Ambroxol
Disclaimer
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
This review is intended for medical-information and educational purposes. Because formulations, approved indications, pediatric dosing, excipients, and regulatory status may differ between countries and may change over time, the current package leaflet, Summary of Product Characteristics (SmPC), and Egyptian regulatory information applicable to the specific pack should take precedence.
1. Summary
Ambroxol hydrochloride is a mucolytic/secretolytic agent used to reduce the viscosity of abnormally thick respiratory secretions and facilitate mucociliary clearance and expectoration.
It is pharmacologically related to bromhexine and is an active metabolite of bromhexine. Its principal respiratory actions include modification of mucus characteristics, improvement of mucociliary transport, and stimulation of pulmonary surfactant secretion.
The historical GSK leaflet supplied with this request describes four oral formulations marketed in Egypt: 30-mg tablets, 75-mg sustained-release capsules, 7.5 mg/mL oral drops, and 15 mg/5 mL syrup. The same four product presentations are still listed in recent Egyptian market sources as products manufactured by GlaxoSmithKline.
Ambroxol is generally well tolerated. However, an important safety update that was absent from the old leaflet is the recognition of a small risk of severe hypersensitivity reactions and severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens–Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Progressive rash or mucosal lesions require immediate discontinuation and medical assessment.
2. Brand Name
Egyptian-market presentations supplied in the request
- Ambroxol 75 mg S.R. 10 capsules
- Ambroxol 7.5 mg/mL oral drops, 15 mL
- Ambroxol 30 mg, 20 tablets
- Ambroxol 15 mg/5 mL syrup, 120 mL
Active ingredient: Ambroxol / ambroxol hydrochloride.
Recent Egyptian listings corroborate the existence of the 75-mg sustained-release capsules, 7.5-mg/mL oral drops, and 30-mg tablets under the Ambroxol name and identify GlaxoSmithKline as the manufacturer.
Ambroxol is marketed under different brand names internationally; therefore, the generic name and formulation strength should always be checked rather than relying on brand name alone.
3. Category
Therapeutic class: Mucolytic / secretolytic agent
ATC classification: R05CB06 — Ambroxol.
It is primarily used as an expectorant/mucolytic to facilitate clearance of pathological respiratory secretions.
4. Active Ingredient
Ambroxol hydrochloride
Ambroxol is the active N-desmethyl metabolite of bromhexine hydrochloride.
The supplied historical GSK leaflet specifies:
- 75-mg SR capsule: 75 mg ambroxol as ambroxol hydrochloride per capsule.
- 30-mg tablet: 30 mg ambroxol as ambroxol hydrochloride per tablet.
- 7.5 mg/mL oral drops: 7.5 mg ambroxol as ambroxol hydrochloride per mL.
- 15 mg/5 mL syrup: 15 mg ambroxol as ambroxol hydrochloride per 5 mL.
5. Pharmaceutical Form & Strength
A. Ambroxol 30 mg tablets
Each tablet contains:
Ambroxol hydrochloride equivalent to 30 mg ambroxol.
The historical leaflet states the following excipients:
- Lactose
- Maize starch
- Microcrystalline cellulose
- Povidone
- Erythrosine red
- Magnesium stearate
- Purified talc
Because excipient composition can change between manufacturing revisions and markets, these historical excipients should not be assumed to be the current composition unless confirmed against the latest package leaflet for the actual Egyptian pack.
B. Ambroxol SR 75 mg capsules
Each sustained-release capsule contains:
75 mg ambroxol as ambroxol hydrochloride.
The historical leaflet lists:
- Sucrose
- Maize starch
- Eudragit RL100
- Diethylphthalate
- Talc
Again, the supplied leaflet is an older document; the current pack insert should be used for definitive excipient information.
C. Ambroxol 7.5 mg/mL oral drops
Each 1 mL contains:
7.5 mg ambroxol as ambroxol hydrochloride.
The historical leaflet lists:
- Glycerin
- Propylene glycol
- Sorbitol 70%
- Strawberry liquid/flavour
- Carmosine red
- Tribasic sodium citrate
- Purified water
D. Ambroxol 15 mg/5 mL syrup
Each 5 mL contains:
15 mg ambroxol as ambroxol hydrochloride.
The historical leaflet lists:
- Glycerin
- Sodium benzoate
- Sorbitol 70%
- Sucrose
- Citric acid monohydrate
- Cherry flavour
- Purified water
Important formulation point
The phrase “Ambroxol 7.5 mg/mL” is equivalent to 37.5 mg per 5 mL. It is therefore not the same concentration as the 15 mg/5 mL syrup. Dose calculations must always be based on the concentration on the actual bottle.
6. Manufacturer & Marketing Authorization Holder
Manufacturer:
GlaxoSmithKline (GSK) Egypt, with the historical supplied leaflet stating El-Salam City, Cairo, Egypt.
Recent Egyptian drug listings also identify GlaxoSmithKline as the manufacturer of the Ambroxol 75-mg SR capsules, 30-mg tablets, and 7.5-mg/mL oral drops.
Marketing Authorization Holder (MAH):
The historical leaflet supplied does not clearly distinguish the MAH from the manufacturing site, and I could not independently verify a current Egyptian official MAH record from a publicly searchable official regulatory source. Therefore, it would be inaccurate to automatically state that the manufacturing company and MAH are legally identical.
For a formal pharmaceutical database or regulatory publication, the MAH should be taken directly from the current Egyptian registered product record or current package leaflet.
7. Mechanism of Action
Ambroxol has several complementary actions:
7.1 Mucolytic/secretolytic action
It modifies abnormal respiratory mucus, reducing its viscosity and facilitating its clearance.
7.2 Improvement of mucociliary clearance
Ambroxol improves transport of respiratory secretions by enhancing the effectiveness of the mucociliary system. This facilitates movement of mucus toward the upper airways where it can be expectorated.
7.3 Stimulation of pulmonary surfactant
Ambroxol promotes pulmonary surfactant secretion, particularly from type II pneumocytes. Increased surfactant may help reduce adhesion of mucus to the respiratory epithelium and support airway secretion clearance.
7.4 Local anaesthetic activity
Ambroxol also has local anaesthetic properties related to blockade of neuronal sodium channels. This property is particularly relevant to ambroxol preparations formulated for sore-throat relief, although it is not the principal reason for using the oral respiratory formulations covered here.
7.5 Anti-inflammatory and antioxidant effects
Anti-inflammatory and antioxidant activities have been demonstrated experimentally and may contribute to the pharmacological profile of ambroxol, but these mechanisms should not be interpreted as establishing ambroxol as an anti-inflammatory disease-modifying treatment for asthma, COPD, or infection.
8. Spectrum of Activity
Not applicable.
Ambroxol is not an antimicrobial drug and has no antibacterial, antiviral, antifungal, or antiparasitic spectrum.
Its therapeutic effect is principally mucolytic/secretolytic and mucociliary, rather than antimicrobial.
9. Pharmacokinetics
Absorption
After oral administration, ambroxol is rapidly absorbed.
Reported oral bioavailability for immediate-release preparations is approximately 79%. Slow-release formulations have a prolonged absorption profile. Peak plasma concentrations are generally reached within approximately 1–2.5 hours with immediate-release formulations, while sustained-release products produce a later peak.
Distribution
Ambroxol is extensively distributed into tissues, with particularly high concentrations in the lungs, which is pharmacologically relevant to its respiratory action.
Plasma protein binding is approximately 90%, and the reported apparent volume of distribution is approximately 552 L.
Metabolism
Ambroxol undergoes substantial hepatic metabolism.
Cytochrome CYP3A4 is involved in its metabolism, including formation of dibromoanthranilic acid, while conjugation/glucuronidation also occurs.
Elimination
Ambroxol and its metabolites are eliminated predominantly through metabolic pathways followed by urinary excretion.
The terminal elimination half-life is approximately 10 hours, although reported values may vary according to the formulation and study conditions.
Renal and hepatic impairment
Because ambroxol undergoes hepatic metabolism and its metabolites are eliminated renally, clinically significant renal or hepatic impairment warrants increased caution, particularly when treatment is prolonged. Product-specific dose-adjustment recommendations should be followed where applicable.
10. Indications
The principal indication is:
Secretolytic/mucolytic treatment of acute and chronic bronchopulmonary disorders associated with abnormal mucus production or impaired mucus transport.
Examples may include conditions with tenacious bronchial secretions such as:
- Acute bronchitis
- Chronic bronchitis
- Exacerbations of chronic bronchitis
- Bronchiectatic disorders with excessive/thick secretions
- Other respiratory disorders associated with difficult-to-clear mucus
The historical GSK leaflet additionally lists:
- Asthmatic bronchitis
- Bronchial asthma
- Pre- and postoperative treatment
These historical indications should be interpreted cautiously. Ambroxol is not a substitute for established asthma therapy and should not be regarded as a bronchodilator, inhaled corticosteroid, or disease-modifying asthma treatment.
Similarly, ambroxol does not treat the underlying infection when an infectious cause is present.
The modern regulatory description of ambroxol generally focuses on its role as an expectorant/mucolytic for clearing mucus in acute or chronic respiratory disease.
11. Administration
General principles
Oral formulations should be administered according to the strength and formulation actually prescribed.
Adequate fluid intake is generally useful during mucolytic treatment because hydration can facilitate mucus clearance.
A. Ambroxol 30 mg tablets
The historical GSK leaflet states:
Adults:
30 mg three times daily.
For longer-term treatment, the historical leaflet states that the dose may be reduced to twice daily.
The tablets were instructed to be taken after meals with liquid.
B. Ambroxol SR 75 mg capsules
The historical GSK leaflet states:
Adults:
75 mg once daily, either in the morning or evening after a meal.
The SR capsule should be:
- swallowed whole;
- not opened;
- not chewed;
- taken with an adequate amount of liquid.
The presence of an inactive/empty carrier material in the stool may occur with some modified-release capsule systems and does not necessarily indicate treatment failure, because the active ingredient may already have been released.
The historical leaflet states that the SR capsules are not suitable for children.
C. Ambroxol 15 mg/5 mL syrup
The historical GSK leaflet states:
Adults and children >12 years:
10 mL three times daily for the first 2–3 days, then 5 mL three times daily.
Children 5–12 years:
5 mL two to three times daily.
Children 2–5 years:
2.5 mL three times daily.
Children under 2 years:
2.5 mL twice daily in the historical leaflet.
The leaflet states that the above regimen was intended for acute respiratory disease and initial treatment of chronic conditions, with treatment of longer duration potentially using a reduced dose.
D. Ambroxol 7.5 mg/mL oral drops
The historical GSK leaflet states:
Adults:
4 mL three times daily initially; in long-term treatment, 2 mL three times daily.
Children >5 years:
2 mL (stated as approximately 50 drops) two to three times daily.
Children 2–5 years:
1 mL (stated as approximately 25 drops) three times daily.
Children <2 years:
1 mL (stated as approximately 25 drops) twice daily.
The drops were stated to be capable of dilution with tea, fruit juice, milk, or water and administered with meals.
Important pediatric qualification
The pediatric doses above are reproduced from the historical GSK leaflet supplied by you, because you specifically requested that the original information be retained.
They should not automatically be treated as the universally current pediatric dosing standard for every ambroxol product. Pediatric recommendations differ among countries and formulations, and very young children require particular caution because ineffective clearance of increased/liquefied secretions may theoretically contribute to secretion retention. The current package leaflet for the Egyptian product should therefore be checked before prescribing to infants or very young children.
12. Method of Preparation
No special preparation is required for the ordinary marketed oral formulations.
- Tablets: swallow with liquid.
- SR capsules: swallow whole; do not crush, open, or chew.
- Syrup: measure the prescribed volume using an appropriate measuring device.
- Oral drops: measure accurately using the supplied dropper/device.
Do not substitute one formulation for another on a millilitre-for-millilitre basis, because the concentrations differ.
13. Contraindications
The principal contraindication is:
Known hypersensitivity to ambroxol hydrochloride or any component of the formulation.
The historical leaflet states:
“There are no known contraindications.”
That wording is too broad by current pharmacovigilance standards. Hypersensitivity is a recognized contraindication/avoidance condition, and formulation-specific excipient hypersensitivity must also be considered.
For example, some tablet formulations may contain lactose, while liquid preparations may contain sorbitol and/or sucrose; clinically relevant excipient restrictions depend on the actual product. The historical GSK composition should therefore not be used to infer the current excipient profile without checking the current pack insert.
14. Warnings & Precautions
14.1 Severe allergic reactions
Rare but potentially serious hypersensitivity reactions have been reported, including:
- Angioedema
- Anaphylaxis
- Anaphylactic shock
- Urticaria
- Pruritus
- Other hypersensitivity reactions
14.2 Severe cutaneous adverse reactions
This is one of the most important updates missing from the historical leaflet.
Severe cutaneous adverse reactions associated with ambroxol include:
- Erythema multiforme
- Stevens–Johnson syndrome
- Toxic epidermal necrolysis
- Acute generalized exanthematous pustulosis
The overall risk is considered low, and frequencies cannot reliably be estimated from available data. Patients should discontinue ambroxol immediately and seek medical assessment if a progressive rash, blistering, skin detachment, or mucosal involvement develops.
14.3 Gastric ulceration
Caution is reasonable in patients with a history of significant gastric ulceration or severe upper-GI disease, particularly where dyspeptic symptoms occur.
14.4 Renal impairment
Patients with significant renal impairment should be treated cautiously, particularly during prolonged therapy, because metabolites may accumulate.
14.5 Hepatic impairment
Caution is appropriate in clinically significant hepatic impairment because ambroxol is extensively metabolized in the liver.
14.6 Asthma and severe respiratory disease
Ambroxol should not be used as a replacement for:
- bronchodilators;
- inhaled corticosteroids;
- antibiotics when a bacterial infection genuinely requires them;
- other established disease-specific treatment.
Patients with severe uncontrolled asthma, suspected pneumonia, significant dyspnea, hemoptysis, high fever, or substantial clinical deterioration require medical evaluation rather than symptomatic mucolytic treatment alone. A patient-information source specifically advises medical review when pneumonia or another significant lung infection is suspected.
14.7 Children
Pediatric dosing must be formulation-specific.
The historical GSK leaflet contains doses for children younger than 2 years, but modern prescribing should follow the current local product information, particularly in infants.
14.8 Driving and machinery
Ambroxol is not generally associated with clinically important sedation or impairment of driving ability, although individual adverse reactions should be considered.
15. Drug Interactions
Pharmacokinetic interactions
No major clinically significant interaction profile has been established for ambroxol at conventional therapeutic doses.
Antibiotics
Ambroxol may be co-administered with antibiotics when clinically indicated.
Some pharmacological studies and product information indicate that ambroxol can increase the concentrations/penetration of certain antibiotics into bronchopulmonary secretions, including agents such as amoxicillin, cefuroxime, doxycycline and erythromycin. This is not generally regarded as a harmful drug interaction; it has potentially been considered a complementary pharmacodynamic feature.
Corticosteroids, bronchodilators, diuretics and cardiac glycosides
The historical GSK leaflet mentions these medicines among drugs that can be used with ambroxol.
This statement should not be interpreted as evidence that ambroxol has important interactions with all of these classes. The historical wording is better understood as indicating that ambroxol can be used as part of conventional respiratory treatment.
Antitussives
This is clinically more important.
Combining a mucolytic with a strong cough suppressant can theoretically produce retention of liquefied respiratory secretions, because ambroxol makes mucus easier to mobilize while cough suppression reduces the mechanism by which the mucus is expelled.
Therefore, routine combination with centrally acting antitussives should be avoided unless there is a clear clinical rationale and appropriate medical supervision.
16. Side Effects
Ambroxol is generally well tolerated.
Gastrointestinal adverse effects
These may include:
- Nausea
- Vomiting
- Dyspepsia/indigestion
- Diarrhea
- Abdominal discomfort or pain
- Heartburn
- Bloating
Oral/pharyngeal effects
Possible effects include:
- Dry mouth
- Dry throat
- Oral or pharyngeal hypoaesthesia
Taste disturbances
Dysgeusia/altered taste has been reported.
Allergic/hypersensitivity reactions
Rare reactions include:
- Rash
- Urticaria
Frequency unknown:
- Angioedema
- Pruritus
- Anaphylactic reactions
- Anaphylactic shock
Severe skin reactions
Frequency is unknown, but potentially severe reactions include:
- Erythema multiforme
- Stevens–Johnson syndrome
- Toxic epidermal necrolysis
- Acute generalized exanthematous pustulosis
These are rare but clinically important.
17. Use in Special Populations
Pregnancy
Available nonclinical data have not demonstrated direct or indirect reproductive toxicity, and clinical experience after the 28th week has not identified evidence of fetal harm. However, adequate controlled human pregnancy data are limited.
Current product information from several regulatory sources therefore advises the usual precautions during pregnancy and specifically discourages use during the first trimester unless clinically justified.
Therefore:
- Avoid unnecessary use during the first trimester.
- During later pregnancy, use only when the expected benefit justifies exposure.
- Treatment should be guided by the current local product information and the treating clinician.
Breastfeeding
Ambroxol passes into breast milk in animal studies. Human exposure data are limited.
Several product information sources therefore state that use during breastfeeding is not recommended or should occur only after careful risk–benefit evaluation.
The historical GSK leaflet similarly states that safety during lactation had not been established.
Pediatric patients
Formulation and country-specific dosing must be followed carefully.
In particular, dosing in infants and children younger than 2 years should not be extrapolated from adult dosing or from another ambroxol formulation.
Older adults
No routine age-based adjustment is generally required solely because of age, but renal and hepatic function and concomitant medications should be considered.
Renal impairment
Use with caution in significant renal impairment, particularly with prolonged treatment.
Hepatic impairment
Use with caution in significant hepatic impairment, particularly when treatment is prolonged.
18. Storage Conditions
The historical GSK leaflet states:
Store at a temperature not exceeding 30°C in a dry place.
The exact storage instructions printed on the current Egyptian package should be followed, because storage requirements can differ between formulations and manufacturing revisions.
Keep all formulations out of the reach of children.
19. Additional Sections
19.1 Overdose
The historical leaflet states that no symptoms of overdose had been reported at the time of publication and that symptomatic treatment should be provided if overdose occurs.
Because the historical information is old, it should not be interpreted as proof that overdose is harmless.
In suspected significant overdose:
- assess the clinical condition;
- provide supportive and symptomatic care;
- consider the formulation and amount taken;
- seek urgent medical/toxicological advice when clinically appropriate.
There is no established role for inducing vomiting at home.
19.2 Clinical role
Ambroxol is primarily a symptomatic mucus-clearance drug.
It can be useful when the clinical problem is thick or difficult-to-expectorate respiratory mucus. Its role is considerably less compelling when the patient has an uncomplicated dry cough without problematic secretions.
It should not be viewed as a treatment for the cause of every cough.
19.3 Important distinction from bronchodilators
Ambroxol is not a bronchodilator.
It does not replace:
- salbutamol or other β2-agonists;
- antimuscarinic bronchodilators;
- inhaled corticosteroids;
- systemic corticosteroids when otherwise indicated.
Its purpose is primarily to facilitate secretion clearance.
19.4 Important distinction from antibiotics
Ambroxol does not kill bacteria.
The presence of yellow or green sputum alone does not establish a need for an antibiotic, and the addition of an antibiotic should be based on the clinical diagnosis.
19.5 Long-term treatment
The historical leaflet allows longer-term treatment in chronic respiratory conditions and indicates that the dose may be reduced during prolonged therapy.
However, prolonged treatment should be based on an ongoing clinical indication rather than continued self-medication for an unexplained chronic cough.
19.6 Historical GSK statement on pediatric dosing
The old leaflet states that pediatric recommendations were based on a total daily dose of approximately:
1.2–1.6 mg ambroxol/kg/day.
Because this information comes from an old product document, it should be regarded as historical product-specific information rather than a universal current dosing rule.
For contemporary prescribing, the exact current dose should be calculated from the current formulation's label and the child's age/weight.
19.7 Historical pack information
The supplied leaflet states:
Ambroxol SR Capsule 75 mg
Carton containing an Al/PVC/PVDC strip of 10 capsules with an insert leaflet.
Ambroxol 30 mg tablets
Carton containing two Al/PVC strips of 10 tablets each with an insert leaflet.
Ambroxol 7.5 mg oral drops
Carton containing a 15-mL bottle.
Ambroxol 15 mg/5 mL syrup
Carton containing an amber glass bottle with 120 mL syrup, ROPP cap and inner leaflet.
These are historical pack specifications and should be confirmed against the current Egyptian presentation before publication or dispensing.
19.8 Important correction to the old leaflet
The statement:
“There are no known contraindications.”
is no longer an adequate description of the medicine's safety profile.
Likewise, the old statement that only “rare allergic reactions” occur is incomplete because subsequent pharmacovigilance identified rare/low-frequency severe allergic reactions and serious cutaneous reactions, including SJS/TEN and AGEP.
This is the single most important safety modernization when updating the old leaflet.
20. Frequently Asked Questions (FAQ)
1. Is Ambroxol an antibiotic?
No. Ambroxol is a mucolytic/secretolytic drug. It does not have antibacterial, antiviral, or antifungal activity.
2. Does Ambroxol stop cough?
Not directly.
It mainly makes abnormal respiratory mucus easier to mobilize and expectorate. Consequently, cough may become more productive and may improve as mucus clearance improves.
3. Is Ambroxol suitable for a dry cough?
Its benefit is generally more relevant when thick or difficult-to-clear mucus is present. It is not primarily a treatment for a purely dry cough.
4. Can Ambroxol be taken with an antibiotic?
Yes, ambroxol can generally be co-administered with appropriately selected antibiotics when an antibiotic is clinically indicated. Some data suggest increased antibiotic concentrations in bronchopulmonary secretions.
5. Can Ambroxol be taken with a cough suppressant?
This combination should not be used routinely without medical advice because suppression of the cough reflex may impair clearance of mucus that has been liquefied by the mucolytic.
6. Can Ambroxol be used during pregnancy?
It should be used cautiously during pregnancy. In particular, available product information generally advises avoiding use during the first trimester unless clearly justified.
7. Can Ambroxol be used while breastfeeding?
Ambroxol is excreted into breast milk in animal studies, and several product information sources do not recommend routine use during breastfeeding. A risk–benefit assessment should be made by the clinician.
8. Is Ambroxol safe for children?
Ambroxol has pediatric formulations, but the dose is formulation- and age-dependent. The historical Egyptian GSK leaflet contains doses for young children, including children under 2 years; however, current product-specific labeling should be checked before treatment, particularly in infants.
9. Can Ambroxol cause a serious allergy?
Yes, although the risk is low.
Rare hypersensitivity reactions and severe allergic reactions, including angioedema and anaphylaxis, have been reported.
10. Can Ambroxol cause Stevens–Johnson syndrome?
It has been reported rarely as part of the group of severe cutaneous adverse reactions associated with ambroxol.
A rapidly progressive rash, blistering, skin detachment, or involvement of the mouth, eyes, nose or genital mucosa requires immediate discontinuation and urgent medical assessment.
11. Does Ambroxol cause drowsiness?
It is not generally considered a sedating drug, and clinically significant impairment of driving ability is not expected in most patients.
12. Can Ambroxol be used in asthma?
It may be used as an adjunct where abnormal secretions are present, but it does not treat airway inflammation or bronchospasm and must never replace standard asthma therapy.
13. Can the 7.5 mg/mL drops be dosed like the 15 mg/5 mL syrup?
No.
They are different concentrations:
- 7.5 mg/mL = 37.5 mg/5 mL
- 15 mg/5 mL = 3 mg/mL
Therefore, the same volume does not contain the same amount of ambroxol.
14. Should the 75-mg SR capsule be opened or chewed?
No. The historical product instructions specify swallowing the sustained-release capsule whole with sufficient liquid.
15. Is Ambroxol safe for long-term use?
It is generally well tolerated, and some product information allows prolonged use in chronic respiratory disease. Nevertheless, persistent long-term use should have a clear clinical indication and should not delay assessment of an unexplained chronic cough.
21. References
-
European Medicines Agency (EMA). Ambroxol and bromhexine-containing medicines — referral and pharmacovigilance review concerning severe allergic reactions and severe cutaneous adverse reactions.
-
EMA/CMDh. Updated product-information recommendations for ambroxol and bromhexine, including hypersensitivity reactions, anaphylaxis, angioedema, rash, SJS/TEN and AGEP.
-
Saudi Food and Drug Authority (SFDA) Drug Information System. Ambroxol product information, pharmacokinetics, pregnancy/lactation, adverse effects and warnings.
-
Health Products Regulatory Authority (HPRA). Ambroxol hydrochloride product information including pregnancy and lactation recommendations.
-
MIMS. Ambroxol drug information, including absorption, bioavailability, distribution, metabolism, elimination and pharmacokinetic parameters.
-
Ambroxol pharmacology review. Review of ambroxol's mucokinetic, surfactant-stimulating, anti-inflammatory, antioxidant and local-anesthetic properties.
-
Supplied historical GSK Egypt leaflet for Ambroxol 75 mg SR capsules, 30 mg tablets, 7.5 mg/mL oral drops and 15 mg/5 mL syrup. This source was used to preserve the historical product-specific composition, pack information, and dosage instructions, but those details should not supersede the current approved Egyptian package leaflet.
-
Recent Egyptian market listings confirming current listings/manufacturer information for several Ambroxol GSK presentations.
22. Final Clinical Assessment
Ambroxol remains a well-established oral mucolytic/secretolytic agent whose principal clinical role is to facilitate clearance of pathological respiratory secretions.
The four GSK Egypt presentations supplied in this report are:
- Ambroxol 30 mg tablets
- Ambroxol 75 mg sustained-release capsules
- Ambroxol 7.5 mg/mL oral drops
- Ambroxol 15 mg/5 mL syrup
The historical leaflet remains useful for understanding the formulations and historical dosing, but it should not be treated as a fully current safety reference. The most important modernized information is the recognized, albeit low, risk of anaphylactic reactions, angioedema, and severe cutaneous adverse reactions including SJS/TEN and AGEP.
The historical broad statement that there were “no known contraindications” should therefore be replaced with a formulation- and patient-specific assessment of hypersensitivity, serious allergic reactions, severe skin reactions, pregnancy/lactation, renal or hepatic impairment, gastrointestinal disease, age, and concomitant antitussive therapy.
For actual prescribing or dispensing in Egypt, the current approved Egyptian package leaflet and regulatory record for the exact presentation should be regarded as the controlling source for final dose, age restrictions, excipients, storage instructions, manufacturer/MAH designation, and approved indications.