Registered Kenya · PPB

NUCET TABLETS

AMBROXOL HYDROCHLORIDE BP 60MG CETRIZINE HYDROCHLORIDE BP 5MG

H2015/CTD2556/010 AMBROXOL HYDROCHLORIDE BP 60MG & CETRIZINE HYDROCHLORIDE BP 5MG 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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Registration & product details

Registration no.
H2015/CTD2556/010
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
AMBROXOL HYDROCHLORIDE BP 60MG CETRIZINE HYDROCHLORIDE BP 5MG
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
R02AD - Anesthetics, local
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
625
Manufacturer / MAH
Wessex Pharmaceuticals
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
MVCP+JGP, Mombasa Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:48:59 · updated 2026-07-26 11:39:28

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 cetrizine

Cetirizine is an antihistamine that helps relieve allergy symptoms.

What it treats

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

How it works

It works by blocking a substance in the body called histamine, which causes allergic symptoms.

Who it's for

It is suitable for adults and children over the age of 6 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: cetrizine

BNF-referenced

Cetirizine is an antihistamine drug, specifically a metabolite of hydroxyzine, that primarily functions through the selective inhibition of peripheral H1 receptors. It is utilized to alleviate symptoms associated with allergic conditions, including allergic rhinitis and urticaria, and is noted for its minimal sedative effects compared to first-generation antihistamines.

Indications

  • Chronic idiopathic urticaria
  • Perennial allergic rhinitis
  • Seasonal allergic rhinitis
  • Allergic asthma
  • Physical urticaria
  • Atopic dermatitis

Dosage

Children: For children aged 6 to 12 years, the dosage is typically 5 mg to 10 mg once daily depending on the severity of symptoms. For children aged 2 to 6 years, the usual dose is 2.5 mg to 5 mg once daily. Specific dosing should refer to the BNF for Children.

Adults: The typical adult dose is 10 mg once daily, which can be adjusted based on the severity of symptoms and patient response.

Mechanism of action

Cetirizine selectively inhibits peripheral H1 receptors, effectively blocking the action of histamine, which is responsible for allergic symptoms. It has demonstrated negligible anticholinergic and antiserotonergic effects, and studies indicate minimal penetration into the central nervous system, reducing the likelihood of sedation.

Pharmacodynamics

Cetirizine exhibits antihistaminic activity that effectively minimizes or eliminates symptoms of various allergic conditions such as chronic idiopathic urticaria and allergic rhinitis. It has anti-inflammatory properties that may assist in asthma management and can significantly reduce the duration and dosage of topical anti-inflammatory treatments for conditions like atopic dermatitis. Its effects can be observed within 20 minutes of administration, lasting up to 24 hours.

Pharmacokinetics

Cetirizine is well absorbed orally with peak plasma concentrations occurring approximately 1 hour after dosing. It has a half-life of about 8 hours, allowing for once-daily dosing in most cases. The drug is primarily excreted in the urine, with minimal hepatic metabolism, making it suitable for patients with liver impairment.

Adverse effects

  • dry mouth
  • drowsiness
  • fatigue
  • headache
  • nausea

Precautions

  • Use with caution in patients with renal impairment
  • Caution advised in individuals with a history of seizures

Pregnancy

Cetirizine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Cetirizine is excreted in breast milk; caution is advised when administered to breastfeeding mothers.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • tablets
  • oral solution
  • 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: ambroxol

PubChem CID 2132

Molecular formula: C13H18Br2N2O

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

Molecular reference: cetrizine

PubChem CID 2678

Molecular formula: C21H25ClN2O3

Mechanism of action

Cetirizine, a metabolite of _hydroxyzine_, is an antihistamine drug. Its main effects are achieved through selective inhibition of peripheral H1 receptors. The antihistamine activity of cetirizine has been shown in a variety of animal and human models. _In vivo_ and _ex vivo_ animal models have shown insignificant anticholinergic and antiserotonergic effects. In clinical studies, however, dry mouth was found to be more frequent with cetirizine than with a placebo. In vitro receptor binding studies have demonstrated no detectable affinity of cetirizine for histamine receptors other than the H1 receptors. Studies with radiolabeled cetirizine administration in the rat have demonstrated insignificant penetration into the brain. _Ex vivo_ studies in the mouse have shown that systemically administered cetirizine does not occupy cerebral H1 receptors significantly. Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H1 receptors.

Pharmacodynamics

**General effects and respiratory effects** Cetirizine, the active metabolite of the piperazine H<sub>1</sub>-receptor antagonist hydroxyzine, minimizes or eliminates the symptoms of chronic idiopathic urticaria, perennial allergic rhinitis, seasonal allergic rhinitis, allergic asthma, physical urticaria, and atopic dermatitis. The clinical efficacy of cetirizine for allergic respiratory diseases has been well established in numerous trials. **Effects on urticaria/anti-inflammatory effects** It has anti-inflammatory properties that may play a role in asthma management. There is evidence that cetirizine improves symptoms of urticaria. Marked clinical inhibition of a wheal and flare response occurs in infants, children as well as adults within 20 minutes of one oral dose and lasts for 24 h. Concomitant use of cetirizine reduces the duration and dose of topical anti-inflammatory formulas used for the treatment of atopic dermatitis.

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.