盐酸阿扑吗啡舌下片, Apomorphine Hydrochloride Sublingual Tablets, 3mg*3 Tablets, for Male Erectile Dysfunction (ED)

Comparison of Drugs for Male Erectile Dysfunction: Tadalafil, Sildenafil & Apomorphine Hydrochloride Sublingual Tablets

Drug Name
盐酸阿扑吗啡舌下片
Apomorphine Hydrochloride Sublingual Tablets
Yansuan Apumafei Shexiapian

Ingredients
Apomorphine Hydrochloride
Chemical Name: (R)-6-Methyl-5,6,6α,7-tetrahydro-4H-dibenzo[de,g]quinoline-10,11-diol hydrochloride hemihydrate;
Molecular Formula: C₁₇H₁₇NO₂·HCl·½H₂O)

Description
White or almost white tablets that gradually turn green when exposed to air or sunlight.

Indications
For the treatment of male erectile dysfunction (ED).

Dosage and Administration

• Administer sublingually 20 minutes before sexual activity, typically dissolving within 10 minutes. If not fully dissolved after 20 minutes, swallow the remaining tablet.
• Moisten the mouth with a small amount of water before administration to aid dissolution.
• Initial Dose: 2 mg for all patients.
• Dose Adjustment: May increase to 3 mg if the therapeutic effect is insufficient. No dose adjustment required for elderly patients.

Adverse Reactions
Mild, transient adverse reactions may occur, including nausea, headache, dizziness, drowsiness, pharyngitis, aggravated cough, arthritis, facial flushing, dysgeusia, and sweating. Syncope is rarely reported.

Contraindications

1. Hypersensitivity to any component of this product.
2. Severe variant angina, recent myocardial infarction, severe heart failure, hypotension, or other conditions unsuitable for sexual activity.
3. Sexual partners who are pregnant or breastfeeding.

Precautions

1. Ineffective if swallowed; must be administered sublingually.
2. Do not exceed 3 mg within 8 hours.
3. Avoid concurrent use with other ED treatments.
4. Discontinue sexual activity immediately if chest pain occurs.
5. Avoid driving or operating machinery until 2 hours after administration.
6. Consult a physician before use in patients with hepatic or renal impairment.
7. Inform the physician of abnormal blood pressure, dizziness, or pre-syncope.
8. Use with caution in patients with penile deformities or other relevant conditions.
9. Inform the physician if using nitrates (for angina/chest pain) or antihypertensive agents.
10. Store out of reach of children. Follow the instructions and use as directed by a physician.

Special Populations

• Pediatric Use: Not suitable for children or adolescents under 18 years.
• Pregnancy and Lactation: Contraindicated in pregnant or breastfeeding women.
• Geriatric Use: No dose adjustment required.

Drug Interactions

1. Potential interactions with nitrate medications.
2. Use with caution alongside antihypertensive agents.
3. Avoid concurrent use with central dopamine receptor agonists or antagonists.
4. Alcohol consumption may increase hypotension risk and reduce efficacy.
5. No interactions observed with ondansetron, prochlorperazine maleate, or domperidone.
6. Limited data on interactions with antidepressants, anticonvulsants, or other CNS-active drugs; no clinical interactions reported.

Pharmacology
Apomorphine hydrochloride activates dopamine receptors in the hypothalamus, transmitting electrical impulses from the paraventricular nucleus to the spinal cord, promoting penile blood flow. It also modulates nitric oxide activation, inducing a cascade of physiological effects that enhance blood circulation and facilitate erection.

Storage
Store in a tightly sealed container, protected from light and moisture.

Specification
3 mg per tablet.

Packaging
3 mg × 3 tablets per plate (aluminum-aluminum blister packaging).

Expiration
24 months.