NORVARTAN PLUS 5/160/12,5 mg
Tablets

Antihypertensive drugs

  • Chemical Composition

    Amlodipine Besylate 6,9 mg Amlodipine 5 mg - Valsartan 160 mg - Hydrochlorothiazide 12,5 mg

  • Packing

    30Coated Tablets

  • Medical Id

    T106

  • License Number

    114/2015

  • License date

    20/5/2015

Excipients Microcrystalline cellulose ‚ Crospovidone ‚Colloidal silicon oxide ‚Magnesium stearate ‚ PEG 4000 ‚Talc ‚TiO2 ‚HPMC ‚Yellow iron oxide ‚Red iron oxide .
Mechanism Of Action The active ingredients of This drug target 3 separate mechanisms involved in blood pressure regulation. Amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; valsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume.
INDICATIONS This drug is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. This fixed combination drug is not indicated for the initial therapy of hypertension
CONTRAINDICATIONS It is contraindicated in: • Patients with anuria, • Patients with hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. • Do not coadminister aliskiren with This drug in patients with diabetes.
Side EFFECTS The most frequent adverse events: Dizziness, Peripheral edema, Headache Dyspepsia, Fatigue, Muscle spasms, Back pain, Nausea, Nasopharyngitis.
WARNINGS Hypotension in Volume- or Salt-Depleted Patients: Symptomatic hypotension may occur in patients receiving angiotensin receptor blockers. Correct this condition prior to administration of this drug. Increased Angina and/or Myocardial Infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. Impaired Renal Function: Patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion may be at particular risk of developing acute renal failure on this drug. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on this drug. Potassium Abnormalities: Some patients with heart failure have developed increases in potassium on valsartan. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required. Hydrochlorothiazide can cause hypokalemia and hyponatremia. Monitor serum electrolytes periodically. If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), This drug should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides. Hypersensitivity Reaction: Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Systemic Lupus Erythematosus:Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Lithium:Monitor lithium levels in patients receiving This drug and lithium, because this combination increases in serum lithium concentrations Metabolic Imbalances: Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level due to reduced its clearance and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving this drug. Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. using in Special Population: Pediatric Use: The safety and effectiveness of this drug in pediatric patients have not been established. Geriatric Use: Exposure to amlodipine is increased in elderly patients, thus consider lower initial doses of drug.
DRUG INTERACTIONS Amlodipine: Simvastatin: Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. CYP3A4 Inhibitors: Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A4 inhibitors to determine the need for dose adjustment. CYP3A4 Inducers: Blood pressure should be monitored when amlodipine is coadministered with CYP3A4 inducers. Valsartan: Potassium: If co-medication is considered necessary, monitoring of serum potassium is advisable. NSAIDs including Selective COX-2 Inhibitors: coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. Dual Blockade of the Renin-Angiotensin System (RAS): Closely monitor blood pressure, renal function, and electrolytes in patients on This drug and other agents that affect the RAS. Aliskiren: Do not coadministeraliskiren with drug in patients with diabetes. Avoid use of aliskiren with drug in patients with renal impairment, Hydrochlorothiazide: Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required. Antineoplastic agents:Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance their myelosuppressive effects. Alcohol, barbiturates, or narcotics: Orthostatic hypotension may occur. Skeletal muscle relaxants:Possible increased responsiveness to muscle relaxants such as curare derivatives. Digitalis glycosides:Thiazide-induced hypokalemia or hypomagnesemia may predispose the patient to digoxin toxicity. Carbamazepine: May lead to symptomatic hyponatremia. Cyclosporine: Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications. Ion exchange resins: When hydrochlorothiazide is administered at least 4 hours before or 4 hours after the administration of resins (e.g.,cholestyramine, colestipol) would potentially minimize the interaction
Pregnancy And lactations Pregnancy :Category D This drug should not be used to treat hypertension during the second and third trimesters pregnancy, when pregnancy is detected, discontinue This drug as soon as possible. Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Dosage And Administration Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Welvas Plus. The maximum recommended dose of This drug is 10/320/25 mg. Add-on / Switch Therapy: This drug may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of This drug may be switched to This drug containing a lower dose of that component to achieve similar blood pressure reductions. Replacement Therapy This drug may be substituted for the individually titrated components. Use with Other Antihypertensive Drugs This drug may be administered with other antihypertensive agents
OVERDOSE The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Storage Conditions Store at room temperature, between 15° – 30 °C Away from moisture . Keep out of reach of children . Prescription only medicine