FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Drospirenone And Ethinyl Estradiol Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Drospirenone and ethinyl estradiol tablets USP are indicated for use by women to prevent pregnancy.
History
There is currently no drug history available for this drug.
Other Information
Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg, provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:
- 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE
- 7 inert white to off-white tablets
The inactive ingredients in the yellow tablets are corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc, titanium dioxide and yellow iron oxide. The inert white to off-white tablets contains corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch and titanium dioxide.
Drospirenone and ethinyl estradiol tablets are not USP for dissolution.
Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15, 15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a] phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.
Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.
The structural formulas are as follows:
Sources
Drospirenone And Ethinyl Estradiol Manufacturers
-
Lupin Pharmaceuticals, Inc.
Drospirenone And Ethinyl Estradiol | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult PatientsThe dose of Moxifloxacin Hydrochloride is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Table 1: Dosage and Duration of Therapy in Adult PatientsType of Infectiona
Dose
Every 24 hoursDurationb
(days)Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia (1.3)
400 mg
7–14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7–21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5–14
Plague (1.7)C
400 mg
10–14
a) Due to the designated pathogens [see Indications and Usage (1)]. b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Conversion of Intravenous to Oral Dosing in AdultsIntravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin Hydrochloride Injection may be switched to Moxifloxacin Hydrochloride Tablets when clinically indicated at the discretion of the physician.
2.2 Important Administration Instructions With Multivalent CationsAdminister Moxifloxacin Hydrochloride Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
With FoodMoxifloxacin Hydrochloride Tablets can be taken with or without food, drink fluids liberally.
Login To Your Free Account