Tadalafil 5mg Blister Pack Tablets
It is used to treat erectile dysfunction (ED).It is used to treat the signs of an enlarged prostate.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Erectile Dysfunction Agent; Benign Prostatic Hyperplasia Agent
Pharmacologic Class
Phosphodiesterase-5 (PDE5) Inhibitor
Pregnancy Category
Category B
FDA Approved
Nov 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tadalafil is a medication used to treat erectile dysfunction (ED) by helping to increase blood flow to the penis when sexually aroused, allowing for an erection. It is also used to treat symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) by relaxing muscles in the prostate and bladder, which can improve urine flow and reduce urinary symptoms. Unlike some other ED medications, tadalafil can work for up to 36 hours, earning it the nickname 'the weekend pill'.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to take the tablet whole and not split or break it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
Missing a Dose
If you have an enlarged prostate and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
For erectile dysfunction (ED), the dosage instructions vary:
- If taking this medication as needed, do not take it more frequently than prescribed by your doctor.
- If taking it daily, follow the same guidelines as for an enlarged prostate: take a missed dose as soon as you remember, but skip it if it's close to the time for your next dose. Avoid taking two doses at the same time or extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to take the tablet whole and not split or break it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
Missing a Dose
If you have an enlarged prostate and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses.
For erectile dysfunction (ED), the dosage instructions vary:
- If taking this medication as needed, do not take it more frequently than prescribed by your doctor.
- If taking it daily, follow the same guidelines as for an enlarged prostate: take a missed dose as soon as you remember, but skip it if it's close to the time for your next dose. Avoid taking two doses at the same time or extra doses.
Lifestyle & Tips
- Avoid excessive alcohol consumption (e.g., 5 or more units) as it can increase the risk of dizziness and low blood pressure.
- Do not take with nitrates (e.g., nitroglycerin for chest pain) as this can cause a dangerous drop in blood pressure.
- Inform your doctor about all medications you are taking, especially alpha-blockers, blood pressure medications, and certain antifungals or HIV medications.
- This medication does not protect against sexually transmitted diseases (STDs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For ED: 5 mg once daily; For BPH: 5 mg once daily; For ED/BPH: 5 mg once daily. For PRN ED: 10 mg prior to anticipated sexual activity, may increase to 20 mg or decrease to 5 mg based on efficacy and tolerability. Max 1 dose per day.
Dose Range:
2.5 - 20 mg
Condition-Specific Dosing:
Erectile Dysfunction (ED):
5 mg once daily, or 10 mg PRN (may adjust to 5 mg or 20 mg PRN)
Benign Prostatic Hyperplasia (BPH):
5 mg once daily
ED and BPH:
5 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
For once-daily use: 2.5 mg once daily. For PRN use: 5 mg PRN, not more than once every 48 hours.
Severe:
For once-daily use: Not recommended. For PRN use: 5 mg PRN, not more than once every 72 hours.
Dialysis:
For PRN use: 5 mg PRN, not more than once every 72 hours. Consider lower starting dose.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
For once-daily use: 2.5 mg once daily. For PRN use: 10 mg PRN, not more than once daily.
Severe:
Not recommended for once-daily use. For PRN use: Not recommended.
Pharmacology
Mechanism of Action
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes local release of nitric oxide, PDE5 inhibition by tadalafil leads to increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, causing an erection. For BPH, the mechanism is thought to involve relaxation of smooth muscle in the bladder, prostate, and vascular supply to these organs, mediated by the nitric oxide/cGMP pathway.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as a percentage, but well absorbed orally.
Tmax:
Approximately 2 hours (range 0.5-6 hours)
FoodEffect:
No clinically significant effect on the rate or extent of absorption.
Distribution:
Vd:
Approximately 63 L
ProteinBinding:
Approximately 94% (primarily to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17.5 hours
Clearance:
Approximately 2.5 L/hr
ExcretionRoute:
Primarily in feces (approximately 61% of dose) and to a lesser extent in urine (approximately 36% of dose)
Unchanged:
Less than 4% of the dose is excreted as unchanged drug in urine.
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes
PeakEffect:
Approximately 2 hours
DurationOfAction:
Up to 36 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Chest pain or pressure
Fast or abnormal heartbeat
Dizziness or fainting
Severe headache
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Ringing in the ears, hearing loss, or other changes in hearing
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex (seek immediate medical attention to prevent potential long-term sexual problems)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
Signs of a common cold
This list is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Chest pain or pressure
Fast or abnormal heartbeat
Dizziness or fainting
Severe headache
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Ringing in the ears, hearing loss, or other changes in hearing
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex (seek immediate medical attention to prevent potential long-term sexual problems)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
Signs of a common cold
This list is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, dizziness, or nausea during sexual activity (stop and seek immediate medical attention).
- Sudden decrease or loss of vision in one or both eyes (seek immediate medical attention).
- Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness (seek immediate medical attention).
- An erection lasting longer than 4 hours (priapism - seek immediate medical attention, as this can cause permanent damage).
- Allergic reactions (rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
To ensure safe and effective treatment, it is crucial to inform your doctor about the following:
Allergies and Sensitivities
If you are allergic to this medication, any of its components, or other substances, including foods or drugs, notify your doctor. Describe the allergic reaction and its symptoms.
Pre-existing Medical Conditions
Inform your doctor if you have:
- Kidney disease or liver disease
- Certain hereditary eye problems, such as retinitis pigmentosa
- Pulmonary veno-occlusive disease (PVOD)
- Unstable angina (a specific type of chest pain)
- A history of heart attack within the last 90 days
- Chest pain during sexual activity
- Heart failure
- Abnormal heartbeat
- High or low blood pressure
- A stroke within the last 6 months
Medication Interactions
Tell your doctor if you use:
- "Poppers" like amyl nitrite and butyl nitrite
- Medications such as isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin. These drugs should not be taken with this medication, and you may need to avoid them for a period after your last dose.
- Any prescription, over-the-counter, or natural products that should not be taken with this medication, including those for high blood pressure, enlarged prostate, HIV, infections, and others. Your doctor or pharmacist can advise on potential interactions.
Concurrent Medications
Inform your doctor if you are taking:
- Another medication containing the same active ingredient
- A different medication for erectile dysfunction (ED) or pulmonary hypertension
Age and Gender Considerations
- This medication is not approved for use in children.
- For erectile dysfunction (ED) or enlarged prostate, this medication is not approved for use in females.
Sexual Activity
If you have been advised against sexual activity due to health reasons, inform your doctor before taking this medication for ED.
General Guidance
This list is not exhaustive. It is essential to discuss all your medications (prescription, over-the-counter, natural products, vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor.
To ensure safe and effective treatment, it is crucial to inform your doctor about the following:
Allergies and Sensitivities
If you are allergic to this medication, any of its components, or other substances, including foods or drugs, notify your doctor. Describe the allergic reaction and its symptoms.
Pre-existing Medical Conditions
Inform your doctor if you have:
- Kidney disease or liver disease
- Certain hereditary eye problems, such as retinitis pigmentosa
- Pulmonary veno-occlusive disease (PVOD)
- Unstable angina (a specific type of chest pain)
- A history of heart attack within the last 90 days
- Chest pain during sexual activity
- Heart failure
- Abnormal heartbeat
- High or low blood pressure
- A stroke within the last 6 months
Medication Interactions
Tell your doctor if you use:
- "Poppers" like amyl nitrite and butyl nitrite
- Medications such as isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin. These drugs should not be taken with this medication, and you may need to avoid them for a period after your last dose.
- Any prescription, over-the-counter, or natural products that should not be taken with this medication, including those for high blood pressure, enlarged prostate, HIV, infections, and others. Your doctor or pharmacist can advise on potential interactions.
Concurrent Medications
Inform your doctor if you are taking:
- Another medication containing the same active ingredient
- A different medication for erectile dysfunction (ED) or pulmonary hypertension
Age and Gender Considerations
- This medication is not approved for use in children.
- For erectile dysfunction (ED) or enlarged prostate, this medication is not approved for use in females.
Sexual Activity
If you have been advised against sexual activity due to health reasons, inform your doctor before taking this medication for ED.
General Guidance
This list is not exhaustive. It is essential to discuss all your medications (prescription, over-the-counter, natural products, vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Before consuming alcohol, consult with your doctor to discuss potential interactions. If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor, as this may affect the medication's efficacy or increase the risk of side effects.
Rare but severe side effects, including abnormal heartbeat, heart attack, stroke, and severe hypertension, have been associated with tadalafil. Discuss these risks with your doctor.
Sudden vision loss or decreased eyesight may be a symptom of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). If you experience a sudden decline or loss of vision, seek medical attention immediately, as vision loss may be permanent. Individuals who have previously experienced NAION in one eye are at increased risk.
If you have a history of bleeding disorders, consult with your doctor before taking this medication. Additionally, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Specific Considerations for Erectile Dysfunction (ED)
This medication does not protect against the transmission of diseases like HIV or hepatitis during sexual activity. Always use a latex or polyurethane condom during sex, and consult with your doctor if you have any questions or concerns.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Before consuming alcohol, consult with your doctor to discuss potential interactions. If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor, as this may affect the medication's efficacy or increase the risk of side effects.
Rare but severe side effects, including abnormal heartbeat, heart attack, stroke, and severe hypertension, have been associated with tadalafil. Discuss these risks with your doctor.
Sudden vision loss or decreased eyesight may be a symptom of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). If you experience a sudden decline or loss of vision, seek medical attention immediately, as vision loss may be permanent. Individuals who have previously experienced NAION in one eye are at increased risk.
If you have a history of bleeding disorders, consult with your doctor before taking this medication. Additionally, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Specific Considerations for Erectile Dysfunction (ED)
This medication does not protect against the transmission of diseases like HIV or hepatitis during sexual activity. Always use a latex or polyurethane condom during sex, and consult with your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Headache
- Flushing
- Dizziness
- Dyspepsia (indigestion)
- Nasal congestion
- Visual disturbances (e.g., blurred vision, color tinge to vision)
What to Do:
In case of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance due to high protein binding. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) - risk of severe hypotension
- Riociguat (soluble guanylate cyclase stimulator) - risk of severe hypotension
Major Interactions
- Alpha-blockers (e.g., doxazosin, tamsulosin) - risk of symptomatic hypotension; use with caution, start tadalafil at lowest dose
- Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole, clarithromycin, erythromycin, saquinavir) - significantly increase tadalafil exposure; dose adjustment needed
- Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil) - increased risk of adverse effects, not recommended for co-administration
- Antihypertensives - additive hypotensive effects
Moderate Interactions
- Alcohol - excessive alcohol intake (e.g., 5 units or more) may increase the potential for orthostatic signs and symptoms
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - may decrease tadalafil exposure
- Antacids (magnesium hydroxide/aluminum hydroxide) - may reduce the rate of tadalafil absorption, but not the extent
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Cardiovascular status assessment
Rationale: To determine if the patient is at risk for cardiovascular events due to sexual activity or the hypotensive effects of tadalafil.
Timing: Prior to initiation of therapy
Blood pressure (BP)
Rationale: To establish baseline and identify potential for hypotension, especially if co-administered with alpha-blockers or antihypertensives.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (erectile function, BPH symptoms)
Frequency: Periodically, as needed based on patient response
Target: Improved erectile function, reduced BPH symptoms (e.g., IPSS score)
Action Threshold: Lack of desired effect or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (e.g., headache, flushing, dyspepsia, back pain, myalgia, visual/hearing disturbances, priapism)
Frequency: Regularly, especially during initial therapy and dose adjustments
Target: Absence or mild, tolerable side effects
Action Threshold: Persistent or severe side effects may require dose reduction or discontinuation.
Blood pressure (if on alpha-blockers or antihypertensives)
Frequency: As clinically indicated, especially during initiation or dose changes of either drug
Target: Stable, normotensive BP
Action Threshold: Symptomatic hypotension or significant BP drop requires intervention.
Symptom Monitoring
- Chest pain (seek immediate medical attention)
- Sudden decrease or loss of vision (seek immediate medical attention)
- Sudden decrease or loss of hearing (seek immediate medical attention)
- Erection lasting longer than 4 hours (priapism - seek immediate medical attention)
- Dizziness or lightheadedness (especially when standing)
- Severe headache
- Severe back pain or muscle aches
Special Patient Groups
Pregnancy
Tadalafil is not indicated for use in women. Pregnancy Category B: Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Not applicable; not indicated for use in women.
Second Trimester:
Not applicable; not indicated for use in women.
Third Trimester:
Not applicable; not indicated for use in women.
Lactation
Tadalafil is not indicated for use in women. It is unknown if tadalafil is excreted in human milk. Due to potential for serious adverse reactions in a breastfed infant, use is not recommended.
Infant Risk:
L3 - Moderate risk; potential for unknown effects on infant. Not indicated for use in women.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for ED or BPH. Tadalafil (Adcirca) is approved for pediatric use in pulmonary arterial hypertension (PAH) in specific age groups, but this is a different indication and dosing.
Geriatric Use
No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the hypotensive effects and may have age-related renal or hepatic impairment, which would necessitate dose adjustments as per renal/hepatic impairment guidelines.
Clinical Information
Clinical Pearls
- Known as the 'weekend pill' due to its long duration of action (up to 36 hours), offering more spontaneity compared to other PDE5 inhibitors.
- Can be taken with or without food, as food does not significantly affect its absorption.
- Patients should be counseled on the absolute contraindication with nitrates due to the risk of life-threatening hypotension.
- Educate patients on the signs and symptoms of priapism (erection lasting >4 hours) and the need for immediate medical attention.
- For BPH, daily low-dose tadalafil can improve urinary symptoms and also treat co-existing ED.
- Caution with alpha-blockers; ensure patient is stable on alpha-blocker therapy before initiating tadalafil, and start tadalafil at the lowest dose.
Alternative Therapies
- Other PDE5 inhibitors (e.g., Sildenafil, Vardenafil, Avanafil)
- Alprostadil (intracavernosal injection or urethral suppository)
- Vacuum erection devices
- Penile implants (surgical)
- Lifestyle modifications (e.g., diet, exercise, smoking cessation, weight loss)
- For BPH: Alpha-blockers (e.g., tamsulosin, alfuzosin), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), combination therapy, surgical options (e.g., TURP)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per tablet for brand, significantly less for generic per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or Tier 3 for brand, Tier 1 for generic. Coverage may vary based on indication (ED vs. BPH).
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.