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Dienestrol

"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...

Dienestrol

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

ORTHO Dienestrol Cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae.

ORTHO DIENESTROL CREAM HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE DESCRIPTION: BOXED WARNING)

DOSAGE AND ADMINISTRATION

Given cyclically for short term use only:

For the treatment of atrophic vaginitis, or kraurosis vulvae associated with the menopause.

The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptlyas possible.

Attempts to discontinue or taper medication should be made at 3 to 6 month intervals.

The usual dosage range is one or two applicatorsful per day for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of one applicatorful, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

HOW SUPPLIED

Available in 2.75 oz. (78g) tubes with or without ORTHO* Measured Dose Applicator, 5g.

    With applicator: NDC 0062-5450-77
    Without applicator: NDC 0062-5450-00

Store at controlled room temperature.

Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

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