Oseltamivir is an ethyl ester pro-drug requiring ester hydrolysis for conversion to the active form, Oseltamivir carboxylate. The proposed mechanism of action of Oseltamivir is via inhibition of influenza virus neuraminidase.

 

Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of Oseltamivir phosphate and it is extensively converted predominantly by hepatic esterases to Oseltamivir carboxylate. At least 75% of an oral dose reaches the systemic circulation as Oseltamivir carboxylate.

Plasma concentrations of Oseltamivir carboxylate are proportional to doses up to 500 mg given twice daily.

Coadministration with food has no significant effect on the peak plasma concentration.

The binding of Oseltamivir carboxylate to human plasma proteins is low (3%). The binding of Oseltamivir to human plasma proteins is 42%, which is insufficient to cause significant displacement-based drug interactions.

Oseltamivir is extensively converted to Oseltamivir carboxylate by esterases located predominantly in the liver. Neither Oseltamivir nor Oseltamivir carboxylate is a substrate for, or inhibitor of, cytochrome P450 isoforms.

Absorbed Oseltamivir is primarily eliminated by conversion to Oseltamivir carboxylate. Plasma concentrations of Oseltamivir declined with a half-life of 1 to 3 hours in most subjects after oral administration. Oseltamivir carboxylate is not further metabolized and is eliminated in the urine. Plasma concentrations of Oseltamivir carboxylate declined with a half-life of 6 to 10 hours in most subjects after oral administration.

 

- TE-FLU is indicated for the treatment of viral infections especially flu viruses influenza A and influenza B.

- TE-FLU can also decrease the ailments that occur together with flu such as weakness, headache, cough, fever, and sore throat in just the first day of intake.

- TE-FLU is indicated for prophylaxis of flu in adults and adolescents older than 13 years.

 

Oseltamivir is contraindicated in patients with hypersensitivity to Oseltamivir.

 

- Efficacy of Oseltamivir in patients who begin treatment after 40 hours of symptoms has not been established.

- Efficacy of Oseltamivir in subjects with chronic cardiac disease and/or respiratory disease has not been established.

- Safety and efficacy of repeated treatment courses have not been studied.

- Patients should be instructed to begin treatment with Oseltamivir as soon as possible from the first appearance of flu symptoms.

- Patients should be instructed to take any missed doses as soon as they remember, except if it is near the next scheduled dose (within 2 hours), and then continue to take Oseltamivir at the usual times.

- The safety and efficacy of Oseltamivir in children (<1 years) have not been established.

- The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated.

- Dose adjustment is recommended for patients with creatinine clearance ≤ 30 mL/min.

- Efficacy for treatment and prophylaxis in immunocompromised patients are not established.

- Serious bacterial infections can occur with flu like symptoms or may accompany flu infection as a complication. The product does not prevent these complications.

- This product does not substitute vaccination, so annually vaccinated patients must still be vaccinated according to the immune guidelines.

 

Pregnancy Category C.

Oseltamivir should be used during pregnancy and nursing only if the potential benefit justifies the potential risk to the fetus or breast-fed infant.

 

Cough, phlegm production, wheezing, nausea, vomiting, diarrhea, stomach cramps and upsets, nosebleed, itching, swelling and redness of eyes, skin flushing, fatigue, headache, insomnia and dizziness.

 

Adults: The recommended oral dose of TE-FLU is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza. TE-FLU may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.

No dose adjustment is necessary for patients with creatinine clearance above 30 ml/min. In patients with a creatinine clearance of less than 30 ml/min, it is recommended that the dose be reduced to 75 mg of TE-FLU once daily for 5 days. The drug has not been studied in patients with renal failure (creatinine clearance below 10 ml/min); therefore, caution is advised when administering the drug to those patient populations.

Children: The recommended dose of TE-FLU oral suspension for pediatric patients 1 year and older is:

Prophylactic dose of adults and adolescents older than 13 years after contact with infected person is 75 mg per day for not less than 7 days and the treatment must be started during the first two days after the contact. The recommended prophylactic dose during flu epidemic infection is 75 mg per day. The safety and efficacy of the drug lasts for 6 weeks. The prophylaxis is lasting for this dose course.

 

- TE-FLU ELSaad – Capsules: A pack of 10 capsules. Each capsule contains Oseltamivir (Phosphate) 75 mg.

- TE-FLU ELSaad - Dry Powder for Oral Suspension: A pack of glass bottle of 25 or 60 mL. Each 1 ml of the suspension contains Oseltamivir (Phosphate) 12 mg.

 

Store TE-FLU ELSaad – Capsules and Dry Powder for Oral Suspension at temperature between (15-30)°C.