Registered Tanzania · TMDA

CODACTIV FORT

Butamirate Citrate 22.5 mg/5mL

TAN 21 HM 0184 Syrup respiratory system INN generic

What it does

Butamirate is a medicine used to relieve coughing.

Commonly used for: cough, dry cough

Read more in plain English ↓

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

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Registration & product details

Registration no.
TAN 21 HM 0184
Registration date
2021-03-29
Expiry date
2026-03-28
Status
Registered/Compliant
Active ingredient
Butamirate Citrate 22.5 mg/5mL
Dosage form
Syrup
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
R05DB - Other cough suppressants
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
19862
Manufacturer / MAH
Humanis Saglik
Applicant / LTR
Humanis Saglik A.S
Country of origin
TURKEY
Manufacturer location
Link Plaza, Maslak, Eski Büyükdere Cd. No: 3-5 Kat: 6-7, 34398 Sarıyer/İstanbul, Türkiye

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:08

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Butamirate is a medicine used to relieve coughing.

What it treats

  • cough
  • dry cough

How it works

Butamirate works by calming the cough reflex in the brain, making it easier to manage a dry cough.

Who it's for

Butamirate is suitable for adults and children who are experiencing a dry cough.

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

Clinical monograph: butamirate

BNF-referenced

Butamirate is a drug primarily used as an antitussive agent, which means it is employed to relieve cough. It is effective in treating dry coughs associated with various respiratory conditions. Butamirate works by suppressing the cough reflex without affecting the respiratory function. It is often preferred for its non-narcotic properties, making it suitable for patients who may be sensitive to narcotic cough suppressants.

Indications

  • Dry cough
  • Cough associated with upper respiratory tract infections
  • Cough due to bronchitis
  • Cough as a symptom of allergic rhinitis

Dosage

Children: For children aged 6 to 12 years, the recommended dosage is 5 to 10 mg three times a day. For children under 6 years, dosing should be determined by a healthcare professional, and it is advisable to consult the BNF for Children for specific guidance.

Adults: The usual adult dosage of butamirate is 15 mg three times a day. It is important to follow the prescribing information or consult a healthcare professional for specific dosing instructions.

Mechanism of action

Butamirate acts centrally on the cough center in the medulla oblongata, reducing the cough reflex. It is believed to inhibit the activity of the afferent pathways of the cough reflex, thus decreasing the urge to cough. Additionally, it may have a mild bronchodilator effect, which can help ease respiratory symptoms.

Pharmacodynamics

The pharmacodynamics of butamirate involve its action on the central nervous system, specifically in modulating the cough reflex. Its effectiveness in reducing cough is attributed to its ability to suppress the neural pathways responsible for the cough response, without causing drowsiness or respiratory depression, which is often seen with traditional narcotic cough suppressants.

Pharmacokinetics

Butamirate is absorbed from the gastrointestinal tract and undergoes extensive metabolism in the liver. Its half-life and the exact pathways of metabolism are not well-documented, but it is known to be excreted mainly in urine. The onset of action typically occurs within a few hours of administration, providing relatively quick relief from cough symptoms.

Contra-indications

  • Hypersensitivity to butamirate or any of its components
  • Severe respiratory failure

Adverse effects

  • Drowsiness
  • Nausea
  • Vomiting
  • Rash
  • Dizziness

Interactions

  • CNS depressants may enhance the sedative effects of butamirate
  • May interact with other cough suppressants

Precautions

  • Use with caution in patients with a history of respiratory conditions
  • Monitor patients for signs of sedation
  • Consider potential for misuse in patients with a history of substance abuse

Pregnancy

Butamirate should only be used in pregnancy if clearly needed and after careful consideration of risks and benefits.

Breast-feeding

It is not known whether butamirate is excreted in human breast milk. Caution should be exercised when administering to breastfeeding women.

Storage

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

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.

Molecular reference: butamirate

PubChem CID 28892

Molecular formula: C18H29NO3

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