13 NONCLINICAL TOXICOLOGY
These measures will help to protect the environment. Contents of the pack and other information The active ingredient is Sildenafil (as citrate).
What do I need to tell my doctor BEFORE I take Sildenafil Oral Suspension?
Check with your doctor or pharmacist if you are not sure. For adults, the recommended dose is 20 mg (2 ml of Oral suspension) three times a day (taken 6 to 8 hours apart) taken with or without food. For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of Oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of Oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food. Higher doses should not be used in children. The oral suspension must be shaken well sildenafil citrate 100mg tablets before use.
12.2 Pharmacodynamics
Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
Dosage for erectile dysfunction (ED)
Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C). Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B). Close the bottle with the plastic screw cap. Each 1 ml of Sildenafil Oral suspension contains 10 mg of Sildenafil.
| Product | Dosage | Quantity + Bonus | Price | |
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What Sildenafil Oral suspension looks like and contents of the pack Sildenafil Oral suspension is a white to off white suspension.
Frequently asked questions for Sildenafil
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This medicine is supplied in amber glass bottle with a white child resistant tamper evident closure containing 122 ml of liquid product.
6 ADVERSE REACTIONS
or search for MHRA Yellow Card in the Google Play or Apple App Store. Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not store above 25°C after first opening of the bottle. Discard after 90 days of first opening. The package contains a 2 ml oral syringe with a polypropylene body, purple HDPE plunger, graduations printed at 0.5 ml 1.0 ml, 1.5 ml and 2.0 ml together with a low density polyethylene bottle adaptor.
| Side Effect | Frequency | Severity | Management |
|---|---|---|---|
| Headache | Common | Mild | Analgesics, hydration |
| Flushing | Common | Mild | Cool environment, monitor |
| Nasal congestion | Common | Mild | Decongestants, hydration |
| Dizziness | Less common | Moderate | Avoid sudden movements |
| Vision disturbances | Rare | Moderate | Discontinue, consult physician |
| Priapism (prolonged erection) | Rare | Severe | Emergency medical attention |
The Marketing Authorisation Holder and Manufacturer is: Rosemont Pharmaceuticals LtdYorkdale Industrial ParkBraithwaite StreetLeedsLS11 9XEUK LM Manufacturing LimitedSandretto BuildingCavalry Hill Industrial ParkWeedonNorthamptonNN7 4PPUnited Kingdom This leaflet was last revised in
Related/similar drugs
John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy). Blood thinning medicines (for example warfarin) although these did not result in any side effect. Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms of low blood pressure (e.g. Medicines containing sacubitril/valsartan used to treat heart failure.
Placing an Order
Sildenafil Oral suspension with food and drink You should not drink grapefruit juice while you are being treated with Sildenafil Oral suspension. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil Oral suspension should not be used during pregnancy unless strictly necessary. Sildenafil Oral suspension should not be given to women of child bearing potential unless using appropriate contraceptive methods. Sildenafil Oral suspension passes into your breast milk at very low levels and would not be expected to harm your baby.
Clinical monitoring
Sildenafil Oral suspension can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines. This medicine contains 2.0 mg sodium benzoate in each ml. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. Always take this medicine exactly as your doctor has told you. April 2024 DescriptionDosage FormOral SuspensionIndicationPulmonary Arterial hypertensionBrand NameRevatio®TE CodeABLactoseNoGlutenNoColorOff-White to Light Yellow PowderShapeNAMarkingsNAStorage ConditionBEFORE
12.1 Mechanism of Action
Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature. Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men. Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data). The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities. The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
What is sildenafil used for?
Side effects reported very commonly (may 20mg sildenafil affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed. Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose. If you get any side effects, talk to your doctor or nurse. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. RECONSTITUTION: Store below 30°C (86°F) in the original package in order to protect from moisture.
Society and culture
Empty the contents of the syringe into your mouth. After dosing, wash the syringe with water only (figure 7). If you take more Sildenafil Oral suspension than you should You should not take more medicine than your doctor tells you to. If you take more medicine than you have been told to take contact your doctor immediately. Taking more Sildenafil Oral suspension than you should may increase the risk of known side effects.
2.2 Recommended Dosage in Pediatric Patients
If you forget to take Sildenafil Oral suspension If you forget to take Sildenafil Oral suspension, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose. If you stop taking Sildenafil Oral suspension Suddenly stopping your treatment with Sildenafil Oral suspension may lead to your symptoms getting worse. Do not stop taking Sildenafil Oral sildenafil oral jelly 100mg lovegra suspension unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.
Regional issues
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should stop taking Sildenafil Oral suspension and contact a doctor immediately (see also section 2): if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known). Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs. AFTER RECONSTITUTION: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F) Do not freeze.
- Sildenafil syrup is sometimes used in pediatric cases, off-label.
- Off-label use in children requires careful dosage adjustment.
- Lack of standardization makes typical dosing guidelines difficult.
- Pharmacokinetics in syrup form are less well-studied.
- Always seek professional medical advice before use.
Discard any unused portion 60 days after reconstitution.PACK SIZE: “112 mL following ReconstitutionNDC#: 27241-0175-29Click to View Package Insert Click to View Material Data Safety Sheet
| Aspect | Sildenafil Syrup | Sildenafil Tablets |
|---|---|---|
| Ease of administration | Easy for children or those swallowing difficulties | Convenient for most adults |
| Dosage flexibility | Precise dosage adjustments possible | Fixed doses, less flexible |
| Onset of action | Usually quicker due to liquid form | Similar, around 30–60 min |
| Bioavailability | Slightly higher (due to faster absorption) | Slightly lower |
| Storage requirements | Same storage conditions | Same storage conditions |
Revatio ® is registered trademark of Pfizer Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men.
- Investigational drugs or supplements claim to mimic sildenafil effects.
- The safety of homemade sildenafil syrup is not guaranteed.
- Pharmacovigilance involves monitoring adverse effects.
- Patients should inform providers of all medications taken.
- Regulatory oversight ensures quality and efficacy of medications.
Sildenafil (Liqrev, Revatio) is used to improve the ability to exercise in adults (Liqrev, Revatio) and children 1 year of age and older (Revatio) with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness).
| Parameter | Value | Description | Remarks |
|---|---|---|---|
| Absorption | Rapid, within 30-60 min | Time to peak plasma concentration | 最佳服用时间为餐前或空腹 |
| Bioavailability | Approx. 40% | Percentage of dose reaching systemic circulation | 影响药效强度 |
| Half-life | 4 hours | Time taken to reduce plasma concentration by half | 影响药物持续时间 |
| Metabolism | Hepatic (mainly CYP3A4) | Liver enzymes metabolize sildenafil | 酒精或药物相互作用可能影响代谢 |
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