Advertisement

Topics

Felodipine Extended-Release Tablets, USP Rx only | FELODIPINE [WOCKHARDT LIMITED] | BioPortfolio

12:48 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.
MEAN REDUCTIONS IN BLOOD PRESSURE (mmHg)*
Dose N Systolic/Diastolic Mean Peak Response Mean Trough Response Trough/Peak Ratios (%s)
Study 1 (8 weeks)
2.5 mg 68 9.4/4.7 2.7/2.5 29/53
5 mg 69 9.5/6.3 2.4/3.7 25/59
10 mg 67 18.0/10.8 10.0/6.0 56/56
Study 2 (4 weeks)
10 mg 50 5.3/7.2 1.5/3.2 33/40**
20 mg 50 11.3/10.2 4.5/3.2 43/34**
Percent of Patients with Adverse Events in Controlled Trials* of Felodipine Extended-Release Tablets (N=861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)
Body System
Adverse Events
  Placebo
N=334
2.5 mg
N=255
5 mg
N=581
10 mg
N=408
Body as a Whole
Peripheral Edema 3.3 (0.0) 2.0 (0.0) 8.8 (2.2) 17.4 (2.5)  
Asthenia 3.3 (0.0) 3.9 (0.0) 3.3 (0.0) 2.2 (0.0)
Warm Sensation 0.0 (0.0) 0.0 (0.0) 0.9 (0.2) 1.5 (0.0)
         
Cardiovascular
Palpitation 2.4 (0.0) 0.4 (0.0) 1.4 (0.3) 2.5 (0.5)
           
Digestive
Nausea 1.5 (0.9) 1.2 (0.0) 1.7 (0.3) 1.0 (0.7)
Dyspepsia 1.2 (0.0) 3.9 (0.0) 0.7 (0.0) 0.5 (0.0)
Constipation 0.9 (0.0) 1.2 (0.0) 0.3 (0.0) 1.5 (0.2)
         
Nervous
Headache 10.2 (0.9)   10.6 (0.4)   11.0 (1.7)   14.7 (2.0)  
Dizziness 2.7 (0.3) 2.7 (0.0) 3.6 (0.5) 3.7 (0.5)
Paresthesia 1.5 (0.3) 1.6 (0.0) 1.2 (0.0) 1.2 (0.2)
         
Respiratory
Upper Respiratory Infection 1.8 (0.0) 3.9 (0.0) 1.9 (0.0) 0.7 (0.0)
Cough 0.3 (0.0) 0.8 (0.0) 1.2 (0.0) 1.7 (0.0)
Rhinorrhea 0.0 (0.0) 1.6 (0.0) 0.2 (0.0) 0.2 (0.0)
Sneezing 0.0 (0.0) 1.6 (0.0) 0.0 (0.0) 0.0 (0.0)
         
Skin
Rash 0.9 (0.0) 2.0 (0.0) 0.2 (0.0) 0.2 (0.0)
Flushing 0.9 (0.3) 3.9 (0.0) 5.3 (0.7) 6.9 (1.2)

Manufacturer

WOCKHARDT LIMITED

Active Ingredients

Source

Clinical Trials [11 Associated Clinical Trials listed on BioPortfolio]

Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of co...

The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.

The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in ...

Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Primary: - To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients Secondary: - To assess tolerability of Ramipril-Felodipine in hypertensive Arg...

Felodipine Event Reduction Study

FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized, placebo-controlled,parallel-group trial. The primary objective is to compare the long-term effects on t...

Copenhagen Acute Renal Complications After Transplantations Study Group

Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal functio...

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Application of biorelevant saliva-based dissolution for optimisation of orally disintegrating formulations of felodipine.

The oral cavity is of great importance to the performance of orally retained formulations, including: orally disintegrating tablets, taste-masked formulations, and buccal/sublingual delivery systems. ...

Does the intake of ethanol affect oral absorption of poorly soluble drugs?

The presence of ethanol in gastrointestinal (GI) fluids may increase the solubility of poorly water-soluble drugs. This suggests that intake of ethanol with such compounds could result in increased dr...

Predicted Amorphous Solubility and Dissolution Rate Advantages Following Moisture Sorption: Case Studies of Indomethacin and Felodipine.

Water is often readily absorbed by amorphous compounds, lowering their glass transition temperature (T) and facilitating their recrystallization (via nucleation-and-growth). At the same time, the incr...

Early stages of drug crystallization from amorphous solid dispersion via fractal analysis based on chemical imaging.

Early stages of crystallization from amorphous solid dispersion (ASD) are typically not detected by means of standard methods like powder X-ray diffraction (XRPD). The aim of this study is therefore t...

A novel thermal imaging method for rapid screening of drug-polymer miscibility for solid dispersion based formulation development.

This study aimed to develop a rapid, simple and inexpensive screening method for selecting the best polymeric candidates possessing high active pharmaceutical ingredient (API) miscibility during the e...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record