ADISARTZ 5mg/160 mg Tablets/Film-coated

What is ADISARTZ 5mg/160 mg

ADISARTZ^® is a fixed-dose, enteric-coated tablet that combines two well-established antihypertensives—amlodipine 5 mg and valsartan 160 mg—into a single once-daily medicine. The formulation is supplied in calendarised packs of 28 tablets (4 × 7) to encourage adherence in adults whose blood pressure remains uncontrolled on either agent given alone or on the free combination.

• Active ingredients: 5 mg amlodipine besylate (equivalent to 5 mg base) + 160 mg valsartan.
• Pharmacological classes: Amlodipine is a long-acting dihydropyridine calcium-channel blocker (CCB); valsartan is an angiotensin-II type-1 receptor blocker (ARB).
• Therapeutic indication: First-line treatment of essential hypertension or as add-on therapy when monotherapy is insufficient; may also be used to help achieve tighter blood-pressure targets in high cardiovascular-risk patients.
• Why combine? The agents act on distinct pathways—amlodipine causes peripheral arteriolar dilation, whereas valsartan blocks vasoconstrictive and volume-expanding effects of angiotensin II—yielding additive BP reduction and fewer dose-limiting adverse reactions than higher-dose monotherapy.
• Clinical benefits: Randomised trials show ≥20/15 mmHg mean office BP reduction in up to 70 % of previously uncontrolled patients, with early onset (≤1 week) and durable control (>24 months).
• Dosing convenience: The enteric coat shields valsartan from gastric acidity, allowing reliable once-daily intake with or without meals and obviating poly-tablet regimens.
• Regulatory status: Approved across multiple MENA markets and manufactured under GMP conditions; bioequivalent to separately administered components.
• Proprietary note: “ADISARTZ” is a brand name; functionally equivalent fixed-dose combinations may be sold under other trademarks.

How to use ADISARTZ 5mg/160 mg

ADISARTZ is intended for oral use, one tablet daily. Consistency—same hour, same conditions—reinforces adherence and stabilises plasma levels.

• Starting therapy: Replace separate amlodipine and valsartan tablets with the equivalent fixed dose the next morning, or initiate after documenting inadequate control on either monotherapy.
• Dosing schedule: Take each morning with water; evening dosing is acceptable if peripheral oedema develops.
• With or without food: Meals do not meaningfully alter exposure; nonetheless, avoid grapefruit products (raise amlodipine levels).
• Missed dose: Take the same day when remembered; skip if the next day’s dose is imminent—never double up.
• Titration: Re-evaluate BP after 4–6 weeks; escalate to 10/160 mg or 10/320 mg, or add a thiazide diuretic if needed.
• Special populations: • Renal impairment: No preset adjustment for eGFR 30–89 mL/min/1.73 m²—monitor creatinine/potassium. • Hepatic impairment: Avoid in Child–Pugh C; use cautiously in A/B. • Elderly: Start low and monitor orthostatic BP.
• Concomitant drugs: Introduce gradually when combined with other antihypertensives to avoid excessive hypotension.
• Patient counselling tips: Keep a home BP diary, reduce dietary salt, maintain healthy weight, and report ankle swelling, dizziness, or facial swelling promptly.

Mode of Action ADISARTZ 5mg/160 mg

ADISARTZ targets complementary regulatory pathways of vascular resistance and fluid balance.

• Amlodipine (CCB): Blocks L-type calcium channels in arterial smooth muscle → arteriolar dilation → ↓ systemic vascular resistance with minimal effect on heart rate or contractility.
• Valsartan (ARB): Selectively antagonises AT₁ receptors → prevents vasoconstriction, aldosterone release, sodium retention, and sympathetic drive while sparing bradykinin.
• Additive BP reduction: Combining peripheral dilation with renin–angiotensin blockade offsets compensatory mechanisms (reflex tachycardia, renin surge), yielding greater BP fall than either agent alone.
• Renal effects: Efferent arteriolar dilation (valsartan) plus afferent dilation (amlodipine) lowers intraglomerular pressure and proteinuria without compromising GFR.
• End-organ protection: Trials document regression of left-ventricular hypertrophy, improved arterial compliance, and reduced micro-albuminuria.
• Time course: Amlodipine onset 24–48 h; valsartan peak 2–4 h; maximal combined BP lowering in 4–6 weeks.
• Pharmacokinetics: Minimal interaction—amlodipine metabolised by CYP3A4; valsartan largely excreted unchanged.

ADISARTZ 5mg/160 mg Interactions ADISARTZ 5mg/160 mg

Most interactions derive from amlodipine’s CYP3A4 metabolism and valsartan’s effects on the renin–angiotensin–aldosterone system (RAAS).

• CYP3A4 inhibitors: Azoles, macrolides, protease inhibitors, grapefruit juice ↑ amlodipine levels → oedema/hypotension.
• CYP3A4 inducers: Rifampicin, carbamazepine, phenytoin, St John’s wort ↓ amlodipine efficacy.
• Potassium-raising agents: ACEIs, aliskiren, potassium-sparing diuretics, trimethoprim — risk of hyperkalaemia.
• NSAIDs: May blunt valsartan’s antihypertensive action and precipitate AKI, especially in the elderly/dehydrated.
• Diuretics & other antihypertensives: Additive BP drop—monitor for symptomatic hypotension when starting or up-titrating.
• Lithium: Risk of lithium accumulation and neurotoxicity; monitor levels.
• Simvastatin > 20 mg: OATP1B1 competition with amlodipine ↑ simvastatin exposure—limit dose or use alternative statin.
• Digoxin: Slight ↑ digoxin AUC—check levels in narrow therapeutic-index situations.
• Alcohol/CNS depressants: Enhanced orthostatic symptoms—caution patients.
• Dual RAAS blockade: Valsartan + ACEI/aliskiren ↑ renal events without clear BP benefit—generally avoid.

Check electrolytes and renal function 1–2 weeks after adding interacting drugs, and counsel patients to declare OTC/herbal products and avoid grapefruit.

Dosage of ADISARTZ 5mg/160 mg

• Usual adult dose: 1 tablet (5/160 mg) once daily.
• From monotherapy: Switch when BP uncontrolled on amlodipine 5 mg or valsartan 160 mg alone.
• Titration: Reassess after 4–6 weeks; if BP remains above target, step to 10/160 mg, 10/320 mg, or add thiazide.
• Maximum: 10 mg amlodipine + 320 mg valsartan daily (±HCT).
• Renal impairment: No preset change for eGFR 30–89 mL/min/1.73 m²; avoid if eGFR < 30 without specialist input.
• Hepatic impairment: Contra-indicated in Child–Pugh C; use lower strengths cautiously in A/B.
• Elderly: Consider starting at half-strength or alternate-day dosing.
• Pediatric use: Not established—avoid.
• Dose omissions/overdose: Skip forgotten doses near next schedule; overdose manifests as profound hypotension—treat supportively (IV fluids, calcium, vasopressors).

Lifestyle measures—salt restriction, weight optimisation, physical activity—remain essential irrespective of drug dose.

Possible side effects of ADISARTZ 5mg/160 mg

• Very common (≥ 10 %): Peripheral ankle oedema (amlodipine-related).
• Common (1–10 %): Dizziness, flushing, palpitations, fatigue, mild GI upset, nasopharyngitis, headache.
• Uncommon (0.1–1 %): Symptomatic hypotension, hyperkalaemia, mild creatinine rise, gingival hyperplasia, rash, muscle cramps.
• Rare (< 0.1 %): Angioedema, cholestatic jaundice, exfoliative dermatitis, agranulocytosis, rhabdomyolysis (with statins).
• Very rare/post-marketing: Gynecomastia, sprue-like enteropathy (class effect ARBs).

Monitor: Sudden facial/laryngeal swelling, excessive hypotension (< 90/60 mmHg), unexplained renal impairment—seek prompt medical attention.

Laboratory checks: renal function/electrolytes baseline + 1–2 weeks post-dose change; liver enzymes if jaundice/pruritus. Discontinuation rates in trials parallel placebo, underscoring favourable tolerability when monitored appropriately.

ADISARTZ 5mg/160 mg Contraindications ADISARTZ 5mg/160 mg

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Relative contraindications warranting specialist input include bilateral renal-artery stenosis, uncompensated NYHA IV heart failure, unstable angina, and significant electrolyte disturbances.

Storage of ADISARTZ 5mg/160 mg

• Temperature: Store below 30 °C (86 °F); brief excursions ≤ 40 °C for < 24 h are acceptable.
• Humidity: Keep tablets in the original alu-alu blisters until use.
• Light: Shield from direct sunlight; use outer carton or opaque pillbox during transport.
• Handling: Do not cut, crush, or split the tablet—the enteric coat is integral.
• Travel: Carry in hand luggage; avoid aircraft hold extremes.
• Disposal: Return expired tablets to pharmacy take-back; do not flush.
• Shelf-life: 24 months under controlled room conditions—check the blister expiry date.
• Child safety: Store out of sight and reach; a single dose can induce hypotension in toddlers.

For residents in hot climates, consider an insulated container (not a fridge) and inspect tablets periodically for discolouration, chipping, or swelling—discard compromised units and obtain a fresh supply.