Sildenafil 10 mg/ml Oral suspension

The following serious adverse events are

discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Vision Loss [see Warnings and Precautions (5.4)]

• Sildenafil has been investigated for alternative uses like altitude sickness.
• The syrup form is rarely available in commercial pharmacies.
• Reactions to sildenafil can vary based on individual health.
• Do not share sildenafil syrup with others to avoid adverse effects.
• Always adhere to prescribed dosages to prevent health risks.

Hearing Loss [see Warnings and Precautions

Side Effects of Sildenafil For Oral Suspension

Before prescribing sildenafil, 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. 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 to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.

12.1 Sildenafil Oral Suspension Mechanism of Action

The incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. This effect was not sildenafil citrate 200mg price seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil 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 post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil.

Other Interactions

Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil. There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended. Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil. (5.5)] Priapism [see Warnings and Precautions

(5.7)] Vaso-occlusive Crisis in Patients with

6. Adverse Reactions/Side Effects

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

8.1 Pregnancy

Package insert / product label Generic name: sildenafil citrate Dosage form: powder, for oral suspension Drug classes: Agents for pulmonary hypertension, Impotence medications Adults Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor 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. Pediatric Patients (1 to 17 years old) Sildenafil for oral suspension is 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 standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise (1, 14) Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. Pediatric patients (2.2) ≤ 20 kg: 10 mg three times a day20 kg to 45 kg: 20 mg three times a day> 45 kg: 20 mg three times a day. ≤ 20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day > 45 kg: 20 mg three times a day.

How it works

Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. Pulmonary Hypertension Secondary to Sickle Cell

What other drugs will affect Liqrev?

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Sildenafil for oral suspension is 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 for oral suspension is 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 underlie improvements in exercise [see Clinical Studies (14)]. The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. 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)].

What are the serious side effects of sildenafil?

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 in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)]. The recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of sildenafil injection does not need to buy pills sildenafil be adjusted for body weight. A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. The recommended dosage in patients ≤ 20 kg is 10 mg three times a day.

5.4 Visual Loss

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)]. Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Disease [see Warnings and Precautions (5.8)] Because clinical trials are conducted under

5.8 Priapism

Tap the bottle to loosen the powder. Add 60 mL of water to the bottle. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. Add another 30 mL of water to the bottle. Remove cap and press the bottle adaptor into the neck of the bottle.

12.2 Pharmacodynamics

Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution). Do not mix with any other medication or additional flavoring agent. White to off-white granular over the counter drugs containing sildenafil powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

Drugs you should not use with sildenafil

Sildenafil for oral suspension 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 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. widely varying conditions, adverse reaction rates observed in the clinical trials of

• Sildenafil works by relaxing blood vessels to improve blood flow.
• Used primarily to treat erectile dysfunction and pulmonary hypertension.
• Syrup formulations may be used in children or those with swallowing difficulties.
• Proper storage of sildenafil syrup is essential to maintain efficacy.
• It is important to follow a healthcare provider’s instructions when using.

a drug cannot be directly compared to rates in the clinical trials

What do I need to tell my doctor BEFORE I take Sildenafil Oral Suspension?

In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil. The safety and efficacy of combinations of sildenafil with VIAGRA or other PDE-5 inhibitors have not been studied. of another drug and may not reflect the rates observed in practice.

16 HOW SUPPLIED/STORAGE AND HANDLING

Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo. The effectiveness and safety of sildenafil in the treatment of PH secondary to sickle cell disease has not been established.