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primary and secondary amenorrhea menstrual irregularity functional uterine bleeding endocrine infertility habitual abortion. · threatened abortion

PACKAGING: 5-mg. scored tablets, bottles of 30.

PARKE, DAVIS & COMPANY DETROIT 32, MICHIGAN PARKE-DAVIS

12660

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EXHIBIT 49

(From J.A.M.A., April 23, 1960)

orally effective progestational therapy

NORLUTIN

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(norethindrone, Parke-Dava

in conditions involving deficiency of progesterone... primary and secondary amenorrhea menstrual irregularity func tional uterine bleeding endocrine infertility habitual abortion ⚫ threatened abortion

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PACKAGING: 5-mg. scored tablets, bottles of 30.

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EXHIBIT 51) (Package Insert)

|_ NORLUTATER and NORLU

Norlutate is the acetic acid ester of Norlutin (norethindrone, P, D. & Co.) which is the 17-alpha-ethinyl derivative of 19-nortestosterone, first synthesized by Djerassi and co-workers.' It is a purified crystalline compound which provides orally potent progestational action. Laboratory studies have demonstrated that this ester of norethindrone is identical in physiologic activity with the parent alcohol, differing only in potency. According to studies by McGinty in animals and clinical investigative idies by Greenblatt, Kupperman and others, the ester is approxiately twice as potent as the alcohol. The use of either norethindrone or the acetate form is indicated in those clinical conditions associated with a deficiency in the secretion of progesterone. Both forms are available in 5-mg. scored tablets, bottles of 30.

DOSAGE AND ADMINISTRATION

As with Norlutin, therapy with Norlutate must be adapted to the specific indication and therapeutic response of the individual patient. The dosage schedule presented here is based on experience with both the parent Norlutin product and the acetate ester and takes account of the increased potency of the acetate ester.

Amenorrhea, menstrual irregularity, functional uterine bleeding, infertility: 2.5-10 mg. Norlutate (or 5-20 mg. Norlutin) daily starting on the fifth day of the menstrual cycle, and ending with the twenty-third day. Allow a 5-day period for withdrawal bleeding to

occur.

Habitual abortion: 2.5 mg. Norlutate (or 5 mg. Norlutin) twice daily as soon as test for pregnancy is positive, and continued through thirty-eighth week.

Threatened abortion: 10 mg. Norlutate (or 20 mg. Norlutin) twice daily for 5 days and then 2.5 mg. twice daily through thirty. eighth week.

Premenstrual tension, dysmenorrhea: 5 mg. Norlutate (or 10 mg. Norlutin) once or twice daily starting in pre-ovulatory phase, and ending with the twentieth to the twenty-third day.

Endometriosis: Initial daily dosage is 5 mg. Norlutate (or 10 mg. Norlutin) for 2 weeks with increments of 5 mg. Norlutate (or 10 mg. Norlutin) every 2 weeks until a maintenance dose of 10 to 15 mg. Norlutate (or 20 to 30 mg. Norlutin) daily is reached. Total period of therapy-6 to 9 months.

Pregnancy test: 5 mg. Norlutate (or 10 mg. Norlutin) daily for 3 consecutive days will produce withdrawal bleeding in the nonpregnant

woman.

This dosage schedule assumes the interval between menses to be 28 days.

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