Sofvasc HCT 10/320/25mg Tablet 14 ‘S

Description

About

{{Product}} is an antihypertensive (blood pressure lowering) agent which comes as a fixed-dose combination of three active ingredients: Amlodipine, Valsartan, Hydrochlorothiazide. Sofvasc HCT 10/320/25mg Tablet 14 ‘S combines three different chemical groups in one tablet to lower raised blood pressure (Hypertension) levels to normal (120/80mmHg). Hypertension left untreated can cause severe damage to the brain, heart, kidney, blood vessels, and other body organs. A tablet a day of Sofvasc HCT 10/320/25mg Tablet 14 ‘S is prescribed to the patient for the optimum performance of their heart muscles and blood vessels. Sofvasc HCT 10/320/25mg Tablet 14 ‘S may be ingested with or without food and the dose may be lowered for elderly patients and patients with kidney impairment. Given that, Amlodipine is a Calcium channel blocker that works by blocking the entry of calcium ions in the vascular and cardiac smooth muscles membrane, thereby causing relaxation of vasodilatory effect which leads to lowering in blood pressure. This way it increases the supply of oxygen and reduces the workload on the heart. 

Valsartan, on the other hand, is an Angiotensin II receptor blocker that relaxes the blood vessels by inhibiting angiotensin II (involved in vasoconstriction and cardiac stimulation). Hydrochlorothiazide is a diuretic that acts as a water pill which means it increases urination along with the removal of electrolytes like sodium and potassium and hence reduces blood volume that ultimately leading to a reduction in high blood pressure.

Together, these three agents give a significant lowering in blood pressure by working through different pathways. The combination of Amlodipine, Valsartan, and Hydrochlorothiazide is usually taken as 5mg/160/12.5 mg once daily as a starting dose. The maximum daily dose is 10/320/25 mg. 

Indications

{{Product}} is prescribed to hypertensive patients in which high blood pressure is with or without the risk of fatal or nonfatal cardiovascular diseases such as myocardial infarction (heart attack) and stroke. {{Product}} is not given to the patients in which hypertension is newly diagnosed. It is rather indicated as a switch or add-on therapy in patients who are unable to respond to other antihypertensive drugs.

How Does Sofvasc HCT 10/320/25mg Tablet 14 ‘S Work

{{Product}} contains three therapeutically active ingredients which collectively regulate blood pressure. The blood pressure-lowering mechanism of each agent is described below:

Amlodipine

Amlodipine is a vasodilator that reduces peripheral vascular resistance by relaxing the vascular smooth muscles. It blocks the calcium channels present on the membrane junction and prevents the influx of calcium ions in the cardiac and vascular smooth muscles. This way, it causes vasodilation and hence reduces blood pressure. 

Valsartan

Valsartan is an antagonist to the angiotensin II receptor which is the key receptor in the renin-angiotensin system (a fluid, electrolytes, and blood pressure regulating hormone system through renal blood flow). Angiotensin II causes vasoconstriction stimulates aldosterone hormone and reabsorption of sodium from the kidneys. Valsartan opposes these effects to lower blood pressure by reducing aldosterone levels, reducing the workload on the heart, and increasing the excretion of sodium. 

Hydrochlorothiazide 

It’s a thiazide diuretic that works by increasing urination to excrete out sodium, chloride, and potassium ions from the body. This diuretic effect causes a reduction in plasma volume, a rise in renin (an enzyme that regulates blood pressure) activity, and aldosterone secretion (a hormone that maintains salt and water balance in the body). All these effects ultimately lead to a reduction in blood pressure. 

How To Use Sofvasc HCT 10/320/25mg Tablet 14 ‘S

{{Product}} is usually taken as a once-daily dose for oral administration (by mouth). Swallow the whole tablet with a glass full of water irrespective of food. {[Product}} should not be administered with grapefruit juice as it may increase the bioavailability and lead to excessive hypotension.

Dosage

Form and strength

The combination of Amlodipine + Valsartan + Hydrochlorothiazide is available in tablet form  as the following strengths:

• 5MG + 160MG +12.5MG

• 5MG + 160MG + 25MG

• 10MG +160MG + 12.5MG

• 10MG +160MG + 25MG

• 10MG + 320MG + 25MG

Adult Dose

5/160/12.5 mg is the recommended dose at the start of the therapy and is supposed to be taken once daily. There may be an increase in the dose after 2 weeks of treatment depending upon the clinical response. 10mg + 320mg +25 mg per day is the maximum recommended dose. 

Hepatic Impairment 

The maximum recommended dose of valsartan in hepatic impairment (no Cholestasis) is 80mg. So, the dose should be adjusted accordingly in need. However, it is not suitable for this population. 

Pediatric Dose

As the safety and efficacy of Sofvasc HCT 10/320/25mg Tablet 14 ‘S are not built-in pediatric population, it is not suitable to give Sofvasc HCT 10/320/25mg Tablet 14 ‘S to children. 

Pregnancy And Lactation 

{{Product}} should be discontinued as soon as pregnancy is detected as Sofvasc HCT 10/320/25mg Tablet 14 ‘S may directly harm disturb the renin-angiotensin system of the fetus and may cause fetal injury and death. Amlodipine is secreted in the milk of the lactating mother. Hydrochlorothiazide, on the other hand, is excreted in mother’s milk and crosses the placenta as well, so it is advised that Sofvasc HCT 10/320/25mg Tablet 14 ‘S should not be taken by lactating mother. 

Contraindications

{{Product}} is contraindicated in:

• Those who have known hypersensitivity to any of the excipients of active ingredients.

• Those who have a severe renal hepatic impairment or any significant live and kidney disease such as biliary cirrhosis, cholestasis, anuria, dialysis, etc. 

• Patients with refractory hypokalemia (low potassium levels in the blood), hyponatremia (insufficiency of sodium), hyperuricemia (high uric acid in the blood). 

• In pregnant women or breastfeeding mothers. 

• In children and adolescents below 18 years of age. 

• Patients with Type 2 diabetes who are on Aliskiren (Antihypertensive that works by renin inhibition). 

Precautions

Following are the precautions one must take to avoid adverse effects associated with Sofvasc HCT 10/320/25mg Tablet 14 ‘S:

• Avoid using Sofvasc HCT 10/320/25mg Tablet 14 ‘S in the second and third trimester of pregnancy as it has the potential to produce effects on the renal function of the fetus that can lead to fetal death. It can cause oligohydramnios (less amniotic fluid) which leads to lung hypoplasia and skeletal deformation in the fetus. 

• {{Product}} should be discontinued as soon as pregnancy is detected.

• Thiazides can cause jaundice and thrombocytopenia in neonates. So breastfeeding mothers should also avoid using Sofvasc HCT 10/320/25mg Tablet 14 ‘S.

• You should first take the treatment of salt depletion before starting treatment with Sofvasc HCT 10/320/25mg Tablet 14 ‘S. In salt depletion, the patient’s renin-angiotensin system is activated due to which symptomatic hypotension can occur.  The patient should lie down in a supine position and should be given intravenous saline if there is excessive hypotension.

• {[Product}} can cause worsening of angina and acute myocardial infarction with an increase in the dose of Sofvasc HCT 10/320/25mg Tablet 14 ‘S. Patients with severe obstructive coronary artery disease are more vulnerable to developing this. 

• People with heart failure may develop hyperkalemia upon the intake of valsartan. People with renal impairment are more prone to it so Sofvasc HCT 10/320/25mg Tablet 14 ‘S should be administered with a significant reduction in such patients. 

• Serum electrolytes should be monitored along with the treatment so that electrolyte imbalances may be detected. 

• Potassium supplements and potassium-sparing diuretics may increase the levels of potassium that oppose the desired effect so they should be avoided, and potassium monitoring should be carried out at certain intervals. 

• {{Product}} can make you susceptible to sun damage and skin cancer. Hydrochlorothiazide is associated with the risk of non-melanoma skin cancer with long-term use of Sofvasc HCT 10/320/25mg Tablet 14 ‘S. People with a history of non-melanoma skin cancer should be given Sofvasc HCT 10/320/25mg Tablet 14 ‘S with caution.

• {{Product}} should not be administered with grapefruit juice as it increases the bioavailability of Sofvasc HCT 10/320/25mg Tablet 14 ‘S and leads to increased hypotension.   

Interactions With Other Medications

Concomitant administration of the following agents is not indicated with Sofvasc HCT 10/320/25mg Tablet 14 ‘S:

• Lithium 

• Potassium-sparing diuretics (Amiloride, Spironolactone)

• Antifungals (ketoconazole, itraconazole)

• Anticonvulsants (Carbamazepine, Phenytoin)

• COX 2 inhibitors (Rofecoxib) 

• Rifampicin

• Cyclosporin

• Ritonavir

• Vitamin D and Calcium supplements

• Skeletal muscle relaxants (Tubocurarine)

• Methyldopa

• Allopurinol

• Beta-blockers (e.g., Atenolol, Bisoprolol)

• Metformin 

Adverse Effects

Common Adverse Effects

Following are adverse effects associated with any of the active agents in Sofvasc HCT 10/320/25mg Tablet 14 ‘S:

• Dizziness

• Headache

• Edema

• Dyspepsia (discomfort and pain in the upper abdominal region)

• Fatigue and muscle spasm

• Elevation in liver enzymes (Amlodipine induced)

• Jaundice (Amlodipine induced)

• Anemia 

• Hyponatremia

• Hypokalemia

• Hypercalcemia

• Non-melanoma skin cancer

• Acute angle glaucoma

• Uncontrolled diabetes

Potential Adverse Effects 

If overdosed, {{Product} has the potential to cause:

• Tachycardia

• Excessive hypotension

• Shock 

• Circulatory collapse 

• Electrolytes depletion 

• Dehydration

Rare Adverse Effects

• Spontaneous bleeding

• Irregular heart rhythms

• Hepatic disorders

How To Cope with Some of The Adverse Effects

• Dyspepsia – Drink a suitable amount of water, avoid overeating and lying down, take a diet having anti-colic properties such as ginger and mint. Smoking and drinking should also be ceased. 

• Dizziness – Avoid usage of caffeine, alcohol, and drugs that make you feel drowsy. Lifting heavy machinery and driving should also be avoided until you get back to normal. 
• Anemia– Take a diet rich in iron such as beetroot, dates, spinach. Iron administration along with vitamin C helps get hemoglobin levels back to normal. You can also take fresh fruit juices to restore hemoglobin. 
• Dehydration – Drink lots of water to stay hydrated, intake of oral rehydration salt also makes the lost electrolytes back to normal. If there is excessive loss of body fluid, taking an IV fluid hydration is recommended. 

• Headaches– In which case make sure you rest and drink plenty of fluids. Avoid the use of alcohol. Take a prescribed painkiller. Consult your doctor if the headaches last longer than a week or are severe.

• Fatigue – Patients are advised to have a healthy diet with a healthy balance of fruits and vegetables to help reduce fatigue in patients. Avoid unnecessary activities for a few days.

Key Facts

• {{Product}} is a combination of three therapeutically active agents which are Amlodipine, Valsartan, and Hydrochlorothiazide who collectively lower the blood pressure by working through different systemic pathways. 

• {{Product}} is used in patients who have the risk of developing serious cardiovascular diseases such as stroke and heart attack. 

• The goal of the therapy is to reduce the workload on the heart along with the reduction in blood pressure. 

FAQs

Q. WHEN CAN I HAVE A SIGNIFICANT DECLINE IN HIGH BLOOD PRESSURE?

{{Product}} may take 2 weeks of the interval to cure hypertension. You should regularly monitor your blood pressure during the treatment. The healthcare provider makes changes to the dose if there is no significant change in your blood pressure readings. 

Q. IS THERE ANY DIETARY LIMITATION WITH THE USAGE OF {{PRIDUCT}}?

{{Product}} can be administered with or without food at any time of the day. It is advised to take {[product}} at the same time as you have taken the previous dose. 

Q. CAN I DRIVE AFTER TAKING {{PRODUCT}}?

You can drive during the treatment unless you feel dizzy or light-headed. {{Product}} has the potential to cause dizziness as a side effect. So do not drive or lift heavy machinery if you are exposed to this side effect of Sofvasc HCT 10/320/25mg Tablet 14 ‘S. 

Q. WHAT IF I MISS THE DOSE?

{{Product}} is usually taken once daily. You can take the dose as soon as you remember at any time of the day. But beware of doubling the dose as it may expose to the side effects. 

Q. WHAT IF THE DOSE OF {{PRODUCT}} IS DOUBLED?

The dose of Sofvasc HCT 10/320/25mg Tablet 14 ‘S is increased after 1 to 2 weeks of the treatment and the maximum dose should not be exceeded more than 10/320/25 mg per day. In case, if you mistakenly take the dose twice a day, you may suffer from the symptoms of excessive hypertension depending on your clinical condition. If you feel symptoms like dizziness, fast heartbeat, shallow breathing, and cold, you should approach your healthcare provider and take professional aid in minimizing the toxicity. 

Q. MY BLOOD PRESSURE REMAINS NORMAL. SHOULD I DISCONTINUE {{PRODUCT}}?

Even if you feel well, you should not stop taking Sofvasc HCT 10/320/25mg Tablet 14 ‘S abruptly. It may reverse the effects and make you more prone to develop adverse effects. {{Product}} should only be stopped upon the suggestion of your healthcare provider as it is maintaining the function of your vital organ. 

Q. HOW TO STORE {{PRODUCT}}?

Protect Sofvasc HCT 10/320/25mg Tablet 14 ‘S to get exposed to direct sunlight and moisture. It should not be stored above 30°C. 

Q. CAN A BREASTFEEDING MOTHER TAKE {{PRODUCT}}?

Amlodipine is an active agent that releases in breast milk and can cause adverse effects in neonates so it should be avoided in a breastfeeding mother.

Q. CAN {{PRODUCT}} BE TAKEN DURING PREGNANCY?

Discontinue Sofvasc HCT 10/320/25mg Tablet 14 ‘S if pregnancy upon suspicion and confirmation of pregnancy as it crosses the placental barrier and may affect the renin-angiotensin system of the fetus leading to fetal injury. 

Q. CAN LIFESTYLE CHANGES HELP ME WITH MY CONDITION?

Yes. you can adopt certain healthy lifestyle changes to help with high blood pressure. These include quitting smoking, avoiding alcohol, eating a wholesome diet consisting of fresh vegetables and fruits with the cut down of salt, and incorporating physical activity in your daily routine.

Q. DOES Sofvasc HCT 10/320/25mg Tablet 14 ‘S CAUSE ADDICTION?

No. This drug has shown no evidence to prove addiction of any kind in any patient.

Q. IS IT SAFE TO TAKE CHOLESTEROL MEDICINES ALONG WITH Sofvasc HCT 10/320/25mg Tablet 14 ‘S?

Certain cholesterol medications along with calcium channel blockers (amlodipine) cause increased retention of cholesterol medication in the body which may lead to liver and kidney failure and therefore, it is advised to consult a doctor before taking any other medication along with Sofvasc HCT 10/320/25mg Tablet 14 ‘S.

Q. WHAT LAB TESTS WILL BE PRESCRIBED WHILE TREATMENT WITH Sofvasc HCT 10/320/25mg Tablet 14 ‘S AND HOW OFTEN?

Kidney and liver function tests along with blood tests to keep a check on serum potassium levels are advised to be done periodically. It is also advised that patients learn to monitor their blood pressure levels daily from the comfort of their homes and inform their doctor of any changes seen.

Q. IS IT NORMAL TO HAVE INCREASED FREQUENCY OF URINATION WITH Sofvasc HCT 10/320/25mg Tablet 14 ‘S?

Yes. It is completely normal as this drug includes a diuretic that works by decreasing unnecessary fluid retention in the body and thus, lowering raised levels of blood pressure back to normal.

Q. WHY MUST I PROTECT MY SKIN FROM THE SUN WHILE TAKING Sofvasc HCT 10/320/25mg Tablet 14 ‘S?

Sofvasc HCT 10/320/25mg Tablet 14 ‘S can make the skin susceptible to certain non-melanoma cancers of the lip and skin. Patients are advised to wear sunscreen along with hats and gloves whenever possible to protect themselves from sun damage.