Oseltamivir Phosphate Capsule USP 75mg Technical Specification:
Product Name: | Oseltamivir Phosphate Capsule USP 75mg |
Brand Name: | Generics |
Strength: | (30mg), (75mg) |
Dosage Form: | Capsule (Hard-Gelatine) |
Route of Administration: | Via oral Route |
Packing: | 10s, 30s, 90s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antiviral agents, Anti-influenza |
Indication: | oseltamivir phosphate is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age and older whose flu symptoms have not lasted more than two days. |
Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Oseltamivir Phosphate Capsule USP 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oseltamivir Phosphate Capsule USP 75mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………98.5mg
Equivalent to oseltamivir…………………….75mg
Excipients……………………………. q.s.
Approved Colours used in the empty capsule shell.
THERAPEUTIC INDICATIONS:
Oseltamivir phosphate is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age and older whose flu symptoms have not lasted more than two days.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.
Why Taj Pharmaceuticals?
Taj Pharma, we prioritize your well-being by providing top-quality healthcare solutions. Our Oseltamivir Phosphate Capsule USP, commonly known as Tamiflu, is a testament to our dedication to combating influenza. We understand the critical importance of antiviral medications, especially during flu seasons and pandemics. Our state-of-the-art manufacturing facilities and stringent quality control processes ensure that every capsule of Oseltamivir meets the highest pharmaceutical standards. With a team of experienced professionals and a commitment to innovation, we are at the forefront of antiviral medication production. We recognize that influenza can have a significant impact on public health, and our mission is to contribute to its prevention and management. Trust Taj Pharma for Oseltamivir Phosphate Capsule USP, and you’re choosing a partner dedicated to your health and the health of your community. Together, we can face the challenges of flu seasons with confidence and resilience.
What is Oseltamivir Phosphate Capsule USP and its Use?
Oseltamivir Phosphate Capsule USP, commonly known by its brand name Tamiflu, is a prescription medication used for the treatment and prevention of influenza (the flu), including influenza A and B viruses. It belongs to a class of antiviral drugs called neuraminidase inhibitors.
Uses of Oseltamivir Phosphate Capsule USP:
- Treatment of Influenza: Oseltamivir is prescribed to individuals who have confirmed or suspected cases of influenza. It is most effective when started within 48 hours of the onset of flu symptoms. The medication helps reduce the severity and duration of flu symptoms, such as fever, cough, sore throat, runny or stuffy nose, muscle aches, fatigue, and headache.
- Prevention of Influenza: Oseltamivir can also be used as a preventive measure for individuals at high risk of developing influenza, especially during flu outbreaks or as a prophylactic measure for those in close contact with individuals who have the flu. This is often recommended for healthcare workers, household members of flu-infected individuals, and individuals with certain underlying medical conditions.
Oseltamivir does not cure the flu but can help alleviate symptoms and shorten the duration of illness when taken promptly. Additionally, it may reduce the risk of complications associated with influenza, such as pneumonia, in some cases. Oseltamivir Phosphate Capsules should be used under the guidance of a healthcare provider, and the prescribed dosage and duration should be followed precisely. Treatment with Oseltamivir should not replace annual flu vaccination, which remains a critical measure for preventing influenza. Individuals who suspect they have the flu or are at high risk of exposure to the virus should consult a healthcare professional to determine whether Oseltamivir is an appropriate option for their specific situation.
How does Oseltamivir Phosphate Capsule USP Work?
Oseltamivir Phosphate Capsule USP, commonly known as Tamiflu, is an antiviral medication used for the treatment and prevention of influenza (the flu). It works by inhibiting the activity of the neuraminidase enzyme found on the surface of influenza viruses, specifically influenza A and B viruses. Here’s how Oseltamivir works:
- Viral Entry and Replication: Influenza viruses enter and infect human respiratory cells to replicate and spread. The virus must first attach to the host cell’s surface and then enter the cell to replicate.
- Release of New Virus Particles: Once inside the host cell, influenza viruses replicate, producing new virus particles. These new virus particles need to be released from the host cell to continue infecting other cells in the respiratory tract and spreading the infection.
- Role of Neuraminidase: The neuraminidase enzyme is crucial for the release of new influenza virus particles from infected host cells. Neuraminidase functions by breaking the bonds between the newly formed virus particles and the host cell’s surface, allowing the virus to be released and infect other cells.
- Inhibition by Oseltamivir: Oseltamivir is a neuraminidase inhibitor. When it is taken orally in the form of capsules or suspension, the active ingredient, oseltamivir phosphate, is absorbed into the bloodstream. Oseltamivir is then metabolized in the body to its active form, oseltamivir carboxylate.
- Blocking Neuraminidase Activity: Oseltamivir carboxylate circulates in the bloodstream and reaches the respiratory tract, where it enters respiratory cells. Inside these cells, it binds to the neuraminidase enzyme on the surface of the influenza virus.
- Preventing Virus Release: By binding to neuraminidase, oseltamivir carboxylate inhibits the enzyme’s activity. As a result, the newly formed influenza virus particles remain tethered to the surface of infected cells, unable to be released and infect new cells
- Reduced Viral Spread: With neuraminidase activity inhibited, the spread of the influenza virus within the respiratory tract is significantly reduced. This helps limit the severity and duration of flu symptoms and may also reduce the risk of complications associated with the flu.
Benefits of Oseltamivir Phosphate Capsule USP:
- Treatment of Influenza: Oseltamivir is effective in reducing the severity and duration of influenza (flu) symptoms when taken promptly after the onset of symptoms. It can help individuals recover more quickly from the flu.
- Prevention of Influenza: Oseltamivir can be used prophylactically to prevent influenza in individuals at high risk of exposure during flu outbreaks. This is especially valuable for healthcare workers and those in close contact with infected individuals.
- Reduction of Complications: Timely treatment with Oseltamivir may reduce the risk of complications associated with the flu, such as pneumonia, particularly in individuals with underlying health conditions.
- Public Health Management: Oseltamivir can play a role in public health measures by helping to control the spread of influenza during outbreaks and pandemics.
Side Effects of Oseltamivir Phosphate Capsule USP:
- Nausea: Nausea is one of the most common side effects of Oseltamivir. Taking the medication with food can help reduce this side effect.
- Vomiting: Some individuals may experience vomiting while taking Oseltamivir. If this occurs, the medication may be taken with a light meal or snack.
- Headache: Headaches are a relatively common side effect but are generally mild.
- Dizziness: Dizziness can occur in some individuals taking Oseltamivir.
- Stomach Pain: Abdominal discomfort or stomach pain may occur, particularly if Oseltamivir is taken on an empty stomach.
- Insomnia: Difficulty sleeping or insomnia may occur in some individuals.
Less Common or Rare Side Effects:
While the side effects listed above are more common, Oseltamivir may also cause less common or rare side effects in some individuals. These can include:
- Allergic Reactions: Rarely, Oseltamivir may cause allergic reactions, such as rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if any signs of an allergic reaction occur.
- Neuropsychiatric Events: There have been reports of neuropsychiatric events, such as hallucinations, confusion, and self-injury, in some individuals, primarily in pediatric patients. If unusual behavior or symptoms are observed, medical attention should be sought.
- Hepatitis: Rare cases of hepatitis (liver inflammation) have been reported in individuals taking Oseltamivir.
- Skin Reactions: Skin reactions, including rash and hives, can occur but are less common.
Frequently asked questions (FAQs) about Oseltamivir Phosphate Capsule USP:
- What is Oseltamivir Phosphate Capsule USP used for?
Oseltamivir is used for the treatment and prevention of influenza (the flu), including both influenza A and B viruses.
- How does Oseltamivir work in treating the flu?
Oseltamivir inhibits the neuraminidase enzyme on the surface of influenza viruses, preventing their release from infected cells. This reduces the spread of the virus within the body and helps alleviate flu symptoms.
- When should I start taking Oseltamivir if I have the flu?
Oseltamivir is most effective when started within 48 hours of the onset of flu symptoms. It can still be beneficial when initiated after this time frame, but the sooner it is taken, the better.
- Can Oseltamivir prevent the flu if I’ve been exposed to an infected person?
Yes, Oseltamivir can be used as a preventive measure for individuals at high risk of developing the flu after close contact with infected individuals. This is known as postexposure prophylaxis.
- Are there any age restrictions for using Oseltamivir?
Oseltamivir is approved for use in individuals of all ages, including children and infants. The dosage may vary depending on age and weight.
- Is Oseltamivir effective against all strains of the flu virus?
Oseltamivir is effective against both influenza A and B viruses. However, resistance to the medication can develop over time, so its effectiveness can vary depending on the specific strain of the virus.
- What are the common side effects of Oseltamivir?
Common side effects include nausea, vomiting, headache, dizziness, stomach pain, and insomnia. These side effects are generally mild and temporary.
- Can I take Oseltamivir if I am pregnant or breastfeeding?
Pregnant or breastfeeding individuals should consult their healthcare provider before taking Oseltamivir. The decision to use the medication will depend on the potential benefits and risks in each specific case.
- Can Oseltamivir be taken with other medications?
Oseltamivir may interact with certain medications, so it’s important to inform your healthcare provider about all medications and supplements you are taking. They can assess potential interactions and adjust your treatment plan if necessary.
- Is Oseltamivir available over the counter (OTC) or by prescription only?
Oseltamivir is available by prescription only. A healthcare provider will assess your condition and determine if it is necessary for your specific situation.
- Should I still get a flu vaccine if I’m taking Oseltamivir?
Yes, getting an annual flu vaccine is still recommended even if you are taking Oseltamivir. The flu vaccine remains a crucial preventive measure against influenza.
- What should I do if I miss a dose of Oseltamivir?
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
As Oseltamivir Phosphate Capsule USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Oseltamivir Phosphate Capsule USP product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Oseltamivir Phosphate Capsule USP Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Oseltamivir Phosphate Capsule USP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Oseltamivir Phosphate Capsule USP 30mg
b) Oseltamivir Phosphate Capsule USP 75mg
b) Oseltamivir Phosphate Capsule USP 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Oseltamivir Phosphate Capsule USP 30mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………45.5mg
Equivalent to oseltamivir…………………….30mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
b) Oseltamivir Phosphate Capsule USP 75mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………98.5mg
Equivalent to oseltamivir…………………….75mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………45.5mg
Equivalent to oseltamivir…………………….30mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
b) Oseltamivir Phosphate Capsule USP 75mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………98.5mg
Equivalent to oseltamivir…………………….75mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
THERAPEUTIC INDICATIONS:
Oseltamivir phosphate is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age and older whose flu symptoms have not lasted more than two days.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach the dispensing label as per the end country
Dosage: As directed by the Physician.
Attach the dispensing label as per the end country