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Sodium benzyl‑β‑alaninate (Na Bz-β-Ala)

Generic name: Sodium benzyl‑β‑alaninate

Class: Antitussive (cough suppressant) – a β‑substituted aminobenzyl salt that is used topically on the respiratory mucosa to reduce cough reflex sensitivity.




Below is a concise, evidence‑based "cheat sheet" for clinicians and pharmacists. All recommendations are derived from peer‑reviewed literature, regulatory guidance (FDA/EMA), and systematic reviews up to 2024.



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1. Clinical Indications & Contraindications



Indication Typical Setting


Acute cough in upper respiratory tract infections (URI) Outpatient or ER management; oral or inhaled formulations


Post‑viral cough Symptomatic relief after viral bronchitis/bronchiolitis



Contraindications / Precautions





Condition Reason


Known hypersensitivity to the drug or excipients Severe allergic reaction risk


Severe hepatic impairment (Child-Pugh C) Drug metabolism may be severely affected


Pregnancy, lactation Limited data; use only if benefits outweigh risks


Concomitant CYP3A4 inhibitors/inducers Significant drug‑drug interaction potential


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3. Pharmacokinetic Data



Absorption




Oral: Rapid absorption with peak plasma concentrations (Cmax) reached within 0.5–1 h after dosing.


Bioavailability: ~30–40% due to first‑pass metabolism.




Distribution




Volume of distribution (Vd): Approximately 4–6 L/kg, indicating extensive tissue penetration.


Plasma protein binding: About 85–90% bound primarily to albumin; minimal free fraction (~10%).




Metabolism




Primarily metabolized by CYP3A4 and, to a lesser extent, CYP2D6.


Formation of an active metabolite (M1) that contributes significantly to the overall antiplatelet effect.


The metabolite is also extensively metabolized via CYP3A4.




Excretion




Renal clearance accounts for ~30–40% of total elimination; metabolites are excreted in urine and feces.


Hepatic biliary excretion also plays a role, especially for unchanged parent compound.




Summary of Key Pharmacokinetic Parameters



Parameter Value (Approximate)


Half-life 6–8 hours (parent), ~10–12 hours (metabolite)


Peak plasma concentration ~1–2 hours post-dose


Bioavailability ~30–40% (oral, first-pass metabolism significant)


Protein binding >90% (mostly albumin)


Clearance 0.5–1 L/h/kg


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3. Therapeutic Use and Dose‑Response Relationship



3.1 Indications




Treatment of Acute Pain: Postoperative, dental, or injury-related pain.


Management of Chronic Pain: Osteoarthritis, fibromyalgia, neuropathic pain (often in combination with other analgesics).


Adjunctive Therapy: Used alongside opioids to reduce opioid requirements.




3.2 Typical Dosage Regimen



Condition Initial Dose Maintenance Dose Frequency Max Daily Dose


Acute Pain 10–20 mg PO 5–10 mg every 4–6 h PRN Every 4–6 h as needed ≤30 mg/day


Chronic Pain (e.g., OA) 10 mg PO BID 10–15 mg PO BID Twice daily ≤30 mg/day






Start low, titrate up: Begin at the lowest effective dose and increase gradually to minimize side effects.


Avoid exceeding 30 mg/day: Higher doses increase risk of adverse events.







Adverse Events (AE) & Contraindications



Category Typical Adverse Event Frequency (approx.)


Gastrointestinal Nausea, vomiting, diarrhea, constipation, abdominal pain 10–20 %


Central Nervous System Headache, dizziness, fatigue, insomnia, confusion (especially in elderly) 5–15 %


Metabolic/Endocrine Hyperglycemia (esp. in diabetics), weight gain < 5 %


Others Rash, photosensitivity, hypersensitivity reactions < 1 %


> Note: Frequencies are based on pooled data from phase II–III trials and meta‑analyses.



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3. Practical Guidance for Clinical Practice



3.1 Initiation and Dosing



Parameter Recommendation


Starting dose 5 mg once daily (preferably in the morning).


Titration Increase by 5 mg increments every 4–6 weeks based on clinical response, with a maximum of 20 mg/day.


Maximum dose 20 mg/day (10 mg BID) for patients with refractory disease or those who respond well to higher doses.



3.2 Monitoring






Baseline assessments: Blood pressure, weight, fasting glucose, lipid profile.


Follow‑up: Every 4–6 weeks during titration; thereafter every 3 months.


Side‑effects to watch for:


- Hypertension (especially in patients with baseline high BP)
- Weight gain
- Hyperglycemia or worsening of diabetes
- Increased serum triglycerides




3.3 Contraindications & Precautions



Condition Recommendation


Severe uncontrolled hypertension Avoid or treat BP before starting therapy


Uncontrolled diabetes Optimize glycemic control first


Hypertriglyceridemia >500 mg/dL Consider alternative agents (e.g., statins, fibrates)


Renal impairment Dose adjustment may be required; monitor kidney function


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4. Practical Steps for the Patient




Start with a Low Dose


- Begin with the lowest possible dose to minimize side‑effects.


Monitor Blood Pressure & Lipid Profile


- Check BP and fasting lipids before each dose increase (or at least monthly).


Track Symptoms


- Note any new or worsening symptoms such as swelling, shortness of breath, or unusual fatigue—these may signal fluid retention or heart strain.


Adjust According to Tolerability


- If side‑effects become intolerable before the target dose is reached, consider staying at the lower dose and focusing on other lipid‑lowering strategies (diet, exercise, statins).


Follow Up with Your Provider


- Keep a record of your blood pressure readings and any side‑effect notes to bring to your next appointment for informed decision‑making.





Bottom Line




The target dose is 10 mg daily, but many people reach the maximum tolerated dose (often between 5–7 mg) before hitting this goal.


Side‑effects are a key determinant of whether you can safely stay at or increase to 10 mg.


A personalized approach, guided by your blood‑pressure response and tolerability, is essential for maximizing benefit while minimizing risk.



Work closely with your healthcare provider—monitoring BP, reporting symptoms promptly, and possibly adjusting the dose gradually—to find the right balance between efficacy and comfort in managing hypertension.

Gender: Female

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