4 CONTRAINDICATIONS
In fixed-dose studies, the incidence of some adverse reactions increased with dose.
- Sildenafil citrate tablets 50mg are used to treat erectile dysfunction.
- These tablets work by increasing blood flow to the penis.
- Take sildenafil 50mg approximately 30 minutes before activity.
- Do not exceed one dose in a 24-hour period.
- Common side effects include headache and flushing.
- Sildenafil can interact with nitrates, causing dangerous drops in blood pressure.
- Store tablets in a cool, dry place away from direct sunlight.
- Consult a doctor before use, especially if you have heart conditions.
At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil citrate was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil citrate at least once weekly, and the following adverse reactions were reported: †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. In these studies, only one patient discontinued due to abnormal vision. The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil citrate is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.
What is Cryotag Skin Tag Remover
In fixed-dose studies, the incidence of some adverse reactions increased with dose. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil citrate was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil citrate at least once weekly, and the following adverse reactions were reported: †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. In these studies, only one patient discontinued due to abnormal vision.
Sildenafil vs. tadalafil
The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil citrate is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory:asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages:urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
Product Salbutamol 1.0 mg+Ambroxol 15.0 mg+ Guaphenesin 50 mg / 5 ml
Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil citrate with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions sildenafil syrup have been identified during post approval use of sildenafil citrate. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil citrate. Respiratory:asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages:urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
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Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil citrate with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions sildenafil syrup have been identified during post approval use of sildenafil citrate. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil citrate. It is not possible to determine whether these events are related directly to sildenafil citrate, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)]. Hemic and Lymphatic:vaso-occlusive crisis: In a small, prematurely terminated study of sildenafil tablets, 20 mg (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets, 25 mg, 50 mg and 100 mg for ED is not known.
- Sildenafil citrate 50mg may cause priapism, a prolonged erection needing medical attention.
- Use with caution in men taking blood pressure medications.
- Check for contraindications: heart disease, stroke history, or liver issues.
- Avoid taking sildenafil with fatty meals to improve absorption time.
- The drug's effectiveness can be reduced if taken with certain drugs.
- Patients should inform their doctor of all medications they are taking.
- The medication does not protect against sexually transmitted infections.
- Follow the prescribed dosage schedule strictly to avoid adverse reactions.
Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)]. Ocular:diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)]. Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects.
Avarante 10mg - 2 Tablets
It is not possible to determine whether these events are related directly to sildenafil citrate, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)]. Hemic and Lymphatic:vaso-occlusive crisis: In a small, prematurely terminated study of sildenafil tablets, 20 mg (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets, 25 mg, 50 mg and 100 mg for ED is not known. Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil citrate.
CYP3A4 Inhibitors
It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)]. Ocular:diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)]. Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria.
Incidence not known
7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects. When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.3 AmlodipineWhen sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.4 Ritonavir and other CYP3A4 inhibitorsCo-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C maxand AUC, respectively. When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.3 AmlodipineWhen sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.4 Ritonavir and other CYP3A4 inhibitorsCo-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C maxand AUC, respectively.
GPhC Regulated Pharmacy
Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 25 mg of sildenafil citrate should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].7.5 AlcoholIn a drug-drug interaction study sildenafil citrate 150 mg red pill sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [see Clinical Pharmacology (12.2)]. Administration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)]. Use caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects.
Comparing Sildenafil vs. Tadalafil Dosage
When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. When sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively.
Patient resources
A starting dose of 25 mg of sildenafil citrate should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)]. In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [see Clinical Pharmacology (12.2)]. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummarySildenafil Citrate is not indicated for use in females.There are no data with the use of Sildenafil Citrate in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2basis (see Data).DataAnimal DataNo evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir.
- The use of sildenafil citrate 50mg is often combined with psychological counseling.
- Alcohol and large meals can delay the medication’s effectiveness.
- Do not use sildenafil if you are pregnant or nursing.
- Patients with severe vision problems should consult their doctor before use.
- Sildenafil may cause flushing, nasal congestion, or diarrhea.
- Discontinuation may be advised if adverse reactions occur.
- Use caution in men over the age of 65, as side effects may increase.
- Always follow the instructions provided by your medical professional.
A starting dose of 25 mg of sildenafil citrate should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].7.5 AlcoholIn a drug-drug interaction study sildenafil citrate 150 mg red pill sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [see Clinical Pharmacology (12.2)].
UK Registered Pharmacy
Administration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)]. Use caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects.
5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives
Revatio Tablets
How is sildenafil supplied (dosage forms)?
When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. When sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].
| Condition | Reason | Precaution |
|---|---|---|
| Use with Nitrates | Risk of severe hypotension | Avoid combination entirely |
| Severe Cardiovascular Disease | Increased risk of adverse events | Use with caution; consult healthcare provider |
| Retinitis Pigmentosa | Possible worsening of symptoms | Evaluate risks before prescribing |
| Hypotension (<90/60 mmHg) | Blood pressure drops dangerously low | Monitor blood pressure closely |
Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively. A starting dose of 25 mg of sildenafil citrate should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].
- Sildenafil citrate tablets 50mg are commonly used in erectile dysfunction treatment.
- They help relax blood vessels in the penis for improved blood flow.
- Taking the medication on an empty stomach may result in quicker action.
- Do not use if you are taking other medications containing nitrates.
- Side effects like flushing or indigestion are usually mild.
- Discontinue use and seek medical help if an erection lasts longer than 4 hours.
- Sildenafil should be used only as prescribed by a healthcare practitioner.
- Consult your doctor if you experience adverse or unexpected effects.
In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [see Clinical Pharmacology (12.2)].
| Side Effect | Incidence Rate | Severity | Comments |
|---|---|---|---|
| Headache | 20-30% | Mild to moderate | Usually resolves within hours |
| Flushing | 15-25% | Mild | Facial redness |
| Indigestion | 10-15% | Mild to moderate | Related to vasodilation |
| Nasal Congestion | 10% | Mild | Due to blood vessel dilation |
| Vision Changes | 2-3% | Mild to moderate | Blue tint or blurred vision |
8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummarySildenafil Citrate is not indicated for use in females.There are no data with the use of Sildenafil Citrate in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2basis (see Data).DataAnimal DataNo evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis.
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