Tamiflu 6mg/ml Suspension

Manufacturer GENENTECH Active Ingredient Oseltamivir Suspension(oh sel TAM i vir) Pronunciation oh sel TAM i vir
It is used to treat or prevent the flu. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiviral
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Pharmacologic Class
Neuraminidase inhibitor
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Pregnancy Category
C
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FDA Approved
Oct 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tamiflu is an antiviral medicine used to treat or prevent the flu (influenza). It works by stopping the flu virus from spreading in your body, which can help you feel better faster or prevent you from getting sick if you've been exposed to the flu.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Continue taking the medication as directed by your doctor or healthcare provider, even if you feel well.

Before using the liquid form, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for one to ensure accurate measurement.

Storing and Disposing of Your Medication

Store the liquid medication in the refrigerator to keep it from freezing. Discard any unused portion after 17 days. Alternatively, you can store it at room temperature, but be sure to discard any unused portion after 10 days. To protect the medication from light, store it in the original outer carton.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's almost time for your next dose (less than 2 hours), skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Start treatment as soon as possible, ideally within 48 hours of flu symptom onset, for best results.
  • Take the full course of medication as prescribed, even if you start to feel better.
  • This medication does not replace the flu vaccine. Get vaccinated annually.
  • Practice good hygiene: wash hands frequently, cover coughs/sneezes, avoid touching face.
  • Stay home when sick to prevent spreading the flu to others.
  • Get plenty of rest and drink fluids.

Dosing & Administration

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Adult Dosing

Standard Dose: Treatment: 75 mg (12.5 mL of 6mg/mL suspension) orally twice daily for 5 days. Prophylaxis: 75 mg (12.5 mL of 6mg/mL suspension) orally once daily for 10 days (post-exposure) or up to 6 weeks (community outbreak).
Dose Range: 75 - 75 mg

Condition-Specific Dosing:

treatment: 75 mg BID for 5 days
prophylaxis: 75 mg QD for 10 days (post-exposure) or up to 6 weeks (community outbreak)
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Pediatric Dosing

Neonatal: Treatment (full-term infants <1 year): 3 mg/kg twice daily for 5 days. Prophylaxis: Not established for infants <1 year.
Infant: Treatment (1-12 months): 3 mg/kg twice daily for 5 days. Prophylaxis (1-12 months): Not established.
Child: Treatment (1-12 years, weight-based): 15 kg or less: 30 mg (5 mL) BID; >15 kg to 23 kg: 45 mg (7.5 mL) BID; >23 kg to 40 kg: 60 mg (10 mL) BID; >40 kg: 75 mg (12.5 mL) BID. All for 5 days. Prophylaxis (1-12 years, weight-based): Same doses once daily for 10 days (post-exposure) or up to 6 weeks (community outbreak).
Adolescent: Treatment/Prophylaxis (â‰Ĩ13 years): Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >60 mL/min).
Moderate: Treatment (CrCl 30-60 mL/min): 30 mg (5 mL) twice daily for 5 days. Prophylaxis: 30 mg (5 mL) once daily.
Severe: Treatment (CrCl 10-30 mL/min): 30 mg (5 mL) once daily for 5 days. Prophylaxis: 30 mg (5 mL) every other day.
Dialysis: Hemodialysis: 30 mg (5 mL) after each hemodialysis cycle. Peritoneal dialysis: 30 mg (5 mL) once, then 30 mg (5 mL) once every 3-4 days. (For treatment, 5 days total; for prophylaxis, continue as needed).

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

Pharmacology

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Mechanism of Action

Oseltamivir phosphate is a prodrug that is hydrolyzed to its active metabolite, oseltamivir carboxylate (OC). OC is a potent and selective inhibitor of influenza A and B virus neuraminidase, an enzyme essential for viral replication, release of new virions from infected cells, and further spread of infectious virus in the body.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80% (of oseltamivir carboxylate from oseltamivir phosphate)
Tmax: Oseltamivir phosphate: 0.65 hours; Oseltamivir carboxylate: 2.5-5 hours
FoodEffect: Food does not significantly affect absorption, but may reduce gastrointestinal side effects.

Distribution:

Vd: Approximately 23 L (for oseltamivir carboxylate)
ProteinBinding: Approximately 3% (for oseltamivir carboxylate)
CnssPenetration: Limited (detectable but low levels in CSF)

Elimination:

HalfLife: Oseltamivir phosphate: 1-3 hours; Oseltamivir carboxylate: 6-10 hours
Clearance: Renal clearance of oseltamivir carboxylate is 26.3 L/hr (in healthy subjects)
ExcretionRoute: Renal (primarily unchanged oseltamivir carboxylate)
Unchanged: Approximately 90% (of oseltamivir carboxylate in urine)
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Pharmacodynamics

OnsetOfAction: Within hours (inhibition of viral replication)
PeakEffect: Viral load reduction typically observed within 24-48 hours of initiation.
DurationOfAction: Effect lasts for the duration of therapeutic drug levels (typically 12-24 hours for BID/QD dosing).
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you exhibit any of the following symptoms, which may indicate a serious adverse reaction:

Signs of an allergic reaction, including:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Neurological and behavioral problems, particularly in individuals with the flu, which may lead to death, especially in children. Seek immediate medical attention if you experience:
+ Confusion
+ Changes in behavior
+ Speech problems
+ Shakiness
+ Seizures
+ Hallucinations
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause persistent and potentially life-threatening health issues. Get medical help right away if you notice:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

As with any medication, you may experience side effects, although many people have none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
* Headache

This is not an exhaustive list of potential side effects. If you have concerns or questions about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening flu symptoms or development of new symptoms (e.g., difficulty breathing, chest pain, severe headache, stiff neck).
  • Signs of secondary bacterial infection (e.g., persistent high fever, productive cough with colored sputum).
  • Unusual behavior, confusion, hallucinations, delirium, or self-injury (especially in children and adolescents). Seek immediate medical attention.
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing or swallowing).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect your ability to take this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and supplements with your doctor. This includes:

All prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor and pharmacist need to be aware of all your medications and health problems to ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This medication is not a substitute for a flu shot. If your doctor has recommended that you receive a flu shot, it is crucial that you follow their advice and get vaccinated. This medication is specifically designed to treat the flu, not the common cold.

Additionally, taking this medication will not prevent you from spreading the flu to others. It is also important to note that this medication contains sorbitol, which can cause stomach upset and diarrhea in individuals with fructose intolerance. If you have this condition, be sure to discuss it with your doctor.

Before receiving a flu vaccine, talk to your doctor about the best timing, as it is recommended to wait for a certain period after taking this medication. Conversely, if you have recently received a flu vaccine, inform your doctor before starting this medication.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive.

Drug Interactions

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Major Interactions

  • Probenecid (increases oseltamivir carboxylate exposure, requires dose adjustment of oseltamivir)
  • Live Attenuated Influenza Vaccine (LAIV) (administer oseltamivir 2 weeks after or 48 hours before LAIV)
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Moderate Interactions

  • Drugs eliminated by renal tubular secretion (e.g., chlorpropamide, methotrexate, phenylbutazone, trimethoprim/sulfamethoxazole) - theoretical potential for competition, but generally not clinically significant with oseltamivir.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Influenza diagnosis (rapid antigen test or PCR)

Rationale: To confirm influenza infection and justify antiviral treatment.

Timing: Prior to initiation of therapy.

Renal function (CrCl)

Rationale: To guide dosage adjustment in patients with impaired renal function.

Timing: Prior to initiation of therapy, especially in elderly or those with suspected renal impairment.

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Routine Monitoring

Symptom improvement (fever, cough, body aches)

Frequency: Daily

Target: Resolution or significant reduction of symptoms

Action Threshold: Worsening or lack of improvement after 2-3 days may indicate secondary infection or treatment failure.

Neuropsychiatric symptoms (e.g., delirium, hallucinations, unusual behavior)

Frequency: Daily

Target: Absence of new or worsening symptoms

Action Threshold: Immediate medical evaluation if such symptoms occur, especially in children and adolescents.

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Symptom Monitoring

  • Worsening respiratory symptoms (e.g., shortness of breath, chest pain)
  • Signs of secondary bacterial infection (e.g., persistent fever, productive cough, purulent sputum)
  • Neurological changes (e.g., confusion, seizures, hallucinations, delirium, self-injury)
  • Severe allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)

Special Patient Groups

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Pregnancy

Oseltamivir is generally considered for use during pregnancy when the potential benefit justifies the potential risk. Observational studies and postmarketing data have not shown an increased risk of major birth defects or miscarriage. Influenza infection itself can lead to severe complications in pregnant women.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human data.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Oseltamivir and its active metabolite are excreted into breast milk in low amounts. Infant exposure is low, and adverse effects in breastfed infants are not expected. Generally considered compatible with breastfeeding.

Infant Risk: Low risk to breastfed infant.
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Pediatric Use

Approved for treatment of influenza in full-term infants aged 2 weeks and older, and for prophylaxis in individuals 1 year and older. Dosing is weight-based. Neuropsychiatric events (e.g., delirium, hallucinations) have been reported, particularly in children and adolescents, requiring close monitoring.

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Geriatric Use

No specific dosage adjustment is required based on age alone. However, renal function should be assessed in elderly patients, and dosage adjusted if renal impairment is present.

Clinical Information

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Clinical Pearls

  • Oseltamivir is most effective when initiated within 48 hours of influenza symptom onset.
  • It is effective against both influenza A and B viruses.
  • The suspension formulation requires reconstitution by a pharmacist or healthcare professional.
  • Patients should be advised to complete the full prescribed course of therapy, even if symptoms improve.
  • While rare, neuropsychiatric events (e.g., delirium, hallucinations) have been reported, particularly in children and adolescents. Caregivers should monitor for unusual behavior.
  • Oseltamivir does not prevent bacterial infections that may occur as complications of influenza.
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Alternative Therapies

  • Baloxavir marboxil (Xofluza) - oral, single dose
  • Zanamivir (Relenza) - inhaled
  • Peramivir (Rapivab) - intravenous
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Cost & Coverage

Average Cost: Varies widely, typically $100-$200 per 75mg x 10 capsules (or equivalent suspension)
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 3 (brand) on most commercial and Medicare Part D plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.