AMTEL 80/10MG TABS 30S

Amtel 80/10mg is a fixed-dose combination antihypertensive tablet containing telmisartan 80 mg and amlodipine 10 mg, two complementary mechanisms in a single tablet to improve patient adherence and blood pressure control.

Telmisartan is a long-acting, highly selective angiotensin II type 1 (AT1) receptor blocker. It prevents angiotensin II from constricting blood vessels and promoting sodium retention, thereby lowering blood pressure and reducing the risk of cardiovascular events. Amlodipine is a third-generation dihydropyridine calcium channel blocker (CCB) that relaxes vascular smooth muscle by blocking L-type calcium channels, reducing peripheral vascular resistance.

The combination targets two different pathways in hypertension, providing additive blood pressure reduction with fewer side effects than using high doses of either agent alone. In Kenya, this combination is increasingly preferred in patients with uncontrolled hypertension on monotherapy, particularly those with concurrent diabetes or chronic kidney disease.

Approved Indications

•       Hypertension not adequately controlled by either telmisartan or amlodipine alone

•       Hypertension with concurrent type 2 diabetes mellitus

•       Hypertension with chronic kidney disease (CKD) with proteinuria

•       Hypertension with high cardiovascular risk (post-MI, stable angina, atherosclerosis)

•       As substitution therapy for patients already on separate telmisartan and amlodipine

General Instructions

Take one tablet once daily, with or without food. Swallow whole with a glass of water. Take at the same time each day for consistent blood pressure control. Avoid taking with grapefruit juice.

Dosage, Adults

Amtel 80/10mg: one tablet once daily. Do not exceed one tablet per day. This is the higher-strength combination; ensure the patient has been titrated appropriately.

Elderly Patients

Use with caution. Start with the lower-strength combination (Amtel 80/5mg) if tolerated. Monitor for excessive hypotension and ankle oedema.

Missed Dose

Take as soon as remembered on the same day. If the next day, skip the missed dose; do not double up.

Duration of Treatment

Antihypertensive therapy is typically lifelong. Do not stop without consulting your doctor, even if blood pressure readings appear normal.

Common Side Effects

•       Peripheral oedema (ankle/foot swelling), more common with the 10 mg amlodipine component

•       Dizziness and lightheadedness, especially on standing (postural hypotension)

•       Flushing and facial warmth (amlodipine effect)

•       Headache

•       Fatigue

Less Common Side Effects

•       Palpitations

•       Upper respiratory tract infection

•       Back pain and joint pain

•       Nausea and abdominal discomfort

•       Hyperkalaemia (particularly in patients with diabetes or CKD)

Serious / Seek Immediate Medical Attention

•       Severe hypotension, especially after the first dose in volume-depleted patients

•       Acute kidney injury in patients with bilateral renal artery stenosis

•       Angioedema (rare, swelling of face, lips, tongue, throat); seek emergency care immediately

•       Monitor blood pressure and renal function regularly, especially in the first month of therapy.

•       Volume-depleted patients (from diuretics, poor intake, vomiting) are at high risk of first-dose hypotension; correct dehydration before initiating.

•       Ankle oedema from amlodipine is common and should be distinguished from heart failure-related oedema.

•       In Kenyan patients, co-administration with herbal remedies (e.g., neem, hibiscus/sobolo) may potentiate hypotension; enquire routinely.

•       Avoid during breastfeeding; telmisartan is excreted in breast milk.

•       Liver impairment: telmisartan is almost exclusively eliminated by biliary excretion; use with caution and at lower doses in hepatic disease.

•       Hyperkalaemia risk is elevated in patients with diabetes, CKD, or on potassium-sparing diuretics.

Always inform your pharmacist and prescriber about all medicines, supplements, and herbal remedies you are currently taking.

ACE inhibitors (e.g., enalapril, lisinopril): Dual RAAS blockade, increased risk of hypotension, hyperkalaemia, and renal failure

Aliskiren: Contraindicated in diabetics and renal impairment; avoid combination

Potassium-sparing diuretics/potassium supplements: Increased hyperkalaemia risk with telmisartan

Lithium: ARBs may increase lithium levels; monitor carefully

NSAIDs: Reduced antihypertensive effect; increased risk of renal dysfunction

CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole): May increase amlodipine plasma concentrations

Simvastatin: Amlodipine inhibits CYP3A4, may increase simvastatin exposure; cap simvastatin at 20 mg/day

Grapefruit juice: Inhibits CYP3A4, may increase amlodipine levels; advise avoidance

Store below 30°C in a dry place, protected from light and moisture. Keep in the original blister pack until use. Keep out of reach of children. Do not use after the expiry date.

Amtel 80/10mg is a Prescription Only Medicine (POM) in Kenya. Combination antihypertensives must be prescribed by a qualified medical practitioner following assessment of blood pressure targets and comorbidities. Pharmily requires a valid prescription for dispensing.

The Amtel 80/10mg combination represents a step-up strategy for patients whose blood pressure remains uncontrolled on the lower-strength Amtel 80/5mg. Confirm that the prescriber has documented the failure of lower-dose therapy before dispensing the 10 mg amlodipine formulation.

Ankle oedema from 10 mg amlodipine affects up to 20–30% of patients and is a leading cause of discontinuation; proactive counselling and follow-up improve persistence. Adding spironolactone or switching to a diuretic-based combination may help if oedema is problematic. In diabetic Kenyan patients on RAAS blockade, quarterly renal function and potassium monitoring is best practice. Be alert to dual RAAS blockade in patients on concurrent ACE inhibitors; this combination is no longer recommended except in specialist nephrology settings.

Q1: Why are my ankles swelling since I started Amtel 80/10mg?

A: Ankle swelling (peripheral oedema) is a well-known side effect of amlodipine, especially at the 10 mg dose. It is caused by fluid shifting into the tissues in the lower limbs, not by heart or kidney failure. Elevate your feet when resting and inform your doctor; a dose adjustment may be possible.

Q2: Can I take Amtel 80/10mg during pregnancy?

A: No. Telmisartan, like all ARBs, is strictly contraindicated in pregnancy (especially the second and third trimesters). It can cause severe fetal kidney damage and death. If you are pregnant or planning to conceive, speak to your doctor immediately about a safer alternative.

Q3: Why should I avoid grapefruit juice with this medicine?

A: Grapefruit juice inhibits an enzyme (CYP3A4) that breaks down amlodipine. This can raise amlodipine levels in your blood, increasing the risk of side effects like low blood pressure and ankle swelling.

Q4: How long will I need to take Amtel 80/10mg?

A: Hypertension is usually a lifelong condition. Most patients take antihypertensives indefinitely. Do not stop taking your medicine because your blood pressure seems normal; it is what keeps it controlled.