Difficulty Swallowing / Dysphagia Support
TrocheOralNon sterile Rx only

Amlodipine Oral Troche

Troche Formulation

Amlodipine compounded as an oral troche that dissolves in the mouth. A non sterile option for patients who cannot swallow tablets. Chino, CA.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Dissolves in the mouth, no swallowing a tablet
  • Strength set by the prescriber
  • Troche base chosen for the patient
  • Flavored for palatability
  • Non sterile preparation

How It Works

What is amlodipine?

Amlodipine is a prescription calcium channel blocker. FDA labeling for amlodipine besylate tablets lists use for high blood pressure and for coronary artery disease, including chronic stable angina and vasospastic angina [1]. The label also lists use in children ages 6 to 17 for high blood pressure [1][2].

What is a troche?

A troche, also called a lozenge, is a solid dose that dissolves slowly in the mouth instead of being swallowed whole. It is not a tablet that is chewed or washed down with water. A compounding pharmacy makes it to a prescriber's order.

What is a troche base?

The base is the material that holds the medicine in a solid shape and lets it dissolve in the mouth. Troche bases come in several types, so the choice of base is part of the preparation.

One example is NataTroche from PCCA. Its manufacturer describes it as an anhydrous, lipid based troche base made without polyethylene glycol or gelatin, with a melting point of 55 to 61 degrees Celsius [3]. These are the manufacturer's descriptions.

What compounding in a troche base provides

  • A dose that dissolves in the mouth, for patients who cannot swallow a tablet
  • No water needed to take a dose
  • A choice of base, such as one made without polyethylene glycol or gelatin, when a patient needs to avoid an ingredient
  • A strength set by the prescriber, such as a dose between tablet strengths
  • Flavoring chosen to the patient's preference
  • A nonaqueous (anhydrous) base, which USP 795 allows a longer default beyond use date than a water based liquid [4]

How a troche is absorbed, and how it compares with a swallowed tablet, is not described in FDA labeling.

When prescribers choose it

  • Cardiologists, primary care providers, and geriatricians whose patients have trouble swallowing tablets
  • Hospice and palliative care providers
  • Prescribers who want a strength the approved tablets do not offer

Clinical Details

What does the evidence show?
  • FDA approved amlodipine besylate tablets are labeled for hypertension and coronary artery disease [1].
  • FDA approved amlodipine oral suspension (Katerzia) is labeled for the same uses [2].
  • Amlodipine is not FDA approved as a troche, and the FDA has not reviewed this preparation.

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

Amlodipine is FDA approved as tablets in 2.5, 5, and 10 mg strengths and as a 1 mg/mL oral suspension [1][2]. No approved product is a troche. A prescriber who wants a dissolving form or a different strength orders it compounded.

Dosage forms and strengths

  • Strength set by the prescriber
  • Troche base chosen with the pharmacist, with flavoring on request
  • Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these troches in Chino, California under USP 795 standards for non sterile preparations [4]. Our pharmacist confirms the strength, base, and flavor with the prescriber before compounding. The pharmacist assigns the beyond use date. Finished troches ship across California.

Safety information

Amlodipine labeling lists known sensitivity to amlodipine as a contraindication [1].

The label warns of symptomatic low blood pressure, and of worsening angina or heart attack after starting or raising the dose in patients with severe obstructive coronary artery disease. It advises slow dose increases in severe liver impairment [1].

The most common reaction is swelling (edema), which is related to dose. Fatigue, nausea, abdominal pain, and sleepiness are also listed [1]. Pregnancy data are limited [1].

No FDA labeling describes how much medicine is absorbed from a troche. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References
  1. Amlodipine besylate tablets, USP. Prescribing information. DailyMed
  2. KATERZIA (amlodipine) oral suspension. Prescribing information. DailyMed
  3. PCCA. NataTroche troche base, manufacturer description (2019). Used only to describe the base, not as evidence for any clinical claim.
  4. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

Related Solutions

Amlodipine Oral Liquid SuspensionORAL SUSPENSION Amlodipine Topical GelAnhydrous topical gel Sildenafil Oral Troche (Dissolving)TROCHE Commonly prescribed for Difficulty Swallowing / Dysphagia Support

Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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Want to learn more about Amlodipine Oral Troche

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Amlodipine Oral Trochefor practitioners across Southern California.

(909) 378-7301

Serving Los Angeles County, Orange County, San Bernardino County, Riverside County, Ventura County, and the Inland Empire