Lodiptan Plus

Information about Lodiptan Plus
Composition:

Each F.C. tablet contains:

Either: Amlodipine besylate equivalent to 5 mg Amlodipine free base, valsartan 160 mg and hydrochlorothiazide 12.5 mg

Or: Amlodipine besylate equivalentto 10 mg Amlodipine free base, valsartan 160 mg and hydrochlorothiazide 12.5 mg

Pharmacological Properties

Lodiptan Plus is a fixed combination of amlodipine, valsartan and hydrochloro thiazide. These active ingredient starget three separate mechanisms involved in blood pressure regulation.

Specially, amlodipine blocks the contractile effects of calcium on cardiac muscle 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 intravascular volume.

Lodiptan Plus is effective in lowering blood pressure. The three components of Lodiptan Plus lower the blood pressure through complementary mechanisms, each working at a separate site and blocking different effect or pathway.

Lodiptan Plus has not been studied in indications other than hypertension.

Pharmacokinetics: Following and administration of Lodiptan Plus in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and HCTZ are readied in about 6, 3 and 2 hours, respectively. The rate and extent of absorption of components the same as when administered as individual dosage forms.

Indications:

Lodiptan Plus is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy.

Contraindications:

Because of the hydrochlorothiazide component ,Lodiptan Plus is contributed in patients with anuria or hypersensitivity to other sulfonamide drugs.

Warnings and Precautions:

Lodiptan Plus can cause harm to the fetus when administered to a pregnant woman.

Excessive hypotensive, including or thostatic hypotension was seen in patients treated with the maximum dose of Lodiptan Plus (10/320/25). If excessive hypotension occurs, the patient should be placed in supine position and given an intravenous infusion saline, if necessary.

Lodiptan Plus should be avoided in patients with severe hepatic impairment.

Lodiptan Plus should be avoided in patients with severe renal disease (creatinine clearance ≤ 30 ml/min).

Evaluation of patients with heart failure or post myocardial infarction should always include assessment of renal function.

Thiazide diuretics may cause exacerbation or activation of systemic lupus erythematous.

Serum electrolytes should be periodically monitored posted on Lodiptan Plus and other factors such as renal function, other medications, or history of prior electrolyte imbalance.

Hydrochlorothiazide can cause an idiosyncratic reaction, resulting in acute transient myopia andacute angle-closure and acute angle-closure glaucoma Prompt or surgical treatment may be considered.

Side Effect

Adverse reactions have generally been mild and transient in nature and have infrequently required discontinuation of therapy. The most frequent side effects that occurred in theactive controlled clinical trial in the least 2 % of the patients treated with Lodiptan Plus are the following:

Dizziness, edema, headache,dyspepsia, fatigue, muscle spasms, back pain and nausea.

Dosage and Administration:

Generalconsideration

Dose: oncedaily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Lodiptan Plus.

The maximum recommended dose of Lodiptan Plus is 10/320/25 mg.

Lodiptan Plus may be administered with or without food.

No initial dosage adjustment is required for elderly patients.

Renal impairment: The usual regimens of therapy with Lodiptan Plus may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoiduse of Lodiptan Plus.

Hepatic impairment: Avoid Lodiptan Plus in patients with severe hepatic impairment.In patients with lesser degrees of hepatic impairment, monitor for worsening of hepatic or renal function and adverse reactions .

Add-on/switchtherapy

Lodiptan Plus may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptors blockers, and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Lodiptan Plus may be switched to Lodiptan Plus containing a lower dose of that component to achieve similar blood pressure reductions.

Replacement therapy:

Lodiptan Plus may be substituted forthe individually titrated components.

Use in SpecificPopulations

PregnancyCategory D

Pregnancy:Avoid use in pregnancy.

Nursing Matters: Avoid use while nursing-discontinue either nursing or drug.

Geriatric Use: Incontrolled clinical trials, 82 hypertensive patients treated with Lodiptan Pluswere ≥65 years and 13 were ≥75 years. No overall differences in the efficacy orsafety of Lodiptan Plus were observed in this patient population, but greatersensitivity of some older individual cannot be ruled.

The safety and effectiveness of Lodiptan Plus in pediatric have not been established.

Storage

Lodiptan Plus should be stored at room temperature (25° C) protected from moisture.

Packing

Packs of 14  F.C. tablets.

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