Codryl®

Prescribing Details



Description

CODRYL is a preparation of Gefapixant which is a selective antagonist of the P2X3 receptor. P2X3-containing receptors belong to the family of purinergic receptors and are ATP-dependent ion channels, which are also located on sensory C-fibers of the vagus nerve in the airways. C-fibers are activated in response to inflammation or chemical irritants. Under inflammatory conditions, ATP is released by mucosal cells of the respiratory tract. The binding of extracellular ATP to P2X3 receptors is recognized by C-fibers as a damage signal and is perceived as a coughing stimulus, which in turn triggers a cough reflex. Gefapixant blocks ATP-mediated activation of P2X3 receptors, which are thought to be responsible for chronic cough.


Uses

No Data


Indications

CODRYL is indicated for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.


Dosage and administration

Route of administration: CODRYL should be taken in oral route with or without food.
Recommended dose of CODRYL is one 45 mg tablet twice daily.
If a dose is missed, patients should be advised to skip it and take the next dose at the regular time.

Renal impairment
The recommended dose of CODRYL in patients with severe renal impairment (eGFR < 30 ml/min/1.73 m2), not requiring dialysis, is one 45 mg tablet once daily. Insufficient data are available in patients with end stage renal disease requiring dialysis.


Use in pregnancy & lactation

Pregnancy: There are no well controlled studies of use of gefapixant during pregnancy.
Lactation: There is no information regarding the presence of gefapixant in human milk, the effects on the breastfed infant or the effects on milk production.

Use in children and adolescents
The safety and effectiveness in children and adolescents below 18 years of age have not been established.


Geriatric use
No Data

Precautions

Gefapixant should be used with caution in patients with known hypersensitivity to sulfonamides. For patients of RCC/UCC with comorbid OSA, gefapixant should not be used.


Side effects

The most common side effects are upper respiratory tract infection, decreased appetite, dysgeusia, ageusia, hypogeusia, taste disorder, dizziness, cough, oropharyngeal pain, nausea, diarrhea, dry mouth, salivary hypersecretion, upper abdominal pain, hypoesthesia oral and paresthesia oral.


Contraindications

It is contraindicated in patients with known hypersensitivity to gefapixant or any other components of this product.


Drug interactions

Drug interaction with medication: No significant interaction has been reported.

Drug interaction with food and others: Not applicable.


Overdose

In case of overdose, general supportive measures and proper monitoring should be initiated.


Preparation

No Data


Pharmaceutical precautions

No Data


Presentation

CODRYL Tablet: Each coated tablet contains Gefapixant 45 mg as Gefapixant Citrate INN.


Package quantities

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
CODRYL Tablet: Carton of 10 tablets in blister pack.