LUIZZA 1.5/30 30 ug/1

norethindrone acetate and ethinyl estradiol · TABLET · Xiromed LLC

No Recall History

Plain English

LUIZZA 1.5/30 is a tablet containing norethindrone acetate and ethinyl estradiol at 30 ug/1, taken oral. Manufactured by Xiromed LLC.

Key Facts

Brand Name: LUIZZA 1.5/30
Generic Name: norethindrone acetate and ethinyl estradiol
NDC Code (Product): 70700-314
Manufacturer: Xiromed LLC
Strength: 30 ug/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA202770
Drug Class: Estrogen [EPC]
Marketing Start: 01/29/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue35 reports

headache31 reports

nausea27 reports

diarrhoea23 reports

dizziness19 reports

rash17 reports

dyspnoea16 reports

abdominal pain14 reports

pruritus14 reports

anxiety13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Luizza 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. Typical ** (No contraception) (85) (85) Oral contraceptives 3 combined 0.1 N/A *** progestin only 0.5 N/A *** Diaphragm with spermicidal cream…

Dosage & Administration

DOSAGE AND ADMINISTRATION The tablet blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in three rows of seven tablets each, with the days of the week appearing on the tablet blister above the first row of tablets. Note: Each blister card has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 21-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Luizza 1.5/30 must be taken exactly as directed and at intervals …

Warnings

WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives …

Contraindications

CONTRAINDICATIONS Oral contraceptives are contraindicated 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 diagnosis of, or history of, breast cancer, which may be hormone sensitive Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

Drug Interactions

7. Drug Interactions Effects of Other Drugs on Oral Contraceptives (69) Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Anticonvulsants: Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a reduction in contraceptive effectiveness. Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids. Atorvastat…

Adverse Reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1) (70-74). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1) (70, 73, 75). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of …

Frequently Asked Questions

What is LUIZZA 1.5/30 used for?

LUIZZA 1.5/30 contains norethindrone acetate and ethinyl estradiol. It is a tablet taken oral. Consult your doctor for specific uses.

Is LUIZZA 1.5/30 a controlled substance?

LUIZZA 1.5/30 is not classified as a controlled substance by the DEA.

What is the generic name for LUIZZA 1.5/30?

The generic name for LUIZZA 1.5/30 is norethindrone acetate and ethinyl estradiol. There are 12 other brand versions of norethindrone acetate and ethinyl estradiol.

What is the NDC code for LUIZZA 1.5/30 30 ug/1?

The NDC (National Drug Code) for LUIZZA 1.5/30 30 ug/1 is 70700-314, listed by Xiromed LLC.

Product NDC

70700-314

Package NDC

70700-314-79

Other Norethindrone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)