Co-Disys 5 mg+80 mg

Indications
The combination of Amlodipine and Valsartan is prescribed for the management of hypertension. This fixed-dose combination is not intended for initial hypertension treatment.
Take this medication as per the guidance of a registered physician.

Pharmacology
Amlodipine is a calcium channel blocker belonging to the dihydropyridine class. It functions by inhibiting the influx of calcium ions across cell membranes in vascular smooth muscle and cardiac muscle, leading to vasodilation. Valsartan, on the other hand, is an angiotensin II receptor blocker (ARB) that selectively inhibits the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. By doing so, it prevents vasoconstriction and aldosterone secretion, contributing to blood pressure reduction. Since these two mechanisms complement each other—calcium channel blockade and angiotensin II inhibition—the combination of Amlodipine and Valsartan effectively lowers blood pressure by reducing peripheral resistance.

Dosage & Administration
For hypertension management, Amlodipine is effective at once-daily doses ranging from 2.5 mg to 10 mg, while Valsartan is effective in doses between 80 mg and 320 mg. Clinical trials using Amlodipine doses of 5 mg–10 mg combined with Valsartan doses of 160 mg–320 mg have demonstrated enhanced antihypertensive effects with increasing doses. The primary blood pressure-lowering effect is typically achieved within two weeks of initiating treatment or adjusting the dose. If necessary, the dose may be increased after 1 to 2 weeks to a maximum of 10/320 mg once daily.

• This combination can be taken with or without food.
• It may be used alongside other antihypertensive medications.
• Patients who do not achieve adequate blood pressure control with Amlodipine or Valsartan alone may be switched to this combination therapy.

Special Populations:

• Elderly Patients: Due to reduced Amlodipine clearance, treatment should generally start at 2.5 mg.
• Renal Impairment: No initial dose adjustment is necessary for mild to moderate renal impairment, but dosage should be increased gradually in cases of severe renal dysfunction.
• Hepatic Impairment: Patients with mild to moderate liver impairment do not require an initial dose adjustment; however, dose titration should be done cautiously in those with hepatic dysfunction.
  Take this medication as per the guidance of a registered physician.

Drug Interactions
No specific drug interaction studies have been conducted for the combination of Amlodipine and Valsartan. However, interaction studies have been performed on each individual component.

Contraindications
This combination therapy should not be used in individuals with known hypersensitivity to any of its components.

Side Effects
The side effects observed with this combination are generally mild and temporary. Common adverse reactions include:

• Peripheral edema
• Nasal congestion
• Sore throat or difficulty swallowing
• Upper respiratory tract infections
• Dizziness

Pregnancy & Lactation

• Pregnancy Category D: This medication should not be used during pregnancy due to potential risks to the fetus.
• It is unclear whether Amlodipine or Valsartan is excreted in human breast milk. Given the potential risks to a nursing infant, a decision should be made to either discontinue breastfeeding or stop the medication, depending on its necessity for the mother.

Precautions & Warnings

• Avoid exposure to this medication during pregnancy or neonatal development.
• Monitor blood pressure regularly to prevent hypotension.
• Patients with severe obstructive coronary artery disease should be warned about the risk of worsening angina or myocardial infarction.
• Dose adjustments should be made cautiously in patients with hepatic impairment or severe renal dysfunction.

Use in Special Populations
The safety and effectiveness of this medication in pediatric patients have not been established.

Therapeutic Class
Combination antihypertensive agents.

Storage Conditions
Store below 30°C, away from light and moisture. Keep out of reach of children