Fortacin (Lidocaine/Prilocaine)
Topical anaesthetic spray for the treatment of premature ejaculation in adult men
Fortacin is a metered-dose cutaneous spray containing lidocaine (150 mg/ml) and prilocaine (50 mg/ml), two local anaesthetics that work together to temporarily reduce penile sensitivity. It is used to treat primary premature ejaculation in adult men aged 18 years and over. Applied to the head of the penis at least 5 minutes before intercourse, Fortacin helps prolong the time to ejaculation by desensitizing sensory nerve endings.
Quick Facts
Key Takeaways
- Fortacin is a topical anaesthetic spray combining lidocaine and prilocaine, specifically developed for premature ejaculation treatment
- Apply 3 sprays to the glans penis at least 5 minutes before intercourse; effect lasts approximately 20 minutes
- Clinical trials showed a 3- to 5-fold increase in intravaginal ejaculatory latency time (IELT) compared to baseline
- Using a condom is recommended to prevent transfer of the anaesthetic to your partner
- Do not exceed 3 applications (9 sprays total) within 24 hours, with at least 4 hours between uses
What Is Fortacin and What Is It Used For?
Fortacin was specifically developed to address primary (lifelong) premature ejaculation, a common sexual dysfunction affecting an estimated 20–30% of men worldwide. Premature ejaculation is defined as ejaculation that consistently occurs sooner than desired, either before or shortly after penetration, leading to distress for the individual or couple. Fortacin provides a targeted, topical approach that avoids the systemic side effects associated with oral medications.
The spray contains two well-established local anaesthetics — lidocaine (150 mg/ml) and prilocaine (50 mg/ml) — formulated as a eutectic mixture. In a eutectic mixture, the two substances lower each other’s melting points, creating a stable liquid at room temperature that penetrates mucosal surfaces more effectively than either drug alone. This innovative formulation enables rapid onset of local anaesthesia when applied to the glans penis, the most sensory-rich area of the male genitalia.
The mechanism of action involves blocking voltage-gated sodium channels in the sensory nerve membranes of the glans penis. By preventing the initiation and conduction of nerve impulses, Fortacin produces a reversible, temporary reduction in sensation. This raises the ejaculatory reflex threshold, giving men greater control over ejaculation timing. Clinical studies demonstrated that Fortacin significantly increased the intravaginal ejaculatory latency time (IELT) from a baseline of approximately 0.6 minutes to between 2.4 and 3.8 minutes — representing a 3- to 5-fold improvement.
Fortacin was first authorized in the European Union in 2013 through the European Medicines Agency’s centralized procedure (EMEA/H/C/002693). It is marketed by Recordati Ireland Ltd and is available as a metered-dose pressurized spray canister. Each canister provides approximately 20 applications of 3 sprays each. The product is available over the counter in many markets, making it accessible without a prescription.
How Fortacin Differs from Other Treatments
Unlike oral medications used for premature ejaculation — such as dapoxetine (a selective serotonin reuptake inhibitor) or off-label use of SSRIs — Fortacin acts locally at the site of application. This means it does not produce the systemic side effects commonly associated with oral therapies, such as nausea, dizziness, drowsiness, or serotonin-related effects. The localized action also results in a faster onset (5 minutes versus 1–3 hours for oral medications) and a shorter duration of effect, making it suitable for on-demand use.
Behavioral techniques such as the “squeeze technique” and “stop-start method” are also used for premature ejaculation but require considerable practice and partner cooperation. Fortacin offers a pharmacological option that can be used independently and can complement behavioral approaches for optimal results.
What Should You Know Before Taking Fortacin?
Contraindications
Fortacin must not be used in the following situations:
- Known hypersensitivity to lidocaine, prilocaine, or any other amide-type local anaesthetic (such as bupivacaine, mepivacaine, or ropivacaine), or to any of the excipients in the formulation
- Partner allergy: If the female sexual partner has a known history of hypersensitivity to lidocaine, prilocaine, or other amide-type local anaesthetics
- Congenital or idiopathic methaemoglobinaemia, as prilocaine can increase methaemoglobin levels
Warnings and Precautions
Several important precautions should be considered before using Fortacin:
- Partner transfer: Without adequate removal or condom use, the anaesthetic can transfer to the partner during intercourse, causing vaginal numbness and reduced sexual pleasure. Using a condom is strongly recommended
- Oral sex: Should be avoided after application due to the risk of oropharyngeal numbness in the partner
- Damaged or inflamed skin: Do not apply to wounded, inflamed, or broken genital skin, as this significantly increases systemic absorption and risk of toxicity
- Hepatic impairment: Use with caution in patients with severe liver disease. Both lidocaine and prilocaine are metabolized in the liver, and impaired hepatic function may lead to elevated plasma levels
- G6PD deficiency: Patients with glucose-6-phosphate dehydrogenase deficiency are at increased risk of methaemoglobinaemia when exposed to prilocaine
- Eye contact: Avoid contact with the eyes. If accidental exposure occurs, rinse immediately with water
- Concurrent local anaesthetics: Do not use other topical anaesthetic products on the same area, as this increases the risk of systemic toxicity
Fortacin is for external use on intact penile skin only. Do not apply to open wounds, mucous membranes other than the glans, or damaged skin. If you experience signs of an allergic reaction (rash, swelling, difficulty breathing), discontinue use immediately and seek medical attention.
Pregnancy and Breastfeeding
Fortacin is indicated exclusively for use by adult men and is not intended for use by women. However, important considerations apply regarding the sexual partner:
If your partner is pregnant: Lidocaine and prilocaine can cross the placental barrier. To prevent vaginal absorption and potential fetal exposure, using a condom during intercourse is strongly recommended when the female partner is pregnant. Animal studies have not demonstrated direct harmful effects on pregnancy or fetal development at therapeutic doses, but as a precaution, minimizing any exposure is advised.
If your partner is breastfeeding: Both lidocaine and prilocaine are excreted in breast milk in small quantities. While no adverse effects on the breastfed infant are expected at normal therapeutic doses, using a condom is recommended to minimize drug transfer to the breastfeeding partner.
Fertility considerations: Local anaesthetics may have some spermicidal effects at the concentrations present in Fortacin. Couples actively trying to conceive should be aware that the product could potentially affect sperm motility. However, Fortacin should not be relied upon as a contraceptive method. Consult a healthcare provider if fertility is a concern.
How Does Fortacin Interact with Other Drugs?
Because Fortacin is applied topically and systemic absorption is low, clinically significant drug interactions are uncommon at recommended doses. However, several theoretical and pharmacologically relevant interactions should be considered:
Major Interactions
These interactions carry the highest risk and should generally be avoided:
- Other local anaesthetics: Concurrent use of additional topical or injectable local anaesthetics (e.g., benzocaine, bupivacaine, ropivacaine) increases the risk of additive systemic toxicity, including central nervous system and cardiovascular effects
- Class IB antiarrhythmics: Medications such as mexiletine and tocainide are structurally related to amide-type local anaesthetics. Combined use may potentiate the cardiac and neurological effects of both drugs
Minor Interactions
These interactions are of lower clinical significance but warrant awareness:
- Methaemoglobin-inducing drugs: Concurrent use with sulfonamides, nitrofurantoin, phenytoin, phenobarbital, dapsone, antimalarials (chloroquine, primaquine), and nitrates/nitrites may increase the risk of methaemoglobinaemia, particularly with prilocaine. This is especially relevant in patients with G6PD deficiency
- CYP enzyme inhibitors: Lidocaine is metabolized by CYP1A2 and CYP3A4. Strong inhibitors of these enzymes (e.g., fluvoxamine, erythromycin, itraconazole, ciprofloxacin) may theoretically increase systemic lidocaine levels, though this is unlikely to be clinically relevant with topical application
| Drug / Drug Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| Other local anaesthetics (benzocaine, bupivacaine) | Additive toxicity | Major | Avoid concurrent use |
| Class IB antiarrhythmics (mexiletine, tocainide) | Additive cardiac/CNS effects | Major | Avoid concurrent use |
| Sulfonamides, dapsone, nitrates | Increased methaemoglobinaemia risk | Moderate | Use with caution; monitor |
| Antimalarials (chloroquine, primaquine) | Increased methaemoglobinaemia risk | Moderate | Use with caution |
| CYP1A2/3A4 inhibitors (fluvoxamine, erythromycin) | Theoretical increased lidocaine levels | Low | Unlikely clinically relevant |
No clinically significant drug interactions have been observed in clinical trials with Fortacin at recommended doses. The low systemic absorption from topical penile application means that most theoretical interactions are unlikely to manifest in practice. However, always inform your healthcare provider about all medications you are taking.
What Is the Correct Dosage of Fortacin?
Adults
The recommended dose for adult men aged 18 years and over is 3 sprays (actuations) applied to the glans penis (head of the penis) before sexual intercourse. The sprays should cover the entire surface of the glans evenly.
Standard Adult Dose
- Per application: 3 sprays
- Each spray delivers: 7.5 mg lidocaine + 2.5 mg prilocaine
- Total per application: 22.5 mg lidocaine + 7.5 mg prilocaine
- Onset of action: Minimum 5 minutes after application
- Duration of effect: Approximately 20 minutes
- Maximum frequency: 3 applications (9 sprays) per 24 hours
- Minimum interval: At least 4 hours between applications
How to apply Fortacin correctly:
- Shake the canister well before each use
- Prime the pump if using for the first time by pressing down 3 times (direct away from body and face)
- Hold the canister upright and apply 3 sprays to the head (glans) of the penis, covering the entire surface
- Wait at least 5 minutes before sexual intercourse to allow the anaesthetic to take effect
- Wipe off any excess spray before intercourse, or wear a condom to prevent transfer to your partner
Children
Fortacin is not indicated for use in children or adolescents under 18 years of age. Safety and efficacy have not been established in this population. The product is specifically developed and authorized for adult men with primary premature ejaculation.
Elderly
There are limited clinical data on the use of Fortacin in men over 65 years of age. Elderly patients may have altered pharmacokinetics due to age-related changes in hepatic and renal function. While no specific dose adjustment has been established, elderly patients should use Fortacin with caution. If hepatic impairment is present, the risk of elevated systemic levels of lidocaine and prilocaine is increased, and medical supervision is recommended.
Missed Dose
Fortacin is used on an as-needed (on-demand) basis before sexual activity, so the concept of a missed dose does not apply. Simply apply the spray before the next planned sexual intercourse as directed. Do not apply extra sprays to compensate for a previous occasion when the product was not used.
Overdose
Excessive application of Fortacin or use on damaged skin could theoretically lead to elevated systemic levels of lidocaine and prilocaine. Signs of local anaesthetic systemic toxicity (LAST) may include:
- CNS symptoms: Dizziness, lightheadedness, tinnitus (ringing in the ears), perioral numbness (numbness around the mouth), metallic taste, visual disturbances, confusion, and in severe cases seizures
- Cardiovascular symptoms: Bradycardia (slow heart rate), hypotension (low blood pressure), and in extreme cases cardiac arrhythmias
- Methaemoglobinaemia: Cyanosis (bluish discoloration of skin), headache, fatigue, dizziness, and shortness of breath — particularly associated with prilocaine
If you suspect an overdose or experience symptoms of systemic toxicity (dizziness, tinnitus, perioral numbness, confusion, or difficulty breathing), discontinue use immediately and seek emergency medical attention. Methaemoglobinaemia can be treated with intravenous methylene blue.
| Patient Group | Dose per Application | Maximum Daily | Special Considerations |
|---|---|---|---|
| Adults (18+ years) | 3 sprays (22.5 mg lidocaine + 7.5 mg prilocaine) | 9 sprays (3 applications) | Wait at least 5 min before intercourse; 4 hours between doses |
| Elderly (65+ years) | 3 sprays (same dose) | 9 sprays (3 applications) | Use with caution; monitor for hepatic impairment |
| Hepatic impairment | 3 sprays (same dose) | Use with caution | Reduced metabolism; medical supervision advised |
| Children (<18 years) | Not indicated | Not indicated | Safety and efficacy not established |
What Are the Side Effects of Fortacin?
Like all medicines, Fortacin can cause side effects, although not everybody gets them. Most side effects are localized, mild, and temporary, typically resolving within 30–60 minutes as the anaesthetic effect wears off. The side effects listed below are based on data from clinical trials and post-marketing surveillance.
Side effects are classified by their frequency of occurrence:
Common
May affect up to 1 in 10 people
- Hypoaesthesia of the penis (numbness or reduced sensation at the application site)
- Erectile dysfunction (difficulty achieving or maintaining an erection due to reduced sensation)
- Burning sensation at the application site
Uncommon
May affect up to 1 in 100 people
- Local skin reactions (redness, irritation, itching at the application site)
- Failure to ejaculate (anejaculation)
- Headache
- Vulvovaginal burning sensation in the female partner (if product is transferred)
- Vaginal hypoaesthesia (numbness) in the female partner
Rare
May affect up to 1 in 1,000 people
- Hypersensitivity reactions (allergic reactions to lidocaine or prilocaine)
- Contact dermatitis at the application site
Very Rare / Not Known
Frequency cannot be estimated from available data
- Methaemoglobinaemia (with excessive use or in predisposed patients, particularly those with G6PD deficiency)
- Systemic toxicity — CNS symptoms: dizziness, tinnitus, perioral numbness, confusion, seizures
- Systemic toxicity — Cardiovascular: bradycardia, hypotension, cardiac arrhythmias
Side Effects in the Female Partner
If Fortacin is not adequately removed before intercourse and a condom is not used, the anaesthetic agents can transfer to the female partner. Reported effects include vaginal numbness (hypoaesthesia) and a burning sensation, which are temporary and resolve as the drug is absorbed or washed away. These effects can reduce sexual pleasure for the partner, which is why condom use is recommended.
When to Seek Medical Attention
While most side effects of Fortacin are mild and self-limiting, you should seek immediate medical attention if you experience:
- Signs of a severe allergic reaction: rash, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing
- Signs of methaemoglobinaemia: unusual bluish discoloration of the skin or lips, shortness of breath, confusion, rapid heart rate
- Signs of systemic toxicity: persistent dizziness, ringing in the ears, numbness around the mouth, visual disturbances, confusion, or seizures
If you experience any side effects, including those not listed in the product information, please report them to your national pharmacovigilance authority. In the EU, you can report via the European Medicines Agency. Reporting helps monitor the safety profile of medicines and protects future patients.
How Should You Store Fortacin?
Proper storage of Fortacin is essential to maintain the product’s effectiveness and safety. As a pressurized metered-dose spray, the canister requires specific storage conditions:
- Temperature: Store below 30°C (86°F). Do not refrigerate and do not freeze
- Light protection: Protect the canister from direct sunlight
- Heat protection: Do not expose to temperatures exceeding 50°C (122°F), as the pressurized container may burst
- Canister integrity: Do not pierce, break, or burn the canister, even when empty
- Child safety: Keep out of the reach and sight of children
- Shelf life: Check the expiry date printed on the canister and outer packaging. Do not use after this date
- After opening: Once first used, the product should be used within the period stated on the label
Do not dispose of Fortacin canisters in household waste or down drains. Return unused or expired products to your pharmacy for proper disposal in accordance with local regulations. This helps protect the environment.
What Does Fortacin Contain?
Active Substances
Each milliliter of Fortacin solution contains:
- Lidocaine: 150 mg (15% w/v) — an amide-type local anaesthetic that reversibly blocks nerve impulse conduction
- Prilocaine: 50 mg (5% w/v) — an amide-type local anaesthetic with a shorter duration of action than lidocaine
Together, lidocaine and prilocaine form a eutectic mixture, which means the combination has a lower melting point than either individual component. This allows the mixture to exist as a liquid (oil) at room temperature, significantly enhancing penetration through intact skin and mucosal surfaces compared to solid crystalline forms of the individual drugs.
Inactive Ingredients (Excipients)
The formulation is relatively simple, consisting of the eutectic mixture of the active substances dissolved in:
- Norflurane (HFA-134a): A non-flammable, non-ozone-depleting propellant used to deliver the solution as a metered-dose spray
Fortacin does not contain preservatives, fragrances, or dyes. The simple formulation reduces the risk of local irritation and allergic reactions from excipients. If you have known allergies to any pharmaceutical excipients, consult the full list of ingredients on the product packaging or ask your pharmacist.
Frequently Asked Questions About Fortacin
Fortacin is a topical anaesthetic spray containing lidocaine (150 mg/ml) and prilocaine (50 mg/ml). It is applied to the head of the penis before sexual intercourse to treat premature ejaculation. The spray works by temporarily desensitizing penile nerve endings through blocking voltage-gated sodium channels, which raises the ejaculatory reflex threshold and prolongs the time to ejaculation. Clinical trials showed an average 3- to 5-fold increase in intravaginal ejaculatory latency time.
You should apply 3 sprays of Fortacin to the glans penis at least 5 minutes before sexual intercourse. The anaesthetic effect typically lasts for approximately 20 minutes after application. Wipe off any excess spray before intercourse or use a condom to prevent transfer to your partner. Do not apply more than 3 sprays per application.
Yes. If Fortacin is not wiped off or if a condom is not used, the anaesthetic can transfer to your partner, potentially causing vaginal numbness (hypoaesthesia) and a burning sensation. These effects reduce sexual pleasure and are the most commonly reported partner-related side effects. Using a condom is recommended to minimize this risk. Additionally, oral sex should be avoided after application due to the risk of oropharyngeal numbness.
Fortacin is available over the counter (OTC) in several countries, meaning you can purchase it from a pharmacy without a prescription. However, prescription requirements may vary by country. In some markets, it may be classified as a pharmacy-only medicine, meaning you can buy it without a prescription but must obtain it from a pharmacist. Always check your local regulations or consult a pharmacist for availability in your area.
The most common side effects of Fortacin include hypoaesthesia (numbness) of the penis, erectile dysfunction (which may occur due to reduced sensation), and a burning sensation at the application site. These effects are usually mild and temporary, typically resolving within 30–60 minutes as the anaesthetic wears off. Less common effects include local skin irritation, failure to ejaculate, and headache. If side effects persist or worsen, consult a healthcare provider.
If your partner is pregnant, you should use a condom during intercourse when using Fortacin. Lidocaine and prilocaine can cross the placental barrier if absorbed vaginally by the partner. While animal studies have not shown harmful effects at therapeutic doses, preventing exposure is recommended as a precaution. Consult your healthcare provider for personalized advice regarding use during your partner’s pregnancy.
References
- European Medicines Agency (EMA). Fortacin — Summary of Product Characteristics. EMEA/H/C/002693. Available at: ema.europa.eu/en/medicines/human/EPAR/fortacin
- Dinsmore WW, Hackett G, Goldmeier D, et al. Topical eutectic mixture for premature ejaculation: results of a randomized, double-blind, placebo-controlled study. J Sex Med. 2007;4(4 Pt 1):1040–1050.
- Dinsmore WW, Wyllie MG. PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study. BJU Int. 2009;103(7):940–949.
- Salonia A, Bettocchi C, Boeri L, et al. European Association of Urology (EAU) Guidelines on Sexual and Reproductive Health, 2023. Available at: uroweb.org/guidelines/sexual-and-reproductive-health
- Althof SE, McMahon CG, Waldinger MD, et al. An update of the International Society of Sexual Medicine’s guidelines for the diagnosis and treatment of premature ejaculation (PE). J Sex Med. 2014;11(6):1392–1422.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023. Geneva: WHO; 2023.
- British National Formulary (BNF). Lidocaine with prilocaine. Available at: bnf.nice.org.uk
- McMahon CG. Premature ejaculation. Indian J Urol. 2007;23(2):174–177.
- Serefoglu EC, McMahon CG, Waldinger MD, et al. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. J Sex Med. 2014;11(6):1423–1441.
- Recordati Ireland Ltd. Fortacin Patient Information Leaflet. Revised 2024.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in clinical pharmacology, urology, and sexual medicine.
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