Baloxa 40 mg (Tablet)

Indications

• Treatment of acute uncomplicated influenza
• Post-exposure prophylaxis of influenza in patients 12 years of age and older
• Symptomatic for no more than 48 hours
• Otherwise healthy
• At high risk of developing influenza-related complications

Pharmacology

• Antiviral polymerase endonuclease inhibitor
• Active component: Baloxavir Marboxil
• Prodrug converted by hydrolysis to active form
• Inhibits the endonuclease activity of the polymerase acidic (PA) protein
• Required for viral gene transcription
• Inhibition of influenza virus replication

Dosage & Administration

• Oral administration
• Single dose within 48 hours of symptom onset
• Dependent on weight
• 40 to less than 80 kg: Two 20 mg tablets for a total single dose of 40 mg
• At least 80 kg: Two 40 mg tablets for a total single dose of 80 mg
• Established safety and effectiveness in pediatric patients 12 years of age and older weighing at least 40 kg

Interaction

• Avoid coadministration with dairy products
• Avoid coadministration with calcium-fortified beverages
• Avoid coadministration with polyvalent cation-containing laxatives
• Avoid coadministration with antacids
• Avoid coadministration with oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc)
• Potential interference with live attenuated influenza vaccines

Contraindications

• History of hypersensitivity to Baloxavir Marboxil or any of its ingredients

Side Effects

• Diarrhea
• Bronchitis
• Nausea
• Sinusitis
• Headache

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Risks to the mother and fetus associated with influenza virus infection in pregnancy
• No data on the presence of baloxavir marboxil in human milk
• No data on the effects on the breastfed infant
• No data on the effects on milk production

Precautions & Warnings

• Hypersensitivity reactions such as anaphylaxis, angioedema, urticaria, and erythema multiforme
• Risk of bacterial infection
• Alertness to potential secondary bacterial infections
• Treatment of suspected allergic-like reactions
• Not shown to prevent secondary bacterial infections

Overdose Effects

• Treatment should consist of general supportive measures
• Monitoring of vital signs
• Observation of the clinical status
• No specific antidote for overdose

Therapeutic Class

• Respiratory viral infections (Influenza)

Storage Conditions

• Keep below 30°C temperature
• Keep away from light & moisture
• Keep out of the reach of children

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