Registered Malawi · PMRA

JEKOF 15/1MG SYRUP

AMBOXOL HCL AND SULBUTAMOL SULFATE

PMPB/PL492/2 SYRUP

What it does

Ambroxol is a medication used to help relieve cough and clear mucus from the airways.

Commonly used for: cough, mucus clearance, chronic obstructive pulmonary disease (COPD), bronchitis

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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.
PMPB/PL492/2
Registration date
13/09/2018
Expiry date
30/06/2019
Status
Registered
Active ingredient
AMBOXOL HCL AND SULBUTAMOL SULFATE
Dosage form
SYRUP
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:44 · updated 2026-09-29 04:33:06

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About amboxol

Ambroxol is a medication used to help relieve cough and clear mucus from the airways.

What it treats

  • cough
  • mucus clearance
  • chronic obstructive pulmonary disease (COPD)
  • bronchitis

How it works

It works by thinning mucus in the lungs, making it easier to cough up and clear out.

Who it's for

It is suitable for adults and children who have conditions that produce excess mucus in the airways.

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

About sulbutamol

Sulbutamol is a medication that helps open the airways in the lungs, making it easier to breathe.

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • exercise-induced bronchospasm

How it works

It relaxes the muscles in the airways, allowing them to widen and improve airflow.

Who it's for

This medicine is for people who have breathing problems, such as asthma or COPD.

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

Clinical monograph: amboxol

BNF-referenced

Ambroxol is a mucolytic agent used primarily for the treatment of respiratory conditions associated with excessive mucus production. It helps to reduce the viscosity of mucus, making it easier to expel from the airways. Ambroxol is derived from bromhexine, which is a well-known expectorant. It is commonly used in conditions such as chronic obstructive pulmonary disease (COPD), bronchitis, and asthma, where mucus clearance is impaired.

Indications

  • Chronic obstructive pulmonary disease (COPD)
  • Bronchitis
  • Asthma
  • Pneumonia
  • Cystic fibrosis

Dosage

Children: For children aged 5 to 12 years, the recommended dose is 15 mg two to three times daily. For children aged 2 to 5 years, the dose is 7.5 mg two to three times daily. For children under 2 years, refer to the BNF for Children for specific dosing guidelines.

Adults: The usual adult dose of ambroxol is 30 mg three times daily, which may be adjusted according to clinical response.

Mechanism of action

Ambroxol works by stimulating the production of surfactant in the alveoli and enhancing mucociliary clearance. It acts on the respiratory epithelium, promoting the secretion of mucus and decreasing its viscosity through the breakdown of glycoprotein structures. This mechanism facilitates expectoration and improves overall respiratory function.

Pharmacodynamics

Ambroxol exhibits mucolytic and expectorant properties, enhancing the clearance of mucus from the respiratory tract. It also has a local anesthetic effect on the bronchial mucosa, which can help reduce coughing. The drug may also have anti-inflammatory properties, contributing to its therapeutic effects in respiratory diseases.

Pharmacokinetics

Ambroxol is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring 1-3 hours after oral administration. It has a bioavailability of approximately 70%. The drug is extensively metabolized in the liver, primarily through glucuronidation and oxidation, with an elimination half-life of about 10 hours. Ambroxol is excreted mainly through urine as metabolites, with a small proportion being eliminated unchanged.

Adverse effects

  • Gastrointestinal disturbances
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Allergic reactions

Interactions

  • May interact with other mucolytics or cough suppressants
  • Caution with concomitant use of antibiotics

Precautions

  • Use with caution in patients with a history of peptic ulcer disease
  • Consider risks in patients with renal impairment

Pregnancy

Ambroxol should only be used if the benefits outweigh the risks, particularly in the first trimester.

Breast-feeding

Ambroxol is excreted in breast milk; caution is advised.

Storage

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

Formulations

  • Tablets
  • Syrup
  • Injection
  • Lozenges

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: sulbutamol

Sulbutamol is a selective beta-2 adrenergic agonist used primarily as a bronchodilator in the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles of the airways, leading to dilation and improved airflow. Sulbutamol is commonly administered via inhalation, but can also be given orally or intravenously. It is known for its rapid onset of action, making it a popular choice for acute asthma attacks.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Exercise-induced bronchospasm

Dosage

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

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Sulbutamol exerts its effects by binding to beta-2 adrenergic receptors on the bronchial smooth muscle. This binding activates adenylate cyclase, leading to an increase in cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP results in the phosphorylation of proteins that cause relaxation of smooth muscle, thus dilating the airways and facilitating easier breathing.

Pharmacodynamics

The primary pharmacodynamic effect of sulbutamol is bronchial smooth muscle relaxation, which results in bronchodilation. This effect is dose-dependent and can begin within minutes after administration, providing rapid relief from bronchospasm. Additionally, sulbutamol has some effects on other smooth muscles, such as those in the uterus and blood vessels, although these effects are not the primary therapeutic targets.

Pharmacokinetics

Sulbutamol is rapidly absorbed after inhalation, with peak plasma concentrations typically occurring within 30 minutes to 2 hours. Its bioavailability is affected by the route of administration; inhaled sulbutamol has a higher bioavailability compared to oral formulations due to first-pass metabolism. The drug is metabolized primarily in the liver, with a half-life of approximately 3 to 7 hours. Sulbutamol is excreted mainly in the urine as inactive metabolites.

Contra-indications

  • Hypersensitivity to sulbutamol or any of its components
  • Severe tachyarrhythmias
  • Cardiac arrhythmias

Adverse effects

  • Tremor
  • Nervousness
  • Palpitations
  • Tachycardia
  • Headache
  • Dizziness
  • Nausea
  • Muscle cramps
  • Hypokalemia
  • Increase in blood glucose levels

Interactions

  • Beta-blockers may reduce the effectiveness of sulbutamol
  • Diuretics may increase the risk of hypokalemia
  • Monoamine oxidase inhibitors (MAOIs) can potentiate the effects of sulbutamol
  • Tricyclic antidepressants may enhance the cardiovascular effects

Precautions

  • Use with caution in patients with cardiovascular disorders
  • Caution in patients with hyperthyroidism
  • Caution in patients with diabetes mellitus
  • Risk of paradoxical bronchospasm

Pregnancy

Sulbutamol should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Sulbutamol is excreted in breast milk, caution is advised when administered to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Do not freeze.

Formulations

  • Inhalation aerosol
  • Inhalation solution
  • Tablet
  • Syrup

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: amboxol

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.