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Desogestrel and Ethinyl Estradiol
Overview
What is Caziant?
Caziant
(desogestrel and ethinyl estradiol tablets USP) is a triphasic oral contraceptive containing two active components, desogestrel and ethinyl estradiol, USP. Each 28 day treatment cycle pack consists of three active dosing phases: 7 beige tablets containing 0.1 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol) and 0.025 mg ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); 7 orange tablets containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP, and 7 pink tablets containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide and vitamin E. Beige tablets also contain iron oxide red and iron oxide yellow. Pink and orange tablets also contain FD&C Red No. 40 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Caziant
also contains 7 white tablets with the following inert ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The structural formulas are as follows:
DESOGESTREL ETHINYL ESTRADIOL, USP
C
H
O M.W. 310.48 C
H
O
M.W. 296.40
The 7 beige, 7 pink and 7 orange tablets meet Dissolution Test 2.
What does Caziant look like?
What are the available doses of Caziant?
Sorry No records found.
What should I talk to my health care provider before I take Caziant?
Sorry No records found
How should I use Caziant?
Caziant (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. TABLE 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
To achieve maximum contraceptive effectiveness, Caziant tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. Caziant tablets may be initiated using either a Sunday start or a Day 1 start.
NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different "day label strips" are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.
During the First Cycle of Use
IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Caziant tablets should be considered. A woman can begin to take Caziant tablets either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, Caziant tablets should be started on the same day that a new pack of the previous oral contraceptive would have been started.
Sunday Start
When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking Caziant tablets.
Using a Sunday start, tablets are taken daily without interruption as follows: The first beige tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first beige tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the dispenser. One beige tablet is taken daily for 7 days, followed by 1 orange tablet daily for 7 days, 1 pink tablet daily for 7 days, and then 1 white (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28 tablet regimen on the next day (Sunday) after taking the last white (inactive) tablet. [If switching from a Sunday Start oral contraceptive, the first Caziant tablet should be taken on the second Sunday after the last tablet of a 21 day oral contraceptive regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]
If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive pink (active) tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.
Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("
" section).
Day 1 Start
Counting the first day of menstruation as "Day 1", the first beige tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One beige tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 pink tablet daily for 7 days and then 1 white (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last white (inactive) tablet. [If switching directly from another oral contraceptive, the first beige tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]
If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive pink tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after she restarts her pills.
Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("
" section).
ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS
If Spotting or Breakthrough Bleeding Occurs
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of Oral Contraceptives in The Event of a Missed Menstrual Period:
1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Oral contraceptive use should be discontinued if pregnancy is confirmed.
The use of Caziant for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see
and
concerning thromboembolic disease. See also
,
).
If the patient starts on Caziant postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a beige tablet has been taken daily for 7 consecutive days.
What interacts with Caziant?
- Oral contraceptives should not be used in women who currently have the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral vascular or coronary artery disease (current or history)
- Valvular heart disease with thrombogenic complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast (or personal history of breast cancer)
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
- Hepatic tumors (benign or malignant) or active liver disease
- Known or suspected pregnancy
- Heavy smoking (≥ 15 cigarettes per day) and over age 35
- Hypersensitivity to any of the components of Caziant
What are the warnings of Caziant?
Sorry No Records found
What are the precautions of Caziant?
1. Sexually Transmitted Diseases
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow Up
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
3. Lipid Disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
4. Liver Function
If jaundice develops in any woman receiving oral contraceptives, the medication should be discontinued. The hormones in Caziant may be poorly metabolized in patients with impaired liver function.
5. Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. Emotional Disorders
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
7. Contact Lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. Drug Interactions
9. Interactions with Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
a. Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
b. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
c. Other binding proteins may be elevated in serum.
d. Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.
e. Triglycerides may be increased, and levels of various other lipids and lipoproteins may be affected.
f. Glucose tolerance may be decreased.
g. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
10. Carcinogenesis
See
section.
11. Pregnancy
Array
Teratogenic Effects
12. Nursing Mothers
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
13. Pediatric Use
Safety and efficacy of Caziant tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
14. Geriatric Use
This product has not been studied in women over 65 years of age and is not indicated in this population.
INFORMATION FOR THE PATIENT
See Patient Labeling printed below.
What are the side effects of Caziant?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see
section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
What should I look out for while using Caziant?
Oral contraceptives should not be used in women who currently have the following conditions:
What might happen if I take too much Caziant?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
NON-CONTRACEPTIVE HEALTH BENEFITS
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiologic studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
How should I store and handle Caziant?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Caziant (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 51862-238-03Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Caziant (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 51862-238-03Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Caziant (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 51862-238-03Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Caziant (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 51862-238-03Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Caziant (desogestrel and ethinyl estradiol tablets USP - triphasic regimen) is available in a 28 day blister card tablet dispenser. Each 28 day treatment cycle pack consists of four different dosing phases, as follows: 7 beige, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 333 on the other side) containing 0.1 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 orange, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 332 on the other side) containing 0.125 mg desogestrel and 0.025 mg ethinyl estradiol, USP; 7 pink, round, film-coated, biconvex, unscored tablets (debossed with stylized b on one side and 335 on the other side) containing 0.15 mg desogestrel and 0.025 mg ethinyl estradiol, USP and seven white, round, biconvex, unscored tablets (debossed with stylized b on one side and 334 on the other side) containing inert ingredients. Boxes of 3 NDC 51862-238-03Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Absorption
Desogestrel is rapidly and almost completely absorbed and converted into etonogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of desogestrel, based on the lowest and highest tablet strengths, 0.1 mg desogestrel/0.025 mg ethinyl estradiol and 0.15 mg desogestrel/0.025 mg ethinyl estradiol, compared to solution, as measured by serum levels of etonogestrel, is approximately 100%. Ethinyl estradiol is rapidly and almost completely absorbed. When the lowest and highest tablet strengths, 0.1 mg desogestrel/0.025 mg ethinyl estradiol and 0.15 mg desogestrel/0.025 mg ethinyl estradiol, were compared to solution, the relative bioavailability of ethinyl estradiol was 92% and 98%, respectively. The effect of food on the bioavailability of desogestrel and ethinyl estradiol tablets following oral administration has not been evaluated.
The pharmacokinetics of etonogestrel and ethinyl estradiol following multiple dose administration of desogestrel and ethinyl estradiol tablets were determined during the third cycle in 21 subjects. After multiple dosing with desogestrel and ethinyl estradiol tablets, plasma concentrations of etonogestrel reached steady-state after four days of treatment during dosing Phases 1 and 3. During dosing Phase 2, steady-state was reached after five days of treatment. The dose-normalized AUC
for etonogestrel was increased approximately 20% from Phase 1 to Phase 2 and approximately 10% from Phase 2 to Phase 3. SHBG concentrations were shown to be induced by the daily administration of ethinyl estradiol. Steady state for ethinyl estradiol was reached after four days of dosing in all dosing phases. The pharmacokinetic parameters of etonogestrel and ethinyl estradiol during the third cycle following multiple dose administration of desogestrel and ethinyl estradiol tablets are summarized in TABLE 1.
a
C
– maximum serum drug concentration
t
– time at which maximum serum drug concentration occurs
n-AUC
– area under the concentration- vs. time curve -0 to 24 hours normalized to 1 mcg administered
CL/F – apparent clearance
Note: for information on t
for Day 21, see the
section.
Distribution
Etonogestrel, the active metabolite of desogestrel, was found to be 98% protein bound, primarily to sex hormone-binding globulin (SHBG). Ethinyl estradiol is primarily bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis. Desogestrel, in combination with ethinyl estradiol, does not counteract the estrogen-induced increase in SHBG, resulting in lower serum levels of free testosterone.
Metabolism
Desogestrel: Desogestrel is rapidly and completely metabolized by hydroxylation in the intestinal mucosa and on first pass through the liver to etonogestrel.
data suggest an important role for the cytochrome P450 CYP2C9 in the bioactivation of desogestrel. Further metabolism of etonogestrel into 6ß-hydroxy, etonogestrel and 6ß-13ethyl-dihydroxylated metabolites as major metabolites is catalyzed by CYP3A4. Other metabolites (i.e., 3α-OH-desogestrel, 3ß-OH-desogestrel, and 3α-OH-5α-H-desogestrel) also have been identified and these metabolites may undergo glucuronide and sulfate conjugation.
Ethinyl Estradiol: Ethinyl estradiol is subject to a significant degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol, escaping gut wall conjugation, undergoes phase I metabolism and hepatic conjugation (phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. Sulfate and glucuronide conjugates of both ethinyl estradiol and phase I metabolites, which are excreted in bile, can undergo enterohepatic circulation.
Excretion
Etonogestrel and ethinyl estradiol are primarily eliminated in urine, bile and feces. At steady state, on Day 21, the elimination half-lives of etonogestrel and ethinyl estradiol are 37.1 ± 14.8 hours and 28.2 ± 10.5 hours, respectively.
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions:Changes in contraceptive effectiveness associated with coadministration of other drugs
a. Anti-infective agents and anticonvulsants
Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with some antibiotics, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include barbiturates, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
Since desogestrel is mainly metabolized by the cytochrome P450 2C9 enzyme (CYP 2C9) to form etonogestrel, the active progestin, there is a possibility of interaction with CYP 2C9 substrates or inhibitors (such as ibuprofen, piroxicam, naproxen, phenytoin, fluconazole, diclofenac, tolbutamide, glipizide, celecoxib, sulfamethoxazole, isoniazid, torsemide, irbesartan, losartan, and valsartan). The clinical relevance of these interactions is unknown.
b. Anti-HIV protease inhibitors
Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The efficacy and safety of these oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
c. Herbal products
Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in plasma hormone levels associated with coadministered drugs
Coadministration of atorvastatin and certain ethinyl estradiol containing oral contraceptives increased AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in plasma levels of coadministered drugs
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid have been noted when these drugs were administered with oral contraceptives.
No formal drug-drug interaction studies were conducted with Caziant.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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