Sildenafil - Pfizer
Take sildenafil tablets 3 times a day about 4 to 6 hours apart.
Adult Indications and Dosage
Sildenafil citrate is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Your heart has to work hard to pump blood into your lungs. Sildenafil citrate improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil citrate is not for use in children Sildenafil citrate is not for use in children Adding sildenafil citrate to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise. Adding sildenafil citrate to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.
Viagra and children
Sildenafil citrate contains the same medicine as Sildenafil citrate® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil citrate over the counter drugs containing sildenafil with Sildenafil citrate or other PDE-5 inhibitors. Do not take sildenafil citrate if you: See “What is the most important information I should know about sildenafil citrate?” See “What is the most important information I should know about sildenafil citrate?” Are allergic to sildenafil or any other ingredient in sildenafil tablets. See “What are the ingredients in sildenafil tablets?” at the end of this leaflet. Are allergic to sildenafil or any other ingredient in sildenafil tablets. Take sildenafil tablets at the same times every day.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 25mg | 20 Pills | 37.74€ 35.94€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Viagra Generic | 50mg | 60 + 4 Pills | 83.93€ 79.93€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
| Kamagra Polo | 100mg | 20 Pills | 83.56€ 79.58€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Viagra Generic | 50mg | 270 + 8 Pills | 198.48€ 189.03€ | |
| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
| Kamagra | 100mg | 20 Pills | 86.09€ 81.99€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Viagra Generic | 200mg | 270 + 10 Pills | 379.76€ 361.68€ |
If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
- Sildenafil citrate may cause a drop in blood pressure.
- Do not consume large quantities of grapefruit juice while on sildenafil.
- Pregnant or breastfeeding women should not use sildenafil without guidance.
- The drug does not improve libido, only facilitates blood flow.
- It is not intended for recreational use or enhancement.
- Psychological factors can also affect the efficacy of sildenafil.
- Regular medical check-ups are recommended for long-term users.
Do not change your dose or stop taking sildenafil citrate on your own.
- Sildenafil is not recommended for children or minors.
- Elderly patients may need lower doses due to sensitivity.
- Use with caution if you have a history of stroke or unstable angina.
- Combining sildenafil with other ED drugs increases side effects risks.
- Be aware of counterfeit or substandard sildenafil products.
- Always purchase medication from reputable pharmacies.
- Consult a healthcare professional prior to initiating therapy.
If you take too much sildenafil citrate, call your doctor or go to the nearest hospital emergency room.
- Some users report headaches and dizziness after taking sildenafil.
- A common side effect is facial flushing and nasal congestion.
- Rare side effects include sudden hearing loss or vision loss.
- Priapism requires urgent medical attention to prevent tissue damage.
- Sudden vision loss should be immediately evaluated by a doctor.
- Allergic reactions such as rash, hives, or swelling are possible.
- Discontinue use and seek medical help if serious side effects occur.
Low blood pressure may cause you to feel faint or dizzy.
MeSH terms
Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters). Patients were randomized to 1 of 3 doses of sildenafil citrate: 1 mg, 5 mg, and 20 mg, three times a day. At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian. Similar increases in walk distance (mean increase of 38 to 41 meters) were observed in the 5 and 20 mg dose groups.
FDA-Labeled Indications and Dosage (Adult)
These increases were significantly better than those observed in the 1 mg dose group (Figure 12). A randomized, double-blind, placebo controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. Tell your doctor if you get more short of breath after you start sildenafil citrate. Decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.
| Storage Condition | Details | Temperature Range | Light Exposure | Humidity |
|---|---|---|---|---|
| Preferred Storage | Cool, dry place | 15-30°C | Keep in original container | Avoid humidity |
| Keep away from light | Protect from direct sunlight | N/A | Yes | N/A |
| Out of reach of children | Safety precaution | N/A | N/A | N/A |
If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil citrate, or to other diseases or medicines, to other factors, or to a combination of factors. Heart attack, stroke, irregular heartbeats, and death.
Patient Counseling Information
Tell your doctor about all of your medical conditions, including if you Have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack Have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack Have a disease called pulmonary veno-occlusive disease (PVOD) Have a disease called pulmonary veno-occlusive disease (PVOD) Have high or low blood pressure or blood circulation problems Have high or low blood pressure or blood circulation problems Have an eye problem called retinitis pigmentosa Have an eye problem called retinitis pigmentosa Have or had loss of sight in one or both eyes Have or had loss of sight in one or both eyes Have any problem with the shape of your penis or Peyronie’s disease Have any problem with the shape of your penis or Peyronie’s disease Have any blood cell problems such sickle cell anemia Have any blood cell problems such sickle cell anemia Have a stomach ulcer or any bleeding problems Have a stomach ulcer or any bleeding problems Are pregnant or planning to become pregnant. It is not known if sildenafil citrate could harm your unborn baby. Are pregnant or planning to become pregnant. It is not known if sildenafil citrate passes into your breast milk or if it could harm your baby. Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.
Nonclinical Toxicology
Sildenafil citrate and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil citrate. Especially tell your doctor if you take See “What is the most important information I should know about sildenafil citrate?” See “What is the most important information I should know about sildenafil citrate?” Ritonavir (Norvir®) or other medicines used to treat HIV infection Ritonavir (Norvir®) or other medicines used to treat HIV infection Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Take sildenafil citrate exactly as your doctor tells you. Sildenafil citrate may be prescribed to you as Take sildenafil tablets 3 times a day about 4 to 6 hours apart. Most of these happened in men who already had heart problems. Tell your doctor right away if you have an erection that lasts more than 4 hours.
- Sildenafil is available in most countries through prescription only.
- It is used worldwide, with varying approval statuses.
- FDA and EMA have rigorous testing standards for sildenafil.
- Using the drug responsibly can lead to successful treatment outcomes.
- Combining sildenafil with other medications requires medical supervision.
- Be aware of the potential for drug interactions with heart or blood pressure meds.
- Always consult a healthcare professional for personalized advice.
Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn’t go away.
What Other Drugs Interact with Sildenafil?
Patients on sildenafil citrate achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil citrate (95% CI: -5.7, -2.1) (p = 0.00003). Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Table 4 displays the number of patients with clinical worsening events in Study 2. Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil citrate-treated patients and that sildenafil citrate-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074).
Side effects and risks
Kaplan-Meier plot of time to clinical worsening is presented in Figure 11. Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil citrate compared to placebo. More than twice as many sildenafil citrate-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled. These are not all the possible side effects of sildenafil citrate.
Detection in biological fluids
The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. Sildenafil tablets, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. Bottles of 90: NDC 68001-176-05 Bottles of 90: NDC 68001-176-05 Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). {{#ask: Page Name::Sildenafil ?Pill Name ?Drug Name ?Pill Ingred ?Pill Imprint ?Pill Dosage ?Pill Color ?Pill Shape ?Pill Size (mm) ?Pill Scoring ?NDC ?Drug Author format=template template=DrugPageImages mainlabel=- sort=Pill Name }} {{#ask: Label Page::Sildenafil ?Label Name format=template template=DrugLabelImages mainlabel=- sort=Label Page }} Read this Patient Information before you start taking sildenafil citrate and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment.
Common Side Effects
If you have any questions about sildenafil citrate, ask your doctor or pharmacist. Never take sildenafil citrate with any nitrate medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called “poppers” (amyl nitrate or nitrite) Street drugs called “poppers” (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine. Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine. For more information, ask your doctor or pharmacist. Store sildenafil tablets at controlled room temperature, between 68°F to 77°F (20°C to 25°C).
| Country | Approval Status | Regulatory Agency | Notes |
|---|---|---|---|
| USA | Approved | FDA | For ED and pulmonary hypertension |
| European Union | Approved | EMA | Similar indications |
| India | Approved | CDSCO | Generic versions available |
| Australia | Approved | TGA | Prescription required |
