Amlodipine for Oral Solution

The first and only patent-pending, FDA-approved, amlodipine powder formulation. Ideal for pediatric, geriatric, and dysphagic patients requiring ease-of-use and precision, as well as tube-fed patients.

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Rx   Available by prescription only

Prescription Strength Amlodipine Powdered Oral Solution

Prescription Strength Powdered Oral Solution

Sdamlo™ provides reliable and consistent hypertension treatment while ensuring accurate and easy administration via single-dose bottles. Perfect for pediatric, geriatric, and dysphagic patients. Available by prescription-only.

Easy-to-Swallow

Powdered oral solution that offers flexible, easy-to-swallow, dosing that supports accurate administration for patients who have difficulty with solid dosage forms.

Precision Dosing

Convenient unit-dose containers allow for easy and precise delivery of medication, ensuring patients receive the exact amount prescribed. No measuring, shaking, or stirring required.

Alcohol-Free

Alcohol is a common excipient in many amlodipine liquid formulations, which can reduce their appropriateness for pediatric and geriatric populations. Sdamlo™ is alcohol-free.

Patent Pending

Our patent pending powder formulation utilizes lypholization to freeze dry the active ingredient ensuring uniform distribution that enhances shelf stability and therapeutic performance.

Patient-Centered Treatment

Sdamlo™ provides a superior liquid dosage form that is easier to administer than other liquid and solid amlodipine oral medications. Our powder for oral solution supports treatment adherence in dysphagic, geriatric and pediatric patients, as well as tube-fed patients and patients undergoing immunotherapy.

Easy-to-Swallow

Our powder oral solution format eliminates the need to swallow tablets, reducing aspiration risk and promoting patient's daily use, aiding patients with oropharyngeal dysphagia, pharyngeal dysphagia, and esophageal dysphagia.

Alcohol-Free

Sdamlo™ avoids the use of alcohol commonly found in liquid formulations, enhancing suitability for dysphagic, pediatric, and geriatric populations. Additionally, Sdamlo™ is preservative-free and sucralose-free.

"No Guess" Dosing

Our convenient unit-dose containers allow for easy and precise delivery of medication, ensuring patients receive the exact amount prescribed. Simplified unit-dose treatment improves patient and care giver confidence, promoting more optimal outcomes.

No Refrigeration Required

No refrigeration, measuring, shaking, or stirring of Sdamlo™ is required. Simply open, add water, and take the medication. See our medication guide for full instructions.

Sdamlo
UNIT-DOSE PRECISION

Accurate Dosing Every Time

Our convenient unit-dose containers allow for easy and precise delivery of medication, ensuring patients receive the exact amount prescribed. No measuring, shaking, or stirring required. Patient-centered, simplified unit-dose treatment improves patient and care giver confidence, promoting more optimal outcomes.

Hospitals, LTC & Institutional Care Facilities

Boasting ready compatibility with hospital dispensing systems and offering enhanced workflow efficiency, our unit-dose offering is a game changer in the institutional environment.

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Eliminate the Risk Associated with Compounding

Patients who have difficulty swallowing are often given crushed/compounded formulations of the prescriptions. However, crushed/compounded formulations can exhibit a wide variation in potency due to non-uniformity of compounded materials. These dosing inconsistencies of compounded suspensions have long been a persistent challenge for pharmacists and patients. Crushed/compounded formulations are not tested for safety or efficacy.

No prep. No pharmacy labor. No delays. Crushing can require expensive safety protocols that take up valuable staff time.

In 2007, the CDC found compounded drugs have a higher risk of contamination. Sdamlo™ eliminates this compounding variability and dosing risk.

Crushed and compounded products can have variable and very costly, short shelf lives, while our manufacturer-controlled formulation offers consistent accuracy and integrity.

Removes USP <795> workload, documentation, and QC burden.

The Retail Pharmacy Advantage

Retail pharmacies face challenges when filling prescriptions for (a) patients who cannot swallow tablets, (b) care givers unsure how to measure liquid doses, and (c) patients with sensory or tolerance issues.

A precise, unit-dose oral solution that's easier to dispense, instruct, and administer

No refrigeration required

Alcohol-free and stable — easier to store and counsel

Reduces returns, waste, and patient confusion.

Prescribing Sdamlo™

Sdamlo™ is easy to prescribe and provides considerable patient savings to eligible commercially insured patients

Patients may pay as little as $0* for Sdamlo™

The Sdamlo™ Savings Program offers most eligible commercially insured patients $0* out of pocket cost on a monthly supply of Sdamlo™.

  • No patient registration is required to use the card

  • The savings card can be applied to initial prescriptions, refills, and 30 or 90-day prescription supply

Download Copay Card

* When the maximum savings benefit is not exceeded for eligible patients

Sdamlo™ Prescription Savings Card
Resources
RESOURCE CENTER

Further Resources

Browse our resources below for further specifics and information on Sdamlo™

  • Instructional Video

    Source: Sdamlo™

    Watch our instructional video on how to take or give Sdamlo™.

    View Instructional Video
  • How to Administer Sdamlo™

    Source: Sdamlo™

    Consult the following Sdamlo™ Administration Guide before taking or giving Sdamlo™.

    View/Download
  • Risks of Pharmacy Compounding

    Source: National Institutes of Health

    Regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients.

    View/Download

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Additional Medical Information; Rx only

Indications & Usage

Sdamlo™ is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension

    • Sdamlo™ is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

  • Coronary Artery Disease in adults

    • Chronic Stable Angina

    • Vasospastic Angina (Prinzmetal's or Variant Angina)

    • Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%

Please see Full Prescribing Information, including Boxed Warning, and Important Safety Information on the product itself and/or on www.sdamlorx.com.

Individual patient results may vary. To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also contact Pangea Pharmaceuticals at 855-892-8224 or drugsafety@pangeapharm.com.

How Supplied

Sdamlo™ are supplied as unit-dose powder for oral administration. Sdamlo™ contains 2.5 mg, 5 mg, or 10 mg of amlodipine, USP. NDCs 81279-133-10, 81279-134-10, and 81279-135-10 respectively.

Contraindications

Sdamlo™ are contraindicated in patients with a known sensitivity to amlodipine.

Warnings & Precautions
  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.

  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Sdamlo™, particularly in patients with severe obstructive coronary artery disease.

  • Titrate slowly in patients with severe hepatic impairment.

Adverse Reactions

Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence.

For complete prescribing and dosage information click here