ADISARTZ 10mg/160 mg Tablets/Film-coated

What is ADISARTZ 10mg/160 mg

ADISARTZ 10mg/160mg is a prescription medication that combines two active ingredients: Amlodipine, a calcium channel blocker, and Valsartan, an angiotensin II receptor blocker (ARB). It is formulated as enteric-coated tablets to ensure controlled release and better gastrointestinal tolerance.

• Amlodipine helps relax and widen blood vessels, improving blood flow and lowering blood pressure.
• Valsartan works by blocking the effects of angiotensin II, a hormone that tightens blood vessels and increases blood pressure.
• This fixed-dose combination is primarily indicated for the treatment of hypertension (high blood pressure), especially in patients who require more than one agent for adequate blood pressure control.
• ADISARTZ may also reduce the risk of cardiovascular complications such as stroke, heart attack, and kidney damage associated with long-standing hypertension.
• It comes in a packaging of 28 tablets (7-tablet blisters x 4), offering convenience for monthly therapy adherence.

This combination therapy is often used when monotherapy with either drug does not provide sufficient blood pressure control. It should only be used under the guidance of a healthcare provider.

How to use ADISARTZ 10mg/160 mg

To ensure optimal effectiveness and minimize side effects, it is important to use ADISARTZ properly. Here are key usage guidelines:

• Dosage Form: Oral, enteric-coated tablet.
• Recommended Administration: Take one tablet once daily, preferably at the same time each day to maintain consistent blood levels.
• With or Without Food: ADISARTZ can be taken with or without food.
• Swallow Whole: Do not crush, chew, or break the enteric-coated tablet. Swallow it whole with water.
• Consistency: Do not skip doses or stop the medication suddenly unless advised by your doctor, even if you feel well. High blood pressure often has no symptoms.
• If a Dose is Missed: Take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose—do not double the dose to catch up.
• Monitoring: Your blood pressure, kidney function, and electrolyte levels should be regularly monitored during treatment.

Always follow your doctor’s specific instructions. Do not adjust your dose without medical supervision, as this may lead to serious adverse effects or reduced effectiveness.

Mode of Action ADISARTZ 10mg/160 mg

ADISARTZ works through a dual mechanism by combining two complementary antihypertensive agents:

• Amlodipine (10mg):
  • It is a calcium channel blocker (dihydropyridine class).
  • It inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle.
  • By relaxing the arterial walls, it lowers peripheral vascular resistance and blood pressure.
• Valsartan (160mg):
  • An angiotensin II receptor blocker (ARB) that selectively inhibits the AT1 receptor.
  • It prevents angiotensin II from binding, thereby reducing vasoconstriction and aldosterone release.
  • Results in vasodilation, decreased sodium and water retention, and ultimately lower blood pressure.

The combination provides a more potent antihypertensive effect than either drug alone by targeting different mechanisms involved in blood pressure regulation. The synergy between these two agents offers better blood pressure control with a lower risk of compensatory side effects like reflex tachycardia.

ADISARTZ 10mg/160 mg Interactions ADISARTZ 10mg/160 mg

Drug interactions can affect the efficacy or safety of ADISARTZ. Below are important drug interactions to consider:

• Other Antihypertensives: Additive effects may increase the risk of hypotension. Caution when used with beta-blockers, ACE inhibitors, or diuretics.
• NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effects and increase the risk of kidney dysfunction, especially in elderly or volume-depleted patients.
• Potassium Supplements & Potassium-Sparing Diuretics: Risk of hyperkalemia with valsartan. Monitor serum potassium levels closely.
• Simvastatin: Amlodipine may increase plasma concentrations of simvastatin, raising the risk of muscle toxicity. Limit simvastatin to 20mg daily.
• Diuretics (especially loop and thiazide): Can potentiate the antihypertensive effect but may also exacerbate hypotension or electrolyte imbalances.
• Rifampicin and St. John's Wort: May reduce the effectiveness of Amlodipine by inducing its metabolism.
• Lithium: Valsartan may increase lithium toxicity. Monitor serum lithium levels if used together.

Always inform your healthcare provider about all the medications, supplements, and herbal products you are taking before starting ADISARTZ.

Dosage of ADISARTZ 10mg/160 mg

The dosage of ADISARTZ is tailored to individual patient needs, based on the severity of hypertension and response to treatment. The following are general dosage guidelines:

• Standard Adult Dose: One tablet (10mg Amlodipine / 160mg Valsartan) taken orally once daily.
• Titration:
  • If blood pressure is not adequately controlled, dose adjustment may be required based on prior monotherapy tolerance.
  • Start with a lower dose (e.g., ADISARTZ 5mg/160mg) before escalating to 10mg/160mg if needed.
• Elderly Patients: Start cautiously due to potential sensitivity and adjust based on tolerance and renal function.
• Renal or Hepatic Impairment: Use with caution; dose adjustments may be necessary. Not recommended in severe hepatic impairment.
• Pediatric Use: Not recommended in children under 18 due to limited safety data.

Strict adherence to prescribed dosage and routine monitoring of blood pressure and kidney function is essential for safe and effective treatment.

Possible side effects of ADISARTZ 10mg/160 mg

Like all medications, ADISARTZ can cause side effects, although not everyone will experience them. The side effects are usually mild and transient but can sometimes be serious.

• Common Side Effects:
  • Headache
  • Dizziness or lightheadedness, especially on standing (orthostatic hypotension)
  • Peripheral edema (swelling of legs/ankles)
  • Fatigue
  • Flushing or warmth sensation
• Less Common Side Effects:
  • Nausea or abdominal discomfort
  • Palpitations
  • Muscle cramps
  • Increased potassium levels (hyperkalemia)
• Rare but Serious Side Effects:
  • Severe hypotension
  • Kidney dysfunction or failure
  • Allergic reactions (rash, itching, facial swelling)
  • Angioedema (rare but serious swelling of the face, lips, or throat)

If any serious reactions occur, such as difficulty breathing or swelling, seek emergency medical attention immediately.

ADISARTZ 10mg/160 mg Contraindications ADISARTZ 10mg/160 mg

ADISARTZ is contraindicated in several clinical situations due to potential safety risks. Do not use this medication if:

• Known Hypersensitivity: Allergy to amlodipine, valsartan, or any excipients in the formulation.
• Pregnancy: Especially during the second and third trimesters due to risk of fetal toxicity.
• Severe Hepatic Impairment: Due to the metabolism and clearance of both active components.
• Severe Hypotension: Particularly in patients with volume depletion or heart failure.
• Bilateral Renal Artery Stenosis: Risk of renal function deterioration.
• Cardiogenic Shock: In patients with unstable cardiac status or recent myocardial infarction.
• Co-administration with Aliskiren: Especially in diabetic patients due to increased risk of adverse renal outcomes.

Always consult with a healthcare provider before starting therapy to ensure none of these contraindications apply to you.

Storage of ADISARTZ 10mg/160 mg

Proper storage ensures the medication remains effective and safe for use throughout its shelf life. Follow these guidelines:

• Storage Temperature: Store at room temperature, typically between 20°C to 25°C (68°F to 77°F).
• Avoid Excessive Heat or Humidity: Keep away from direct sunlight, moisture, and heat sources (e.g., bathrooms or near kitchen stoves).
• Keep in Original Packaging: Store tablets in their original blister packs to protect from light and moisture.
• Keep Out of Reach of Children: Store in a secure location to avoid accidental ingestion by children or pets.
• Do Not Use After Expiration Date: Check the packaging for expiry and discard any expired tablets safely.

Improper storage can reduce drug effectiveness or lead to breakdown products that may be harmful. Follow all storage instructions provided by your pharmacist or the product leaflet.