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Therapeutic Category
- ANTIVIRAL DRUGS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Capsules
- Composition : Oseltamivir (Phos.) 75 mg / Cap
- Active Substance : Oseltamivir
MECHANISM OF ACTION
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 with the possibility of alteration of virus particle aggregation and release.
PHARMACODYNAMICS
Absorption and Bioavailability:
Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of Oseltamivir Phosphate and is extensively converted predominantly by hepatic esterase´s to Oseltamivir carboxylate.
At least 75% of an oral dose reaches the systemic circulation as Oseltamivir carboxylate.
INDICATIONS
Treatment of influenza: MEDI-FLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients older than 1 year of age who have been symptomatic for no more than 2 days.
Prophylaxis of influenza: MEDI-FLU is indicated for the prophylaxis of influenza in Patients 1 year and older.
CONTRA INDICATIONS
MEDI-FLU is contraindicated in patients with known hypersensitivity to any of the components of the product.
SIDE EFFECTS
In adults and pediatric patients:
General: Rash, swelling of the face or tongue, nausea, vomiting, diarrhea, dizziness, abdominal pain.
Headache, cough, bronchitis, asthma, otitis media, pneumonia, ear disorder
Cardiac: Arrhythmia.
Neurologic: Seizure, confusion, Insomnia vertigo, fatigue.
Metabolic: Aggravation of diabetes.
PRECAUTIONS
1-.General :There is no evidence for efficacy of MEDI-FLU in any illness caused by agents other than influenza viruses types A and B .
2- Efficacy of MEDI-FLU in patients who begin treatment after 48 hours of symptoms has not been established.
3-Efficacy of MEDI-FLU in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established.
4-. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
5- Efficacy of MEDI-FLU for treatment or prophylaxis courses has not been established in immunocompromised patients.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza.
MEDI-FLU has not been shown to prevent such complications.
6-. Hepatic Impairment: The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated.
7-. Renal Impairment: dose adjustment is recommended for patients with serum creatinine clearance < 30 ml / min
Pregnancy: Pregnancy Category C: There are insufficient human data upon which to base an Evaluation of risk of MEDI-FLU to the pregnant woman or developing fetus.
MEDI-FLU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
It is not known whether Oseltamivir or Oseltamivir carboxylate is excreted in human milk. MEDI-FLU should, therefore, be used only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.
DOSES\INDICATIONS
Recommended oral preparing: Tap the closed bottle several times to loosen the powder, add 55 mL of water with measured spoon. Shake the closed bottle well after adding water for 15 seconds.
MEDI-FLU may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.
Standard Dosage Treatment of influenza:
Adults and adolescents:
The recommended oral dose of MEDI-FLU for treatment of influenza in Adults and adolescents 13 years and older is 75 mg (one capsule) twice daily for 5 days.
Treatment should begin within 2 days of onset of symptoms of influenza.
Pediatric Patients:
The recommended oral dose of MEDI-FLU oral suspension for Pediatric Patients 1 year and older adult patients who cannot swallow a capsule is:
| Weight
(kg) |
Treatment dosing
for 5 days |
Prophylaxis
dosing for 10 days |
Volume of
Oral Suspension (6 mg/mL) for each dose |
Number of
Bottles of Oral Suspension to dispense |
| 15 kg or less | 30 mg twice daily | 30 mg once daily | 5 mL | 1 bottle |
| 16 – 23 kg | 45 mg twice daily | 45 mg once daily | 7.5 mL | 2 bottles |
| 24 – 40 kg | 60 mg twice daily | 60 mg once daily | 10 mL | 2 bottles |
| 41 kg or more | 75 mg twice daily | 75 mg once daily | 12.5 mL | 3 bottles |
Standard Dosage – Prophylaxis of Influenza
Adults and Adolescents
The recommended oral dose of MEDI-FLU for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 10 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily.
Safety and efficacy have been demonstrated for up to 6 weeks in immunocompetent patients. The duration of protection lasts for as long as dosing is continued. Safety has been demonstrated for up to 12 weeks in immunocompromised patients.
Pediatric Patients
The safety and efficacy of MEDI-FLU for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.
The recommended oral dose of MEDI-FLU for pediatric patients 1 year and older following close contact with an infected individual is shown in Table
Prophylaxis in pediatric patients following close contact with an infected individual is recommended for 10 days.
Therapy should begin within 2 days of exposure.
For prophylaxis in pediatric patients during a community outbreak of influenza, dosing may be continued for up to 6 weeks.
Information for Patients:
– Patients should be instructed to begin treatment with MEDI-FLU as soon as possible from the first appearance of flu symptoms. Similarly, prevention should begin as soon as possible after exposure, at the recommendation of physician.
– 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 MEDI-FLU at the usual times .
– MEDI-FLU is not a substitute for a flu vaccination. Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices.
STORAGE CONDITIONS
Store capsules in a cool dry place below 25˚c.
Store powder in a dry place below 25˚c.
Store constituted suspension under refrigeration between (2-8) ˚c for 17 days, or for 10 days at room temperature below 25˚c.
Do not freeze.
PACKING:
Box of 10 capsules.
Glass bottle 60 mL.