Valid Ghana · FDA Ghana

ENROBROM SOLUTION (Each ml contains Enrofloxacin 100mg/ Bromohexine Hydrochloride 10mg)

Each ml contains Enrofloxacin 100mg/ Bromohexine Hydrochloride

What it does

Bromohexine is a medication that helps clear mucus from the airways, making it easier to breathe.

Commonly used for: chronic bronchitis, pneumonia, asthma, chronic obstructive pulmonary disease (COPD)

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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.
FDA/V.255-12210
Registration date
2026-03-16
Expiry date
2030-11-01
Status
Valid
Active ingredient
Each ml contains Enrofloxacin 100mg/ Bromohexine Hydrochloride
Strength
100mg/10mg
Pack size
-
Therapeutic class
-
RxNorm RxCUI
24192
Manufacturer / MAH
Osamed Green Solution
Country of origin
GHANA

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:20 · updated 2026-10-20 04:00:13

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About bromohexine

Bromohexine is a medication that helps clear mucus from the airways, making it easier to breathe.

What it treats

  • chronic bronchitis
  • pneumonia
  • asthma
  • chronic obstructive pulmonary disease (COPD)

How it works

Bromohexine works by breaking down and thinning mucus in the lungs, which helps to clear it out.

Who it's for

This medication is for adults and children with respiratory conditions that involve thick mucus.

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

About contains

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

How it works

The active ingredients in this medicine perform specific functions to help your body in various ways, depending on the condition being treated.

Who it's for

This medicine is meant for individuals with specific health issues as determined by a healthcare provider.

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

About enrofloxacin

Enrofloxacin is an antibiotic used to treat bacterial infections in animals.

What it treats

  • bacterial infections
  • infections in pets

How it works

It kills bacteria or stops their growth, helping to treat infections.

Who it's for

It is mainly used for pets and animals suffering from infections.

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

Clinical monograph: bromohexine

BNF-referenced

Bromohexine is a mucolytic agent that is commonly used to facilitate the clearance of mucus from the respiratory tract. It is structurally related to the benzylamine group and is primarily utilized in the management of respiratory conditions characterized by excessive or thick mucus production. Bromohexine aids in the breakdown of mucus viscosity, making it easier to expel and improve respiratory function.

Indications

  • Chronic bronchitis
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Respiratory tract infections with thick mucus

Dosage

Children: Refer to BNF for Children for specific dosing guidelines based on age and weight.

Adults: The usual oral dosage is 8 to 16 mg three times daily. The dosage may be adjusted according to the severity of the condition and patient response.

Mechanism of action

Bromohexine acts by increasing the production of surfactant in the alveoli and enhancing the secretion of mucus in the respiratory tract. It promotes the hydrolysis of mucopolysaccharides and stimulates the ciliary activity of the respiratory epithelium, leading to increased mucus clearance. This action is facilitated through its effect on serous glands in the bronchial mucosa, thereby reducing mucus viscosity and enhancing expectoration.

Pharmacodynamics

Bromohexine exhibits mucolytic and expectorant properties. It alters the viscosity of mucus, making it less thick and easier to clear from the airways. Its action on the respiratory tract aids in improving airflow and alleviating symptoms associated with respiratory disorders such as chronic bronchitis and asthma. The onset of action typically occurs within a few hours of administration, with a duration of effect that can last several hours.

Pharmacokinetics

Bromohexine is well absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It is metabolized in the liver to form active metabolites. The elimination half-life is approximately 8 to 12 hours, and it is primarily excreted in the urine as metabolites and unchanged drug. The drug's bioavailability can be affected by food, with higher absorption rates observed when taken on an empty stomach.

Adverse effects

  • Gastrointestinal disturbances
  • Allergic reactions including rash and pruritus
  • Headache
  • Dizziness

Precautions

  • Caution in patients with peptic ulcer disease
  • Use with caution in patients with asthma or other respiratory conditions

Pregnancy

There is limited data on the safety of bromohexine in pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Bromohexine is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Oral solution
  • Tablets
  • 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.

Clinical monograph: contains

Contains is a term generally used to refer to formulations that include one or more active pharmaceutical ingredients. The specific effects, uses, and formulations depend on the particular drug in question. It is often used in the context of drug labels to inform about the components of a medication.

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

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.

Clinical monograph: enrofloxacin

BNF-referenced

Enrofloxacin is a fluoroquinolone antibiotic that is used primarily in veterinary medicine but has applications in human medicine. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes that are critical for bacterial DNA replication, transcription, and repair. This leads to bacterial cell death, making it effective against a broad spectrum of gram-negative and some gram-positive bacteria.

Indications

  • Bacterial infections
  • Respiratory tract infections
  • Urinary tract infections
  • Skin infections
  • Gastrointestinal infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients.

Adults: Refer to the specific product guidelines for dosing information, as it can vary based on the indication and formulation used.

Mechanism of action

Enrofloxacin exerts its antibacterial effect through the inhibition of bacterial DNA gyrase and topoisomerase IV, which are essential enzymes for DNA replication and transcription. By interfering with these enzymes, enrofloxacin disrupts the normal function of the bacterial cell, leading to cell death.

Pharmacodynamics

Enrofloxacin has a bactericidal effect, meaning it kills bacteria rather than merely inhibiting their growth. Its activity is concentration-dependent, meaning that higher concentrations lead to more significant antibacterial effects. The drug has a broad spectrum of activity against many gram-negative bacteria, including Pseudomonas aeruginosa, as well as some gram-positive organisms.

Pharmacokinetics

Enrofloxacin is well-absorbed after oral administration, with peak plasma concentrations typically achieved within 1 to 2 hours. It is widely distributed throughout the body, including into tissues and fluids, and has good penetration into the central nervous system. The elimination half-life varies but is generally between 4 to 8 hours in humans. Enrofloxacin is primarily metabolized in the liver, and its metabolites, including ciprofloxacin, are also active against bacteria.

Contra-indications

  • Hypersensitivity to enrofloxacin or any of its components
  • Use in growing animals due to potential effects on cartilage development

Adverse effects

  • Gastrointestinal disturbances such as vomiting and diarrhea
  • Central nervous system effects including seizures and ataxia
  • Tendon rupture or damage, particularly in larger breed dogs
  • Possible cartilage damage in young animals

Interactions

  • Antacids or products containing aluminum, magnesium, or iron may reduce the absorption of enrofloxacin
  • Cationic agents may interfere with its antimicrobial activity
  • Concurrent use with other nephrotoxic drugs may increase the risk of renal toxicity

Precautions

  • Use with caution in animals with a history of seizures or renal impairment
  • Monitor for signs of adverse reactions during therapy
  • Not for use in animals with known hypersensitivity to fluoroquinolones

Pregnancy

Safety during pregnancy has not been established, use only if benefits outweigh risks.

Breast-feeding

Safety during lactation has not been fully established, use with caution.

Storage

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

Formulations

  • Injectable solution
  • Oral tablets
  • Oral suspension

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: bromohexine

PubChem CID 352496

Molecular formula: C6H9Br

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

Molecular reference: enrofloxacin

PubChem CID 71188

Molecular formula: C19H22FN3O3

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.