What Is Amtel 40/5mg
Tablets and What Is It Used For?
Amtel 40/5mg is a fixed-dose combination antihypertensive
containing telmisartan 40 mg and amlodipine 5 mg. This lower-strength
combination is typically the preferred starting point when stepping up from
monotherapy, or as the initial fixed-dose combination in patients with moderate
hypertension.
Telmisartan provides 24-hour blood pressure control with
once-daily dosing due to its exceptionally long half-life (~24 hours). It also
confers additional organ-protective benefits in patients with diabetes and CKD
by reducing proteinuria and slowing renal disease progression. Amlodipine at 5
mg provides meaningful vasodilation with a lower incidence of ankle oedema
compared to the 10 mg dose.
Together, the complementary mechanisms produce synergistic
blood pressure reduction while minimising dose-dependent side effects. This
formulation is widely used across Kenya's public and private healthcare
facilities for patients requiring dual antihypertensive therapy.
Approved Indications
•
Mild to moderate hypertension not controlled by monotherapy
•
Hypertension in patients with type 2 diabetes mellitus
•
Hypertension with CKD and proteinuria
•
Hypertension with stable coronary artery disease
•
First-step fixed-dose combination therapy in high-cardiovascular-risk
hypertensive patients
•
Substitution therapy for patients stable on separate
telmisartan 80 mg and amlodipine 5 mg
How to Take This
Medicine
General Instructions
Take one tablet once daily, with or without food, at the same
time each day. Swallow whole with water. Avoid grapefruit juice.
Dosage, Adults
One tablet (Telmisartan 40 mg + Amlodipine 5 mg) once daily.
If blood pressure remains uncontrolled, the prescriber may switch to Amtel
80/10mg or 80/5mg.
Elderly Patients
No dose adjustment required for elderly patients, but
initiate with caution and monitor for hypotension.
Missed Dose
Take the missed dose on the same day as soon as remembered.
Skip if the next day; never double dose.
Duration of Treatment
Long-term, usually lifelong treatment. Do not discontinue
without medical advice.
Side Effects
Common Side Effects
•
Peripheral oedema (ankle swelling), less frequent than with
10 mg amlodipine
•
Dizziness and lightheadedness
•
Headache
•
Flushing (warm sensation in face/chest)
•
Fatigue
Less Common Side Effects
•
Nasopharyngitis (runny nose, sore throat)
•
Nausea and abdominal discomfort
•
Back pain
•
Hyperkalaemia in high-risk patients (diabetes, CKD)
•
Palpitations
Serious / Seek Immediate Medical Attention
•
Angioedema (face/lip/throat swelling), rare but
life-threatening; stop medicine and seek emergency care immediately
•
Severe hypotension, especially in volume-depleted patients
•
Acute kidney injury in patients with renovascular disease
Contraindications
|
⚠ CONTRAINDICATIONS • Pregnancy
(second and third trimester), causes fetal renal dysgenesis and death • Bilateral
renal artery stenosis or unilateral stenosis of a single kidney • Severe
hepatic impairment • Concomitant
use with aliskiren in diabetics or renal impairment • Hypersensitivity
to telmisartan, amlodipine, other dihydropyridines, or excipients • Severe
aortic stenosis • Cardiogenic
shock |
Safety Warnings and
Special Precautions
•
Identical precautions apply as for Amtel 80/10mg, but the 5
mg amlodipine component carries a lower risk of ankle oedema and flushing.
•
Confirm renal function and electrolytes before initiation in
at-risk patients.
•
Volume depletion (e.g., from diuretic use or poor fluid
intake) increases first-dose hypotension risk.
•
Telmisartan is not recommended during breastfeeding.
•
Caution in patients with obstructive biliary disorders or
hepatic impairment; telmisartan undergoes hepatic elimination.
•
Avoid dual RAAS blockade with ACE inhibitors or aliskiren.
Drug Interactions
Always inform your pharmacist and prescriber about all
medicines, supplements, and herbal remedies you are currently taking.
ACE inhibitors: Dual RAAS blockade, not recommended;
increased risk of hypotension, hyperkalaemia, renal failure
Aliskiren: Contraindicated in diabetics and CKD
patients
NSAIDs: Blunts antihypertensive effect; risk
of renal impairment
Potassium-sparing diuretics/supplements: Hyperkalaemia risk
CYP3A4 inhibitors (e.g., ketoconazole,
clarithromycin): Increased amlodipine exposure
Simvastatin > 20 mg: Amlodipine inhibits
simvastatin metabolism, keep simvastatin ≤ 20 mg/day
Grapefruit juice: Raises amlodipine levels, avoid
Lithium: Telmisartan may alter lithium levels,
monitor
Storage Instructions
Store below 30°C in a cool, dry place away from direct
sunlight. Keep in the original packaging until use. Keep out of reach of
children. Do not use after the expiry date.
Prescription Status in
Kenya
Prescription Only Medicine (POM) in Kenya. Pharmily dispenses
on a valid prescription only.
Patient Guidance
|
✔ PATIENT GUIDANCE, KEY
TAKE-AWAY POINTS • Take one
tablet once daily at the same time each day, do not miss doses. • This
medicine contains two drugs that work together to control your blood
pressure. • Ankle
swelling may occur but is usually mild at this strength; report any severe or
sudden swelling. • Rise
slowly from sitting or lying to reduce dizziness. • Avoid
grapefruit juice throughout treatment. • Inform
your doctor immediately if you become pregnant. • Do not
take NSAIDs (ibuprofen, diclofenac) without consulting your pharmacist. |
Pharmacist / Prescriber
Notes
Amtel 80/5mg is the preferred initial fixed-dose combination
when a patient has failed monotherapy with either telmisartan or amlodipine.
The 5 mg amlodipine dose is better tolerated (lower oedema incidence ~5–8%)
than the 10 mg dose (~18–20%), making it the rational starting point.
Counsel patients that the ARB component (telmisartan) may cause a small rise in serum potassium; this is generally inconsequential in patients with normal renal function but warrants monitoring in those with CKD or diabetes.
Remind patients that blood pressure-lowering medicines do not cure
hypertension; they control it. Regular follow-up monitoring (BP, U&E,
creatinine) at 1-, 3-, and 6-months post-initiation is standard of care in
Kenya.
Frequently Asked
Questions (FAQs)
Can I take Amtel 80/5mg if I have kidney
disease?
A: Telmisartan is actually beneficial in hypertensive
patients with CKD and diabetes, as it slows kidney damage. However, renal
function and potassium must be monitored closely. In severe kidney disease
(eGFR < 30 mL/min), use with caution under specialist supervision.
Is it safe to take Amtel 80/5mg with my
diabetes medication?
A: Yes, generally. Telmisartan may slightly improve insulin
sensitivity. However, monitor potassium levels, as both diabetes and ARBs can
elevate them. Inform your doctor about all medicines, including insulin and oral
hypoglycaemics.
Why does my doctor want me to take blood
pressure medicine if I feel fine?
A: High blood pressure is called a "silent killer"
because it causes no symptoms until it damages organs (heart, kidneys, brain,
eyes). Taking your medicine consistently protects these organs even when you
feel well.
Can I drink alcohol while taking Amtel 80/5mg?
A: Alcohol can lower blood pressure and increase the
dizziness and lightheadedness caused by Amtel. Limit alcohol consumption and
avoid drinking on an empty stomach.
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