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norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Overview
What is Taytulla?
Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. TAYTULLA provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below:
Each pink active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol and glycerin, FD&C Red #40, and titanium dioxide.
Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, lecithin, yellow beeswax, gelatin, sorbitol, glycerin, FD&C Blue #1, FD&C Red #40 and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose.
The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is CHO and the structural formula is:
The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate is CHO and the structural formula is:
What does Taytulla look like?
What are the available doses of Taytulla?
TAYTULLA
3
What should I talk to my health care provider before I take Taytulla?
Nursing mothers: Not recommended; can decrease milk production ()
How should I use Taytulla?
TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy
.
The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m has not been evaluated.
To achieve maximum contraceptive effectiveness, TAYTULLA must be taken exactly as directed. Instruct patients to take one capsule by mouth at the same time every day. Capsules must be taken in the order directed on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see . TAYTULLA may be administered without regard to meals
.
What interacts with Taytulla?
Sorry No Records found
What are the warnings of Taytulla?
Sorry No Records found
What are the precautions of Taytulla?
Sorry No Records found
What are the side effects of Taytulla?
Sorry No records found
What should I look out for while using Taytulla?
Do not prescribe TAYTULLA to women who are known to have the following conditions:
● Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke
[see
]
.
What might happen if I take too much Taytulla?
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
How should I store and handle Taytulla?
Store at Ondansetron Injection, USP 2 mg/mL, is supplied as follows:NDC 60505-6130-0 2 mL Single-use vialNDC 60505-6130-5 2 mL Single-use vials (Carton of 25)Storage:Ondansetron Injection, USP 2 mg/mL, is supplied as follows:NDC 60505-6130-0 2 mL Single-use vialNDC 60505-6130-5 2 mL Single-use vials (Carton of 25)Storage:Ondansetron Injection, USP 2 mg/mL, is supplied as follows:NDC 60505-6130-0 2 mL Single-use vialNDC 60505-6130-5 2 mL Single-use vials (Carton of 25)Storage:Ondansetron Injection, USP 2 mg/mL, is supplied as follows:NDC 60505-6130-0 2 mL Single-use vialNDC 60505-6130-5 2 mL Single-use vials (Carton of 25)Storage:
Clinical Information
Chemical Structure
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Non-Clinical Toxicology
Do not prescribe TAYTULLA to women who are known to have the following conditions:● Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke
[see
]
.
Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive. Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort. Do not co-administer Ayuna with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ). Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g., ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens. During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Ayuna (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive. After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance. Some substances may increase plasma ethinyl estradiol concentrations. These include:
Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g., cyclosporine, theophylline, corticosteroids) or decreased. The prescribing information of concomitant medications should be consulted to identify potential interactions.
Stop TAYTULLA if an arterial or deep venous thrombotic event (VTE) occurs. Stop TAYTULLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
If feasible, stop TAYTULLA at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.
Start TAYTULLA no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors.
Use COCs with caution in women with cardiovascular disease risk factors.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
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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