Sildenafil Citrate Tablets (box of 100 tablets)
Sildenafil Citrate Tablets (blister of 10 tablets)
Sildenafil Citrate Tablets (bottle of 1000 tablets)
Sildenafil Citrate Tablets (box of 100 tablets)
Sildenafil Citrate Tablets (blister of 10 tablets)
Sildenafil Citrate Tablets (bottle of 1000 tablets)
*Packaging color may differ according to distribution region.

Sildenafil Citrate Tablets

ElevātCare™
Sildenafil Citrate Tablets are indicated for erectile dysfunction. AdvaCare Pharma manufactures this drug in its ISO/GMP-compliant facilities which undergo routine inspections to ensure the highest quality and safety standards are met.

Dosage

Packaging

What is Sildenafil Citrate?

Therapeutic Class:

Active Ingredients: Sildenafil Citrate

Sildenafil Citrate Tablets are a drug used in the treatment of sexual function problems (erectile dysfunction, impotence) in males. This medication is not a cure for erectile dysfunction. Sildenafil Citrate is also used to improve exercise capacity in patients with pulmonary arterial hypertension.

Sildenafil is classified as a phosphodiesterase inhibitor. The active ingredient works by preventing the enzyme phosphodiesterase type-5 from working. This relaxes the muscles and blood vessels and allows the flow of blood to increase to the penis during sexual stimulation.

Sildenafil Citrate Tablets are produced with a dosage of 50mg or 100mg. This drug is available in 3 packaging options: a box containing a blister of 4 tablets, a box containing 100 tablets, or a bottle of 1000 tablets.

AdvaCare Pharma is a global distributor and manufacturer of Sildenafil Citrate Tablets. This medicine is produced in our GMP-certified facilities in China, India, and the USA. Our factories are routinely inspected to ensure they meet the high standards necessary to comply with WHO guidelines and standards.

Why choose us as your Sildenafil manufacturer?

AdvaCare Pharma is a trusted Sildenafil 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 Sildenafil manufacturer and global supplier, we implement unique strategies to ensure successful distribution.

Uses

What is Sildenafil Citrate used for?

It is used to treat erectile dysfunction in men. Sildenafil Citrate is also used to improve exercise ability and slow down the progression of pulmonary arterial hypertension in children and adults.

How are Sildenafil Citrate Tablets used?

This medication is intended to be taken orally. It can be taken with or without food, but a high-fat meal may delay the drug's activity.

What dose should be taken?

Adult Dosing For erectile dysfunction, the usual dose is 25-100mg taken 30 minutes to 4 hours before sexual activity. The starting dose should be 50mg. It is recommended to consider a starting dose of 25mg in patients over 65 years old. The maximum dose is 100mg per dose for up to 1 dose per day.

For pulmonary arterial hypertension, the usual dose is 20mg taken 3 times per day. The maximum dose is 240mg per day. Doses should be taken 4-6 hours apart.

Geriatric Dosing For erectile dysfunction in patients 65 years or older, the usual starting dose is 25mg 30 minutes to 4 hours before sexual activity. The dose can be increased based on tolerance and effectiveness. The maximum dosage is 100mg per day.

For pulmonary arterial hypertension, the usual dose is 20mg taken 3 times per day. The dose can be increased up to 80mg taken 3 times per day.

Renal Dosing For erectile dysfunction, a starting dose of 25mg should be considered for patients with severe renal impairment (CrCl < 30). Dosing adjustment guidelines have not been defined for patients with HD/PD.

For pulmonary arterial hypertension, no adjustment is needed for patients with renal impairment. Dosing adjustment guidelines have not been defined for patients with HD/PD.

Hepatic Dosing For erectile dysfunction, a starting dose of 25mg should be considered for patients with hepatic impairment or cirrhosis.

For pulmonary arterial hypertension, no adjustment is needed for patients with Child-Pugh Class A or B. Dosing adjustment guidelines have not been defined for patients with Child-Pugh Class C.

Pediatric Dosing For pulmonary arterial hypertension, doses for pediatric patients from 1 to 17 years old are based on body weight. The usual doses are as follows:

  • body weight < 20kg: 10mg taken 3 times per day. Doses should be taken 4-6 hours apart.
  • body weight 20-45kg: 20mg taken 3 times per day. Doses should be taken 4-6 hours apart.
  • body weight > 45kg: 20mg taken 3 times per day. Doses should be taken 4-6 hours apart. The maximum dosage is 120mg per day.

Renal Dosing for pediatrics No adjustment is needed for children with renal impairment. Dosing adjustment guidelines have not been defined for pediatric patients with HD/PD.

Hepatic Dosing for pediatrics No adjustment is needed for children with Child-Pugh Class A or B. Dosing adjustment guidelines have been defined for pediatric patients with Child-Pugh Class C.

The dosage is based on medical condition, response to treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed what they advise.

What should happen if a dose is missed?

When taken for erectile dysfunction, this drug is used as needed so it is unlikely to be forgotten.

When taken for pulmonary arterial hypertension, the forgotten dose should be taken as soon as it is remembered. If it is nearly time for the next scheduled dose, then the missed dose should be skipped. Never take 2 doses at the same time.

Who can use Sildenafil Citrate Tablets?

Sildenafil Citrate Tablets can be given to adults and children, but caution is advised for specific groups of patients.

Pregnant It is not known whether Sildenafil causes fetal harm. It is important to note that pulmonary hypertension increases the risk of complications during pregnancy, including heart failure or stroke, for both the mother and fetus. Sildenafil should be used if the benefits outweigh the risks under medical discretion.

Breastfeeding This drug should be used if the benefits outweigh the risks. Though harm is not expected based on the drug properties, inadequate human data is available to evaluate the risk of infant harm. There is no human data available that addresses this drug’s effects on milk production.

Children It is advised to avoid high-dose therapy with Sildenafil in pediatric patients, as there is a greater risk of mortality.

Geriatric When used to treat erectile dysfunction, Sildenafil is typically well tolerated by healthy elderly male patients. Studies have not shown significant differences in response but have reported that healthy elderly patients show a reduced clearance of the drug that could increase the risk of adverse effects. As this population is more likely to have medical conditions, it is advised to use a lower starting dose.

How should Sildenafil Citrate Tablets be stored?

This medication should be stored at room temperature between 15-30°C. Keep the tablets out of the reach of children and pets.

Other warnings

For patients taking CYP3A4 inhibitors, the starting dose should be not more than 25mg per day.

For patients taking ritonavir-boosted HIV inhibitors, the maximum dosage is 25mg in 48 hours.

For stable patients taking alpha-blockers, the starting dose should be 25mg.

It is advised to monitor blood pressure and pulse when this drug is used with hypotensive medications.

The combination of Sildenafil with nitrate and nicorandil can lead to a significant drop in blood pressure, which can potentially be fatal.

Side Effects

As with all pharmaceuticals, some unwanted effects can occur from the use of Sildenafil Citrate Tablets.

Common side effects include, but may not be limited to:

  • headache
  • heartburn
  • diarrhea
  • nosebleeds
  • difficulty sleeping
  • sensitivity to light
  • flushing

Seek medical attention if the following symptoms develop:

  • blurred vision or sudden loss of vision
  • ringing in the ears or a sudden decrease or loss of hearing
  • dizziness or lightheadedness
  • fainting
  • chest pain
  • erection that lasts longer than 4 hours
  • rash

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 Sildenafil Citrate Tablets if:

  • You are allergic to sildenafil or any of the other ingredients.
  • You have recently taken riociguat.
  • You are taking a nitrate drug, such as nitroglycerin, isosorbide dinitrate, or or isosorbide mononitrate.
  • You have a severe cardiovascular disorder.
  • You have been advised to currently refrain from sexual activity.
  • You have vision loss due to non-arteritic anterior ischaemic optic neuropathy.
  • You have severe hepatic impairment.
  • You have a history of heart attack or stroke in the past six months.
  • You have known hereditary degenerative retinal disorders such as retinitis pigmentosa.

Drug interactions may increase your risk for serious side effects or change how your medications work. Consult with your doctor about any vitamins, supplements, or medications you are taking before treatment with sildenafil citrate. This drug is known to interact with medications for hypertension or prostate problems, antifungals (e.g. ketoconazole or itraconazole), or medications to treat HIV/AIDs. This is not a complete list of possible interactions.

Do not use other medications for impotence (e.g. alprostadil or yohimbine) without consulting a healthcare professional.

This medication may not be suitable for people with certain conditions, so it is important to consult with a doctor if you have any health conditions. Special considerations, such as lower dosages or regular monitoring, may be necessary for conditions like:

  • anatomical deformation of the penis
  • hematological disorders with a predisposition for priapism
  • pulmonary hypertension secondary to sickle-cell disease
  • eye problems, such as blindness in one or both eyes
  • bleeding problems
  • stomach ulcer
  • blood cell disorders, such as sickle cell anemia, multiple myeloma, or leukemia
  • pulmonary veno-occlusive disease (PVOD)
  • hypertension or hypotension
  • hepatic or renal impairment
  • children
  • pregnancy or breastfeeding

It is recommended to avoid grapefruit products while taking sildenafil. Grapefruit may interact with this drug and cause increased negative side effects.

Alcohol should be avoided while taking sildenafil, as this combination can significantly increase the risk of certain side effects such as hypotension.

References

Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up

This study assesses the long-term efficacy and safety of sildenafil citrate for treating erectile dysfunction following radical prostatectomy (RP).

Ninety-one patients with post-RP erectile dysfunction were included in the study. They were prescribed oral sildenafil citrate and surveyed using a self-administered questionnaire during the first year of treatment to evaluate treatment satisfaction, compliance, and safety. After three years, a follow-up survey was conducted with 48 patients who had responded positively to the drug. Sildenafil citrate was initially prescribed at a dose of 50mg, with a possible increase to 100mg based on need.

At the three-year mark, 71% of the respondents were still responding to sildenafil. Among these patients, 31% had increased their dosage to 100mg. The dropout rate was 27%, with reasons including the return of natural erections, loss of efficacy, and personal circumstances.

The conclusion of this study is that the majority of patients with post-RP erectile dysfunction who initially respond to sildenafil continue to do so at three years. Treated patients with sildenafil citrate remain satisfied and compliant with the treatment.

*Regulatory compliance may vary according to production standard, import requirements and/or manufacturing origin.

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