Tamiflu Contraindications/Precautions
- infants
- neonates
- asthma
- breast-feeding
- bronchitis
- cardiac disease
- children
- chronic obstructive pulmonary disease (COPD)
- emphysema
- hepatic disease
- immunosuppression
- infection
- pregnancy
- pulmonary disease
- renal failure
- renal impairment
- vaccination
- viral infection
Tamiflu (Oseltamivir) Contraindications/Precautions
Tamiflu (Oseltamivir) is contraindicated in any patient who is hypersensitive to the drug or to any component of the formulation.
Serious bacterial infections may begin with influenza-type symptoms or may coexist with or occur as complications during a course of influenza. There is no evidence of efficacy of Tamiflu (Oseltamivir) in viral infection or other types of infection caused by agents other than influenza virus A and B. Data on the treatment of influenza B infection are limited; only 3% of patients in the clinical trials were infected with this virus. There are no data available to support the efficacy of Tamiflu (Oseltamivir) therapy in patients who begin treatment 40 hours after the onset of symptoms. The safety and efficacy of repeated treatment or prophylaxis courses of Tamiflu (Oseltamivir) have not been studied.
The use of Tamiflu (Oseltamivir) should not affect the evaluation of individuals for annual influenza vaccination in accordance with the guidelines for the US Centers for Disease Control (CDC). In addition, Tamiflu (Oseltamivir) does not interfere with the antibody response to the influenza vaccine. The efficacy of Tamiflu (Oseltamivir) in the prevention of influenza infection has not been established, and annual influenza vaccination remains the primary means of prophylaxis. The efficacy of Tamiflu (Oseltamivir) for treatment or prophylaxis in patients with immunosuppression has not been established.
The efficacy of Tamiflu (Oseltamivir) has not been established in patients with chronic pulmonary disease and/or cardiac disease. However, Tamiflu (Oseltamivir) studies have included ‘at-risk’ adult patients with cardiac disease, adults with chronic obstructive pulmonary disease (COPD) (i.e., chronic bronchitis or emphysema), and older pediatric patients with asthma; the incidence of complications in these patient populations did not differ between Tamiflu (Oseltamivir) and placebo. In ongoing studies, there has been no overall difference in safety and efficacy between elderly (age > 65 years) and younger adult patients. Safety and efficacy of Tamiflu (Oseltamivir) have been established in elderly nursing home residents who took Tamiflu (Oseltamivir) for up to 42 days for the prevention of influenza. Many of these individuals had cardiac and/or respiratory disease, and most had received the influenza vaccine that season. No information is available regarding Tamiflu (Oseltamivir) treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered as having an imminent risk of hospitalization.
The dosages of Tamiflu (Oseltamivir) should be adjusted in patients with renal impairment defined as a creatinine clearance of < 30 ml/min. Tamiflu (Oseltamivir) has not been studied in patients with a creatinine clearance < 10 ml/min or renal failure; therefore, caution is advised when administering the drug to these patient populations.
The safety and efficacy of Tamiflu (Oseltamivir) have not been established in patients with hepatic disease.
Tamiflu (Oseltamivir) dosing in children is typically weight-based; the drug requires dosage adjustment for children 1-13 years of age weighing < 40 kg. In clinical trials, pediatric patients >= 1 year of age who were treated with Tamiflu (Oseltamivir) within 2 days of symptom onset experienced a reduction in the duration of flu of about 1.5 days. The drug is also effective in preventing the spread of influenza in close contacts in adolescents aged 13 years and older. Tamiflu (Oseltamivir) safety and efficacy have not been established in infants and neonates; the drug is not indicated for use in infants < 1 year of age. According to the manufacturer, animal studies have identified very high blood and brain concentrations of Tamiflu (Oseltamivir) and associated deaths in very young animals; immature blood-brain barriers might be susceptible to increased Tamiflu (Oseltamivir) penetration and adverse events may result. A single dose of 1000 mg/kg oseltamivir phosphate (about 250 times the recommended human pediatric dose) in 7-day-old rats resulted in deaths associated with unusually high exposure to both oseltamivir and oseltamivir phosphate; concentrations in the brain were roughly 1500 times those seen in adult animals. While the clinical significance of these preclinical data to human infants is uncertain, it is recommended that the drug not be administered to infants < 1 year (1year is the age at which the human blood-brain barrier is generally recognized to be fully developed).
Tamiflu (Oseltamivir) is classified as FDA pregnancy risk category C. In animal studies, slight and marked maternal toxicities and a dose-dependent increase in skeletal abnormalities in offspring were observed. However, there are no adequate and well-controlled studies of Tamiflu (Oseltamivir) in pregnant women. Tamiflu (Oseltamivir) should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
It is not known if Tamiflu (Oseltamivir) is excreted in human milk; however, animal studies have shown that oseltamivir and oseltamivir carboxylate are excreted in breast milk. Because many drugs are excreted in human milk, caution should be used if Tamiflu (Oseltamivir) is administered to a woman who is breast-feeding.
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