Desogestrel and ethinyl estradiol is the generic equivalent of the brand-name drug Isibloom, Volnea. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Desogestrel and ethinyl estradiol through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
INDICATIONS AND USAGE Isibloom (desogestrel and ethinyl estradiol tablets) are 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,…
Important Warnings
WARNINGS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including desogestrel and ethinyl estradiol tablets, should not be used by women who are over 35 years of age and smoke. The use of oral contraceptives is associated with increased risks of several serious conditio…
Adverse Reactions
ADVERSE REACTIONS 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 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast canc…
Drug Interactions
8. Drug Interactions Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Effects of Other Drugs on Combined Hormonal Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and pot…
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Isibloom (desogestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. Isibloom (desogestrel and ethinyl estradiol tablets, USP) may be initiated using either a Sunday start or a Day 1 start. Day 1 Start The dosage of Isibloom (desogestrel and ethinyl estradiol tablets, USP) for the initial cycle of therapy is one orange "active" tablet administered daily from t…
Patient Counseling Information
INFORMATION FOR THE PATIENT See Patient Labeling printed below
Source: FDA. For professional use only. Not a substitute for prescribing information.
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