Indications
Baloflu Tablet is used for:
Influenza
Adult Dose
Hepatic impairment
Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences were observed
Severe: Not studied
Child Dose
Influenza
Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ?48 hr
<12 years: Safety and efficacy not established
>12 years and weight ?40 kg
40 to <80 kg: 40 mg PO as a single dose
>80 kg: 80 mg PO as a single dose
Renal Dose
Renal impairment
CrCl >50 mL/min: Pharmacokinetic analysis did not identify a clinically meaningful effect
Severe: Not studied
Administration
Initiate treatment within 48 hr of influenza symptom onset
Take orally as a single dose
May be taken with or without food
Contra Indications
Hypersensitivity
Precautions
There is no evidence of efficacy in any illness caused by pathogens other than influenza viruses; serious bacterial infections may begin with influenzalike symptoms, may coexist with, or may occur as a complication of influenza; monitor for secondary bacterial infections and treat appropriately
Pregnancy-Lactation
Pregnancy
Data are not available
Animal studies
No adverse developmental effects observed in rats or rabbits with PO administration at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD)
Clinical considerations
Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age
Lactation
Data are not available for excretion in human milk
Baloxavir and its related metabolites were present in milk of lactating rats
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need the drug and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition
Interactions
Polyvalent cations
Baloxavir (active metabolite) may form a chelate with polyvalent cations, such as calcium, aluminum, or magnesium, in food or medications
Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc)
Vaccines
Concurrent use with intranasal live attenuated influenza vaccine (LAIV) not evaluated
Coadministration may inhibit viral replication of LAIV, resulting in decreased LAIV vaccine effectiveness
Side Effects
Side effects of Baloxavir marboxil :
1-10%
Frequency of adverse effects listed below are less than or equal to those reported with placebo
Diarrhea (3%)
Bronchitis (2%)
Nausea (1%)
Nasopharyngitis (1%)
Headache (1%)
Mode of Action
Inhibits cap-dependent endonuclease; it is thought to inhibit viral replication activity of the viral polymerase
Inhibition accomplished by a method called cap snatching, where viruses hijack the host mRNA transcription system to allow viral RNA synthesis
Note
Baloflu 40 mg Tablet generic name is Baloxavir marboxil. Baloflu 40 mg Tablet is manufactured by Navana Pharmaceuticals Ltd.Baloflu is availble in all over Bangladesh.
Mes BD drug index information on Baloflu Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.