Find the prescribing information for Tadalafil in a convenient PDF format. Learn about the dosage, side effects, and precautions of Tadalafil to make informed decisions about its use.

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Tadalafil Prescribing Information PDF

Tadalafil is a medication used to treat erectile dysfunction (ED) and symptoms of benign prostatic hyperplasia (BPH). It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. This prescribing information PDF provides important details about the dosage, side effects, and contraindications of tadalafil.

Dosage

The recommended starting dose of tadalafil for the treatment of ED is 10 mg, taken prior to sexual activity.
For the treatment of BPH, the recommended dose of tadalafil is 5 mg, taken once a day.
Tadalafil can be taken with or without food.
The dosage may be adjusted based on individual response and tolerability.

Side Effects

Tadalafil may cause certain side effects, which can vary in severity. Common side effects include:

Headache
Flushing
Back pain
Indigestion
Muscle aches

These side effects are usually mild and temporary. However, if they persist or worsen, it is important to consult a healthcare professional.

Contraindications

Tadalafil is contraindicated in certain situations, and caution should be exercised in others. It should not be taken if:

The patient is allergic to tadalafil or any of its ingredients.
The patient is taking nitrates, such as nitroglycerin, for chest pain.
The patient has a history of heart problems or stroke.
The patient is currently taking medications that interact with tadalafil.

It is important to inform a healthcare professional about all current medications and medical conditions before starting tadalafil.

Conclusion

The prescribing information PDF for tadalafil provides important details about its dosage, side effects, and contraindications. It is essential to follow the recommended dosage and consult a healthcare professional for any concerns or questions. Tadalafil can be an effective treatment for ED and BPH when used appropriately.

Dosage Recommendations for Tadalafil

1. Erectile Dysfunction

Tadalafil is primarily prescribed for the treatment of erectile dysfunction (ED). The recommended starting dose for most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg based on individual response and tolerability.

It is important to note that tadalafil should not be taken more than once per day. The maximum recommended dosing frequency is once daily.

2. Benign Prostatic Hyperplasia

Tadalafil is also approved for the treatment of benign prostatic hyperplasia (BPH) with or without coexisting ED. The recommended dose for BPH is 5 mg once daily, taken at approximately the same time every day.

In patients with both BPH and ED, the recommended dose is 5 mg once daily, taken at approximately the same time every day.

3. Pulmonary Arterial Hypertension

Tadalafil is approved for the treatment of pulmonary arterial hypertension (PAH) in adults. The recommended dose for PAH is 40 mg once daily. However, the dose may be decreased to 20 mg or increased to 60 mg based on individual response and tolerability.

4. Renal Impairment

In patients with mild to moderate renal impairment (creatinine clearance 30-80 mL/min), the recommended starting dose of tadalafil is 5 mg once daily. In patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease requiring dialysis, the use of tadalafil is not recommended.

5. Hepatic Impairment

In patients with mild to moderate hepatic impairment (Child-Pugh class A or B), the recommended starting dose of tadalafil is 10 mg once daily. In patients with severe hepatic impairment (Child-Pugh class C), the use of tadalafil is not recommended.

It is important to follow the dosage recommendations provided by your healthcare provider and not exceed the recommended dose. Taking more than the prescribed dose of tadalafil may increase the risk of side effects.

Possible Side Effects of Tadalafil

Tadalafil, like any medication, can cause side effects in some individuals. It is important to be aware of these potential side effects before taking the medication. Common side effects of tadalafil include:

Headache
Upset stomach
Back pain
Muscle aches
Flushing (redness or warmth in the face, neck, or chest)
Stuffy or runny nose
Indigestion

These side effects are usually mild and go away on their own within a few hours or days. However, if they persist or become bothersome, it is recommended to consult a healthcare professional.

In rare cases, tadalafil can cause more serious side effects. If any of the following side effects occur, it is important to seek immediate medical attention:

Severe allergic reactions, including rash, itching, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat
Chest pain or an irregular heartbeat
Vision changes or sudden loss of vision
Hearing loss or ringing in the ears
Prolonged or painful erection (priapism)

It is important to note that this is not an exhaustive list of side effects. If you experience any other unusual or bothersome side effects while taking tadalafil, it is recommended to contact a healthcare professional.

Contraindications for Tadalafil Use

Tadalafil is a medication used to treat erectile dysfunction and symptoms of benign prostatic hyperplasia. However, there are certain contraindications that should be considered before using this medication. It is important to consult with a healthcare professional to determine if tadalafil is safe for you.

1. Nitrate Medications

Tadalafil should not be taken with any form of nitrate medication, such as nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate. The combination of tadalafil and nitrates can cause a sudden and significant drop in blood pressure, which can be dangerous.

2. Riociguat

Tadalafil should not be taken with riociguat, a medication used to treat pulmonary arterial hypertension. The combination of tadalafil and riociguat can also cause a sudden drop in blood pressure.

3. Allergies

If you are allergic to tadalafil or any of its ingredients, you should not take this medication. Allergic reactions can range from mild skin rashes to severe difficulty breathing and require immediate medical attention.

4. Cardiovascular Conditions

Tadalafil can increase the risk of cardiovascular events, such as heart attack or stroke, especially in individuals with pre-existing cardiovascular conditions. It is important to discuss your medical history with a healthcare professional before starting tadalafil.

5. Liver or Kidney Disease

Tadalafil is primarily metabolized by the liver and excreted by the kidneys. Individuals with severe liver or kidney disease may have difficulty metabolizing and eliminating tadalafil, which can lead to an increased risk of side effects. Dosage adjustments may be necessary in these cases.

6. Eye Problems

Tadalafil can cause a sudden decrease or loss of vision in some individuals. This is more likely to occur in individuals with pre-existing eye problems or risk factors for eye disorders. If you experience any changes in vision while taking tadalafil, seek immediate medical attention.

7. Priapism

Tadalafil can cause a prolonged and painful erection, known as priapism, which can damage the penis. Individuals with a history of priapism or conditions that may predispose them to priapism, such as sickle cell anemia or leukemia, should use tadalafil with caution.

8. Other Medications

Tadalafil may interact with other medications, including alpha-blockers, antihypertensives, certain antibiotics, antifungals, and HIV protease inhibitors. It is important to inform your healthcare professional about all the medications you are taking to avoid potential interactions.

It is crucial to note that this list of contraindications is not exhaustive. Always consult with a healthcare professional before starting or stopping any medication, including tadalafil.

Important Safety Information for Tadalafil

1. Usage Precautions

Tadalafil should not be taken by individuals who are allergic to it or any of its ingredients.
Patients with a history of heart problems, including heart attack or stroke, should consult their healthcare provider before using tadalafil.
Tadalafil is not recommended for individuals with severe liver or kidney disease.
Patients with a history of priapism (painful and prolonged erection) should use tadalafil with caution.
Tadalafil should not be used by individuals taking nitrates or alpha-blockers, as it can cause a sudden drop in blood pressure.
Patients with certain eye conditions, such as retinitis pigmentosa, should use tadalafil with caution.

2. Dosage and Administration

Tadalafil is available in different strengths, and the dosage should be determined by a healthcare provider.
The recommended starting dose for most patients is 10 mg, taken prior to anticipated sexual activity.
Tadalafil can be taken with or without food, but it should not be taken more than once per day.
If a patient experiences an erection lasting longer than 4 hours, they should seek immediate medical attention.

3. Side Effects

The most common side effects of tadalafil include headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose.
Less common side effects may include dizziness, blurred vision, changes in color vision, and ringing in the ears.
If any side effects persist or worsen, patients should contact their healthcare provider.

4. Contraindications

Tadalafil is contraindicated in individuals who are currently taking nitrates or alpha-blockers.
Patients with a history of allergic reactions to tadalafil or any of its ingredients should not use this medication.
Individuals with severe liver or kidney disease should not use tadalafil.
Tadalafil is not recommended for women or children under the age of 18.

5. Drug Interactions

Tadalafil may interact with certain medications, such as alpha-blockers, nitrates, and antihypertensive drugs.
Patients should inform their healthcare provider about all the medications they are taking before starting tadalafil.
It is important to avoid grapefruit or grapefruit juice while taking tadalafil, as it may increase the risk of side effects.

6. Storage and Handling

Tadalafil should be stored at room temperature, away from moisture and heat.
Keep tadalafil out of reach of children and pets.
Do not use tadalafil after the expiration date printed on the packaging.

How to Take Tadalafil

Tadalafil is a medication used to treat erectile dysfunction (ED) and symptoms of benign prostatic hyperplasia (BPH). It is available in tablet form and should be taken orally, swallowed whole with a glass of water. The dosage and frequency of taking tadalafil may vary depending on the individual’s condition and response to the medication. It is important to follow the instructions provided by your healthcare provider or the prescribing information.

General Guidelines:

Take tadalafil as prescribed by your healthcare provider.
Do not take more than the recommended dosage.
Do not take tadalafil more than once a day.
Take tadalafil at least 30 minutes before sexual activity for the treatment of ED.
For the treatment of BPH, take tadalafil once daily, with or without food.

Important Considerations:

Inform your healthcare provider about any other medications you are taking, as they may interact with tadalafil.
Avoid consuming excessive amounts of alcohol while taking tadalafil, as it may increase the risk of side effects.
If you miss a dose of tadalafil, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take tadalafil if you are allergic to it or any of its ingredients.

Possible Side Effects:

Common side effects of tadalafil may include headache, indigestion, back pain, muscle aches, flushing, stuffy or runny nose, and dizziness. These side effects are usually mild and temporary. However, if you experience any severe or persistent side effects, contact your healthcare provider.

Conclusion:

Tadalafil is an effective medication for the treatment of erectile dysfunction and symptoms of benign prostatic hyperplasia. It should be taken as prescribed by your healthcare provider, and it is important to follow the instructions and guidelines provided. If you have any concerns or questions about taking tadalafil, consult with your healthcare provider.

Drug Interactions with Tadalafil

Tadalafil, the active ingredient in Cialis, can interact with certain medications and substances. It is important to be aware of these interactions to avoid any potential adverse effects or reduced effectiveness of tadalafil.

1. Nitrates

Tadalafil should not be taken in combination with nitrates, as it can cause a sudden and significant drop in blood pressure. Nitrates are commonly used to treat angina (chest pain) and include medications such as nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate.

2. Alpha-blockers

Tadalafil can also interact with alpha-blockers, which are medications used to treat high blood pressure and prostate problems. When taken together, tadalafil and alpha-blockers can cause a significant decrease in blood pressure. Examples of alpha-blockers include doxazosin, tamsulosin, and terazosin.

3. Antihypertensive medications

Tadalafil can enhance the hypotensive effects of antihypertensive medications, leading to a further decrease in blood pressure. It is important to monitor blood pressure closely when tadalafil is used in combination with antihypertensive drugs.

4. CYP3A4 inhibitors

Tadalafil is primarily metabolized by the enzyme CYP3A4 in the liver. Therefore, drugs that inhibit this enzyme can increase the levels of tadalafil in the body, potentially leading to an increased risk of side effects. Common CYP3A4 inhibitors include ketoconazole, ritonavir, clarithromycin, and grapefruit juice.

5. Other erectile dysfunction medications

Tadalafil should not be taken in combination with other medications used to treat erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra). Combining these medications can increase the risk of side effects and may lead to a prolonged erection (priapism) that requires medical attention.

6. Alcohol

Consuming alcohol while taking tadalafil can increase the risk of experiencing side effects, such as dizziness, lightheadedness, and low blood pressure. It is advisable to limit alcohol consumption while using tadalafil.

7. Other medications

Tadalafil may interact with other medications not listed above. It is important to inform your healthcare provider about all the medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal supplements.

Always consult with your healthcare provider or pharmacist about potential drug interactions before starting tadalafil or any other medication.

Warnings and Precautions for Tadalafil Use

Tadalafil is a medication used to treat erectile dysfunction (ED) and symptoms of benign prostatic hyperplasia (BPH). While it is generally safe and effective, there are certain warnings and precautions that should be considered before using tadalafil.

1. Cardiovascular Conditions

Tadalafil should not be used in patients with a history of cardiovascular disease, including heart attack or stroke, within the past 6 months.
Patients with unstable angina or angina occurring during sexual intercourse should not use tadalafil.
It is important to consult a healthcare provider before using tadalafil if you have any underlying cardiovascular conditions.

2. Hypotension

Tadalafil can cause a decrease in blood pressure, especially when taken with other medications that lower blood pressure.
Patients with hypotension (low blood pressure) should use tadalafil with caution.
It is important to inform your healthcare provider about all medications you are taking, especially those for high blood pressure, before starting tadalafil.

3. Priapism

Priapism, a prolonged and painful erection lasting more than 4 hours, has been reported with the use of tadalafil.
If you experience an erection that lasts longer than 4 hours, seek immediate medical attention to avoid permanent damage to the penis.

4. Vision Loss

Rare cases of sudden vision loss have been reported in patients taking tadalafil.
If you experience sudden vision loss in one or both eyes, stop using tadalafil and seek immediate medical attention.

5. Allergic Reactions

Some individuals may be allergic to tadalafil or its ingredients.
If you experience signs of an allergic reaction, such as rash, itching, swelling, or difficulty breathing, stop using tadalafil and seek immediate medical attention.

6. Other Precautions

Tadalafil should not be used in combination with nitrates, as it can cause a sudden drop in blood pressure.
Patients with liver or kidney disease should use tadalafil with caution, as it may take longer to be eliminated from the body.
It is important to disclose your medical history and any medications you are taking to your healthcare provider before starting tadalafil.

It is crucial to follow the prescribed dosage and instructions provided by your healthcare provider when using tadalafil. If you have any concerns or questions about the use of tadalafil, consult your healthcare provider for further guidance.

Storage and Handling of Tadalafil

Tadalafil should be stored in a cool, dry place at a temperature between 15°C and 30°C (59°F and 86°F). It should be kept away from moisture, heat, and direct sunlight to ensure its stability and effectiveness.

It is important to keep tadalafil out of reach of children and pets to prevent accidental ingestion. The medication should be stored in its original packaging, with the container tightly closed to protect it from air and moisture.

If the medication has expired or is no longer needed, it should be properly disposed of according to local regulations. Do not flush tadalafil down the toilet or pour it into a drain unless instructed to do so.

If you have any questions or concerns about the storage or handling of tadalafil, it is best to consult with a healthcare professional or pharmacist for guidance.

Additional Information for Healthcare Professionals

Dosage and Administration

The recommended starting dose of tadalafil for the treatment of erectile dysfunction is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg based on individual efficacy and tolerability. Tadalafil should not be taken more than once per day.

Contraindications

Tadalafil is contraindicated in patients with a known hypersensitivity to tadalafil or any component of the formulation.
Tadalafil should not be used in patients who are taking any form of organic nitrate, either regularly or intermittently, due to the potential for significant hypotension.
Tadalafil is contraindicated in patients who are taking guanylate cyclase stimulators, such as riociguat, as this may lead to hypotension.

Warnings and Precautions

Tadalafil should be used with caution in patients with a history of priapism or conditions that may predispose them to priapism, such as sickle cell anemia, multiple myeloma, or leukemia.
Patients should be advised to seek immediate medical attention in the event of sudden vision loss, as this may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
Tadalafil should be used with caution in patients with a history of cardiovascular disease, including myocardial infarction, unstable angina, or stroke, as it may increase the risk of cardiovascular events.

Adverse Reactions

The most common adverse reactions associated with tadalafil include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and limb pain. These adverse reactions are generally mild to moderate in severity and of short duration.

Drug Interactions

Tadalafil may interact with certain medications and should be used with caution in patients taking alpha blockers, antihypertensives, potent CYP3A4 inhibitors, and moderate CYP3A4 inhibitors. Co-administration of tadalafil with nitrates or guanylate cyclase stimulators is contraindicated.

Use in Specific Populations

Tadalafil should be used with caution in patients with hepatic impairment, as exposure to tadalafil may be increased. The use of tadalafil in patients with severe renal impairment or end-stage renal disease is not recommended.

Overdosage

In the case of an overdose, standard supportive measures should be taken as required. Hemodialysis contributes negligibly to tadalafil elimination.

How Supplied

Product
Strength
Presentation

Tadalafil Tablets	5 mg	Blister packs of 30 tablets
Tadalafil Tablets	10 mg	Blister packs of 30 tablets
Tadalafil Tablets	20 mg	Blister packs of 30 tablets

Storage and Handling

Tadalafil tablets should be stored at controlled room temperature (20°C to 25°C, 68°F to 77°F) in a dry place. Protect from moisture.

Important Instructions for Tadalafil Use

Before starting tadalafil treatment, it is important to carefully read and understand the following instructions:

Prescription Only: Tadalafil is a prescription medication and should only be used under the supervision of a healthcare professional.
Dosage: Take tadalafil exactly as prescribed by your doctor. Do not take more or less than the recommended dose. Follow the instructions on the prescription label.
Timing: Tadalafil is usually taken before sexual activity. Take it at least 30 minutes before engaging in sexual intercourse. The effects of tadalafil can last up to 36 hours, so it is not necessary to take it more than once a day.
Food and Alcohol: Tadalafil can be taken with or without food. However, consuming excessive amounts of alcohol may decrease the effectiveness of tadalafil and increase the risk of side effects.
Medical Conditions: Inform your doctor about any medical conditions you have, especially if you have a history of heart problems, high or low blood pressure, liver or kidney disease, or any other serious health condition.
Contraindications: Tadalafil should not be used if you are taking nitrates or nitric oxide donors, as it can cause a sudden drop in blood pressure. It is also contraindicated in patients with a known hypersensitivity to tadalafil or any of its ingredients.
Side Effects: Tadalafil may cause side effects such as headache, dizziness, flushing, indigestion, back pain, and muscle aches. If these side effects persist or worsen, seek medical attention.
Interactions: Tadalafil may interact with certain medications, including alpha-blockers, antihypertensives, and HIV protease inhibitors. Inform your doctor about all the medications you are currently taking.
Storage: Store tadalafil at room temperature away from moisture and heat. Keep it out of reach of children.

Remember to follow these instructions and consult your doctor if you have any questions or concerns about using tadalafil.

Tadalafil Patient Counseling Information

1. What is Tadalafil?

Tadalafil is a medication used to treat erectile dysfunction (ED) and symptoms of benign prostatic hyperplasia (BPH). It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. Tadalafil works by increasing blood flow to the penis, allowing for a firm and long-lasting erection.

2. How to take Tadalafil?

Tadalafil is available in tablet form and should be taken orally with or without food. The recommended starting dose for most patients is 10 mg, taken prior to anticipated sexual activity. The maximum recommended dose is 20 mg. It is important to follow the instructions provided by your healthcare provider and not exceed the recommended dosage.

3. Possible Side Effects

Common side effects of Tadalafil may include headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects are usually mild and temporary. However, if you experience any severe or persistent side effects, such as sudden vision loss or hearing impairment, you should seek immediate medical attention.

4. Precautions and Contraindications

Tadalafil should not be taken by individuals who are allergic to tadalafil or any of its ingredients. It is also contraindicated in patients taking nitrates or alpha-blockers, as it may cause a sudden drop in blood pressure. Tadalafil should not be used by women or children.

5. Important Information

Tadalafil does not protect against sexually transmitted diseases (STDs), including HIV.
Tadalafil should not be used in combination with other medications for erectile dysfunction.
It is important to disclose your medical history and any current medications to your healthcare provider before starting Tadalafil.
Alcohol consumption should be limited while taking Tadalafil, as it may increase the risk of side effects.
If you experience a prolonged erection lasting more than 4 hours (priapism), you should seek immediate medical attention to prevent permanent damage to the penis.

6. Conclusion

Tadalafil is an effective medication for the treatment of erectile dysfunction and symptoms of benign prostatic hyperplasia. It is important to follow the prescribed dosage and instructions provided by your healthcare provider. If you have any questions or concerns about Tadalafil, consult with your healthcare provider for further guidance.

Important Considerations Before Starting Tadalafil Treatment

Before beginning treatment with tadalafil, it is important to consider certain factors to ensure safe and effective use of the medication. These considerations include:

Medical History: Inform your healthcare provider about any existing medical conditions or history of diseases, especially if you have or have had heart problems, low blood pressure, liver or kidney disease, a blood cell disorder, stomach ulcers, or vision loss.
Medication Interactions: Tadalafil may interact with certain medications and cause adverse effects. It is crucial to inform your doctor about all the medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal supplements.
Allergies: If you have any known allergies to tadalafil or any of its ingredients, it is important to let your healthcare provider know before starting treatment.
Cardiovascular Health: Tadalafil can cause a sudden decrease in blood pressure. Therefore, it is essential to evaluate your cardiovascular health before starting treatment. Your doctor may perform a thorough examination and recommend appropriate precautions.
Sexual Activity: Tadalafil is primarily used to treat erectile dysfunction. It is important to understand that sexual activity may exert strain on your heart. If you have any heart-related concerns, it is crucial to discuss them with your doctor before initiating treatment.
Pregnancy and Breastfeeding: Tadalafil is not intended for use in women and should not be used during pregnancy or while breastfeeding.

It is important to have an open and honest conversation with your healthcare provider about your medical history, current medications, and any concerns or questions you may have before starting treatment with tadalafil. This will help ensure that the medication is safe and appropriate for you.

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Tadalafil Prescribing Information PDF

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