Sdamlo

Description

Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-(2-aminoethoxy)methyl-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5 •C6H6O3S, and it has a molecular weight of 567.1. Amlodipine besylate appears as a white crystalline powder, which is slightly soluble in water and sparingly soluble in ethanol. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively. Inactive ingredients include mannitol and neotame.

Uses and Indications

Sdamlo is indicated for the treatment of hypertension, aimed at lowering blood pressure in adults and pediatric patients aged 6 years and older. Effective blood pressure reduction is associated with a decreased risk of both fatal and nonfatal cardiovascular events, including strokes and myocardial infarctions.

Sdamlo may be utilized as monotherapy or in conjunction with other antihypertensive and antianginal agents for the management of the following conditions:

• Chronic Stable Angina

• Vasospastic Angina (Prinzmetal's or Variant Angina)

• Angiographically Documented Coronary Artery Disease in patients who do not have heart failure or an ejection fraction less than 40%.

There are no teratogenic or nonteratogenic effects associated with Sdamlo.

Dosage and Administration

The recommended starting dose for adults is 5 mg administered orally once daily. The maximum allowable dose for adults is 10 mg orally once daily. For small, fragile, or elderly patients, as well as those with hepatic insufficiency, it is advised to initiate treatment with a reduced dose of 2.5 mg orally once daily.

In pediatric patients, the starting dose ranges from 2.5 mg to 5 mg administered orally once daily. It is important to note that doses exceeding 5 mg daily have not been studied in the pediatric population, and caution should be exercised when considering higher doses.

Contraindications

Use of this product is contraindicated in patients with a known sensitivity to amlodipine. This contraindication is based on the potential for severe allergic reactions in individuals with a history of hypersensitivity to this medication.

Warnings and Precautions

Patients receiving Sdamlo should be closely monitored for symptomatic hypotension, especially those with severe aortic stenosis. While acute hypotension is unlikely, vigilance is warranted due to the potential for symptomatic episodes.

Additionally, healthcare professionals should be aware that worsening angina and acute myocardial infarction may occur following the initiation or dose escalation of Sdamlo, particularly in individuals with severe obstructive coronary artery disease. It is crucial to assess the patient's cardiovascular status regularly and adjust treatment as necessary.

In patients with severe hepatic impairment, it is recommended to titrate the dosage of Sdamlo slowly. This cautious approach helps mitigate the risk of adverse effects associated with altered drug metabolism in this population. Regular liver function tests may be beneficial in monitoring these patients to ensure safe and effective use of the medication.

Side Effects

Patients may experience a range of adverse reactions while receiving treatment with Sdamlo. The most common adverse reactions reported include edema, fatigue, nausea, abdominal pain, and somnolence, each occurring in more than 1.0% of participants in clinical trials.

Serious adverse reactions have been noted, particularly in patients with pre-existing conditions. Symptomatic hypotension may occur, especially in individuals with severe aortic stenosis, although acute hypotension is considered unlikely. Additionally, there is a risk of worsening angina and acute myocardial infarction following the initiation or dose increase of Sdamlo, particularly in patients with severe obstructive coronary artery disease.

Patients with known sensitivity to amlodipine should exercise caution when using this medication. In cases of overdosage, excessive peripheral vasodilation may lead to marked hypotension and potentially reflex tachycardia.

Experience with intentional overdosage of amlodipine in humans is limited. In the event of a massive overdose, it is crucial to initiate active cardiac and respiratory monitoring, with frequent blood pressure measurements. Should hypotension occur, cardiovascular support measures should be implemented, including elevation of the extremities and judicious administration of fluids. If hypotension persists despite these conservative measures, the use of vasopressors, such as phenylephrine, may be warranted, with careful attention to circulating volume and urine output. Due to the high protein binding of amlodipine, hemodialysis is unlikely to provide benefit in cases of overdose.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Sdamlo (amlodipine), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of amlodipine for the treatment of hypertension have been established in pediatric patients aged 6 to 17 years. This indication is supported by evidence from a randomized, placebo-controlled trial conducted in this age group. However, the safety and effectiveness of amlodipine have not been established in pediatric patients less than 6 years of age.

Geriatric Use

Clinical studies of amlodipine did not include a sufficient number of subjects aged 65 and over to determine whether these elderly patients respond differently from younger individuals. However, other reported clinical experiences have not identified significant differences in responses between geriatric patients and their younger counterparts.

In general, dose selection for elderly patients should be approached with caution. It is advisable to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies.

Elderly patients exhibit decreased clearance of amlodipine, resulting in an approximate increase in the area under the curve (AUC) of 40–60%. Consequently, a lower initial dose may be necessary to ensure safety and efficacy in this population. Regular monitoring and assessment of the patient's response to therapy are recommended to optimize treatment outcomes.

Pregnancy

The available data regarding the use of amlodipine in pregnant patients is limited, primarily derived from post-marketing reports, and is insufficient to establish a definitive drug-associated risk for major birth defects or miscarriage. However, it is important to recognize that poorly controlled hypertension during pregnancy poses significant risks to both the mother and fetus.

In animal reproduction studies, no adverse developmental effects were observed when pregnant rats and rabbits were administered amlodipine maleate during organogenesis at doses approximately 10 and 20 times the maximum recommended human dose (MRHD), respectively. Notably, while teratogenicity and other embryo/fetal toxicities were not evident at doses up to 10 mg amlodipine/kg/day, significant concerns arose in rats, where litter size was reduced by approximately 50% and the incidence of intrauterine deaths increased five-fold. Additionally, amlodipine maleate was associated with prolonged gestation and extended labor duration in rats at this dosage.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2%–4% and 15%–20%, respectively, and all pregnancies inherently carry a background risk of adverse outcomes. Hypertension in pregnancy is associated with increased maternal risks, including pre-eclampsia, gestational diabetes, premature delivery, and complications during delivery, such as the need for cesarean section and postpartum hemorrhage. Furthermore, fetal risks associated with maternal hypertension include intrauterine growth restriction and intrauterine death.

Given these considerations, pregnant women with hypertension should be closely monitored and managed to mitigate potential risks to both maternal and fetal health.

Lactation

Amlodipine is present in human milk, with a reported estimated median relative infant dose of 4.2% based on limited available data from a published clinical lactation study. No adverse effects of amlodipine on breastfed infants have been observed. Additionally, there is no available information regarding the effects of amlodipine on milk production in lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be managed with caution. In individuals with severe hepatic impairment, it is recommended to titrate the dosage slowly to minimize the risk of adverse effects. Close monitoring of liver function is advised to ensure patient safety and to adjust treatment as necessary.

Overdosage

Overdosage may lead to significant clinical manifestations, primarily characterized by excessive peripheral vasodilation resulting in marked hypotension, which may be accompanied by reflex tachycardia.

In animal studies, single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg in mice and 100 mg amlodipine/kg in rats have resulted in fatalities. Additionally, in canine models, doses of 4 mg amlodipine/kg or greater have been associated with pronounced peripheral vasodilation and hypotension.

In the event of a massive overdose, it is imperative to initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential to assess the patient's hemodynamic status. Should hypotension occur, it is recommended to provide cardiovascular support, which may include elevating the extremities and judicious administration of intravenous fluids.

If hypotension persists despite these conservative measures, the administration of vasopressors, such as phenylephrine, should be considered. Careful attention must be paid to the patient's circulating volume and urine output during this process.

Due to the high protein binding of amlodipine, hemodialysis is unlikely to provide any significant benefit in the management of overdose.

Nonclinical Toxicology

Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day, showed no evidence of a carcinogenic effect of the drug. In mice, the highest dose administered was, on a mg/m² basis, similar to the maximum recommended human dose of 10 mg amlodipine per day. In rats, the highest dose was approximately twice the maximum recommended human dose based on a patient weight of 50 kg.

Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects at either the gene or chromosome level.

There was no effect on the fertility of rats treated orally with amlodipine maleate, with males treated for 64 days and females for 14 days prior to mating, at doses up to 10 mg/kg/day. This dosage is eight times the maximum recommended human dose of 10 mg per day on a mg/m² basis.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to read the FDA-approved patient labeling, specifically the Instructions for Use, to ensure they understand the proper administration and usage of the medication. This information is crucial for maximizing the therapeutic benefits while minimizing potential risks associated with the treatment.

Storage and Handling

Sdamlo is supplied in its original packaging to ensure integrity and stability. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

Patients are advised to read the FDA-approved patient labeling, which includes the Instructions for Use. The product is manufactured for Pangea Pharmaceuticals, located in Brielle, New Jersey, 08730.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sdamlo as submitted by Pangea Pharmaceuticals, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)