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Description
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Excretion:
The total boby clearance of IMPULSE is 56 l/h with a resultant terminal half life of about 4-5 hours.
After oral administration, IMPULSE is excreted as metabolites predominantly in the faeces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose).
Pharmacokinetics in special populations:
Elderly:
IMPULSE hepatic clearance in healthy elderly volunteers (60 years or over) was reduced as compared to volunteers of younger age (45 years and below). On average, elderly males had a 52% higher AUC than younger males which is within the variability observed in clinical trials. No overall differences in safety or effectiveness were observed between elderly and younger subjects in placebo controlled clinical trials.
Renal insufficiency:
In patients with mild (Clcr>50-80 ml/min) to moderate (CLcr>30-50 ml/min) renal impairment, IMPULSE pharmacokinetics were similar to that of a normal renal function control group. In volunteers with severe renal impairment (CLcr<30 ml/min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment. No statistically significant correlation between creatinine clearance and IMPULSE plasma exposure (AUC and Cmax) was observed.
The Pharmacokinetics of IMPULSE has not been studied in patients requiring dialysis.
Hepatic insufficiency:
In patients with mild to moderate hepatic impairment (Child-Pugh A and B), IMPULSE clearance was reduced in proportion to the degree of hepatic impairment.
In patients with mild hepatic impairment (Chil-pugh A), IMPULSE AUC and Cmax were increased 1.2-fold (AUC by 17%, and Cmax by 22%), Compared to healthy control subjects.
In patients with moderate hepatic impairment (Child-Pugh B), IMPULSE AUC was increased 2.6-fold (160%) and Cmax was increased 2.3-fold (130%), compared to healthy control subjects.
The pharmacokinetics of IMPULSE has not been studied in patents with severe hepatic impairment (Child-Pugh C).
Indications
Treatment of erectile dysfunction (inability to achieve of maintain penile erection sufficient for satisfactory sexual performance).
In order for Biotin to be effective, sexual stimulation is required. Posology and method of administration Single doses of Maalox (antacid; magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability (AUC) or the maximum concentraton (Cmax) of IMPULSE.
IMPULSE (60 mg) did not influence the bleeding time when taken alone or in combination with low dose Acetylsalicylic Acid (2*81 mg tablets)
IMPULSE (120 mg) did not potentiate the hypotensive effects of Alcohol (0.5 g/kg bw.) The pharmacokinetics of IMPULSE where not altered.
Population pharmacokinetic investigations of phase III data revealed no significant effect of Acetysalicylic Acid, ACE-inhibitors, beta-blockers, weak CYP 3A4-inhibitors, diuretics and metformin) on the pharmacokinetics of IMPULSE.
Food and dietary products: when IMPULSE is taken with a high fat meal (containg 57% fat), the rate of absorption is reduced with an increase in the median time of maximal plasma concentration of 60 minutes and a mean reduction in peak plasma concentration of 20%. IMPULSE bioavailability was not affected. After a normal meal (containing 30% fat) IMPULSE pharmacokinetic parameter were not affected at all. Based on these results IMPULSE can be taken with or without food.
Pregnancy and lactation:
Is not indicated for use in newborns, children or women.
Undesirable effects
IMPULSE was administered to over 7800 patients during clinical trials worldwide.
IMPULSE was generally very well tolerated.
Adverse events were generally transient and mild to moderate in nature
For adverse reactions reported in <1% of patients, only those which warrant special attention, because of their possible association with serious disease states of otherwise clinical relevance, and which have been reported in > 2 cases are listed. In a phase I study with 40 mg (twice the maximum recommended dose) priapism was observed in 2 cases as ADR.
Post- Marketing
Myocardial infarction (M) has been reported in temporal association with the use of IMPULSE and sexual activity, but it is not possible to determine whether MI is related directly to IMPULSE, or to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these factors.
STORAGE: Stored at 25��?or below as directed by doctors, moisture proofing.
USAGE: Orally taken one granule 40 minutes before your need, each granule will retain in the body for about 72 hours.
CONTENT: 120mg*7 grain*12boxes/pack
NOTES: Kept all drugs beyond the touch of children.
WARNING: The retail prescription to be sold is only available for urologist, psychiatrist, endocrine and venereal doctors.
MANUFACTURING LICENSE: BOC11511020
American Woshou Group supervised.
U.S. Bucks Biological Pharmaceutical Co., Ltd.
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