Registered Malawi · PMRA

AMBCET 30/5MG SYRUP

AMBROXOL HCL WITH CITIRIZINE HCL

PMPB/PL299/11 SYRUP respiratory system INN generic

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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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL299/11
Registration date
23/02/2010
Expiry date
31/03/2024
Status
Registered
Active ingredient
AMBROXOL HCL WITH CITIRIZINE HCL
Dosage form
SYRUP
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
R02AD - Anesthetics, local
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
625
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:40 · updated 2026-09-29 04:33:05

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). 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 citirizine

Cetirizine is an antihistamine that helps relieve allergy symptoms.

What it treats

  • allergic rhinitis (hay fever)
  • urticaria (hives)

How it works

It blocks the action of histamine, a substance in the body that causes allergy symptoms.

Who it's for

Cetirizine is suitable for adults and children aged 2 years and older who have allergies.

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: citirizine

Cetirizine is a second-generation antihistamine used primarily to relieve allergy symptoms such as runny nose, sneezing, and itching, as well as to treat chronic urticaria (hives). It is less sedating compared to first-generation antihistamines, making it a preferred choice for patients needing allergy relief without significant drowsiness.

Indications

  • Allergic rhinitis
  • Seasonal allergic rhinitis
  • Perennial allergic rhinitis
  • Chronic idiopathic urticaria

Dosage

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

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Cetirizine selectively antagonizes peripheral H1 receptors, thereby inhibiting the effects of histamine, a chemical responsible for allergic symptoms. It blocks the action of histamine at the H1 receptor site, reducing symptoms associated with allergic reactions.

Pharmacodynamics

The onset of action for cetirizine is typically within 1 hour of administration, with peak effects occurring around 2 to 3 hours post-dose. The duration of action can last up to 24 hours, allowing for once-daily dosing. Cetirizine exhibits a lower affinity for the central nervous system H1 receptors, resulting in reduced sedation compared to older antihistamines.

Pharmacokinetics

Cetirizine is well absorbed from the gastrointestinal tract, with a bioavailability of approximately 93%. It is primarily metabolized in the liver, but the extent of hepatic metabolism is low, as most of the drug is excreted unchanged in the urine. The elimination half-life is about 8 to 10 hours in adults, and renal function can significantly affect its clearance.

Contra-indications

  • Hypersensitivity to cetirizine or any of the excipients
  • Severe renal impairment

Adverse effects

  • Drowsiness
  • Dry mouth
  • Dizziness
  • Fatigue
  • Nausea
  • Headache

Interactions

  • Alcohol may enhance the sedative effects
  • CNS depressants may have additive effects
  • Theoretical interactions with other antihistamines

Precautions

  • Caution in patients with epilepsy or at risk of seizures
  • Caution in patients with impaired renal function
  • May impair the ability to drive or operate machinery

Pregnancy

Cetirizine should only be used during pregnancy if the benefits outweigh the risks. Limited data suggests it is not harmful, but caution is advised.

Breast-feeding

Cetirizine is excreted in breast milk. Exercise caution when administering to breastfeeding mothers.

Storage

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

Formulations

  • Tablets
  • Oral solution
  • Chewable 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.

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.