Prescription Drugs

CLINICAL PHARMACOLOGY Yohimbine blocks presynaptic alpha-2 adrenergic receptors. Its action on peripheral blood vessels resembles that of reserpine, though it is weaker and of short duration. Yohimbine's peripheral autonomic nervous system effect is to increase parasympathetic (cholinergic) and decrease sympathetic (adrenergic) activity. It is to be noted that in male sexual performance, erection is linked to cholinergic activity and to alpha-2 adrenergic blockade which may theoretically result in increased penile inflow, decreased penile outflow or both. Yohimbine exerts a stimulating action on the mood and may increase anxiety. Such actions have not been adequately studied or related to dosage although they appear to require high doses of the drug. Yohimbine has a mild anti-diuretic action, probably via stimulation of hypothalmic center and release of posterior pituitary hormone. Reportedly Yohimbine exerts no significant influence on cardiac stimulation and other effects mediated by (beta)-adrenergic receptors. Its effect on blood pressure, if any, would be to lower it; however, no adequate studies are at hand to quantitate this effect in terms of Yohimbine dosage.

DESCRIPTION Yohimbine is a 3a-15a-20(beta)-17a- hydroxy Yohimbine-16a-carboxylic acid methyl ester. The alkaloid is found in Rubaceae and related trees and is also found in Rauwolfia Serpentina (L) Benth. Yohimbine is an indolalkylamine alkaloid with chemical similarity to reserpine. It is a crystalline powder, odorless. Each compressed caplet contains 5.4 mg (1/12 gr.) of Yohimbine Hydrochloride.

INDICATIONS APHRODYNE (yohimbine) ® is indicated as a sympatholytic and mydriatic. Impotence has been successfully treated with yohimbine in male patients with vascular or diabetic origins and psychogenic origins (18 mg/day). DOSAGE AND ADMINISTRATION Experimental dosage reported in treatment of erectile impotence: 1,3,4 1 caplet (5.4mg) 3 times a day, to adult males taken orally. Occasional side effects reported with this dosage are nausea, dizziness or nervousness. In the event of side effects dosage is to be reduced to 1/2 caplet 3 times a day, followed by gradual increases to 1 caplet 3 times a day. Reported therapy not more than 10 weeks. 3 HOW SUPPLIED APHRODYNE (yohimbine) ® scored caplets are aqua, debossed with APHRO DYNE. They are available in bottles of 100 NDC 0076-0401-03) and 1000 (NDC 0076-0401-04). MANUFACTURED FOR: Star Pharmaceuticals, Inc.

PATIENT INFORMATION No Information Provided.

OVERDOSE No Information Provided. CONTRAINDICATIONS Renal diseases, and patients sensitive to the drug. In view of the limited and inadequate information at hand, no precise tabulation can be offered of additional contraindications.

SIDE EFFECTS Yohimbine readily penetrates the CNS and produces a complex pattern of responses in lower doses than required to produce peripheral (alpha)-adrenergic blockage. These include anti-diuresis, a general picture of central excitation including elevated blood pressure and heart rate, increased motor activity, irritability and tremor. Sweating, nausea and vomiting are common after parenteral administration of the drug. 1,2 Also dizziness, headache, and skin flushing have been reported. 1,3 DRUG INTERACTIONS No Information Provided.

WARNINGS Generally, this drug is not proposed for use in females and certainly must not be used during pregnancy. Neither is this drug proposed for use in pediatric, geriatric or cardio-renal patients with gastric or duodenal ulcer history. Nor should it be used in conjunction with mood-modifying drugs such as antidepressants or in psychiatric patients in general. PRECAUTIONS No Information Provided.