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U.S. Department of Health and Human Services

Safety

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Twynsta (telmisartan/amlodipine) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

November 2012

Summary View

CONTRAINDICATIONS

  • Do not co-administer aliskiren with TWYNSTA in patients with diabetes

DRUG INTERACTIONS

Drug Interactions with Telmisartan
  • Aliskiren: Do not co-administer aliskiren with TWYNSTA in patients with diabetes. Avoid use of aliskiren with TWYNSTA in patients with renal impairment (GFR <60 ml/min).

Patient Information

Who should not take TWYNSTA?

For patients with diabetes, if you are taking TWYNSTA you should not take aliskiren.

Tell your doctor about all the medicines you take

For patients with diabetes, if you are taking TWYNSTA you should not take aliskiren.

 

 

October 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Hypotension
  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis
  • Amlodipine: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
 
Risk of Myocardial Infarction or Increased Angina
  • Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin level within the therapeutic range
 

DRUG INTERACTIONS

Drug Interactions with Amlodipine
  • The following have no clinically relevant effects on the pharmacokinetics of amlodipine: ...magnesium and aluminum hydroxide antacid
  • CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A4 inhibitors.
  • CYP3A4 Inducers: No information is available on the quantitative effects of CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. John’s Wort) on amlodipine. Patients should be monitored for adequate clinical effect when amlodipine is co-administered with CYP3A4 inducers.
 

OVERDOSAGE

Amlodipine
  • Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m2 basis) caused a marked peripheral vasodilation and hypotension.

 

March 2012

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Twynsta as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

Fetal toxicity

Pregnancy Category D

  • 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. 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 Twynsta as soon as possible.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category D

  • 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. 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 Twynsta as soon as possible. These…
Pediatric Use
  • Neonates with a history of in utero exposure to Twynsta:
  • If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

PATIENT INFORMATION

What is the most important information I should know about Twynsta?

Twynsta can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Twynsta, tell your doctor right away.

 

January 2012

Summary View

4 CONTRAINDICATION 

  • TWYNSTA tablets are contraindicated in patients with  known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component of this product [see Adverse Reactions (6.2)]

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience

Telmisartan

  • The most frequently spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, .....hypoglycemia (in diabetic patients), and angioedema (with fatal outcome)

PATIENT INFORMATION

Who should not take TWYNSTA? [new section added]
  • You should not take TYWNSTA tablets if you are allergic (hypersensitive) to the active ingredients (telmisartan or amlodipine) or any of the other ingredients listed at the end of this leaflet.
What are the possible side effects of TWYNSTA tablets?
  • skin rash.......added
     

November 2011

Summary View

WARNINGS AND PRECAUTIONS

Drug Interactions with Amlodipine
  • Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

 

July 2010 

Summary View

 

ADVERSE REACTIONS

Clinical Trials Experience
  • TWYNSTA tablets:  The adverse reactions that occurred in the placebo-controlled factorial design trial in patients treated with Twynsta and at a higher incidence in Twynsta-treated patients (n=789) than placebo-treated patients (n=46) were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%). Edema (other than peripheral edema), hypotension, and syncope were reported in <2% of patients treated with Twynsta tablets.
  • Amlodipine: Gastrointestinal- change of bowel habit; Psychiatric- mood change