ParoxetineRx formulas contain combinations of the following active ingredients:

1. Paroxetine — Present in all formulas. SSRI that delays ejaculation by regulating serotonin.

2. Tadalafil — Present in all formulas. Tadalafil is a PDE5 inhibitor used for erectile dysfunction.

3. Sildenafil — Max formulas only. A PDE5 inhibitor used for erectile dysfunction.

4. Apomorphine — Max formulas only. Dopamine agonist that stimulates arousal and blood flow.

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Important Safety Information for ParoxetineRx

Paroxetine (in Paroxetine Rx and Paroxetine Rx Max formulas)

Paroxetine is a selective serotonin reuptake inhibitor (SSRI). Its use in this compound is off-label.

SUICIDALITY WARNING

Antidepressants, including paroxetine, have been associated with an increased risk of suicidal thoughts and behaviors in young adults (ages 18-24) during the early months of treatment.

• In clinical studies, approximately 5 additional cases of suicidal thinking or behavior occurred per 1,000 young adults (ages 18-24) treated with antidepressants compared to placebo.
• This risk was not observed in adults aged 25-64. Adults 65 and older showed a reduced risk.
• Paroxetine is not approved for use in anyone under 18 years of age.

If you experience new or worsening depression, anxiety, agitation, panic attacks, irritability, hostility, restlessness, or thoughts of self-harm or suicide — especially during the first few months of treatment or after a dose change — contact your doctor or seek emergency help immediately.

If you are in crisis, call the 988 Suicide and Crisis Lifeline (call or text 988) or go to your nearest emergency room.

1.1. WARNINGS (Paroxetine)

Do not use ParoxetineRx if you:

• Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) within the past 14 days. Examples include phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan), selegiline (Emsam), and the antibiotics linezolid (Zyvox) or intravenous methylene blue. Combining paroxetine with an MAOI can cause serotonin syndrome, a potentially life-threatening condition.
• Are taking thioridazine (Mellaril). Paroxetine increases thioridazine levels in the blood, which can cause dangerous heart rhythm changes (QT prolongation and ventricular arrhythmias).
• Are taking pimozide (Orap). Paroxetine increases pimozide levels in the blood, which can cause dangerous heart rhythm changes.
• Have a known allergy (hypersensitivity) to paroxetine or any inactive ingredient in the capsule. Signs of allergic reaction include rash, hives, itching, swelling, or difficulty breathing.

Pregnancy and breastfeeding:

• Do not use ParoxetineRx if you are pregnant or plan to become pregnant. Paroxetine taken during the first trimester of pregnancy has been associated with an increased risk of heart defects in the baby. Use during late pregnancy may cause a condition called persistent pulmonary hypertension of the newborn (PPHN), as well as complications requiring extended hospitalization for the newborn (breathing problems, seizures, temperature instability, feeding difficulty, low blood sugar).
• Do not use ParoxetineRx if you are breastfeeding. Paroxetine passes into breast milk. Reports include agitation, irritability, poor feeding, and poor weight gain in breastfed infants exposed to paroxetine.
• ParoxetineRx is not appropriate for use in women at all.

Dosage and administration warnings:

• Take ParoxetineRx exactly as prescribed by your physician. Do not take more than the prescribed dose.

1.2. DRUG INTERACTIONS (Paroxetine)

Paroxetine can interact with many other medications. Some combinations are dangerous. Always tell your doctor about everything you take.

Do not take with (contraindicated):

• MAOIs, Thioridazine, Pimozide.

Medications that increase the risk of serotonin syndrome when combined with paroxetine:

• Other SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), tricyclic antidepressants, triptans, opioid pain medications (e.g., fentanyl, tramadol), lithium, tryptophan supplements, buspirone, amphetamines, and St. John's Wort.

1.3. SIDE EFFECTS (Paroxetine)

a. Emergency Symptoms — Seek Immediate Medical Attention

• Signs of an allergic reaction or anaphylaxis
• Signs of serotonin syndrome
• Suicidal thoughts or behaviors
• Seizures
• Severe skin reactions
• Priapism: a painful erection lasting more than 4 hours

b. Common Side Effects

• Nausea, drowsiness, dry mouth, weakness, constipation, dizziness, difficulty sleeping, changes in ejaculation, sweating, tremor, decreased appetite.

Sildenafil & Tadalafil (tadalafil is in Paroxetine Rx and Paroxetine Rx Max formulas, sildenafil is in Paroxetine Rx Max formulas)

Sildenafil and tadalafil are phosphodiesterase-5 (PDE5) inhibitors. They are used for the treatment of erectile dysfunction (ED).

2.1. WARNINGS (Sildenafil & Tadalafil)

Do not use ParoxetineRx if you:

• Are taking nitrates in any form (e.g., nitroglycerin for chest pain), as this can cause a sudden, dangerous drop in blood pressure.
• Are taking guanylate cyclase stimulators such as riociguat.
• Have a known allergy to sildenafil or tadalafil.

Tell your doctor if you have or have ever had:

• Heart problems (e.g., heart attack, irregular heartbeat, angina, heart failure)
• Stroke
• High or low blood pressure
• A deformed penis shape (Peyronie's disease)
• Priapism (an erection lasting more than 4 hours)
• Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
• Retinitis pigmentosa, a rare genetic eye disease
• Severe vision loss, including a condition called NAION
• Kidney or liver problems

2.2. DRUG INTERACTIONS (Sildenafil & Tadalafil)

Do not take with (contraindicated):

• Nitrates (e.g., nitroglycerin)
• Guanylate cyclase stimulators (e.g., riociguat)

Medications that may require dose adjustment or monitoring:

• Alpha-blockers (for high blood pressure or prostate problems)
• Blood pressure medications
• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole)
• Other PDE5 inhibitors

2.3. SIDE EFFECTS (Sildenafil & Tadalafil)

a. Emergency Symptoms — Seek Immediate Medical Attention

• An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away.
• Sudden vision loss in one or both eyes.
• Sudden hearing decrease or hearing loss.

b. Common Side Effects

• Headache, flushing, upset stomach, abnormal vision (blurred vision, changes in color vision), nasal congestion, back pain, muscle aches, nausea, dizziness, rash.

Apomorphine (in Paroxetine Rx Max formulas)

Apomorphine is a dopamine agonist. It is usually used for the acute, intermittent treatment of "off" episodes in patients with advanced Parkinson's disease. Its use in this compound is off-label.

3.1. WARNINGS (Apomorphine)

Do not use ParoxetineRx if you:

• Are taking 5HT3 antagonists (e.g., ondansetron for nausea), as this can cause severe low blood pressure and loss of consciousness.

Tell your doctor if you have or have ever had:

• Low blood pressure or fainting spells
• Dizziness or drowsiness
• Kidney or liver problems
• Heart problems, including a prolonged QT interval

3.2. DRUG INTERACTIONS (Apomorphine)

Do not take with (contraindicated):

• 5HT3 antagonists (e.g., ondansetron, granisetron)

Medications that may require dose adjustment or monitoring:

• Blood pressure medications
• Drugs that prolong the QT interval
• Dopamine antagonists (e.g., metoclopramide, prochlorperazine)

3.3. SIDE EFFECTS (Apomorphine)

a. Emergency Symptoms — Seek Immediate Medical Attention

• Severe nausea and vomiting
• Low blood pressure (hypotension) and fainting
• Hallucinations or psychotic-like behavior
• Falling asleep during normal activities

b. Common Side Effects

• Nausea, vomiting, yawning, drowsiness, dizziness, runny nose.

DISCLAIMERS

Off-label use: The use of paroxetine, sildenafil, tadalafil, and apomorphine in ParoxetineRx for premature ejaculation is off-label. This means your physician is prescribing it, but this combination is not FDA-approved for this purpose.

Compounded medication: ParoxetineRx is a compounded medication. It is not reviewed or approved by the FDA for safety, efficacy, or manufacturing quality. All compounded medications are not FDA-approved.

This information does not replace the judgment of your physician. This is a summary and does not include all possible side effects, warnings, or drug interactions.

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