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Tadalafil Tablets
Dosage
Packaging
What is Tadalafil?
Active Ingredients: Tadalafil
Tadalafil Tablets are used to treat erectile dysfunction (impotence) and benign prostatic hypertrophy (enlarged prostate) in men. It helps reduce BPH symptoms like painful or difficult urination, urgency, and urinary frequency. It should be noted that Tadalafil does not cure erectile dysfunction or increase sexual desire.
Certain formulations of Tadalafil are used to improve exercise capacity and treat pulmonary arterial hypertension (PAH) in both men and women.
Tadalafil is classified as a phosphodiesterase (PDE) inhibitor. It works by increasing blood flow to the penis and relaxing the blood vessels in the lungs.
Tadalafil Tablets are produced in a range of doses, including 2.5mg, 5mg, 10mg, and 20mg. The tablets come packed on blisters and are available in a box of 4 tablets or 30 tablets.
AdvaCare Pharma's Tadalafil Tablets are manufactured in GMP-certified facilities located in China, India, and the USA. We routinely inspect our production facilities to ensure our products meet health, safety, and environmental standards.
Why choose us as your Tadalafil manufacturer?
AdvaCare Pharma is a trusted Tadalafil manufacturer committed to providing quality-assured, cost-effective pharmaceuticals for an ever-changing global market. Manufacturing a wide range of 200+ pharmaceutical products in tablet form, we ensure that all of our oral solid dosage forms adhere to stringent GMP standards.
We operate according to a unique "vested supplier-distributor relationship" business model, in which we tie our success in a market to that of our distributor. Such a model facilitates a closer relationship by working together to achieve pre-defined goals for market entry and expansion. As a Tadalafil manufacturer and global supplier, we implement unique strategies to ensure successful distribution.
Uses
What is Tadalafil used for?
It is used to treat erectile dysfunction and symptoms associated with benign prostatic hypertrophy. It is also used to improve exercise ability in the treatment of pulmonary arterial hypertension.
How are Tadalafil Tablets used?
This medication is intended to be taken orally. The tablets can be taken with or without food. When taken as a daily medicine, the tablets should be taken at the same time every day.
What dose should be taken?
Recommended dosage may vary based on different medical condition. Refer to a doctor or pharmacist for more specific guidelines on dosage. Do not exceed what they advise.
Adult Dosing Recommended dosage may vary based on different medical conditions:
- For erectile dysfunction (as needed), the usual dose is 2-30mg, taken once. The starting dose is typically 10mg and may be increased to 20mg/dose. It should be taken before sexual activity. Effects may last up to 36 hours. A daily dosing schedule may be considered for patients using Tadalafil at least 2 times per week.
- For erectile dysfunction (daily dosing), the usual dose is 2.5-5mg, taken once per day. The dose should be taken without regard for upcoming sexual activity.
- For benign prostatic hypertrophy, the usual dose is 5mg, taken at the same time once per day.
- For men with both BPH and ED, the usual dose is 5mg, taken at the same time once per day. The dose should be taken without regard for upcoming sexual activity.
- For pulmonary arterial hypertension, the usual dose is 40mg, taken once per day.
Renal Dosing For erectile dysfunction (as needed), dosage adjustment recommendations are as follows:
- CrCl 30-50ml/min: A starting dose of 5mg is recommended. The maximum dosage is a single dose of 5mg taken every 24 hours and up to 10mg every 48 hours.
- CrCl <30ml/min: The maximum dosage is 5mg in 72 hours
- HD: The maximum dosage is 5mg in 72 hours. No supplement is needed after dialysis.
- PD: Guidelines have not been defined.
For erectile dysfunction (daily dosing), dosage adjustment recommendations are as follows:
- CrCl <30ml/min: Avoid the use of this drug.
- HD: This drug is not recommended.
- PD: Guidelines have not been defined.
For BPH, dosage adjustment guidelines are as follows:
- CrCl 30-50ml/min: A starting dose of 2.5mg per day.
- CrCl <30ml/min: Avoid the use of this drug.
- HD: This drug is not recommended.
- PD: Guidelines have not been defined.
For pulmonary arterial HTN, dosing guidelines are as follows:
- CrCl 31-80ml/min: A starting dose of 20mg per day is recommended.
- CrCl <31ml/min: This drug is not recommended.
- HD: This drug is not recommended.
- PD: Guidelines have not been defined.
Hepatic Dosing For erectile dysfunction (as needed):
- Child-Pugh Class A or B: The maximum dosage is 10mg in 24 hours.
- Child-Pugh Class C: Avoid the use of this drug.
For erectile dysfunction (daily dosing) or BPH:
- Child-Pugh Class A or B: Guidelines have not been defined. It is advised to use caution when using Tadalafil.
- Child-Pugh Class C: Avoid the use of this drug.
For pulmonary arterial HTN:
- Child-Pugh Class A or B: It is recommended to consider a starting dose of 20mg taken once per day.
- Child-Pugh Class C: Avoid the use of this drug.
Pediatric Dosing Dosing is not applicable for this drug.
Who can use Tadalafil?
Tadalafil Tablets can be given to adults and children, but caution is advised for specific groups of patients.
Pregnant This drug should be used when the benefits outweigh the risks during pregnancy. Limited human data and animal data at up to 7x the maximum recommended human dose have not indicated the risk of fetal harm.
Breastfeeding The benefits should be weighed against the risks before using Tadalafil when breastfeeding. Based on the properties of the drug, there is possible drug excretion into milk.
Children The safety and efficacy of Tadalafil have not been established for this population.
Geriatric Studies have not indicated age-specific problems within geriatric patients. It is advised to start at the lowest dose, as elderly patients are more likely to have other medical problems.
How should Tadalafil Tablets be stored?
The tablets should be kept in their blisters until use. It is recommended to store the medication at room temperature (15-30°) in a place that is protected from moisture.
Other warnings
For patients with ED or BPH, it is advised to evaluate any underlying causes for the condition before starting treatment with Tadalafil.
For patients with retinitis pigmentosa, this drug may cause color discrimination impairment. The severity is dose-related.
If the patient experiences vision problems, therapy should be discontinued. non-arteritic anterior ischemic optic neuropathy (NAION) has been associated with the drug when being used to treat ED.
This drug is not recommended for patients with pulmonary veno-occlusive disease.
Tadalafil should be used cautiously when treating patients with cardiovascular disease, left ventricular outflow obstruction, heart attack within the last 90 days, unstable angina, angina that occurs during sexual activity, recent NYHA class 2 or greater heart failure, or uncontrolled arrhythmia.
It should also be used cautiously for patients with current peptic ulcer, liver disease, renal impairment, hypotension, uncontrolled hypertension, recent cerebrovascular accident, or bleeding disorders.
Use cautiously in patients with anatomic deformation of the penis or those with conditions predisposing to priapism.
Potentially fatal outcomes may occur due to the increased hypotensive effects when this drug is used with any form of organic nitrate or a guanylate cyclase stimulator such as riociguat.
Side Effects
As with all pharmaceuticals, some unwanted effects can occur from the use of Tadalafil Tablets.
Common side effects include, but may not be limited to:
- headache
- flushing or warmth
- nausea
- upset stomach
- stuffy nose
- muscle pain
Stop using this medication and call a doctor if the following symptoms develop:
- any symptom of a heart attack
- changes in vision
- sudden vision loss
- ringing in the ears
- sudden hearing loss
- painful erection
- erection lasting longer than 4 hours
Seek emergency medical care for the following symptoms:
- signs of an allergic reaction
- nausea, chest pain, or dizziness during sex
For a comprehensive understanding of all potential side effects, consult a medical professional.
If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.
Precautions
Do NOT use Tadalafil Tablets if:
- You are allergic or hypersensitive to any of the ingredients.
- You are currently being treated with certain medications (e.g. riociguat) for pulmonary arterial hypertension.
- You have used a nitrate drug within the past 48 hours.
- You are planning to take a nitrate drug in the next week.
It is recommended to inform your doctor of any medications, supplements, or herbal products you are taking before beginning treatment. Many drugs are known to interact with Tadalafil, including sildenafil, avanafil, hypertension medicine, antibiotics (e.g. clarithromycin, erythromycin, rifampin, or telithromycin), antifungals (e.g. ketoconazole, itraconazole), HIV/AIDs medications (e.g. ritonavir), and certain anti-seizure drugs (e.g. carbamazepine, phenytoin). This is not a complete list of possible interactions.
Tadalafil may stay in the bloodstream for more than 2 days. Do not use a nitrate drug. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate but also recreational drugs containing amyl nitrate, butyl nitrate, or nitrite.
Special considerations may be necessary for people with certain medical conditions, including:
- heart problems
- recent heart attack or stroke
- liver or kidney disease
- hypotension or hypertension
- blood cell disorder, such as sickle cell anemia, leukemia, or multiple myeloma
- pulmonary veno-occlusive disease (PVOD)
- physical deformity of the penis, such as Peyronie's disease
- history of erections lasting longer than 4 hours
- blood circulation issues
- hearing problems
- blindness in one or two eyes
- retinitis pigmentosa
- pregnancy or breastfeeding
Grapefruit is known to interact with this drug. It is advised to avoid grapefruit products while taking this medication.
It is recommended to avoid drinking alcohol while being treated with Tadalafil. Alcohol may increase the risk of dizziness or fainting.
References
Efficacy and Safety of Tadalafil for the Treatment of Erectile Dysfunction: Results of Integrated Analyses
This is a comprehensive analysis to evaluate the efficacy and safety of tadalafil for the treatment of erectile dysfunction.
This study included a total of 1,112 men, with an average age of 59 years (range 22 to 82). All the patients experienced mild to severe erectile dysfunction from various causes and were randomly assigned to receive either a placebo or tadalafil.
Tadalafil was administered as needed, without restrictions on food or alcohol intake, at daily doses of 2.5mg, 5mg, 10mg, or 20mg, in five randomized, double-blind, placebo-controlled trials lasting 12 weeks.
Tadalafil led to improvements in all efficacy measures compared to placebo. Patients receiving 20mg of tadalafil experienced a substantial mean improvement of 7.9 in the International Index of Erectile Function erectile function domain score from baseline (p < 0.001 versus placebo). At the end of the study, 81% of patients reported improved erections compared to 35% in the placebo group (p < 0.001).
The findings indicate that this drug is effective and well-tolerated in patients with erectile dysfunction.
Why AdvaCare Pharma?
As an industry leader, we are aware of our responsibility to provide affordable and sustainable solutions to improve healthcare worldwide.