Telmisartan-Amlodipine-Indapamide

Telmisartan-Amlodipine-Indapamide is a combination medication indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure. 

• Telmisartan-Amlodipine-Indapamide is available under the following different brand names: Widaplik

Common side effects of Telmisartan-Amlodipine-Indapamide include:

• low blood pressure 
• low sodium and potassium levels in the blood

Serious side effects of Telmisartan-Amlodipine-Indapamide include:

• fetal toxicity
• hypotension can occur early on during treatment, causing dizziness or fainting. Risk increases with diuretics, low-salt diet, dehydration, heart problems, or illness with vomiting or diarrhea
• changes in levels of electrolyte and glucose in the blood
• kidney problems may cause symptoms like reduced urine output, swelling of the ankles, blood in the urine, loss of appetite, or unexplained weight gain
• symptoms of eye problems may include decrease in vision or eye pain
• increased uric acid levels in the blood

Rare side effects of Telmisartan-Amlodipine-Indapamide include:

• symptoms of serious allergic reactions may include swelling of the face, tongue, and throat, difficulty breathing, and hives

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 10 mg/1.25 mg/0.625 mg
• 20 mg/2.5 mg/1.25 mg
• 40 mg/5 mg/2.5 mg

Hypertension

Adult dosage

• Individualize dose; may increase dose after 2 weeks; almost all the antihypertensive effect is apparent within 2 weeks of initiating treatment
• Initial dose: 10 mg/1.25 mg/0.625 mg or 20 mg/2.5 mg/1.25 mg orally daily, based on anticipated need for blood pressure reduction
• Not to exceed 40 mg/5 mg/2.5 mg orally daily

Geriatric dosage

• Individualize dose; may increase dose after 2 weeks; almost all the antihypertensive effect is apparent within 2 weeks of initiating treatment
• Initial dose: 10 mg/1.25 mg/0.625 mg orally daily
• Not to exceed 40 mg/5 mg/2.5 mg orally daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Drug interaction overview

• Interactions with telmisartan
  • Aliskiren and other renin-angiotensin-aldosterone system (RAAS) inhibitors: Do not coadminister aliskiren with Telmisartan-Amlodipine-Indapamide in patients with diabetes
  • Digoxin: Telmisartan increases in digoxin peak plasma concentration (49%) and trough concentration (20%); monitor digoxin levels
  • Lithium: Increased serum lithium concentrations and toxicity reported; monitor serum lithium levels
  • Non-steroidal antiinflammatory drugs (NSAIDs)/COX-2 inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs or selective COX-2 inhibitors with angiotensin II receptor antagonists may result in deterioration of renal function; effects are usually reversible; monitor renal function; NSAIDs/COX-2 inhibitors may attenuate antihypertensive effects of telmisartan
• Interactions with amlodipine
  • CYP3A4 inhibitors (strong or moderate): Increases amlodipine systemic exposure; monitor for hypotension and edema, and adjust amlodipine dose if necessary
  • Sildenafil: Monitor for additive hypotension if coadministered
  • Simvastatin: Amlodipine may increase systemic exposure of simvastatin; limit simvastatin dose to 20 mg/day
  • Immunosuppressants: Amlodipine may increase systemic exposure of cyclosporine or tacrolimus; monitor cyclosporine and tacrolimus trough blood levels and adjust dose as appropriate
• Interactions with indapamide
  • Lithium: Avoid diuretics with lithium because they reduce lithium renal clearance and pose a high risk of lithium toxicity
  • Norepinephrine: Indapamide, like thiazide diuretics, may decrease arterial responsiveness to norepinephrine

Contraindications

• Anuria
  • Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or any other component in the product
  • Do not coadminister with aliskiren in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Telmisartan-Amlodipine-Indapamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Telmisartan-Amlodipine-Indapamide?”

Cautions

• Fetal toxicity
  • Use of drugs that act on the RAAS (eg, telmisartan) during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
  • Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations
  • Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death
  • When pregnancy is detected, discontinue the drug as soon as possible
• Hypotension
  • Can cause symptomatic hypotension
  • Patients with hypovolemia, salt depletion, or aortic stenosis are at increased risk
  • Monitor blood pressure and adjust dose as needed
  • Hypotension leading to worsening angina and acute myocardial infarction can develop after starting or increasing the dose, owing to the amlodipine component, particularly in patients with severe obstructive coronary artery disease
• Electrolyte and glucose imbalances
  • Thiazide-like diuretics can cause hyponatremia, hypomagnesemia, and hypokalemia
  • Can also alter serum glucose and affect insulin requirements
  • RAAS inhibitors can cause hyperkalemia
  • Patients with renal impairment or heart failure are at increased risk for hyperkalemia
  • Monitor serum electrolytes and glucose periodically
• Impaired renal function
  • Inhibiting RAAS or diuresis can precipitate renal dysfunction, oliguria, and acute renal failure
  • Patients with severe congestive heart failure or renal dysfunction are at increased risk
  • Monitor renal function periodically and adjust dose as needed
  • Acute angle-closure glaucoma, acute myopia, and choroidal effusion
  • Sulfonamide or sulfonamide-derivative drugs, like indapamide, can cause an idiosyncratic reaction resulting in acute angle-closure glaucoma and elevated introocular pressure (IOP) with or without a noticeable acute myopic shift and/or choroidal effusions
  • Symptoms may include the acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation
  • Untreated angle-closure glaucoma may result in permanent visual field loss
  • Primary treatment is to discontinue indapamide as rapidly as possible
  • Prompt medical or surgical treatments may need to be considered if IOP remains uncontrolled
  • Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy
• Hyperuricemia
  • Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide-like diuretics

Pregnancy and Lactation

• May cause fetal harm when administered to a pregnant woman
• Discontinue the drug as soon as possible if pregnancy is detected
• Telmisartan
• Use of drugs that act on the renin-angiotensin-aldosterone system (RAAS) during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
• Indapamide
• Diuretics are known to cross the placental barrier and appear in cord blood
• May be associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults
• Clinical considerations
• Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage)
• Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
• Carefully monitor pregnant women with hypertension and manage accordingly
• Lactation
  • There is no information regarding the presence of Telmisartan-Amlodipine-Indapamide in human milk, its effects on breastfed infants, or milk production
  • Limited published studies report that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infants have been observed
  • There is no available information on the effects of amlodipine on milk production
  • There is no information regarding the presence of telmisartan or indapamide in human milk
  • Owing to the potential for serious adverse reactions in breastfed infants, including hypotension, hyperkalemia, and renal impairment, advise women not to breastfeed during treatment