Prozart Advance

Prozart Advance

Manufacturer:

Stallion Labs

Distributor:

D & G Pharma
Full Prescribing Info
Contents
Losartan potassium, amlodipine besilate.
Description
Each film-coated tablet contains: Losartan potassium 50 mg, Amlodipine (as Besilate) 5 mg.
Action
Pharmacotherapeutic Group: Vasodilators, hypotensive medicines.
Pharmacology: Pharmacokinetics: Absorption: Amlodipine: Plasma levels peak 6-12 hr after oral administration; absolute bioavailability is estimated to be 64-90%. Losartan: Well absorbed; undergoes substantial 1st pass metabolism by CYP450 enzymes; systemic bioavailability is about 33%; about 14% of an oral dose is converted to active metabolites.
Distribution: Amlodipine: 93% bound to plasma proteins. Losartan and its active metabolites: Highly bound to plasma proteins, mainly albumin.
Metabolism: Amlodipine: About 90% converted to inactive metabolites hepatically. Losartan is metabolised to an active carboxylic acid metabolite E-3174 (EXP-3174), which has greater pharmacological activity than Losartan; some inactive metabolites are also formed.
Excretion: Amlodipine: 10% of parent compound and 60% of the metabolites are removed in the urine; elimination from the plasma is biphasic with terminal half-life of about 30-50 hrs. Losartan and its active metabolites: Biliary excretion; terminal half-life: About 2 hr (Losartan) and 6-9 hr (metabolites).
Indications/Uses
Losartan potassium/Amlodipine besilate is indicated for the treatment of hypertension, angina pectoris & mild to moderate hypertension, alone or in combination with other antihypertensives.
Dosage/Direction for Use
The usual starting and maintenance dose is one tablet once daily for most patients. The dose may be increased to 2 tablets once daily. A lower dose should be considered for patients with a history of hepatic impairment. Or as prescribed by the physician.
Overdosage
Hypotension, tachycardia, Bradycardia could occur from parasympathetic (vagal) stimulation. Neither Losartan potassium/Amlodipine besilate (Prozart Advance) nor the active metabolite can be removed by haemodialysis.
Gastric lavage may be of benefit. Intravenous calcium gluconate may be of benefit in reversing the effects of calcium channel blockade.
Contraindications
Losartan potassium/Amlodipine besilate during pregnancy and lactation is contraindicated. Safety and efficacy has not been established in children. Hypersensitivity to any of the ingredients and dihydropyridines.
Special Precautions
Losartan potassium/Amlodipine besilate is contraindicated in pregnancy and should be used with care, if at all, during breastfeeding.
Losartan potassium/Amlodipine besilate (Prozart Advance) should be used with caution in patients with bilateral renal artery stenosis or stenosis of an artery to a single kidney, aortic valve stenosis, and hypertrophic obstructive cardiomyopathy.
Symptomatic hypotension may occur after initiation of Losartan potassium/Amlodipine besilate (Prozart Advance). Reduced doses must be considered in patients with hepatic impairment.
Use in Renal Failure: Severe renal impairment may however require a dosage reduction. Amlodipine is not dialysable.
Use in Impaired Hepatic Function: Losartan potassium/Amlodipine besilate (Prozart Advance) should be administered at lower doses in these patients.
Use in Heart Failure: Losartan potassium/Amlodipine besilate (Prozart Advance) may increase in patients with heart failure.
Porphyria: Safety has not been established.
Use in Children: Safety and efficacy has not been established.
Use in the Elderly: Elderly patients should start Losartan potassium/Amlodipine besilate (Prozart Advance) therapy at a lower dose.
Adverse Reactions
Most Common: edema, dizziness, flushing, and palpitation.
Common: fatigue, nausea, abdominal pain, somnolence.
Other Adverse Effects: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.
Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General: allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight decrease.
Musculoskeletal System: arthralgia, arthritis, muscle cramps, myalgia.
Psychiatric: sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.
Respiratory System: dyspnea, epistaxis.
Skin and Appendages: angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular.
Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: micturition frequency, micturition disorder, nocturia.
Autonomic Nervous System: dry mouth, sweating increased.
Metabolic and Nutritional: hyperglycemia, thirst.
Hematopoietic: leukopenia, purpura, thrombocytopenia.
Drug Interactions
Non-steroidal anti-inflammatory drugs (NSAIDs) may antagonist the antihypertensive effect. Concurrent use with sympathomimetics may reduce the antihypertensive effect Potassium-sparing diuretics: may lead to elevation of serum potassium. Concurrent administration of sublingual nitroglycerin, long-acting nitrates, beta-blockers or other antianginal agents with Amlodipine may produce additive antihypertensive and antianginal effects.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
C09DB06 - losartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
FC tab 100's.
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