Valdipin 5 mg + 160 mg Tablet

Valdipin 5 mg + 160 mg tablet by Renata PLC is a prescription medicine containing Amlodipine + Valsartan. In Bangladesh, it is mainly used to treat high blood pressure when combination therapy is appropriate.

Amlodipine + Valsartan works by relaxing blood vessels: amlodipine blocks calcium entry into vascular smooth muscle, and valsartan blocks angiotensin II receptors. A key caution is that it must not be used during pregnancy because valsartan can harm the unborn baby.

• Treatment of hypertension in adults.
• May be used when blood pressure is not adequately controlled with amlodipine or valsartan alone, or as a substitute for patients already taking both components separately.

The dose and strength should be selected by a registered doctor based on current blood pressure, previous antihypertensive treatment, kidney/liver status, age, and tolerability. It is usually taken once daily, with or without food, at the same time each day. Do not start, stop, or change the dose without medical advice.

• Common: ankle or leg swelling, dizziness, headache, flushing, tiredness, nausea, abdominal discomfort, and palpitations.
• May cause low blood pressure, especially after the first doses or in dehydrated patients.
• Valsartan may increase blood potassium or affect kidney function, particularly in susceptible patients.
• Serious but uncommon: fainting, severe allergic reaction or angioedema, chest pain worsening, marked reduction in urine, severe skin reactions, or signs of liver problems. Seek urgent medical help if these occur.

Use caution in patients with kidney disease, liver disease, heart failure, aortic or mitral valve stenosis, dehydration, low salt levels, high potassium, or those taking diuretics. Blood pressure, kidney function, and potassium may need monitoring. Avoid becoming dehydrated, and rise slowly from sitting or lying positions if dizziness occurs. Use this medicine only under the guidance of a registered doctor or pharmacist.

• ACE inhibitors, aliskiren, or other medicines affecting the renin-angiotensin system may increase the risk of low blood pressure, high potassium, and kidney problems; aliskiren must not be used with valsartan in patients with diabetes.
• Potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, and trimethoprim may increase potassium levels.
• NSAIDs such as ibuprofen, diclofenac, or naproxen may reduce blood pressure control and increase kidney risk, especially in older or dehydrated patients.
• Lithium levels may increase and cause toxicity when used with valsartan.
• Strong CYP3A4 inhibitors such as clarithromycin, ketoconazole, itraconazole, ritonavir, or grapefruit products may increase amlodipine exposure and side effects.
• Rifampicin, carbamazepine, phenytoin, or St John's wort may reduce amlodipine effect.
• Amlodipine can increase simvastatin exposure; the doctor may limit the simvastatin dose.

• Known hypersensitivity to amlodipine, valsartan, other dihydropyridine calcium channel blockers, or any component of the tablet.
• Pregnancy, especially after the first trimester; it should be stopped as soon as pregnancy is detected unless a doctor advises an alternative plan.
• Concomitant use with aliskiren in patients with diabetes.
• Severe hepatic impairment, biliary cirrhosis, or cholestasis.
• Severe low blood pressure or shock, including cardiogenic shock.

Amlodipine + Valsartan is not recommended in pregnancy and is contraindicated after the first trimester because medicines like valsartan can cause fetal injury or death. Patients planning pregnancy or who become pregnant should contact a doctor promptly for a safer alternative. Breastfeeding is generally not recommended during treatment, especially for newborn or premature infants, unless a doctor decides the benefit outweighs the risk.

Store at room temperature, protected from moisture, heat, and direct sunlight. Keep tablets in the original packaging and out of the reach of children. Do not use after the expiry date.