Amlodipine Oral Liquid Suspension

Oral Suspension Vehicle

A compounded amlodipine oral liquid suspension in PCCA's SuspendIt base, made in Chino, CA to a prescriber's order. Not FDA approved.

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

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

At a Glance

Preparation details for Amlodipine Oral Liquid Suspension
Dosage form	Oral suspension
Route	Oral
Active ingredients	Amlodipine
Technology	Oral Suspension Vehicle
Strengths in literature	FDA approved amlodipine oral liquids are 1 mg/mL: Katerzia suspension and Norliqva solution
Commercial product	Commercial product in fixed strengths only
Strength and directions	Per prescriber
Dispensing	Valid prescription

Speak with our pharmacist Send a prescription

Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Custom concentration available
Sugar free base
Dye free base
Weight based dosing
Alternative to swallowing tablets
Non sterile preparation

How It Works

What is amlodipine?

Amlodipine is a prescription calcium channel blocker. FDA approved Katerzia oral suspension is labeled for hypertension in adults and in children 6 years and older, for chronic stable angina, for vasospastic angina, and for angiographically documented coronary artery disease in patients without heart failure [1].
FDA approved Norliqva oral solution has the same labeled uses [2].

Both approved liquids are 1 mg/mL. Katerzia is kept in the refrigerator, and its inactive ingredients include sodium benzoate and sucralose [1]. Norliqva contains glycerin, propylene glycol, and butylated hydroxyanisole [2].

What is the dosage form?

Amlodipine Oral Liquid Suspension is a liquid medicine you swallow, made by a compounding pharmacy to a prescriber's order. It is shaken before each dose and measured with an oral syringe.

What SuspendIt is, and what compounding in it provides

SuspendIt is an aqueous suspending base made by PCCA for oral liquids. Mixwell prepares amlodipine in SuspendIt at the concentration the prescriber orders. PCCA's base page does not name amlodipine. PCCA describes SuspendIt as follows [3]:

A complete oral suspension vehicle, with a polymer complex that allows rapid redispersion of the drug with gentle shaking and reduces settling
A neutral, sugar free sweetener that improves taste without overpowering flavors
Free of gluten, alcohol, parabens, and dyes. Formulated without casein, dairy, soy, egg, nuts, propylene glycol, modified food starch, and carbomer
pH of 5 to 6, with sodium benzoate and potassium sorbate as preservatives
Described as suitable for pediatric, geriatric, and hospice formulas, and for use in G tubes and J tubes
USP Verified Excipient status, and stability data that PCCA says may allow longer beyond use dates

Compounding makes it possible to choose the amlodipine concentration, in place of the fixed 1 mg/mL of the approved liquids [1][2]. These are the manufacturer's descriptions of its base. They are not findings by the FDA, and they are not claims about amlodipine.

When prescribers choose it

Pediatric and primary care providers who need a weight based dose in a different concentration
Cardiologists and geriatric providers whose patients cannot swallow tablets or use a feeding tube
Prescribers whose patients need a sugar free, dye free liquid

Clinical Details

What does the evidence show?

FDA approved Katerzia (amlodipine) oral suspension, 1 mg/mL, is labeled for hypertension in adults and children 6 years and older, chronic stable angina, vasospastic angina, and angiographically documented coronary artery disease [1].
FDA approved Norliqva (amlodipine) oral solution, 1 mg/mL, has the same labeled uses [2].
No FDA approved amlodipine liquid is made in SuspendIt or comes in another concentration. 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

FDA approved amlodipine liquids come in one concentration, 1 mg/mL [1][2]. The Katerzia label gives pediatric doses of 2.5 to 5 mg and adult doses of 2.5 to 10 mg [1]. A prescriber who wants a different concentration, or a different set of base ingredients, orders it compounded.

Dosage forms and strengths

Concentration set by the prescriber
SuspendIt oral suspension base
Flavor options and volumes matched to the prescription

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this suspension in Chino, California under USP 795 standards for non sterile preparations [4]. Our pharmacist confirms the concentration and base with the prescriber before compounding. Batch records document every preparation, and finished suspensions ship across California.

Safety information

The Katerzia label contraindicates use with known sensitivity to amlodipine. It warns of symptomatic low blood pressure, especially with severe aortic stenosis, and of worsening angina or a heart attack after starting or raising the dose in people with severe blocked coronary arteries. It says to raise the dose slowly in severe liver impairment [1].

The most common reaction is swelling, which is dose related. Dizziness, flushing, and palpitations also occur. The label says human pregnancy data are limited, and that amlodipine passes into breast milk [1].

No FDA labeling states how this compounded suspension is absorbed compared with the approved liquids or tablets. Tell your prescriber about every medicine you take and any allergies, including to preservatives such as sodium benzoate. Mixwell can provide the ingredient list for your preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References

KATERZIA (amlodipine) oral suspension. Prescribing information. DailyMed. DailyMed
NORLIQVA (amlodipine) oral solution. Prescribing information. DailyMed. DailyMed
SuspendIt. Product information. PCCA. PCCA product page
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

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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