Telmisartan-Amlodipine

Telmisartan/Amlodipine is a combination medication used to treat high blood pressure (hypertension).

• Telmisartan/Amlodipine is available under the following different brand names: Twynsta

Adult dosage

Tablet

• 40mg/5mg
• 40mg/10mg
• 80mg/5mg
• 80mg/10mg
• Hypertension

Adult dosage

• Initiate with 40 mg/5 mg or 80 mg/5 mg orally once daily, OR
• Substitute for individually titrated components
• May increase dose after at least 2 weeks, not to exceed 80 mg/10 mg once daily
• Dosage range: Telmisartan 20-80 mg/amlodipine 2.5-10 mg orally once daily 
• It may be administered concomitantly with another antihypertensive agent.

Geriatric dosage

• Not recommended as initial therapy for patients above 75 years of age
• Initiate with a decreased dose containing 2.5 mg amlodipine; titrate slowly

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Telmisartan/Amlodipine include:

• swelling in the hands or feet,
• fast or pounding heartbeats,
• dizziness,
• drowsiness,
• flushing (warmth, redness, or tingly feeling),
• back pain, 
• nausea, 
• diarrhea, and
• stomach pain.

Serious side effects of Telmisartan/Amlodipine include:

• a light-headed feeling, like passing out,
• shortness of breath (even with mild exertion), 
• swelling, rapid weight gain,
• new or worsened chest pain,
• pounding heartbeats or fluttering in the chest,
• tremors,
• muscle stiffness or twitching,
• unexplained muscle pain, tenderness
• weakness,
• fever, 
• unusual tiredness, 
• dark-colored urine, and
• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement.

Rare side effects of Telmisartan/Amlodipine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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.

If your medical doctor is using this medicine to treat your pain, 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.

• Telmisartan/Amlodipine has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
  • elagolix
• Telmisartan/Amlodipine has serious interactions with at least 30 other drugs.
• Telmisartan/Amlodipine has moderate interactions with at least 241 other drugs.
• Telmisartan/Amlodipine has minor interactions with at least 45 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Do not coadminister with aliskiren in patients with diabetes mellitus

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Discontinue immediately with pregnancy; increased fetal/neonatal morbidity and mortality (see Black Box Warnings)
• May cause hypotension, particularly if volume or salt depleted (correct before initiating)
• Symptomatic hypotension with or without syncope may occur
• Titrate slowly in patients with hepatic or severe renal impairment
• May increase serum creatinine or BUN in patients with renal artery stenosis
• Monitor for hyperkalemia
• Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
• Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
• Monitor for worsening heart failure; may lead to oliguria or progressive azotemia
• Initiating calcium channel blockers in patients with severe obstructive coronary artery disease may precipitate MI or increase angina

Pregnancy and Lactation

• Can cause fetal harm when administered to a pregnant woman; discontinue drug when pregnancy is detected and treat hypertension according to guidelines during pregnancy
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
• Reports of hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death owing to oligohydramnios
• Oligohydramnios in this setting has also been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development
• Lactation
  • Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia, and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan/amlodipine
  • There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production
  • Limited published studies report that amlodipine is present in human milk; however, there is insufficient information to determine the effects of amlodipine on the breastfed infant