Exforge 5/160mg Tablet

Uses of Exforge 5/160 Tablet

Treats Hypertension (High Blood Pressure)

How does Exforge 5/160 Tablet work?

Amlodipine works by reducing the force at which the heart muscles contract thus reducing blood pressure.

Valsartan works by blocking angiotensin II in the body. Angiotensin II is a natural enzyme present in blood and is secreted by the kidneys. Angiotensin II plays a role in maintaining blood pressure by acting on the blood vessels and release of certain agents that control the volume of blood.

Side Effects of Exforge 5/160 Tablet

• Weakness in arms, hands, legs or feet
• Dizziness
• Stomach pain
• Chills
• Rapid weight gain
• Back pain
• Chest tightness
• Nasal congestion
• Dry mouth
• Visual disturbances
• Heartburn
• Difficulty in breathing
• Cough
• Pruritus
• Muscle pain
• Ear pain
• Diarrhea
• Nausea and Vomiting
• Headache
• Loss of appetite

Quick Suggestions:

• Amlodipine + Valsartan is a combination of two medicines that provides better blood pressure control than either medicine alone.
• Amlodipine + Valsartan may cause dizziness or sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
• It may cause you to feel lightheaded or weak especially when you stand up.  Rise slowly if you have been sitting or lying down.
• Avoid consuming alcohol as it may enhance the blood pressure-lowering effect of this medicine.
• It can cause ankle or foot swelling. Raise your legs while you are sitting down and talk to your doctor if it does not go away.
• Do not take Amlodipine + Valsartan if you are pregnant, planning to conceive, or breastfeeding.

Indication of Exforge 5/160 Tablet

Exforge 5/160 Tablet is an antihypertensive medicine used in the treatment of individuals with high blood pressure. 

Pharmacology

Amlodipine, as a dihydropyridine calcium channel blocker, works by inhibiting the flow of calcium ions through the cell membrane of vascular smooth muscle and myocardium. By blocking calcium entry, it causes relaxation of the blood vessels, resulting in vasodilation. This helps to reduce peripheral resistance and lower blood pressure.

On the other hand, Valsartan is an angiotensin II receptor blocker. It selectively blocks the binding of angiotensin II to AT1 receptors in various tissues, such as vascular smooth muscle and adrenal glands. By blocking the vasoconstrictive effects of angiotensin II, Valsartan reduces the constriction of blood vessels, leading to vasodilation. Additionally, it inhibits aldosterone secretion, which helps to decrease sodium and water retention.

Both Amlodipine and Valsartan have been proven effective in lowering blood pressure. While Amlodipine primarily acts by blocking calcium entry and reducing peripheral resistance, Valsartan primarily works by blocking the effects of angiotensin II. These mechanisms of action are complementary, as they target different aspects of blood pressure regulation.

The combination of Amlodipine and Valsartan in medications like Exforge 5/160 Tablet provides a dual approach to lowering blood pressure, combining the vasodilatory effects of calcium channel blockade with the inhibition of angiotensin II-mediated vasoconstriction and aldosterone secretion.

Dosage & Administration of Exforge 5/160 Tablet

In the treatment of hypertension, Amlodipine is generally prescribed in once-daily doses ranging from 2.5 mg to 10 mg, while Valsartan is prescribed in doses ranging from 80 mg to 320 mg. Clinical trials with Exforge 10/160 Tablet, which combines Amlodipine and Valsartan, have shown that the antihypertensive effects increase with higher doses of both medications. The majority of the antihypertensive effect is usually achieved within 2 weeks after starting the therapy or adjusting the dose.

The initial dosage of Exforge 5/160 Tablet can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily, depending on the individual's blood pressure control needs. This combination medication can be taken with or without food and may be used in combination with other antihypertensive agents.

For elderly patients, it is important to note that Amlodipine is cleared from the body at a slower rate. Therefore, therapy with Exforge 5/160 Tablet is usually initiated at a lower dose of 2.5 mg in this population.

In the case of renal impairment, no initial dosage adjustment is typically necessary for patients with mild or moderate renal impairment. However, in patients with severe renal impairment, the medication should be titrated slowly.

For patients with hepatic impairment, no initial dosage adjustment is usually required for those with mild or moderate liver insufficiency. However, in patients with hepatic impairment, the medication should be titrated slowly.

Take Exforge 5/160 Tablet as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Try to take Exforge 5/160 Tablets at the same time each day.

Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight, and health condition. Continue to take Exforge 5/160 Tablet for the stipulated duration instructed by your doctor without any interruption to achieve better results.

Interaction

Drug-Drug Interactions:

It's important to inform your doctor if you are taking any medications before starting Exforge 5/160 Tablet. There are several drugs that may interact with Exforge 5/160 Tablet, including:

• Other medicines used to treat elevated blood pressure: These may include aliskiren, captopril, enalapril, lisinopril, verapamil, diltiazem, losartan, and other medications used to lower blood pressure.
• Medicines used to treat depression: Lithium and St. John's wort, which are commonly used to treat depression, may interact with Exforge 5/160 Tablet.
• Potassium supplements or potassium-sparing diuretics: Medications such as spironolactone, triamterene, or amiloride, which are used to retain or increase potassium levels in the body, may interact with Exforge 5/160 Tablet.
• Non-steroidal anti-inflammatory drugs (NSAIDs): Medications like indomethacin, celecoxib, ibuprofen, and aspirin, which are commonly used for pain relief, may interact with Exforge 5/160 Tablet.
• Other medications: Heparin (used to prevent or treat blood clots), antibiotics like erythromycin, clarithromycin, telithromycin, trimethoprim, medications to suppress the immune system, dantrolene (used to treat muscle spasms), HIV medications, antifungal medications, digoxin, simvastatin (used to lower cholesterol), baclofen (a muscle relaxant), amifostine (used as a kidney protectant), medications for mental disorders, and corticosteroids like prednisolone may all interact with Exforge 5/160 Tablet.
• It's essential to inform your doctor about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements, to avoid any potential interactions or adverse effects.

Drug-Food Interaction: 

• It is recommended to avoid consuming grapefruit or drinking grapefruit juice while taking Exforge 5/160 tablets. Grapefruit can interfere with the metabolism of certain medications, including Amlodipine, which is one of the components of Exforge 5/160 Tablet. This can increase the concentration of the medication in the body and potentially lead to an increased risk of side effects. Therefore, it's important to follow your doctor's advice and avoid grapefruit products while on this medication.

As always, it's crucial to consult with your doctor or pharmacist for personalized advice regarding potential drug interactions and the specific medications you are taking. They can provide you with detailed guidance and ensure your medications are safe and effective for your individual circumstances.

Contraindications

• If you are allergic to amlodipine or valsartan or any ingredients of Exforge 5/160 Tablet.
• If you are pregnant or may be pregnant.
• If you have any medical conditions such as liver or kidney disease or any kind of heart disorder.
• If you have diabetes or kidney-related disorders and taking Aliskiren to treat high blood pressure.

Pregnancy & Lactation

It is important to note that the FDA uses a pregnancy category system to classify the potential risks of medications to pregnant individuals. The categories range from Category A (well-controlled studies showing no risk) to Category X (evidence of fetal risk outweighs any potential benefits).

Based on the information you provided, it is stated that Exforge 5/160 Tablet is not known to be excreted in human milk. However, due to the potential risk of harm to the nursing child, a decision should be made considering whether to discontinue breastfeeding or stop taking the medication, taking into account the value of the drug to the mother.

It is crucial to consult with a healthcare professional, such as a doctor or pharmacist, to discuss the specific risks and benefits of continuing or discontinuing medication while breastfeeding. They can provide personalized advice based on your individual circumstances and guide you in making an informed decision that prioritizes both your health and the well-being of your child.

Precautions & Warnings

• Hypotension: Symptomatic low blood pressure may occur in patients with volume depletion or those who are on high doses of diuretics. It is advisable to correct this condition before starting treatment with Exforge 5/160 Tablet.
• Hyperkalemia: Exforge 5/160 Tablet may increase potassium levels in the blood, leading to hyperkalemia. It is important to avoid potassium-rich foods and other medications that can increase potassium levels, such as potassium-sparing diuretics and potassium supplements, during treatment with this medication.
• Pediatric population: Exforge 5/160 Tablet is not recommended for use in children, as its safety and efficacy have not been clinically established in this population.
• Primary hyperaldosteronism: This medication is not recommended for use in patients with primary hyperaldosteronism, as it may worsen the condition. It is advisable to consider a suitable alternative under the supervision of a doctor.
• Renal artery stenosis: Exforge 5/160 Tablet should be used with caution in patients with renal artery stenosis due to the increased risk of severe adverse effects. Close monitoring of kidney function is recommended, and dose adjustments or alternative treatments may be necessary based on the individual's clinical condition.
• Driving and operating machines: This medication may cause dizziness or drowsiness in some patients. If you experience these symptoms, it is advised not to engage in activities that require high mental alertness, such as driving or operating machinery.
• Impaired liver function: Exforge 5/160 Tablet should be used with caution in patients with liver diseases due to the increased risk of severe adverse effects. Close monitoring of liver function is recommended, and dose adjustments or alternative treatments may be necessary based on the individual's clinical condition.
• Aortic stenosis: Extreme caution should be exercised when using Exforge 5/160 Tablet in patients with aortic stenosis due to the increased risk of very low blood pressure. Close monitoring of blood pressure is advised, and dose adjustments or alternative treatments may be required based on the individual's clinical condition.
• Impaired renal function: This medication should be used with caution in patients with kidney diseases due to the increased risk of severe adverse effects. Close monitoring of kidney function and electrolyte levels is recommended, and dose adjustments or alternative treatments may be necessary based on the individual's clinical condition.

Storage Conditions

Store it in a cool and dry place away from light and moisture. Keep it out of the reach of children and pets.