Liquid Sildenafil Citrate: Uses and Indications

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.

What special precautions should I follow?

Both the suspension and the solution were slightly pink and fruit-flavored. The suspension demonstrated stability for 91 days at both 4°C and 25°C; however, the solution was stable only for 30 days, possibly related to a nonredispersible sediment at the bottom of the container.3 A study by Nahata and colleagues that involved sildenafil citrate tablets (Revatio 20 mg) with a mixture of 1:1 Ora-Sweet and Ora-Plus at 2.5 mg/mL and pH 4.5-4.7 demonstrated stability of 91 days at both 4°C and 25°C. Also studied was a mixture of 1:7 (1% methyl cellulose:simple syrup) at pH 5.1 to 4.9 that also demonstrated stability of 91 days at both 4°C and 25°C.4 Sildenafil citrate (C22H30N6O4S.C6H8O7, MW 666.70) occurs as a white to off-white, crystalline powder that is soluble 3.5 mg/mL in water. It is formulated as tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration. The tablets also contain microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, lactose, triacetin, and FD&C Blue #2 Aluminum Lake.6,7 Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents, or syrups while still retaining its suspending properties.

Liquid chromatographic-tandem massspectrometric method for the quantitation of sildenafil in human plasma

It has a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is a thixotropic vehicle with a viscosity of approximately 1,000 cps at 25°C. Ora-Plus contains purified water, microcrystalline cellulose, sodium carboxymethyl cellulose, xanthan gum, carrageenan, sodium phosphate, and citric acid as buffering agents; simethicone as an antifoaming agent; and potassium sorbate and methylparaben as preservatives.8 Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent cap lock, a problem associated with many syrups. It is buffered to a pH of approximately 4.2 and it has an osmolality of about 3,240 mOsm/kg.

Storage and Handling

Rockville, MD: U.S. Pharmacopeial Convention, Inc; January 2018.2. Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children. Design and physicochemical stability studies of paediatric oral formulations of sildenafil. Extended stability of morphine and sildenafil for oral use in infants and young children. 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).

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	100mg	180 + 8 Pills	199.37€ 189.88€	Buy
Viagra Generic	100mg	360 + 10 Pills	330.21€ 314.49€	Buy
Viagra Generic	50mg	120 + 6 Pills	129.64€ 123.47€	Buy
Kamagra Soft Tabs	100mg	32 Pills	120.11€ 114.39€	Buy
Kamagra	100mg	120 + 6 Pills	330.74€ 314.99€	Buy
Viagra Generic	100mg	20 Pills	45.58€ 43.41€	Buy
Viagra Generic	150mg	30 + 2 Pills	72.32€ 68.88€	Buy
Viagra Generic	200mg	270 + 10 Pills	379.76€ 361.68€	Buy
Viagra Generic	25mg	360 + 10 Pills	213.68€ 203.50€	Buy
Viagra Generic	200mg	10 Pills	40.96€ 39.01€	Buy
Kamagra Polo	100mg	32 Pills	125.88€ 119.89€	Buy
Kamagra Oral Jelly	100mg	110 + 9 Sachets	334.87€ 318.92€	Buy
Viagra Generic	100mg	10 Pills	28.91€ 27.53€	Buy
Kamagra Soft Tabs	100mg	120 + 6 Pills	311.78€ 296.93€	Buy
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€	Buy
Kamagra Soft Tabs	100mg	272 + 12 Pills	593.42€ 565.16€	Buy

Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.

• The liquid form of sildenafil citrate is often prescribed for patients with swallowing difficulties.
• It provides quicker onset of action compared to traditional tablets.
• Some formulations are designed for sublingual or buccal absorption.
• This form allows for flexible dosing, especially in clinical settings.
• It should be kept out of reach of children and pets.
• Do not mix liquid sildenafil with other medications unless advised.
• Usage instructions often recommend shaking the bottle before use.
• This medication works by relaxing blood vessels in the penis.
• It should only be used under medical supervision to avoid interactions.
• Overdose can lead to severe side effects like vision changes.
• Consult a doctor for proper dosage and whether this form is suitable.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

• The taste of liquid sildenafil citrate can vary based on manufacturer.
• Some formulations include sweeteners to improve palatability.
• It is important to avoid contamination by using clean measuring tools.
• Never double-dose in an attempt to enhance effects.
• The liquid form may be prescribed when pills are not tolerated.
• Be attentive to any visual or hearing changes during treatment.
• It might interact with other medications, like blood thinners.
• Patients should report persistent side effects or lack of improvement.
• Follow safety labeling instructions carefully for optimal results.
• Be aware that generic versions are available in some regions.
• Knowledge of proper storage ensures medication integrity over time.

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.

1. Indications and Usage for Sildenafil Oral Suspension

Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. Bethesda, MD: American Society of Health-System Pharmacists; 2016:1918-1932.7. To comment on this article, contact rdavidson@uspharmacist.com. 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.

Erectile dysfunction

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. Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection.

Eur J Pharmacol

For chew sildenafil 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. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. The incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients.

Proper Use

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. 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).

Comparison of fasting bioavailability among 100-mg commercial, 100-mg generic, and 50-mg chewable generic sildenafil tablets in healthy male mexican volunteers: a single-dose, 3-period, crossover study

Do not mix with any other medication or additional flavoring agent. White sildenafil syrup to off-white granular 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. 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)]. 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).

What special dietary instructions should I follow?

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) sildenafil 50 mg india (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)]. 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)].

Simultaneous determination of sildenafil and its active metabolite UK-103, 320 in human plasma using liquid chromatography-tandem mass spectrometry

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 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. For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day.

Dosage for pulmonary arterial hypertension (PAH)

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). Tap the bottle to loosen the powder. 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.

Ingredient	Quantity per 30ml	Purity (%)	Source Organism	Additives	pH Level
Sildenafil Citrate	20 mg	99.9	Chemical Synthesis	Limonene, Glycerin	4.5
Glycerin	5 ml	—	Synthetic	Preservatives (None)
Deionized Water	24 ml	—	Purified Water	Buffering Agents
Flavoring Agents	0.5 ml	—	Plant Extracts	Artificial Flavors

Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).

Form	Typical Dosage Range	Concentration (mg/30ml)	Suitable Patients	Precautions
Liquid Sildenafil Citrate	20-50 mg	20 mg/30ml	Adults with ED	Not for children or pregnant women
Oral Solution	20 mg/30ml	20 mg/30ml	Males 18-65	Adjust dose for liver impairment
Quick-dissolving Liquid	25 mg	25 mg/30ml	Prescribed for quick action	Avoid mixing with alcohol

Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil.

Condition	Risk Factors	Advice	Alternative Treatment
Use with Nitrates	Severe hypotension risk	Avoid combination	Psychotherapy, Other ED meds
Cardiovascular Disease	Increased cardiac stress	Consult cardiologist	Lifestyle modifications
Retinal Disorders	Worsening of existing visual issues	Medical evaluation needed	Other PDE5 inhibitors
Liver or Kidney Impairment	Altered drug metabolism	Dose adjustment or avoidance	Non-pharmacological options

Site Operator

Fabienne Heyne
[email protected]

Corporate Design

Silvio Ketterer Visuelle Gestaltung
www.silvioketterer.ch

Website Programming

RHOdesign
www.rhodesign.ch

Photography

Angelika Annen
www.angelikaannen.ch