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Marketing Authorization Holder

Pharmaselect International Beteiligungs, GmbH (Germany)

Manufactured By

Solvay Pharma, LLC (Russia)

ATC Code

G04BE04 (Yohimbine)

Active Substance

Yohimbine (BAN)

Dosage Form

Yohimbine "Spiegel"®

Tablets 5 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, flat, with beveled edges.

Excipients: corn starch, gum arabic, lactose monohydrate, sucrose, stearic acid, talc.

20 pcs. – glass bottles (1) – cardboard packs.
100 pcs. – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug used for erectile dysfunction

Pharmacotherapeutic Group

Potency stimulator (alpha-adrenergic blocker)

Pharmacological Action

Alpha₂-adrenergic blocker, acting primarily on presynaptic central and peripheral alpha₂– adrenoreceptors. Improves blood supply to the pelvic organs. Activates adrenergic neurons of the central nervous system (which may be accompanied by an increase in blood pressure), motor activity, and reactivity.

Increases libido and potency. Has an antidiuretic effect, causes an increase in heart rate and a decrease in blood pressure (due to blockade of peripheral alpha₂– adrenoreceptors).

Pharmacokinetics

Rapidly and completely absorbed from the gastrointestinal tract. C_max is reached after 1.3 hours.

10 minutes after oral administration, it penetrates the blood-brain barrier; about 17% is detected in brain tissues for 6 hours.

Metabolized in the liver. T_1/2 – 0.6 hours.

Indications

• Psychogenic impotence;
• Functional impotence (accompanied by erectile dysfunction);
• Bladder atony, male menopause.

ICD codes

Dosage Regimen

Administer orally with a full glass of water. Take with meals to improve tolerability.

Do not chew or crush the tablets; swallow them whole.

The standard adult dose is 1 to 2 tablets (5-10 mg) per administration.

Administer the dose one to three times daily, as directed by a physician.

Initiate therapy at the lower end of the dosage range. Titrate the dose based on individual patient response and tolerability.

The typical course of treatment lasts from 3 to 10 weeks.

Do not exceed the maximum recommended daily dosage.

If a repeat course of therapy is required, wait a minimum of 10 weeks before reinitiating treatment.

Monitor for the development of adverse reactions, particularly tachycardia and changes in blood pressure.

Discontinue use and consult a physician if severe side effects occur.

Adverse Reactions

Dizziness, headache, anxiety, migraine, hand tremor, vomiting, diarrhea, gastralgia, decrease or increase in blood pressure, orthostatic hypotension, tachycardia.

Contraindications

• Hypersensitivity to the drug;
• Hepatic and/or renal failure;
• Arterial hypertension or hypotension;
• Ischemic heart disease;
• Concomitant use of adrenergic stimulants.

With caution gastric and duodenal ulcer, mental illness.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Special Precautions

It is not recommended to combine with antidepressants and other thymoleptic drugs.

Effect on the ability to drive vehicles and use mechanisms

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed and sharpness of psychomotor reactions.

Overdose

Symptoms: general weakness, generalized paresthesia, memory and coordination disorders, headache, dizziness, tremor, tachycardia, increased blood pressure, feeling of fear, hallucinations, nausea, vomiting, mydriasis, salivation and lacrimation, increased sweating, increased plasma norepinephrine levels.

Treatment: antidote – clonidine; administered orally in an initial dose of 0.1-0.2 mg, then repeatedly at hourly intervals in a dose of 0.1 mg. Symptomatic treatment: antihypertensive agents; benzodiazepines are prescribed to eliminate the feeling of fear or hallucinations (phenothiazine neuroleptics should not be prescribed).

Drug Interactions

When taken concomitantly with clonidine – weakening of the effect of both drugs. Possible decrease in the effectiveness of antihypertensive drugs, alprazolam. Enhances the action of antidepressants. Clomipramine increases the plasma concentration of yohimbine hydrochloride.

Storage Conditions

List B. In a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children!

Shelf Life

Shelf life – 5 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.