Lytex SR

Approved Uses:

• Mucolytic therapy for respiratory conditions with viscous or excessive mucus:
• Acute and chronic bronchitis
• Chronic obstructive pulmonary disease (COPD)
• Bronchial asthma (adjunctive use when mucus is problematic)
• Bronchiectasis
• Emphysema with bronchitic component
• Pneumoconiosis and chronic pneumonia
• Symptomatic relief of productive cough
• Lozenges: Sore throat relief through local anesthetic effect

Clinically Accepted Off-label Uses:

• Enhancing antibiotic penetration into sputum when combined with drugs like amoxicillin or cefuroxime
• Experimental adjunct in paraquat poisoning
• Investigational support in lysosomal storage disorders (e.g., Gaucher, Parkinson’s disease)

Pediatric Drops (6 mg/ml)

• 0–6 months: 0.5 ml twice daily
• 6–12 months: 1 ml twice daily
• 1–2 years: 1.25 ml twice daily

Syrup (15 mg/5 ml)

• 2–5 years: 2.5 ml, 2–3 times daily
• 5–10 years: 5 ml, 2–3 times daily
• ≥10 years & adults: 10 ml, 3 times daily for 2–3 days, then 10 ml twice daily

Syrup/Elixir (30 mg/5 ml)

• 6–12 years: 2.5 ml, 2–3 times daily
• ≥12 years & adults: 5 ml, 2–3 times daily

Sustained-Release Capsule (75 mg SR)

• ≥12 years & adults: One capsule once daily

Lozenges (15–20 mg)

• ≥12 years: One lozenge every 2–3 hours (up to 6/day)
• Not for use in children under 12

General Notes:

• All oral forms administered after meals
• Syrups in Bangladesh often sugar-free or low-sugar—suitable for diabetics
• No dose adjustment generally needed for elderly or mild-to-moderate renal/hepatic impairment

Ambroxol enhances mucociliary clearance and reduces mucus viscosity by stimulating type II pneumocytes to produce surfactant and increasing ciliary beat frequency. It also promotes serous secretion to thin mucus, making cough more productive. In lozenge form, ambroxol acts as a local anesthetic by blocking sodium channels in sensory neurons, reducing throat discomfort. Additionally, it exhibits antioxidant and mild anti-inflammatory properties.

• Absorption: Rapid and nearly complete; oral bioavailability ~80%
• Peak Levels: 1–2.5 hours (immediate-release), ~6.5 hours (SR)
• Distribution: Extensive; high lung tissue concentration; plasma protein binding ~90%
• Metabolism: Hepatically via glucuronidation and CYP3A4-dependent oxidation
• Elimination: 90% excreted via urine (mostly metabolites); half-life of 7–12 hours
• Special Populations: Minor pharmacokinetic changes in elderly or mild/moderate organ impairment

• Pregnancy: Avoid during first trimester unless clearly needed; animal studies show no teratogenicity, but limited human data
• Lactation: Excreted in breast milk in small amounts; no reported infant harm, but use with caution

• Primary Class: Mucolytic & Secretolytic agent
• Subclasses: Secretomotor, Local anesthetic (via lozenges)

• Known hypersensitivity to ambroxol or related compounds
• History of severe skin reactions or anaphylaxis to mucolytics
• Children under 12 (lozenge form)
• Fructose intolerance (liquid forms containing fructose or sorbitol)
• Severe hepatic impairment (relative avoidance)

• Serious skin reactions (e.g., SJS, TEN, AGEP): discontinue immediately with rash or mucosal lesions
• Gastrointestinal ulcer history: caution due to increased secretions
• Severe hepatic/renal impairment: use with caution and monitor
• Avoid simultaneous antitussives: risk of impaired expectoration and mucus retention
• Instruct patients to stop and seek help if respiratory symptoms worsen or systemic allergy signs occur

Common (≥1%):

• Gastrointestinal: nausea, vomiting, diarrhea, abdominal discomfort
• Oral: dry mouth, taste alteration, throat numbness (lozenges)

Uncommon to Rare (<1%):

• Skin reactions: rash, urticaria
• Neurological: headache, dizziness

Serious (very rare):

• Life-threatening reactions: anaphylaxis, angioedema, SJS, TEN, AGEP
• Onset typically within days of starting therapy; mild to moderate reactions usually reversible

• Cough suppressants (e.g., codeine): May inhibit productive cough and cause secretion retention
• Antibiotics (e.g., amoxicillin, erythromycin, cefuroxime): Enhanced lung penetration—therapeutically beneficial
• CYP3A4 inhibitors/inducers: Potential impact on ambroxol metabolism, though clinical significance is low
• Alcohol-containing formulations: Avoid in children; otherwise, no major alcohol interactions

• Health authorities continue to stress caution about rare but severe skin reactions
• Ongoing research explores ambroxol’s role in oxidative stress modulation and lysosomal storage disorders
• No changes to approved dosing or indications in recent regulatory updates

• Store at 25–30 °C, protected from moisture and sunlight
• Liquids: Shake well; do not freeze; discard unused after ~14 days (check label)
• Capsules/Lozenges: Keep in original packaging; store in a dry place
• Observe expiry dates; do not use if physical appearance, odor, or taste changes