| Composition |
This drug film-coated tablets are formulated in five strengths with a combination of amlodipine besylate, valsartan and hydrochlorothiazide.
The following chart contains different strength of Tri-Pland and content of each film coated tablet:
- Tri-Pland 5\160\12.5: 5 mg Amlodipine , 160 mg Valsartan, 12.5 mg Hydrochlorothiazide
- Tri-Pland 10\160\12.5: 10 mg Amlodipine , 160 mg Valsartan, 12.5 mg Hydrochlorothiazide
- Tri-Pland 5\160\25: 5 mg Amlodipine , 160 mg Valsartan, 25 mg Hydrochlorothiazide
- Tri-Pland 10\160\25: 10 mg Amlodipine , 160 mg Valsartan, 25 mg Hydrochlorothiazide
- Tri-Pland 10\320\25: 10 mg Amlodipine , 320 mg Valsartan, 25 mg Hydrochlorothiazide |
| Pharmacodynamics properties |
The active ingredients of this drug target three 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. |
| Therapeutic indications |
| This drug (amlodipine, valsartan, hydrochlorothiazide) is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension. |
| Side effect |
THIS DRUG may cause side effects including:
• harm to an unborn baby causing injury or death.
• low blood pressure (hypotension).
• Low blood pressure is most likely to happen if you: take water pills, are on a low salt diet, have heart problems, get dialysis treatments, get sick with vomiting or diarrhea and drink alcohol.
• Kidney problems.
Kidney problems in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of this drug.
• Laboratory blood test changes in people with congestive heart
failure. Some people with congestive heart failure who take valsartan, one of the medicines in this drug, have changes in blood tests including increased potassium and decreased kidney function.
• Allergic reactions
• Skin rash.
The most common side effects of this drug include: dizziness, swelling (edema) of the hands, ankles, or feet, headache, indigestion, tiredness, muscle spasms, back pain and nausea. |
| Warnings and precautions |
AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue this drug as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury or death to the fetus.
Fetal/Neonatal Morbidity and Mortality
This drug can cause harm to the fetus when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Hypotension in Volume- or Salt-Depleted Patients
was seen in 1.7% of patients treated with the maximum dose of This drug (10/320/25 mg).
This drug has not been studied in patients with heart failure, recent myocardial infarction, or in patients undergoing surgery or dialysis.
Angina and/or Myocardial Infarction
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration or severity of angina or acute myocardial infarction upon starting calcium channel blocker therapy or at the time of dosage increase.
Electrolytes and Metabolic Imbalances
In the controlled trial of this drug in moderate to severe hypertensive patients, the incidence of hypokalemia.
Impaired Hepatic Function
Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with impaired hepatic function.
Therefore, avoid the use of this drug in patients with severe hepatic impairment. When administering this drug to patients with mild-tomoderate hepatic impairment, including patients with biliary obstructive disorders, monitor for worsening of hepatic or renal function, including
fluid status and electrolytes, and adverse reactions.
Impaired Renal Function
Avoid use of this drug in severe renal disease (creatinine clearance ≤30 mL/min). The usual regimens of therapy with this drug may be followed if the patient’s creatinine clearance is >30 mL/min.
There is no experience in the use of this drug in patients with a recent kidney transplant. |
| Contraindication |
| Because of the hydrochlorothiazide component, This drug is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. |
| Pregnancy and lactation |
PREGNANCY:
Pregnancy Category D Valsartan, like other drugs that act on the renin angiotensin system, can
cause fetal and neonatal morbidity when used during the second or third trimester of pregnancy. If This drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Nursing Mothers:
It is not known whether amlodipine and valsartan are excreted in human milk, but thiazides are excreted in human milk. 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. |
| Drug interactions |
No drug interaction studies have been conducted with this drug and other drugs, although studies have been conducted with the individual components.
Amlodipine
In clinical trials, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, longacting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
Cimetidine: Co-administration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine.
Grapefruit juice: Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.
Digoxin: Co-administration of amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
Warfarin: Co-administration of amlodipine with warfarin did not change the warfarin prothrombin response time.
Valsartan
No clinically significant pharmacokinetic interactions were observed when valsartan was co-administered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin.
Co-administration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin.
Hydrochlorothiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: Additive effect or potentiation.
Corticosteroids: Intensified electrolyte depletion, particularly hypokalemia.
Non-steroidal anti-inflammatory drugs: In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic.
Carbamazepine: May lead to symptomatic hyponatremia. |
| Dosage and Method of administration |
General Considerations
Dose once-daily.
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 this drug.
The maximum recommended dose of Tri-Pland is 10/320/25 mg.
This drug may be administered with or without food.
No initial dosage adjustment is required for elderly patients.
Renal impairment
The usual regimens of therapy with this drug may be followed if the patient’s creatinine clearance is >30 mL/min.
In patients with more severe renal impairment, so avoid use of this drug.
Hepatic impairment
Avoid this drug 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 / Switch Therapy
This drug may be used for patients not adequately controlled on any two 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. |
| Overdose |
Limited data are available related to over dosage in humans.
The most likely manifestations of over dosage would be hypotension and tachycardia. |
| Package |
10 film coated tablets packed in a cartoon box with a leaflet.
30 film coated tablets packed in a cartoon box with a leaflet. |
| Storage |
| Store at 15-30°C, Protect from moisture. |
