Oseltamivir 6mg/ml Suspension 60ml

Manufacturer ZYDUS 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
Not available
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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?

Oseltamivir is an antiviral medicine used to treat or prevent the flu (influenza). It works by stopping the flu virus from spreading in your body. It is most effective when started within the first 48 hours of flu symptoms.
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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. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.

Before using the liquid form of this medication, shake the bottle well. Measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

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. Keep the medication in its original outer carton to protect it from light.

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

  • Take with food to reduce stomach upset (nausea/vomiting).
  • Complete the full course of medication, even if you start feeling better.
  • Oseltamivir is not a substitute for the annual flu vaccine. Get vaccinated every year.
  • Practice good hygiene (hand washing, covering coughs/sneezes) to prevent spread of flu.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

influenza_treatment: 75 mg BID for 5 days
influenza_prophylaxis: 75 mg QD for 10 days
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Pediatric Dosing

Neonatal: Full-term neonates (0-14 days postnatal age): 3 mg/kg orally twice daily for 5 days (treatment). Prophylaxis: 3 mg/kg orally once daily for 10 days.
Infant: Infants (15 days to <1 year): 3 mg/kg orally twice daily for 5 days (treatment). Prophylaxis: 3 mg/kg orally once daily for 10 days.
Child: Children (1 year to 12 years): Weight-based dosing for treatment (e.g., 15 kg to 23 kg: 45 mg BID; 23 kg to 40 kg: 60 mg BID). Prophylaxis: Weight-based dosing once daily.
Adolescent: Adolescents (>12 years or >40 kg): Same as adult dosing (75 mg BID for treatment, 75 mg QD for prophylaxis).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 60 mL/min).
Moderate: Treatment: 30 mg (5 mL of 6 mg/mL suspension) orally twice daily. Prophylaxis: 30 mg (5 mL of 6 mg/mL suspension) orally once daily (CrCl 30-60 mL/min).
Severe: Treatment: 30 mg (5 mL of 6 mg/mL suspension) orally once daily. Prophylaxis: 30 mg (5 mL of 6 mg/mL suspension) orally every other day (CrCl 10-30 mL/min).
Dialysis: Hemodialysis: Treatment: 30 mg (5 mL of 6 mg/mL suspension) orally after every other hemodialysis cycle. Prophylaxis: 30 mg (5 mL of 6 mg/mL suspension) orally once weekly after a hemodialysis cycle. Peritoneal Dialysis: Treatment: 30 mg (5 mL of 6 mg/mL suspension) orally once. Prophylaxis: 30 mg (5 mL of 6 mg/mL suspension) orally once weekly.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Approximately 80% (of oseltamivir carboxylate)
Tmax: Oseltamivir: 0.65 hours; Oseltamivir carboxylate: 3-4 hours
FoodEffect: Food does not significantly affect absorption, but taking with food can improve tolerability and reduce gastrointestinal side effects.

Distribution:

Vd: Oseltamivir carboxylate: Approximately 23 L
ProteinBinding: Oseltamivir carboxylate: Approximately 3%
CnssPenetration: Limited, but detectable levels in cerebrospinal fluid (CSF).

Elimination:

HalfLife: Oseltamivir carboxylate: 6-10 hours
Clearance: Primarily renal clearance of oseltamivir carboxylate.
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: >90% of the dose is excreted as oseltamivir carboxylate in urine.
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Pharmacodynamics

OnsetOfAction: Rapid, within hours of first dose.
PeakEffect: Within 3-4 hours (corresponding to Tmax of active metabolite).
DurationOfAction: Sufficient to allow twice-daily dosing for treatment and once-daily for prophylaxis.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ 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 significant health problems and potentially death. Seek medical help immediately 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 all medications, you may experience side effects. While many individuals do not experience significant side effects or only have minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
* Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns 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 despite treatment
  • Signs of a serious allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Unusual behavior, confusion, agitation, self-injury, or hallucinations (especially in children and adolescents)
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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 concerns with your doctor. This includes:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
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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 recommends a flu shot, it is crucial to get vaccinated as advised. This medication is specifically designed to treat the flu, not the common cold. Additionally, it does not prevent the spread of the flu to others.

Please note that this medication contains sorbitol, which may cause stomach upset and diarrhea in individuals with fructose intolerance. If you have this condition, it is important to discuss this with your doctor.

Before receiving a flu vaccine, talk to your doctor if you are currently taking or have recently taken this medication. Similarly, if you have recently received a flu vaccine, consult 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
  • In rare cases, seizures or altered mental status

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment is supportive.

Drug Interactions

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Moderate Interactions

  • Probenecid

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in elderly patients or those with known renal impairment.

Timing: Prior to initiation of therapy if renal impairment is suspected or known.

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Routine Monitoring

Clinical symptoms of influenza

Frequency: Daily during treatment

Target: Resolution or improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or alternative diagnosis.

Neuropsychiatric symptoms (e.g., confusion, delirium, hallucinations)

Frequency: Daily during treatment, especially in pediatric and adolescent patients

Target: Absence of new or worsening neuropsychiatric symptoms

Action Threshold: Immediate medical evaluation if such symptoms occur.

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Symptom Monitoring

  • Fever
  • Cough
  • Sore throat
  • Body aches
  • Headache
  • Fatigue
  • Nausea
  • Vomiting
  • Diarrhea
  • Unusual behavior
  • Confusion
  • Hallucinations

Special Patient Groups

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Pregnancy

Oseltamivir is generally considered safe and recommended for pregnant women with confirmed or suspected influenza. The benefits of treatment outweigh potential risks, as influenza can cause severe illness in pregnant women.

Trimester-Specific Risks:

First Trimester: Limited data, but no increased risk of major birth defects observed.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Oseltamivir and its active metabolite are excreted in human milk in low amounts. It is generally considered compatible with breastfeeding, and the benefits of treating the mother outweigh the potential risks to the infant.

Infant Risk: Low risk. Monitor infant for gastrointestinal upset (e.g., diarrhea) or rash, though unlikely.
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Pediatric Use

Approved for treatment and prophylaxis of influenza in full-term neonates (0-14 days postnatal age) and older pediatric patients. Dosing is weight-based for younger children. Close monitoring for neuropsychiatric events is recommended.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, renal function should be assessed, as dose adjustments are required for renal impairment, which is more common in the elderly.

Clinical Information

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Clinical Pearls

  • Oseltamivir is most effective when initiated within 48 hours of influenza symptom onset for treatment.
  • It is effective against both influenza A and B viruses.
  • The suspension formulation is particularly useful for pediatric patients and those who cannot swallow capsules.
  • Ensure patients understand the importance of completing the full course of therapy, even if symptoms improve.
  • Advise patients that oseltamivir does not prevent bacterial infections that may occur as complications of influenza.
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Alternative Therapies

  • Baloxavir marboxil (Xofluza) - for uncomplicated influenza in patients 5 years and older.
  • Zanamivir (Relenza) - inhaled neuraminidase inhibitor, not recommended for patients with underlying respiratory disease.
  • Peramivir (Rapivab) - intravenous neuraminidase inhibitor.
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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 your 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 taken, the amount, and the time it happened.