Oseltamivir


Full Prescribing Info
Dosage/Direction for Use

Oral
Influenza A and B
Adult: 75 mg bid for 5 days. Initiate w/in 2 days of onset of symptoms.
Child: 0-1 mth
2 mg/kg; >1-3 mth 2.5 mg/kg; >3-12 mth 3 mg/kg. >1 yr ≤15 kg: 30 mg; >15-23 kg: 45 mg; >23-40 kg: 60 mg; >40 kg: 75 mg. All doses to be given bid for 5 days. Initiate w/in 2 days of onset of symptoms.
Renal impairment: Haemodialysis patient: 30 mg after each dialysis session. Peritoneal dialysis patient: 30 mg as a single dose.
CrCl (ml/min)Dosage Recommendation
≤10Not recommended.
>10-3030 mg once daily.
>30-6030 mg bid.

Reconstitution:
Reconstitute w/ 55 mL of water to a final concentration of 6 mg/mL susp.

Oral
Prophylaxis of influenza A and B
Adult: 75 mg once daily for at least 10 days. Initiate w/in 2 days of exposure. For community outbreak: May continue dosing for up to 6 wk.
Child: 0-1 mth
2 mg/kg; >1-3 mth 2.5 mg/kg; >3-12 mth 3 mg/kg. >1 yr ≤15 kg: 30 mg; >15-23 kg: 45 mg; >23-40 kg: 60 mg; >40 kg: 75 mg. All doses to be given once daily for 10 days. Initiate w/in 2 days of exposure. For community outbreak: May continue dosing for up to 6 wk.
Renal impairment: Haemodialysis patient: 30 mg after every 2nd dialysis session. Peritoneal dialysis patient: 30 mg once wkly.
CrCl (ml/min)Dosage Recommendation
≤10Not recommended.
>10-3030 mg every 2nd day.
>30-6030 mg once daily.

Reconstitution:
Reconstitute w/ 55 mL of water to a final concentration of 6 mg/mL susp.
Administration
May be taken with or without food. May be taken w/ meals to reduce GI discomfort. Cap may be opened & mixed w/ sweetened food products eg chocolate syr, sweetened condensed milk, apple sauce or yogurt. Swallow mixt immediately after preparation.
Contraindications
Hypersensitivity to oseltamivir.
Special Precautions
Patient w/ resp disease, chronic cardiac disease. Renal and severe hepatic impairment. Immunocompromised patient. Childn. Pregnancy and lactation. Monitoring Parameters Monitor closely for signs and symptoms of behavioural changes.
Adverse Reactions
Nausea, vomiting, abdominal pain, insomnia, bronchitis, vertigo, diarrhoea, cough, dizziness, headache, fatigue, unstable angina, anaemia, arrhythmias, GI bleeding, haemorrhagic or pseudomembranous colitis, pneumonia, pyrexia, peritonsillar abscess, aches and pains, upper resp infections, dyspepsia, rhinorrhoea. In childn: Vomiting and other GI disturbances, bronchitis, asthma, conjunctivitis, dermatitis, ear disorders, otitis media, epistaxis, lymphadenopathy, sinusitis, pneumonia.
Potentially Fatal: Anaphylaxis and skin rashes (e.g. Stevens-Johnson syndrome, erythema multiforme, epidermal necrolysis; neuropsychiatric events (e.g. delirium, hallucinations, abnormal behaviour). Rarely, fulminant hepatitis or hepatic failure.
Drug Interactions
May potentially inhibit replication of influenza virus in live/attenuated influenza virus vaccine.
Action
Oseltamivir is a prodrug of oseltamivir carboxylate. Oseltamivir carboxylate inhibits a neuraminidase (sialidase), a viral surface enzyme which is responsible for the replication and infectivity of influenza virus A and B, thereby preventing the release of viruses from infected cells.
Absorption: Readily absorbed from the GI tract. Bioavailability: 75% (as carboxylate). Time to peak plasma concentration: W/in 3-4 hr (as carboxylate).
Distribution: Distributed throughout the body, including the upper and lower resp tract. Volume of distribution: 23-26 L (as carboxylate). Plasma protein binding: Approx 3% (as carboxylate); 42% (as parent drug).
Metabolism: Extensively metabolised to oseltamivir carboxylate by hepatic esterases.
Excretion: Via urine (>90% as carboxylate); faeces. Elimination half-life: 1-3 hr (as parent drug); 6-10 hr (as carboxylate).
Storage
Oral: Store at 25°C. Reconstituted susp: Store between 2-8°C for up to 17 days or at 25° for up to 10 days. Do not freeze.
CIMS Class
ATC Classification
J05AH02 - oseltamivir ; Belongs to the class of neuraminidase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on oseltamivir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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