Vasotrent s.r for the treatment of patients with intermittent Cclaudication on the basis of chronic occlusive arterial disease of the limbs.

 
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VASOTRENT S.R

Company Name :

Acdima International Trading

Trade Name :

Vasotrent S.R

Generic Name :

Pentoxifylline

Composition :

Active Ingredients:
Pentoxilylline         400 Mg

Inactive Ingredients:
Hydroxypropylmethyl Cellulose – Titanium Dioxide – Carmoisine Red – Propylene Glycol – Hydroxy Ethyl Cellulose – Polyvinyl Pyrrolidone K25 – Talc Powder – Magnesium Stearate – Carnuba Wax

Pharmaceutical Form :

Sustained Release Film-coated Tablets

Pharmacological Action :

– vasotrent 400 Sr And Its Metabolites Improve The Flow Properties Of Blood By Decreasing Its Viscosity. In Patients With Chronic Peripheral Arterial Disease, It Increases Blood- Flow To The Affected Micro Circulation And Enhances Tissue Oxygenation.
– vasotrent 400 Sr Administration Has Been Shown To Produce
Dose Related Hemorheologic Effects, Lowering Blood Viscosity, And Improving Erythrocyte Flexibility.
– improvement 01 Symptoms Of Cerebra-vascular Disorders (Impaired Concenteration, Dizziness, Low Drive, Impaired
Memory, Etc … ) Has Been Demonsterated After Administeration
01 Vasotrent 400 Sr.
– tissue Oxygen Levels Have Been Shown To Be Significantly
Increased By Vasotrent 400 Sr In Patients With Peripheral Arterial Disease. (E.G. Intermittent Claudication) Resulting In An Increase Of Walking Distance And Relief Of Nocturnal Calf Muscle Cramps And Rest Pain.

Pharmacoklnetic :

– after Administeration Of 400 Mg Controlled Release Vasotrent 400 Sr Tablet, Plasma Levels 01 The 01 The Parent Compound And Its Metabolites Reach The Maximum Within 2-4 Hours And Remain Constant Over An Extended Period Of Time. The Controlled Release Of Pentoxifylline Eliminates Peaks And Troughs In Plasma Levels For Improved Gastrointestinal Tolerance.
– Bioavailability 01 Pentoxilylline Is Near 100% For Oral Use.
– Metabolism Of Vasotrent Is Via Hepatic Route And Via Erythrocytes.
– Its Excretion Is Mainly In Urine And Less Than 4% In Feces.

Therapeutic Indications :

– Vasotrent Is Indicated For The Treatment Of Patients With
Intermittent Claudication On The Basis Of Chronic Occlusive Arterial Disease Of The Limbs. Vasotrent Can Improve Function And Symptoms But Is Not Intended To Replace More Delinitive Therapy, Such As Surgical Bypass, Or Removal 01 Arterial
Obstructions When Treating Peripheral Vascular Disease.

Dose And Administration :

– The Usual Dosage 01 Vasotrent 400 Sr In Controlled Release Tablet Form Is One Tablet (400 Mgl, 2-3 Times Daily After Meals To Be Swallowed Whole With Some Liquid                                              – While The Effect 01 Vasotrent 400 Sr May Be Seen Within 2 Or 4 Weeks, It Is Recommended That Treatment Be Continued For At Least 8 Weeks.

Contraindications :

Vasotrent 400 Sr Should Not Be Used In Patients With Recent
Cerebral And/or Retinal Hemorrhage Or In Patients Who Have
Previsouly Exhibited Intolerance To This Product Or Methylxanthines Such As Caffeine,theophylline, And Theobromine.

Side Effects : 

– cardiovascularsystem : anginal – chestpain – flushing – dyspnea –
edema – hypotension – palpitation
– digestive System : Abdominal Discomfort – bleching – diarrhea –
dyspepsia – nausea – vomiting – anorexia-cholecystitis-constipation-dry Mouth-thirst
– nervous System : Agitation – dizziness – drowsiness – headache – insomnia – tremor – blurred Vision
– Respiratory : Epistaxis – Flu – like Symptoms – Laryngitis – Nasal Congestion
– skin & Appendages : Brittle Fingernails – Pruritis – Rash – Urticaria – Angioedema
– special Senses : Blurred Vision – Conjunctivitis – Earache- Scotoma
– Miscellaneous : Bad Taste- Excessive Salivation – Leucopenia – Malaise – Sore Throat – Swollen Neck Glands – Weight Change

Drug Interactions :

Individual adjustment of dosage is required if Vasotrent 400
SR is administered concomitantly with antihypertensive agents.

Pregnancy And Lactation :

Although No Teratogenic Effect Has Been Established In Animal Experiments, The Use Of Vasotrent 400 Sr During Pregnancy Is Not Recommended. This Drug Is Passed Into The Breast Milk.animal Studies Have Shown No Evidence Of Teratogenicity At High Doses.
It Does Not Include Any Risks Conferred By Pharmaceuti- cal Agents Or Their Metabolites That Are Present In Breast Milk.

Warnings And Precautions :

– Patients With Chronic Occlusive Arterial Disease Of The Limbs Frequently Show Other Manifestations Of Arteriosclerotic Disease. Vasotrent Has Been Used Safely For Treatment Of Peripheral Arterial Disease In Patients With Concurrent Coronary Artery And
Cerebrovascular Diseases, But There Have Been Occasional Reports Of Angina, Hypotension, And Arrhythmia. Controlled Trials Do Not Show That Vasotrent Causes Such Adverse Effects More Often Than
Placebo, But, As It Is A Methylxanthine Derivative, It Is Possible Some Individuals Will Experience Such Responses. Patients On Warfarin Should Have More Frequent Monitoring Of Prothrombin Times, While Patients With Other Risk Factors Complicated By Hemorrhage (E.G., Recent Surgery, Peptic Ulceration, Cerebral And/or Retinal Bleeding) Should \Have Periodic Examinations For Bleeding Including, \Hematocrit And/or Hemoglobin.

Package And Storage :

– Carton Box Containing 2 ( All Transparent Orange PVC) Strips each of 10 Film coated tablets and insert leaflet.
– Store At Temperature Not Exceeding 30·c in a dry place.

Instructions To Patients :

– The Drug Shoudn’t Be Used After The Expiry Date Printed On The Pack.
– Keep Out Of Reach Of Children
– Keep Away From Direct Heat Sources And Sun

Manufactured By :

Alexandria Company For Pharmacuticals And Chemical Induslries For Acdima International Trading

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