Sildenafil for oral suspension is contraindicated in patients with: Concomitant use of organic nitrates in any
Adverse effects
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 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. 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.
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Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension.
What should I do if I forget a dose?
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.
8.1 Pregnancy
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 over the counter drugs containing sildenafil day, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
14. Clinical Studies
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 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.
Prior authorization
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). Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure.
- During use, note the onset time and duration of the liquid sildenafil's effect.
- Use with caution if you have heart, kidney, or liver issues.
- Always inform your healthcare provider of other ongoing treatments.
- Potential side effects can include nasal congestion or stomach upset.
- Avoid driving or operating machinery until you know how sildenafil affects you.
- Use only as directed; misuse can cause serious health issues.
- Liquid sildenafil citrate is sometimes compounded into topical gels.
- It’s crucial to maintain a record of dose and timing.
- Be aware that alcohol can impair the effectiveness of sildenafil.
- The medication does not protect against sexually transmitted infections.
- Seek emergency medical help if you experience symptoms like chest pain.
Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients
| Brand Name | Manufacturer | Concentration | Packaging | Price Range (USD) | Availability | Notes |
|---|---|---|---|---|---|---|
| SildeVape Liquid | PharmaTech Ltd. | 20 mg/30 ml | 30 ml bottle | $15-$25 | Global | Approved for oral use |
| VidiVigo Liquid | MedicaPharma | 25 mg/30 ml | 30 ml bottle | $18-$28 | Europe, Asia | Flavored options available |
| LiquidSild | BioMed Inc. | 20 mg/30 ml | 30 ml bottle | $20-$30 | North America | Prescription only |
| SildenafilSolution | HealthMed Co. | 20 mg/30 ml | 30 ml bottle | $10-$20 | Various markets | Generic versions available |
on antihypertensive therapy or with resting hypotension [blood pressure less than
- 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.
90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).
6. Adverse Reactions/Side Effects
Use: Sildenafil citrate oral liquid has been used to treat pediatric pulmonary arterial hypertension in children in whom the risk-benefit profile of sildenafil is deemed acceptable. Packaging: Package in tight, light-resistant containers.1 Labeling: Keep out of reach of children. Stability: A beyond-use date of up to 91 days may be used for this preparation.1-4 Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).5 Discussion: A number of stability studies have been conducted on oral liquid formulations of sildenafil for pediatric use. From these, it appears that sildenafil is relatively stable in vehicles, with an acidic pH around 4 to 5. Sildenafil for oral suspension at 10 mg/mL (Revatio) is commercially available with a beyond-use date of 60 days after reconstitution.
Eur J Pharmacol
One study involved compounded sildenafil citrate in a citrate-buffered solution (0.1 M, pH 4) and either a syrup excipient (resulting in a suspension) or a sugar-free syrup excipient (resulting in a solution); both had pH values of approximately 4.2. 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 sildenafil 25mg tablets 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. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.
Declaration of competing interest
Extended stability of morphine and sildenafil for oral use in infants and young children. 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.
Experimental models of inflammatory bowel disease
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. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
8. Use In Specific Populations
Tap the sildenafil tablets 125 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. 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.
Non-medical use
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. 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.
Erectile dysfunction
It is buffered to a pH of approximately 4.2 and it has an osmolality of about 3,240 mOsm/kg. 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.