Exforge HCT

Generic name:

Amlodipine Besylate; Valsartan; Hydrochlorothiazide

Drug class:

Calcium channel blocker (dihydropyridine); Angiotensin II receptor blocker; Thiazide diuretic

Dosage form:

Oral tablets

Route of administration:

Oral

Dose:

• Amlodipine 5–10 mg / Valsartan 160–320 mg / Hydrochlorothiazide 12.5–25 mg once daily
• Common strengths: 5/160/12.5 mg, 10/160/12.5 mg, 5/320/12.5 mg, 10/320/12.5 mg, 5/160/25 mg, 10/160/25 mg, 5/320/25 mg, 10/320/25 mg
• Adjust based on blood pressure response and tolerability

Mechanism of action:

Amlodipine inhibits L-type calcium channels in vascular smooth muscle, reducing peripheral resistance; Valsartan selectively blocks the angiotensin II type-1 (AT₁) receptor, decreasing vasoconstriction and aldosterone release; Hydrochlorothiazide inhibits sodium reabsorption in the distal renal tubule, increasing diuresis and reducing plasma volume.

Drug usage cases:

• Essential hypertension insufficiently controlled by mono- or dual therapy
• Initial therapy in patients requiring three antihypertensive agents
• Off-label: hypertension with comorbid renal insufficiency under close monitoring

Drug contra indications:

• Hypersensitivity to amlodipine, valsartan, hydrochlorothiazide, sulfonamides, or any component
• Anuria
• Severe renal impairment (creatinine clearance < 30 mL/min) without monitoring
• Severe hepatic impairment
• Second and third trimester of pregnancy
• Concomitant use with aliskiren in diabetic or renal impaired patients
• Obstructive uropathy

Side effects:

• Peripheral edema
• Dizziness, headache, fatigue
• Cough
• Hypotension
• Hyperuricemia, gout attacks
• Electrolyte imbalances: hypokalemia, hyponatremia, hypomagnesemia
• Renal impairment
• Elevated blood glucose
• Orthostatic hypotension
• Palpitations
• Sexual dysfunction
• Photosensitivity reactions

Warnings:

• Monitor blood pressure, renal function, and electrolytes regularly
• Correct volume depletion before initiation to reduce hypotension risk
• Risk of electrolyte disturbances; monitor potassium, sodium, magnesium, and uric acid
• Use caution in patients with hepatic impairment; rare cholestatic hepatitis reported
• Avoid in patients with significant left ventricular dysfunction
• ARB-associated angioedema risk; discontinue if it occurs
• Photosensitivity: advise sun protection
• May exacerbate systemic lupus erythematosus

Use during pregnancy or breastfeeding:

Pregnancy: Contraindicated in the second and third trimesters due to fetal toxicity (renal failure, oligohydramnios, skull hypoplasia). If pregnancy is detected, discontinue immediately. Use in the first trimester only if no alternative. Breastfeeding: Amlodipine and valsartan excrete into breast milk in low amounts; hydrochlorothiazide can inhibit lactation and cause electrolyte disturbances in the infant. Breastfeeding not recommended; if unavoidable, monitor infant for hypotension, renal function, and electrolyte balance.