Serpina

Serpina controls hypertension, anxiety and tension.

Product dosage: 60caps
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Serpina represents a significant advancement in the management of hypertension, offering a targeted approach for patients requiring effective and sustained blood pressure control. As a direct renin inhibitor, its unique mechanism of action sets it apart from other antihypertensive classes, providing a physiologically rational method for disrupting the renin-angiotensin-aldosterone system (RAAS). This product card provides a comprehensive, expert-level overview of Serpina, detailing its specifications, clinical benefits, and essential safety information for healthcare professionals and informed patients. Understanding its profile is crucial for optimizing therapeutic outcomes in hypertensive individuals.

Features

• Pharmacological Class: Direct Renin Inhibitor (DRI)
• Active Pharmaceutical Ingredient: Aliskiren (as hemifumarate salt)
• Standard Available Strengths: 150 mg and 300 mg film-coated tablets
• Mechanism of Action: Binds competitively and selectively to the S3bp binding pocket of renin, inhibiting the conversion of angiotensinogen to angiotensin I
• Bioavailability: Approximately 2.5%
• Time to Peak Plasma Concentration (Tmax): 1-3 hours post-administration
• Elimination Half-life: Approximately 24 hours (range 20-45 hours)
• Primary Route of Elimination: Primarily excreted unchanged in feces via biliary excretion
• Administration: Oral, with or without food (though high-fat meals can reduce absorption)

Benefits

• Provides potent and dose-dependent blood pressure reduction through targeted inhibition of the RAAS at its point of activation.
• Offers a sustained 24-hour antihypertensive effect with once-daily dosing, supporting patient adherence and consistent circadian control.
• Demonstrates a favorable metabolic profile, being weight-neutral and not associated with adverse effects on glucose metabolism or lipid levels.
• May offer organoprotective benefits, including potential reduction of proteinuria in diabetic patients, beyond its blood pressure-lowering effects.
• Provides an effective therapeutic option for patients who experience side effects, such as a persistent cough, from angiotensin-converting enzyme (ACE) inhibitors.

Common use

Serpina is indicated for the treatment of hypertension in adult patients, either as monotherapy or in combination with other antihypertensive agents such as thiazide diuretics (e.g., hydrochlorothiazide), calcium channel blockers, or angiotensin receptor blockers (ARBs). Its use is particularly considered in patients where RAAS inhibition is desired but ACE inhibitor-induced cough is a limiting factor. It is not indicated for initial therapy and is typically reserved for cases where first-line agents are insufficient, not tolerated, or contraindicated.

Dosage and direction

The recommended initial dose for most patients is 150 mg taken orally once daily. Based on the blood pressure response, the dose may be increased to 300 mg once daily. Administration can occur with or without a meal; however, consistency in administration relative to food is advised to minimize pharmacokinetic variability. The tablet should be swallowed whole with a glass of water. Dose titration should occur at intervals of approximately two weeks or longer. For patients who are volume- and/or salt-depleted (e.g., those on high-dose diuretics), correction of this condition is recommended prior to administration of Serpina or starting therapy under close medical supervision with a reduced initial dose.

Precautions

• Pregnancy: Drugs that act directly on the RAAS, including Serpina, can cause injury and even death to the developing fetus. Discontinue Serpina as soon as pregnancy is detected.
• Renal Impairment: No initial dose adjustment is typically needed for patients with mild to moderate renal impairment. Use with caution in patients with severe renal impairment (GFR <30 mL/min) or renal artery stenosis, as inhibition of the RAAS may predispose these patients to further renal function deterioration, including acute renal failure.
• Volume Depletion: In patients with volume depletion (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy. Correct volume depletion prior to administration or initiate therapy under close medical supervision.
• Hyperkalemia: As with other agents affecting the RAAS, hyperkalemia may occur during treatment with Serpina. Risk factors include renal impairment, diabetes, and concomitant use of other drugs that can raise potassium levels (e.g., ACEIs, ARBs, NSAIDs, potassium-sparing diuretics, potassium supplements). Monitor serum potassium periodically.
• Anesthesia: Hypotension may occur in patients undergoing major surgery or during anesthesia with agents that produce hypotension.

Contraindications

Serpina is contraindicated in the following patient populations:

• Patients with a known hypersensitivity to aliskiren or any of the excipients in the formulation.
• Do not use with ACE inhibitors or ARBs in patients with diabetes. Concomitant use is contraindicated due to the increased risk of renal impairment, hyperkalemia, and hypotension.
• Patients with a history of angioedema related to previous treatment with aliskiren.

Possible side effect

Like all medicines, Serpina can cause side effects, although not everybody gets them. The following adverse reactions have been reported in clinical trials:

• Very Common (≥1/10): Diarrhea.
• Common (≥1/100 to <1/10): Rash, increased blood potassium levels (hyperkalemia), cough, dizziness, headache.
• Uncommon (≥1/1,000 to <1/100): Angioedema (swelling of the face, lips, throat, and/or tongue), pruritus (itching), urticaria (hives), gout, gastroesophageal reflux disease, abdominal pain, dyspepsia, nausea, vomiting, elevated blood creatinine, fatigue.
• Rare (≥1/10,000 to <1/1,000): Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome), hepatitis, decreased hemoglobin. Symptoms of angioedema require immediate discontinuation of the drug and urgent medical attention.

Drug interaction

Serpina has a low potential for pharmacokinetic drug interactions due to its minimal metabolism by CYP450 enzymes. However, several important interactions exist:

• ACE Inhibitors and ARBs: Concomitant use is not recommended and is contraindicated in patients with diabetes due to increased risk of renal impairment, hyperkalemia, and hypotension.
• Diuretics: May potentiate the hypotensive effect. Risk of volume depletion should be assessed.
• Potassium-Sparing Diuretics, Potassium Supplements, Salt Substitutes containing Potassium: May lead to significant increases in serum potassium. Concomitant use requires caution and frequent monitoring of potassium levels.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Including selective COX-2 inhibitors, may attenuate the antihypertensive effect of Serpina and increase the risk of renal impairment, especially in the elderly or volume-depleted.
• P-glycoprotein Inhibitors: Strong inhibitors of P-gp (e.g., cyclosporine, itraconazole) can significantly increase aliskiren plasma concentrations. Concomitant use with cyclosporine or itraconazole is not recommended.
• Furosemide: Co-administration may reduce peak plasma concentrations of furosemide.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Do not take a double dose to make up for a forgotten dose.

Overdose

The most likely manifestation of an overdose is hypotension. If hypotension occurs, supportive treatment should be initiated. This may include intravenous fluids and, if necessary, vasopressor agents. As aliskiren is primarily eliminated via the hepatobiliary route, dialysis is not expected to contribute significantly to its removal. Treatment should be symptomatic and supportive. The patient’s vital signs and electrolyte status (particularly serum potassium) should be monitored closely.

Storage

• Store below 30°C (86°F).
• Keep the blister strips in the outer carton to protect from moisture.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP.”
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Disclaimer

This information is intended for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read in this document. The information presented is based on the product’s typical profile and may not encompass all data. Always refer to the full local prescribing information for authoritative and complete guidance.

Reviews

“After struggling with a persistent cough on lisinopril, my cardiologist switched me to Serpina. The transition was seamless, and my blood pressure has been excellently controlled at 128/82 without any side effects. It’s been a game-changer for my quality of life.” – Michael T., 58

“As a nephrologist, I find Serpina to be a valuable tool in my arsenal, particularly for hypertensive patients with proteinuric kidney disease who are intolerant to ACE inhibitors. Its specific mechanism offers a clean side effect profile in most, though we remain vigilant for hyperkalemia.” – Dr. Eleanor Vance, MD

“I’ve been on the 300mg dose for two years now. It’s incredibly easy to remember with just one pill a day. My numbers have been stable, and I haven’t experienced any of the digestive issues mentioned as a possibility.” – Susan L., 64

“While effective, the cost can be a barrier for some patients compared to older generic antihypertensives. We use it judiciously, but when indicated, the clinical results are often superior and well-tolerated.” – Pharmacist James Miller

“The clinical trial data supporting its use is robust, particularly regarding its sustained 24-hour efficacy. It fills a specific niche in our hypertension treatment algorithms.” – Clinical Researcher