Depo-provera
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Questions & Answers
Side Effects & Adverse Reactions
The use of progestational drugs during the first four months of pregnancy is not recommended. Progestational agents have been used beginning with the first trimester of pregnancy in attempts to prevent abortion but there is no evidence that such use is effective. Furthermore, the use of progestational agents, with their uterine-relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion.
Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias (5 to 8 per 1,000 male births in the general population) may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but insofar as some of these drugs induce mild virilization of the external genitalia of the female fetus, and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy.
If the patient is exposed to DEPO-PROVERA Sterile Aqueous Suspension during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus.
The physician should be alert to the earliest manifestations of thrombotic disorder (thrombophlebitis, cerebrovascular disorder, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined.
Multi-dose use of DEPOPROVERA Sterile Aqueous Suspension from a single vial requires special care to avoid contamination. Although initially sterile, any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed.
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
Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma.
History
There is currently no drug history available for this drug.
Other Information
DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200° and 210° C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether and insoluble in water.
The chemical name for medroxyprogesterone acetate is Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is:
DEPO-PROVERA for intramuscular injection is available as 400 mg/mL medroxyprogesterone acetate. Each mL of the 400 mg/mL suspension contains:
Medroxyprogesterone acetate .............400 mg
Polyethylene glycol 3350.....................20.3 mg
Sodium sulfate anhydrous ......................11 mg
with
Myristyl-gamma-picolinium
chloride ............................................1.69 mg
added as preservative
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
Sources
Depo-provera Manufacturers
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Physicians Total Care, Inc.
![Depo-provera (Medroxyprogesterone Acetate) Injection, Suspension [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Depo-provera | Physicians Total Care, Inc.
The suspension is intended for intramuscular administration only.
Endometrial or renal carcinoma— doses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
When multi-dose vials are used, special care to prevent contamination of the contents is essential (See WARNINGS).
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Pharmacia And Upjohn Company
Depo-provera | Temple Industrial Welding Supply Co
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Pharmacia And Upjohn Company
Depo-provera | Parke-davis Div Of Pfizer Inc
When given in equal doses, Dilantin Infatabs yield higher plasma levels than Dilantin Kapseals®. For this reason serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form.
Dilantin® Kapseals® is formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in Dilantin-125 Suspension and Dilantin Infatabs. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.
GeneralNot for once-a-day dosing.
Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum level is usually 10–20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.
Dilantin Infatabs can be either chewed thoroughly before being swallowed or swallowed whole.
Adult DosagePatients who have received no previous treatment may be started on two Infatabs three times daily, and the dose is then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be six to eight Infatabs daily; an increase to twelve Infatabs daily may be made, if necessary.
Dosing in Special Populations Patients with Renal or Hepatic DiseaseDue to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution. Unbound phenytoin concentrations may be more useful in these patient populations.
Elderly PatientsPhenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.
PediatricInitially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years old and adolescents may require the minimum adult dose (300 mg/day). If the daily dosage cannot be divided equally, the larger dose should be given before retiring.
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A-s Medication Solutions Llc
Depo-provera | A-s Medication Solutions Llc
2.1 Prevention of PregnancyBoth the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.
The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Depo-Provera CI should not be used as a long-term birth control method (i.e. longer than 2 years) unless other birth control methods are considered inadequate. Dosage does not need to be adjusted for body weight [See Clinical Studies (14.1)].
To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Depo-Provera CI depends on adherence to the dosage schedule of administration.
2.2 Switching from other Methods of ContraceptionWhen switching from other contraceptive methods, Depo-Provera CI should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of Depo-Provera CI on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
![Depo-provera (Medroxyprogesterone Acetate) Injection, Suspension [Pharmacia And Upjohn Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=958c5a56-51aa-4d04-a29c-e69b12f26a28&name=liquidoxygen.jpg)
![Depo-provera (Medroxyprogesterone Acetate) Injection, Suspension [Pharmacia And Upjohn Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca119a89-2394-4d34-8078-cd1fa4e8e2f1&name=dilantin-03.jpg)
![Depo-provera (Medroxyprogesterone Acetate) Injection, Suspension [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=571982db-e1ce-4c64-98c3-86f66f3e77b9&name=3701-0.jpg)
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