derivatives may enhance the thrombogenic effect of Thalidomide. |
|
Theophylline Derivatives |
Estrogen Derivatives may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. |
|
Thyroid Products |
Estrogen Derivatives may diminish the therapeutic effect of Thyroid Products. |
|
Tocilizumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Ursodiol |
Estrogen Derivatives may diminish the therapeutic effect of Ursodiol. |
|
Valproate Products |
Estrogen Derivatives (Contraceptive) may decrease the serum concentration of Valproate Products. |
|
Voriconazole |
May decrease the metabolism of Estrogen Derivatives (Contraceptive). Estrogen Derivatives (Contraceptive) may increase the serum concentration of Voriconazole. |
|
Voriconazole |
May increase the serum concentration of Progestins (Contraceptive). Progestins (Contraceptive) may increase the serum concentration of Voriconazole. |
|
Risk Factor D (Consider therapy modification) |
|
|
Anticoagulants |
Estrogen Derivatives may diminish the anticoagulant effect of Anticoagulants. More specifically, the potential prothrombotic effects of some estrogens and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of estrogens against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. |
|
Anticoagulants |
Progestins may diminish the therapeutic effect of Anticoagulants. More specifically, the potential prothrombotic effects of some progestins and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of progestins against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. |
|
Acitretin |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Given the potential for progestin-only preparations to fail to prevent pregnancy during acitretin therapy, such products should not be relied upon. Alternative, nonhormonal forms of contraception must be employed during acitretin therapy. |
|
Aprepitant |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Use of a non-hormone-based contraceptive is recommended. |
|
Aprepitant |
May decrease the serum concentration of Progestins (Contraceptive). Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. |
|
Armodafinil |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: The manufacturer recommends that patients use nonhormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil. |
|
Artemether |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. |
|
Artemether |
May decrease the serum concentration of Progestins (Contraceptive). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. |
|
Asunaprevir |
May decrease the serum concentration of Ethinyl Estradiol. Management: For patients using hormone-based contraception, a high-dose oral contraceptive containing at least 30 mcg of ethinyl estradiol combined with norethindrone acetate/norethindrone is recommended during treatment with asunaprevir. |
|
Asunaprevir |
May decrease serum concentrations of the active metabolite(s) of Norgestimate. Management: For patients using hormone-based contraception, a high-dose oral contraceptive containing at least 30 mcg of ethinyl estradiol combined with norethindrone acetate/norethindrone is recommended during treatment with asunaprevir. |
|
Atazanavir |
May increase the serum concentration of Progestins (Contraceptive). However, atazanavir may lead to decreased ethinyl estradiol concentrations and decreased effectiveness of oral contraceptive products. Management: Consider an alternative or additional method of contraception, particularly with combined estrogen/progestin products. Depot medroxyprogesterone acetate may be used without a need for additional contraception. |
|
Barbiturates |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of a non-hormonal contraceptive is recommended. |
|
Barbiturates |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. |
|
Bexarotene (Systemic) |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). |
|
Bexarotene (Systemic) |
May decrease the serum concentration of Progestins (Contraceptive). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). |
|
Bile Acid Sequestrants |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Administer estrogen-based oral contraceptives at least 1 to 4 hours prior to or 4 to 6 hours after administration of a bile acid sequestrant. |
|
Bile Acid Sequestrants |
May decrease the serum concentration of Progestins (Contraceptive). Management: Administer oral progestin-containing contraceptives at least 1 to 4 hours prior to or 4 to 6 hours after administration of a bile acid sequestrant. |
|
Bosentan |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Use an alternative (i.e., non-hormonal) means of contraception for all women of childbearing potential who are using bosentan, and do not rely on hormonal contraceptives alone. |
|
Bosentan |
May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative (i.e., non-hormonal) means of contraception for all women of childbearing potential who are using bosentan, and do not rely on hormonal contraceptives alone. |
|
Brigatinib |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Females of childbearing potential should use an alternative, non-hormonal contraceptive during brigatinib therapy and for at least 4 months after the final brigatinib dose. |
|
Brigatinib |
May decrease the serum concentration of Progestins (Contraceptive). Management: Females of childbearing potential should use an alternative, non-hormonal contraceptive during brigatinib therapy and for at least 4 months after the final brigatinib dose. |
|
CarBAMazepine |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of a nonhormonal contraceptive is recommended. |
|
CarBAMazepine |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. |
|
Carfilzomib |
May enhance the thrombogenic effect of Estrogen Derivatives (Contraceptive). Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib. |
|
Carfilzomib |
May enhance the thrombogenic effect of Progestins (Contraceptive). Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib. |
|
Cladribine |
May diminish the therapeutic effect of Hormonal Contraceptives. Management: Women using systemically acting hormonal contraceptives should add a barrier method during cladribine dosing and for at least 4 weeks after the last dose in each treatment course. |
|
CloBAZam |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). |
|
CloBAZam |
May decrease the serum concentration of Progestins (Contraceptive). |
|
Cobicistat |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Consider an alternative, nonhormone-based contraceptive in patients receiving cobicistat-containing products. |
|
Cobicistat |
May increase the serum concentration of Progestins (Contraceptive). Management: Consider an alternative, nonhormone-based contraceptive in patients receiving cobicistatcontaining products. Drospirenone is specifically contraindicated with atazanavir and cobicistat. |
|
Colesevelam |
May decrease the serum concentration of Ethinyl Estradiol. Management: Oral contraceptives containing ethinyl estradiol and norethindrone should be administered at least 4 hours before colesevelam. |
|
Cosyntropin: |
Estrogen Derivatives may diminish the diagnostic effect of Cosyntropin. Management: Discontinue estrogen containing drugs 4 to 6 weeks prior to cosyntropin (ACTH) testing. |
|
CYP3A4 Inducers (Strong) |
May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. |
|
Dabrafenib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). |
|
Dabrafenib |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Females of reproductive potential should use an alternative, highly effective, nonhormonal means of contraception during and at least 2 weeks (dabrafenib alone) or 4 months (dabrafenib + trametinib) after discontinuation of dabrafenib treatment. |
|
Dabrafenib |
May decrease the serum concentration of Progestins (Contraceptive). Management: Females of reproductive potential should use an alternative, highly effective, non-hormonal means of contraception during and at least 2 weeks (dabrafenib alone) or 4 months (dabrafenib + trametinib) after discontinuation of dabrafenib treatment. |
|
Darunavir |
May decrease the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. |
|
Efavirenz |
May decrease serum concentrations of the active metabolite(s) of Norgestimate. Management: Use a reliable barrier contraceptive if efavirenz is used in combination with norgestimate. Continue using barrier contraception for 12 weeks after discontinuation of efavirenz. |
|
Elagolix |
Estrogen Derivatives (Contraceptive) may diminish the therapeutic effect of Elagolix. Management: Use an alternative, non-hormonal contraceptive during treatment with elagolix and for at least 1 week following discontinuation of elagolix treatment. |
|
Elvitegravir |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Consider the use of an alternative, non-hormone-based contraceptive, in patients who are being treated with elvitegravir-containing products. |
|
Enzalutamide |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. |
|
Eslicarbazepine |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Alternative non-hormonal means of birth control should be considered for women of child-bearing potential. |
|
Eslicarbazepine |
May decrease the serum concentration of Progestins (Contraceptive). Management: Alternative, non-hormonal means of birth control should be considered for women of child-bearing potential. |
|
Exenatide |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Administer oral contraceptives at least one hour prior to exenatide. |
|
Exenatide |
May decrease the serum concentration of Progestins (Oral Contraceptive). Management: Administer oral contraceptives at least one hour prior to exenatide. |
|
Felbamate |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of a nonhormonal contraceptive is recommended. |
|
Felbamate |
May decrease the serum concentration of Progestins (Contraceptive). Management: Contraceptive failure is possible. Use of an alternative, nonhormonal method of contraception is recommended. |
|
Fosamprenavir |
Progestins (Contraceptive) may decrease serum concentrations of the active metabolite(s) of Fosamprenavir. Fosamprenavir may decrease the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. |
|
Fosaprepitant |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). The active metabolite aprepitant is likely responsible for this effect. Management: Alternative or additional methods of contraception should be used both during treatment with fosaprepitant or aprepitant and for at least one month following the last fosaprepitant/aprepitant dose. |
|
Fosaprepitant |
May decrease the serum concentration of Progestins (Contraceptive). The active metabolite aprepitant is likely responsible for this effect. Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. |
|
Fosphenytoin |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal means of contraception is recommended. |
|
Fosphenytoin |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. |
|
Hyaluronidase |
Estrogen Derivatives may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving estrogens (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. |
|
Ivosidenib |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. |
|
Ivosidenib |
May decrease the serum concentration of Progestins (Contraceptive). Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. |
|
LamoTRIgine |
Estrogen Derivatives (Contraceptive) may decrease the serum concentration of LamoTRIgine. Management: Monitor for increased serum concentrations/effects of lamotrigine in patients in whom a hormonal contraceptive is discontinued/dose decreased (this includes during a pill-free week). A reduced dosage of lamotrigine may be needed. |
|
Lesinurad |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Use of an additional, nonhormonal contraceptive is recommended in patients being treated with lesinurad who desire effective contraception. |
|
Lesinurad |
May decrease the serum concentration of Progestins (Contraceptive). Management: Use of an additional, nonhormonal contraceptive is recommended in patients being treated with lesinurad who desire effective contraception. |
|
Lixisenatide |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Administer oral contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. |
|
Lixisenatide |
May decrease the serum concentration of Progestins (Contraceptive). Management: Administer oral contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. |
|
Lomitapide |
Ethinyl Estradiol may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 40 mg/day. |
|
Lopinavir |
May decrease the serum concentration of Progestins (Contraceptive). Lopinavir may increase the serum concentration of Progestins (Contraceptive). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate and etonogestrel implants may be used without a need for additional contraception. |
|
Lorlatinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. |
|
Lumacaftor |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Do not rely on hormone-based contraceptives with concurrent use of lumacaftor/ivacaftor; an alternative, non-hormonal, method of contraception should be used if this combination is required. |
|
Lumacaftor |
May decrease the serum concentration of Progestins (Contraceptive). Management: Do not rely on hormone-based contraceptives with concurrent use of lumacaftor/ivacaftor; an alternative, non-hormonal, method of contraception should be used if this combination is required. |
|
MiFEPRIStone |
May diminish the therapeutic effect of Progestins (Contraceptive). MiFEPRIStone may increase the serum concentration of Progestins (Contraceptive). Management: Women of childbearing potential should use an effective, nonhormonal means of contraception during and 4 weeks following mifepristone treatment. |
|
MiFEPRIStone |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). MiFEPRIStone may increase the serum concentration of Estrogen Derivatives (Contraceptive). Management: Women of childbearing potential should use an effective, nonhormonal means of contraception during and 4 weeks following mifepristone treatment. |
|
Mitotane |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. |
|
Modafinil |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: The manufacturer recommends that patients use nonhormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with modafinil. |
|
Mycophenolate |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Average AUC values were unchanged, but there was evidence of substantial patient-to-patient variability in response to this combination. Management: Women of childbearing potential who are receiving mycophenolate mofetil should consider using an alternative and/or additional form of contraception. |
|
Mycophenolate |
May decrease the serum concentration of Progestins (Contraceptive). Management: Use of an additional or alternative (nonhormonal) method of contraception should be considered. |
|
Nafcillin |
May increase the metabolism of Estrogen Derivatives (Contraceptive). Management: Use of an alternative, nonhormonal form of contraception during nafcillin therapy is recommended. |
|
Nelfinavir |
May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. |
|
Nevirapine |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). |
|
Nevirapine |
May decrease the serum concentration of Progestins (Contraceptive). Management: Instruct patients receiving nevirapine to use an alternative or additional nonhormonal contraceptive. Nevirapine product labeling however suggests that depo-medroxyprogesterone acetate may be used as a sole method of contraception. |
|
OXcarbazepine |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. |
|
OXcarbazepine |
May decrease the serum concentration of Progestins (Contraceptive). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. |
|
Perampanel |
May decrease the serum concentration of Progestins (Contraceptive). Management: Patients should use an alternative, nonhormonal-based form of contraception both during the concurrent use of perampanel and for 1 month after discontinuing perampanel. |
|
Phenytoin |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal means of contraception is recommended. |
|
Phenytoin |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. |
|
Pitolisant |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Management: The combination of hormonal contraceptives with pitolisant should be avoided, and an alternate means of contraception should be used. |
|
Pitolisant |
May diminish the therapeutic effect of Progestins (Contraceptive). Management: The combination of hormonal contraceptives with pitolisant should be avoided, and an alternate means of contraception should be used. |
|
Pitolisant |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. |
|
Pomalidomide |
May enhance the thrombogenic effect of Estrogen Derivatives. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. |
|
Pomalidomide |
Progestins may enhance the thrombogenic effect of Pomalidomide. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. |
|
Primidone |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. |
|
Protease Inhibitors |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Use oral contraceptives containing at least 35mcg ethinyl estradiol with atazanavir/ritonavir, or no more than 30mcg in patients receiving atazanavir alone. Use of an alternative, non-hormonal contraceptive is recommended with other protease inhibitors. Exceptions: Indinavir. |
|
Retinoic Acid Derivatives |
May diminish the therapeutic effect of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease the serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Particularly, microdosed progesterone-only preparations may be inadequately effective. Exceptions: Adapalene; Bexarotene (Topical); Tretinoin (Topical). |
|
Rifamycin Derivatives |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. |
|
Rifamycin Derivatives |
May decrease the serum concentration of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. |
|
Rufinamide |
May decrease the serum concentration of Ethinyl Estradiol. |
|
Saquinavir |
May decrease the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. |
|
St John's Wort |
May diminish the therapeutic effect of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Consider an alternative to St John's wort if possible. If this combination is used, an alternative, nonhormonal contraceptive is recommended. |
|
St John's Wort |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. Management: Consider using a product other than St John's wort. Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. |
|
St John's Wort |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. |
|
Sugammadex |
May decrease the serum concentration of Progestins (Contraceptive). Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. |
|
Sugammadex |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. |
|
Tipranavir |
Estrogen Derivatives may enhance the dermatologic adverse effect of Tipranavir. The combination of tipranavir/ritonavir and ethinyl estradiol/norethindrone was associated with a high incidence of skin rash. Tipranavir may decrease the serum concentration of Estrogen Derivatives. Management: Women using hormonal contraceptives should consider alternative, non-hormonal forms of contraception. |
|
Tipranavir |
May increase the serum concentration of Progestins (Contraceptive). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. |
|
TiZANidine |
CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. |
|
Tobacco (Smoked) |
May enhance the adverse/toxic effect of Estrogen Derivatives (Contraceptive). Specifically, the risk of serious cardiovascular events (eg, stroke, venous thromboembolism, myocardial infarction) may be increased. Management: Avoid cigarette smoking in patients who use estrogen containing contraceptives whenever possible. If combined, monitor for signs and symptoms of serious cardiovascular events (eg, stroke, venous thromboembolism, myocardial infarction). |
|
Topiramate |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Risk appears greatest for higher topiramate doses (200 mg/day or greater). Some have recommended using at least 50 mcg/day of ethinyl estradiol, but the effectiveness of this is unclear. Consider a nonhormonal form of contraception. |
|
Topiramate |
May decrease the serum concentration of Progestins (Contraceptive). Management: Caution patients that this combination may be associated with reduced contraceptive effectiveness. Consider adding an additional (non-hormonal) contraceptive method. |
|
Vitamin K Antagonists (eg, warfarin) |
Estrogen Derivatives (Contraceptive) may diminish the anticoagulant effect of Vitamin K Antagonists. In contrast, enhanced anticoagulant effects have also been noted with some products. |
|
Vitamin K Antagonists (eg, warfarin) |
Progestins (Contraceptive) may diminish the anticoagulant effect of Vitamin K Antagonists. In contrast, enhanced anticoagulant effects have also been noted with some products. Management: When possible, concomitant hormonal contraceptives and coumarin derivatives should be avoided in order to eliminate the risk of thromboembolic disorders. Consider using an alternative, nonhormonal contraceptive. |
|
Risk Factor X (Avoid combination) |
|
|
Anastrozole |
Estrogen Derivatives may diminish the therapeutic effect of Anastrozole. |
|
Antihepaciviral Combination Products |
Ethinyl Estradiol may enhance the hepatotoxic effect of Antihepaciviral Combination Products. Management: Use of ethinyl estradiol must be discontinued prior to use of this combination; ethinyl estradiol can be restarted 2 weeks after cessation of the antihepaciviral combination product. |
|
Dasabuvir |
Ethinyl Estradiol may enhance the hepatotoxic effect of Dasabuvir. |
|
Dehydroepiandrosterone |
May enhance the adverse/toxic effect of Estrogen Derivatives. |
|
Encorafenib |
May decrease the serum concentration of Estrogen Derivatives (Contraceptive). |
|
Encorafenib |
May decrease the serum concentration of Progestins (Contraceptive). |
|
Exemestane |
Estrogen Derivatives may diminish the therapeutic effect of Exemestane. |
|
Glecaprevir and Pibrentasvir |
Ethinyl Estradiol may enhance the adverse/toxic effect of Glecaprevir and Pibrentasvir. Specifically, the risk for ALT elevation may be increased with this combination. |
|
Griseofulvin |
May diminish the therapeutic effect of Progestins (Contraceptive). Contraceptive failure is possible. |
|
Hemin |
Estrogen Derivatives may diminish the therapeutic effect of Hemin. |
|
Indium 111 Capromab Pendetide |
Estrogen Derivatives may diminish the diagnostic effect of Indium 111 Capromab Pendetide. |
|
Ixazomib |
May decrease the serum concentration of Progestins (Contraceptive). More specifically, use of ixazomib with dexamethasone may decrease the serum concentrations of contraceptive progestins. Management: Patients of childbearing potential should use a nonhormonal barrier contraceptive during and 90 days following ixazomib treatment. |
|
Ospemifene |
Estrogen Derivatives may enhance the adverse/toxic effect of Ospemifene. Estrogen Derivatives may diminish the therapeutic effect of Ospemifene. |
|
Tranexamic Acid |
Progestins (Contraceptive) may enhance the thrombogenic effect of Tranexamic Acid. |
|
Tranexamic Acid |
Estrogen Derivatives (Contraceptive) may enhance the thrombogenic effect of Tranexamic Acid. |
|
Ulipristal |
May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Management: Ulipristal for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping ulipristal; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping ulipristal. |
Monitoring parameters:
- Assessment of pregnancy status (prior to therapy);
- blood pressure (prior to therapy and yearly);
- weight (optional;
- BMI at baseline may be helpful to monitor changes during therapy);
- assess potential health status changes at routine visits.
If all doses have not been taken on schedule and one menstrual period is missed, the possibility of pregnancy should be considered. If two consecutive menstrual periods are missed, assess pregnancy status before a new dosing cycle is started. Monitor patient for:
- vision changes;
- blood pressure;
- signs and symptoms of thromboembolic disorders;
- signs or symptoms of depression;
- glycemic control in patients with diabetes;
- lipid profiles in patients being treated for hyperlipidemias.
- Adequate diagnostic measures should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.
How to administer Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo)?
- Administer at the same time each day at intervals no more than 24 hours.
- Combined hormonal contraceptives may be initiated at any time during the menstrual cycle if it is reasonably sure the woman is not pregnant.
- Back-up contraception should be used for weak unless contraception is initiated within the first 5 days of menstrual bleeding or the woman abstains from sexual intercourse.
- Combined hormonal contraceptives may be started immediately following or within the weak of a first or second-trimester abortion; backup contraception is needed for 7 days unless contraception is started at the time of the surgical abortion.
- According to the manufacturer, if severe diarrhea or vomiting occurs within 3 to 4 hours after taking an active tablet, it should be considered a missed dose; additional contraceptive measures are recommended.
- Additional guidelines are also available.
Mechanism of action of Ethinyl estradiol and norgestimate (Ortho Tri Cyclen Lo):
- Combination hormonal contraceptives can inhibit ovulation through a negative feedback mechanism on hypothalamus.
- This alters the normal pattern gonadotropin production of a follicle stimulating hormone (FSH), and luteinizing hormone from the anterior pituitary.
- FSH in the follicular phase and a midcycle surge with gonadotropins is inhibited.
- Combination hormonal contraceptives can also cause alterations in the genital system, including cervical mucus changes, which makes it difficult for sperm penetration, even if there is ovulation.
- Alterations in the endometrium can also cause unfavorable conditions for nidation.
- Combinations of hormonal contraceptives drugs could alter tubal transport of the eggs through the fallopian tubes.
- The fertility of sperm may also be affected by progestational drugs.
Absorption:
- Ethinylestradiol (EE) and norgestimate (NGM): Rapid and well absorbed
Protein binding:
- EE: >97% to albumin
- Norelgestromin (NGMN): >97% to albumin
- Norgestrel (NG): >97% to sex hormone-binding globulin (SHBG); SHBG capacity is affected by plasma Ethinyl estradiol levels
Metabolism:
- EE: Hepatic; forms metabolites
- NGM: Hepatic; forms NGMN (major active metabolite) which is further metabolized to NG (active) and other metabolites
Half-life elimination:
- EE: 10-16 hours
- NGMN: 18-25 hours
- NG: 38-45 hours
Time to peak, plasma:
- EE and NGM: ~2 hours
Excretion:
- EE: Urine and feces
- NGM: Urine (~47%) and feces (~37%) as metabolites
International Brand Names of Ethinyl estradiol and norgestimate:
- Ortho Tri-Cyclen (28)
- Ortho TriCyclen Lo
- Ortho-Cyclen (28)
- Previfem
- Sprintec 28
- Tri Femynor
- Tri-Estarylla
- Estarylla
- Femynor
- Mili
- Mono-Linyah
- MonoNessa
- Tri-Linyah
- Tri-LoEstarylla
- Tri-Lo-Marzia
- Tri-Lo-Sprintec
- Tri-Mili
- VyLibra
- Cyclen
- Tri-Cyclen
- Tri-Cyclen Lo
- Tricira Lo 21
- Tricira Lo 28
- Cilest
- Cileste
- Cilique
- Edelsin
- Lizinna
- Mactex
- Ortrel
- Tri-Previfem
- Tri-Sprintec
- Tri-VyLibra
- Tri-VyLibra Lo
- TriNessa (28)
- TriNessa Lo
- Triafem
Ethinyl estradiol and norgestimate Brand Names in Pakistan:
No Brands Available in Pakistan
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