Sildenafil Tablets: Package Insert / Prescribing Info

Throw away any unused medication after the expiration date. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Drug Class	Interaction Effect	Recommendation
Nitrates	Severe hypotension	Avoid combination
Alpha-blockers	Additive blood pressure lowering effect	Use with caution
CYP3A4 inhibitors (e.g., ketoconazole)	Increased sildenafil levels	Dose adjustment may be necessary
Antihypertensives	Enhanced blood pressure reduction	Monitor blood pressure
Grapefruit juice	Increased plasma concentration	Avoid during treatment

Sign up for our Health Essentials emails for expert guidance on nutrition, fitness, sleep, skin care and more. Note: Introduction and Additional Common Questions written and medically approved by Cleveland Clinic professionals. SILDENAFIL CITRATE- sildenafil citrate tablet Advanced Rx Pharmacy of Tennessee, LLC Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)]. The recommended dosage of sildenafil tablets are 20 mg three times a day.

2.1 Recommended Dosage in Adults

Follow the directions on the prescription label. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medication more often than directed. Talk to your care team about the use of this medication in children.

Incidence not known

This sildenafil 200 mg medication is not used in children for this condition. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others. Do not take this medication with any of the following: Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin This medication may also interact with the following: Other medications may affect the way this medication works.

Oral Administration

Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended. This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil chewable tablets sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)]. 2.2 Recommended Dosage in Pediatric Patients The recommended dosage in patients ≤20 kg is 10 mg three times a day. For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day. For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day. A maximum dose in pediatric patients has not been identified. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients >45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14)].

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	150mg	270 + 10 Pills	326.61€ 311.06€	Buy
Kamagra Oral Jelly	100mg	10 Sachets	54.55€ 51.95€	Buy
Viagra Generic	50mg	90 + 6 Pills	107.37€ 102.26€	Buy
Kamagra	100mg	180 + 6 Pills	436.79€ 415.99€	Buy
Kamagra	100mg	32 Pills	121.24€ 115.47€	Buy
Viagra Generic	100mg	120 + 6 Pills	149.50€ 142.38€	Buy
Viagra Generic	50mg	30 + 4 Pills	54.26€ 51.68€	Buy
Viagra Generic	200mg	20 Pills	61.69€ 58.75€	Buy
Viagra Generic	25mg	180 + 6 Pills	154.93€ 147.55€	Buy
Kamagra Polo	100mg	84 + 4 Pills	244.49€ 232.85€	Buy

Sildenafil tablets, USP are supplied as white to off-white, round, biconvex, film-coated tablets debossed with '85' on one side and plain on other side containing sildenafil citrate equivalent to 20 mg of sildenafil.

Condition	Risk Factors	Recommendations
Use with Nitrates	Risk of severe hypotension	Avoid concurrent use
Severe Heart Disease	Increased cardiac stress	Consult cardiologist before use
Severe Liver or Kidney Impairment	Altered drug metabolism	Dose adjustment or avoid use
Hypotension	Blood pressure too low	Use caution, monitor blood pressure
Retinitis Pigmentosa	Risk of vision changes	Consult eye specialist

Sildenafil citrate is contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions ( 5.1)] . Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

Pregnancy & Lactation

Some items may interact with your medicine. Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Tell your care team right away if you have any change in your eyesight or hearing. This medication may affect your coordination, reaction time, or judgment.

6.1 Clinical Trials Experience

Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure.

What other drugs will affect sildenafil?

This product's label may have been updated. For current full prescribing information, please visit Viagra (sildenafil citrate), Revatio (sildenafil), Cardura (doxazosin mesylate), and Minipress (prazosin HCl) are registered trademarks of Pfizer Inc. The other brands listed are trademarks of their respective owners and are not trademarks of Pfizer Inc. The makers of these brands are not affiliated with and do not endorse Pfizer Inc or its products. International Pharmaceutical Procurement and Logistics 2220 Leah Drive, Suite 2, Hillsborough, NC 27278 United States Home Services Third Party Logistics End-to-end warehousing, distribution, and fulfillment solutions Wholesale Over-the-Counter (OTC) Medications & Supplements Pharmaceutical Products Veterinary ProductsMedical Supplies Products & Devices Learn about our portfolio of products Drug Approval End-to-end warehousing, distribution, and fulfillment solutions Product Search End-to-end warehousing, distribution, and fulfillment solutions Drug Approval End-to-end warehousing, distribution, and fulfillment solutions Drug Shortages Drug shortage database Company support Contact Track Your Order About About Us Our Team Our Licenses Resources FDA Database Access regulatory data and drug listings directly from the FDA Product Search Find clinical overviews for every drug Programs Expanded Access Program Supply Chain Logistics Quality Assurance Quality Control Contact Login Sign up Search Our Product Library Browse over 120,000 articles to find the exact drug you are looking for.

Sildenafil Oral Film for ED

Sildenafil is a treatment for erectile dysfunction. It works by increasing blood flow to your penis. The brand name for this medication is Viagra®. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission.

5.4 Hearing Loss

We do not endorse non-Cleveland Clinic products or services. SILDENAFIL (sil DEN a fil) treats erectile dysfunction (ED). It works by increasing blood flow to the penis, which helps to maintain an erection. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. They need to know if you have any of these conditions: History of blood diseases, such as sickle cell anemia or leukemia Stomach ulcers, other stomach or intestine problems An unusual or allergic reaction to sildenafil, other medications, foods, dyes, or preservatives Take this medication by mouth with a glass of water. Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.

5.6 Combination with Other PDE-5 inhibitors

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medication, you should refrain from further activity and call your care team as soon as possible. Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs). Side effects that you should report to your care team as soon as possible: Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision Sudden vision loss in one or both eyes Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): This list may not describe all possible side effects. Keep out of reach of children and pets. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.

• Regulatory status of sildenafil varies by country but generally requires a prescription.
• In the UK, it is a Prescription Only Medicine (POM) but can be prescribed by pharmacists.
• In some countries, it may be available in limited quantities without a prescription.
• The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Revatio.
• The REMS is designed to inform healthcare providers about the serious risks.
• This includes the risk of use with nitrates and the potential for hearing loss.
• The medication is subject to controlled substance regulations in some regions.
• Traveling with prescription medication requires carrying it in original packaging.
• It is advisable to have a copy of the prescription or a doctor's note when traveling.
• Laws regarding the importation of prescription drugs are strict and vary.
• Always check the legal status of the medication in your destination country.

The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil.

• Sildenafil works by relaxing blood vessels to increase blood flow.
• 20mg dosage is suitable for men with mild to moderate ED.
• It is available by prescription or over-the-counter in some regions.
• Avoid alcohol while taking sildenafil to prevent side effects.
• Do not exceed the prescribed dose to reduce health risks.