Registered Kenya · PPB

BROXOL SYRUP

AMBROXOL HYDROCHLORIDEGUAIPHENSINTERBUTALINE SULPHATEMENTHOL

What it does

Ambroxol is a medication that helps relieve cough and improve breathing by making mucus thinner and easier to clear from the airways.

Commonly used for: cough due to respiratory conditions, chronic bronchitis, asthma

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2011/22064/086
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
AMBROXOL HYDROCHLORIDEGUAIPHENSINTERBUTALINE SULPHATEMENTHOL
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
R02AD - Anesthetics, local
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
625
Manufacturer / MAH
Theralife Pharma
Applicant / LTR
-
Country of origin
FOREIGN

Source: Pharmacy and Poisons Board · fetched 2026-01-28 22:10:27 · updated 2026-03-23 04:55:38

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About ambroxol

Ambroxol is a medication that helps relieve cough and improve breathing by making mucus thinner and easier to clear from the airways.

What it treats

  • cough due to respiratory conditions
  • chronic bronchitis
  • asthma

How it works

It works by breaking down mucus in the lungs, making it easier to cough up and clear from the airways.

Who it's for

Ambroxol is suitable for adults and children over a certain age who have a productive cough or difficulty breathing due to mucus.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About hydrochlorideguaiphensinterbutaline

This medication is used to help relieve symptoms caused by certain breathing problems.

What it treats

  • chest tightness
  • cough
  • wheezing
  • shortness of breath

How it works

It helps to relax and open the airways in the lungs, making it easier to breathe.

Who it's for

It is commonly prescribed for people with asthma or chronic obstructive pulmonary disease (COPD).

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About sulphatementhol

Sulphatementhol is often used to relieve minor pain and reduce inflammation.

What it treats

  • coughs (cough relief)
  • muscle pain (myalgia)
  • joint pain (arthritis)

How it works

It helps to soothe irritation and reduce swelling in the affected areas.

Who it's for

This medication is suitable for adults and children who need relief from minor pain or irritation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ambroxol

BNF-referenced

Ambroxol is a mucolytic agent that facilitates the clearance of mucus from the respiratory tract. It is primarily used to treat respiratory disorders associated with excessive mucus production, such as chronic obstructive pulmonary disease (COPD), asthma, and bronchitis. Ambroxol is known for its ability to thin and loosen mucus, making it easier to expel from the lungs.

Indications

  • Chronic obstructive pulmonary disease (COPD)
  • Asthma
  • Bronchitis
  • Respiratory infections with excessive mucus production

Dosage

Children: For children aged 2 to 5 years, the recommended dose is 15 mg to 30 mg daily, divided into two or three doses. For children aged 6 to 12 years, the recommended dose is 30 mg to 60 mg daily, divided into two or three doses.

Adults: The usual adult dose is 30 mg to 120 mg daily, divided into two or three doses.

Mechanism of action

Ambroxol acts by stimulating the secretion of serous mucus in the respiratory tract, which helps to reduce the viscosity of sputum. This mucolytic action enhances the clearance of mucus, facilitating expectoration. It may also influence the production of surfactant in the lungs, contributing to improved lung function.

Pharmacodynamics

Ambroxol exhibits a dose-dependent effect on mucus viscosity and secretion. By enhancing mucociliary clearance, it aids in reducing airway obstruction and improving respiratory function. The onset of action typically occurs within a few hours after administration, with peak effects observed within 1 to 2 days of treatment.

Pharmacokinetics

Ambroxol is well absorbed after oral administration, with a bioavailability of approximately 70%. It is metabolized primarily in the liver through conjugation and oxidation, resulting in active metabolites. The elimination half-life is about 10 hours, and the drug is excreted predominantly via urine, both as unchanged drug and metabolites.

Contra-indications

  • Hypersensitivity to ambroxol or any of the excipients
  • Severe hepatic impairment
  • Severe renal impairment

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Skin reactions (rash, urticaria)
  • Headache
  • Dizziness
  • Dry mouth
  • Anaphylactic reactions (rare)

Interactions

  • Ambroxol may enhance the absorption of other drugs due to its mucolytic properties
  • Caution should be exercised when used with other cough suppressants

Precautions

  • Use with caution in patients with a history of peptic ulcer disease
  • Avoid use in patients with asthma unless prescribed by a healthcare professional
  • Monitor renal and hepatic function in patients with pre-existing conditions

Pregnancy

Ambroxol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data on human pregnancy are limited.

Breast-feeding

Ambroxol is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Formulations

  • Oral solution
  • Syrup
  • Tablets
  • Effervescent tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: hydrochlorideguaiphensinterbutaline

Hydrochloride guaifenesin butaline is a combination medication that includes guaifenesin, an expectorant, and butaline, a bronchodilator. It is primarily used to alleviate symptoms associated with respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) by helping to clear mucus and dilate the airways. The formulation aims to improve breathing by reducing airway resistance and facilitating mucus clearance.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Bronchitis
  • Respiratory tract infections with productive cough

Dosage

Children: Refer to the BNF for Children for appropriate dosing information.

Adults: Refer to prescribing guidelines for specific dosing recommendations.

Mechanism of action

Guaifenesin works by increasing the volume and reducing the viscosity of secretions in the tracheobronchial passages, thereby promoting the expulsion of mucus. Butaline, on the other hand, is a β2-adrenergic agonist that relaxes bronchial smooth muscle, leading to bronchodilation. This dual action helps to alleviate cough and improve airflow in patients with obstructive airway diseases.

Pharmacodynamics

The pharmacodynamic effects of hydrochloride guaifenesin butaline involve a combination of enhanced mucus clearance due to guaifenesin and bronchodilation from butaline. The bronchodilatory effect is characterized by a rapid onset of action, typically within minutes, and can last for several hours, improving respiratory function and reducing symptoms of bronchoconstriction.

Pharmacokinetics

Guaifenesin is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 1 to 2 hours. It is metabolized in the liver and excreted in the urine. Butaline also has a rapid onset of action and is primarily eliminated through hepatic metabolism. The half-life of butaline is approximately 2 to 6 hours, depending on individual factors. Both drugs have a wide distribution in body tissues.

Contra-indications

  • Hypersensitivity to guaifenesin, hydrochloride, or terbutaline
  • Severe asthma exacerbation
  • Cardiac arrhythmias
  • Hyperthyroidism

Adverse effects

  • Tachycardia
  • Nervousness
  • Dizziness
  • Nausea
  • Headache
  • Tremors
  • Insomnia

Interactions

  • Beta-blockers may reduce the effectiveness of terbutaline
  • Caution with monoamine oxidase inhibitors (MAOIs) due to potential hypertensive crisis
  • Other sympathomimetics may enhance cardiovascular effects

Precautions

  • Use with caution in patients with cardiovascular disorders
  • Caution in patients with diabetes mellitus
  • Assess for potential drug interactions
  • Monitor for worsening of respiratory condition

Pregnancy

Use only if clearly needed. Terbutaline is classified as Category C, where potential benefits might outweigh risks.

Breast-feeding

Use with caution. Guaifenesin and terbutaline are excreted in breast milk; assess risk versus benefit.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral tablets containing guaifenesin and terbutaline
  • Syrup formulations with guaifenesin and terbutaline
  • Inhalation solutions (for terbutaline)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: sulphatementhol

Sulphatementhol is a compound primarily used for its analgesic and anti-inflammatory properties. It is often utilized in topical formulations to relieve minor aches and pains associated with muscle strains, sprains, and arthritis. Its menthol component provides a cooling sensation that helps to alleviate discomfort.

Indications

  • Muscle strains
  • Sprains
  • Arthritis
  • Minor aches and pains

Dosage

Children: Refer to specific product instructions, as formulations may vary.

Adults: Refer to specific product instructions, as formulations may vary.

Mechanism of action

Sulphatementhol acts by activating TRPM8 receptors, which are responsible for the sensation of coolness. This activation leads to the opening of cation channels, resulting in depolarization of sensory neurons and the perception of a cooling effect. Additionally, it may inhibit the synthesis of pro-inflammatory mediators, contributing to its analgesic effect.

Pharmacodynamics

The pharmacodynamic profile of sulphatementhol includes anti-inflammatory and analgesic properties, making it effective for topical pain relief. Its ability to induce a cooling sensation can distract from pain, while its potential effects on inflammatory pathways help reduce swelling and discomfort in affected areas.

Pharmacokinetics

Sulphatementhol is generally applied topically, where it is absorbed through the skin. The systemic absorption is minimal, leading to localized effects with a reduced risk of systemic side effects. The onset of action is typically rapid due to its direct application to the site of pain, and the duration of effect can vary depending on the formulation and specific concentration used.

Pregnancy

There is limited data on the use of sulphatementhol during pregnancy. Caution is advised and it should only be used if the potential benefits outweigh the risks.

Breast-feeding

It is not known whether sulphatementhol is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: ambroxol

PubChem CID 2132

Molecular formula: C13H18Br2N2O

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.