Flavor | Active Ingredient | Colorants | Notes |
|---|---|---|---|
| Orange | Sildenafil Citrate eq. to Sildenafil 100 mg | Sunset Yellow | Orange flavor |
| Pineapple | Sildenafil Citrate eq. to Sildenafil 100 mg | Quinoline Yellow | Pineapple flavor |
| Chocolate | Sildenafil Citrate eq. to Sildenafil 100 mg | Carmine | Chocolate flavor |
| Strawberry | Sildenafil Citrate eq. to Sildenafil 100 mg | Quinoline Yellow & Sunset Yellow | Strawberry flavor |
| Banana | Sildenafil Citrate eq. to Sildenafil 100 mg | Quinoline Yellow & Sunset Yellow | Banana flavor |
| Mango | Sildenafil Citrate eq. to Sildenafil 100 mg | Brilliant Blue & Tartrazine Yellow | Mango flavor |
| Mint | Sildenafil Citrate eq. to Sildenafil 100 mg | Brilliant Blue | Mint flavor |
| Cherry | Sildenafil Citrate eq. to Sildenafil 100 mg | Erythrosine | Cherry flavor |
Pharmacodynamics
Mechanism of Action
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Sildenafit has no direct relaxant.etfect.on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of GMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDES by sildenafil causes increased levels of GMP in the corpus cavernosum resulting in smooth muscle relaxation and inflow of blood to the corpus cavemosum. Sildenafil at recommended doses has no effectin the absence of sexual stimulation.
Effects of sildenatil on Erectile Response
In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections, after sildenafil administration compared with placebo.
Effects of sildenafil on Blood Pressure
Single oral doses of siidenafil (100 mg) administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.4/5.5 mmHg). The decrease in blood pressure was most notable approximately 1–2 hours after dosing, and was not different than placebo at 8 hours. Larger effects were recorded among patients receiving concomitant nitrates.
Effects of sildenatil on Cardiac Parameters
Single oral doses of sildenafil up to 100 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
Effecis of sildenatil on Vision
At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels.
PHARMACOKINETICS
Absorption and Distribution
Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When sildenafil is taken with a high fat meal, the rate of absorption is reduced.
Metabolism and Excretion
Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP29 (minor route) hepatic microsomal soenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% of the parent drug.
INDICATIONS
Redsun is indicated for the treatment of erectile dysfunction in men.
DOSAGE AND METHOD OF ADMINISTRATION
Take 100 mg/ Dose approximately 1 hour before sexual activity.
The maximum recommended dosing frequency is once per day.
Cut, open the sachet and squeeze the jelly into mouth and swallow the whole content of the sachet. One sachet for one time use only.
Redsun jelly melt very fast and is absorbed by the body's enzymes in approximately 30 minutes atter taking the medicines. It works for about 2–3 hours atter consumption.
The following factors are associated with increased plasma levels of sildenafil:
age > 65 (40% increase in AUC)
hepatic impairment 8.9. cirrhosis, 80%)
severe renal impairment (creatinine clearance < 30 mL/min, 100%)
concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, ritonavir, saquinavir >200%)
CONTRADICTIONS
Use ot Redsun is contraindicated in patients with a known hypersensitivity to any component of the jelly.
Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated.
Sildenafil is not indicated for use in women and individuals below 18 years of age.
WARNINGS AND PRECAUTIONS
Drug Interactions
Effects of other drugs on sildenatil
In vitro studies
Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 209 (minor route). Therefore, inhibitors of these iscenzymes may reduce sildenafil clearance.
In vivo studies
Cimetidine (800 mg), a non-specific CYP inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole would be expected to have stili greater effects, and population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine).
It can be expected that concomitant administration of CYP3A4 inducers, such as rifampin, will decrease plasma levels of sildenafil.
Ritonavir, a highly potent P450 inhibitor, resulted in 300% increase in sildenatil C max and 1000% Increase in sildenafil plasma AUC.
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Ellects of sildenafil on other drugs
In vitro studies
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC 50 > 150 mM).
Given sildenafil peak plasma concentrations of approximately 1uM atter recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
In vivo studies
No significant interactions were shown with toibutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.
Sildenati (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg).
Slidenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol loveis of 0.08%.
There is no controlled clinical data on the safety or efficacy of sildenafil in the following groups, if prescribed, this should be done with caution.
Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
Patients with resting hypotension (BP < 90/50) or hypertension (BP > 170/110).
Patients with cardiac failure or coronary artery disease causing unstable angina.
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Renal impairment
In patients with severe renal impairment a starting dose of 25mg should be considered.
Hepatic impairment
In patients with hepatic impairment a starting dose of 25mg should be considered.
PREGNANCY
Category B
There are no adequate and well-controlled studies of sildenafil in pregnant women. Sildenafil is not indicated in women.
LACTATION
Sildenafil is not indicated in nursing mothers.
PAEDIATRIC USE
Sildenatil is not indicated in children.
GERIATRIC USE
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil. Since higher plasma levels may increase both the etficacy and incidence of adverse events, a starting dose of 25 mg should be considered.
UNDESIRABLE EFFECTS
The most frequent side effects reported with sildenafil use include:
headache
flushing
dyspepsia
nasal congestion
abnormal vision (mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision)
urinary tract infection
diarrhea
dizziness
rash
OVERDOSE
In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.
STORAGE
Store in cool & dry place below 30°C.
Protect from light.
Keep medicines out of reach and sight o children.
PRESENTATION
Redsun jelly is available in 4 × 5 gm Sachets.
DATE OF PUBLICATION
May 2022
DATE OF REVIEW
Every three years
FDA Reg. No.
FDA/SD.193-4212
Manufactured in India by / Fabriqué en Inde par
RONAK EXIM PVT. LTD.
RONAK
Gendigate, Baroda-1, (Guj) INDIA/INDE.
E-mail: ahmedi@ronakoverseas.com
Customer Care No: +91 9998953750