Lotrel 5/20 capsule

Lotrel (Novartis Pharmaceuticals), manufactured drug form of Amlodipine besylate and benazepril hydrochloride, 5mg/capsule amlodipine besylate ; 20mg/capsule benazepril hydrochloride capsule, NDC 0078-0406

Available in:

NDC Product ID:

  • 0078-0406

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Oct 10, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Warning: Avoid Use In Pregnancy
  • Yes
  • WARNING: AVOID USE IN PREGNANCY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue Lotrel as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.4)
  • 34066-1
  • 1 Indications And Usage
  • No
  • Lotrel is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Lotrel is indicated for the treatment of hypertension (1) in patients not adequately controlled on monotherapy with either agent
  • 34067-9
  • 2 Dosage And Administration
  • No
  • Dose once-daily May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor (2.2) Patients who experience edema with amlodipine may be switched to Lotrel containing a lower dose of amlodipine (2.2) Start Lotrel at 2.5/10 mg in patients ≥ 75 years old or in patients with hepatic impairment (2)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20, 10/40 (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Lotrel is contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine. (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Watch for anaphylactoid reactions, including angioedema (head, neck or intestinal). Warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina (5.2) Assess for hypotension and hyperkalemia (5.3 and 5.7) Titrate slowly in patients with impaired hepatic (5.5) or severely impaired renal (5.6) function.
  • 43685-7
  • 6 Adverse Reactions
  • No
  • Discontinuation because of adverse reactions occurred in 4% of Lotrel-treated patients and 3% of placebo-treated patients. The most common reasons for discontinuation of therapy with Lotrel were cough and edema. (6) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 34084-4
  • 7 Drug Interactions
  • No
  • Potassium supplements / Potassium-sparing diuretics: risk of hyperkalemia Lithium: Increased serum Lithium levels; toxicity symptoms Injectable gold: facial flushing, nausea, vomiting, or hypotension may occur NSAID: Risk of renal dysfunction, loss of antihypertensive effect (7.1). If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin (7.1)
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Nursing Mothers: It is not known whether amlodipine is excreted in human milk. Nursing or drug should be discontinued. (8.3)
  • 43684-0
  • 10 Overdosage
  • No
  • 34088-5
View entire collection »

Discontinued:

  • No

Marketing start date:

  • Mar 3, 1995

Patents:

Patent expiry date:

  • Dec 19, 2017

FDA application number:

  • NDA020364

Color:

Shape:

Size:

  • 19 mm (0.75 in )

Scoring:

  • 1

Imprint:

  • Lotrel;2265

Therapeutic equivalents:

View entire collection »
top ↑

Consumer product

Brand:

top ↑

You can help improve this topic by adding more facts here

Edit this topic
Edit and Show details

Add or delete facts, download data in JSON or RDF formats, and explore topic metadata.

Freebase Logo
What is Freebase?

Freebase is a huge collection of facts, built by people like you. Freebase connects facts in ways other sites can't, giving you new ways to explore millions of subjects.
You can help improve it!