Gefan 45 Tablet

✔️ Dosage and Administration of Gefapixant

Treatment should be initiated and supervised by physicians experienced in managing chronic cough disorders.

Adults

• 45 mg orally twice daily
• May be taken with or without food

Missed Dose

If a dose is missed:

• Skip the missed dose.
• Take the next scheduled dose at the usual time.
• Do not take a double dose to compensate for a missed dose.

Elderly Patients

• No routine dose adjustment is required based solely on age.
• Since renal function may decline with age, elderly patients should be monitored carefully during treatment.

Pediatric Patients

• Safety and efficacy have not been established in individuals younger than 18 years.
• Use is not recommended in pediatric patients.

Patients with Renal Impairment

Patients with Hepatic Impairment

• Gefapixant has not been adequately studied in patients with liver disease.
• Use with caution until further data become available.

Obstructive Sleep Apnea

Gefapixant should not be used in patients with refractory or unexplained chronic cough who also have obstructive sleep apnea.

✔️ Side Effects

Very Common

• Dysgeusia (altered taste sensation)
• Ageusia (loss of taste)
• Hypogeusia (reduced taste sensation)

Common

• Upper respiratory tract infection
• Decreased appetite
• Taste disturbances
• Dizziness
• Nausea
• Diarrhea
• Dry mouth
• Excessive salivation
• Epigastric pain
• Dyspepsia
• Oral hypoesthesia (reduced oral sensation)
• Oral paresthesia (tingling or abnormal oral sensations)

Uncommon

• Urinary stones
• Bladder stones
• Nephrolithiasis (kidney stones)

Most adverse effects are mild to moderate in severity, although taste-related side effects are among the most frequently reported reasons for treatment discontinuation.

✔️ Pregnancy & Lactation & Fertility

Pregnancy

There are no adequate human studies evaluating the safety of Gefapixant during pregnancy.

As a precaution:

• Use during pregnancy is not recommended unless clearly necessary.
• Women of childbearing potential should use effective contraception during treatment.

Breastfeeding

It is unknown whether Gefapixant is excreted into human breast milk.

Animal studies have demonstrated transfer into milk. Therefore:

• Caution is advised during breastfeeding.
• The potential benefits of treatment should be weighed against possible risks to the infant.

Fertility

• Human fertility data are unavailable.
• Animal studies have not demonstrated adverse effects on fertility.

✔️ Gefan should be used cautiously in:

• Patients with known hypersensitivity to sulphonamides
• Elderly individuals with impaired renal function
• Patients experiencing significant taste disturbances that may affect nutrition or quality of life

✔️ Gefan is contraindicated in patients with:

• Known severe hypersensitivity to Gefapixant
• Hypersensitivity to any component of the formulation

✔️ Interaction

Proton Pump Inhibitors (PPIs)

• Concomitant administration with omeprazole has not demonstrated clinically significant effects on Gefapixant pharmacokinetics.

Effect of Gefan on Other Medicines

• In vitro studies suggest a low potential for inhibition or induction of cytochrome P450 (CYP) enzymes.
• No clinically significant drug interactions have been identified.

Effect of Other Medicines on Gefan

• No clinically meaningful interactions have been observed with concomitant medications.

✔️ Storage:

• Store below 30°C.
• Keep in a cool and dry place.
• Protect from light and moisture.
• Keep out of the reach of children.