Ribavirin Capsule USP 200mg Technical Specification:

Product Name:                                                             Ribavirin Capsule USP
Brand Name:Generics
Strength:200mg
Dosage Form:Capsule (Hard-Gelatine)
Route of Administration:Via oral Route
Packing:90s, 100s, 500s, 1000s
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
Indication: Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues.
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  •  Ribavirin Capsule USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ribavirin Capsule USP 200mg
    Each Hard-gelatin capsules contains:
    Ribavirin USP…………………200mg
    Excipients……………………………. q.s.
    Approved Colours used in empty capsule shell.

THERAPEUTIC INDICATIONS:

Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

*Not suitable for children under 3 years.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  Ribavirin capsule are to be administered orally each day in two divided doses (morning & evening) with food. In the cases in which no specific dose recommendation is made, the following dose should be used. Patient weight: <75 kg = 1000mg and >75 kg = 1200mg.

Why Taj Pharmaceuticals?

Taj Pharma is your premier destination for Ribavirin Capsule USP, and here’s why you should choose us for your pharmaceutical needs. At Taj Pharma, we prioritize your health and well-being above all else. Our Ribavirin Capsules are manufactured with the utmost care and precision, ensuring the highest standards of quality and safety. We adhere to rigorous quality control measures, guaranteeing that each capsule meets and exceeds industry regulations. What sets us apart is our unwavering commitment to affordability. We understand the importance of accessible healthcare, and that’s why we offer Ribavirin Capsules at competitive prices, making effective treatment within reach for all.

With Taj Pharma, you’re not just a customer; you’re a valued member of our healthcare family. Our team of experts is dedicated to providing exceptional service, answering your queries, and ensuring your treatment journey is as smooth as possible. Trust Taj Pharma for Ribavirin Capsules, and experience healthcare excellence at every step. Your health is our priority, and we’re here to support you on your path to recovery.

What is Ribavirin Capsule USP and its use?

Ribavirin Capsule USP is a medication that contains the active ingredient ribavirin. Ribavirin is a synthetic nucleoside analog, which means it is a chemical compound similar in structure to the building blocks of genetic material (RNA and DNA). Ribavirin has antiviral properties and is used in the treatment of several viral infections, most notably in combination therapy for chronic hepatitis C.

Here’s an overview of the primary use of Ribavirin Capsule USP:

  • Treatment of Chronic Hepatitis C: Ribavirin is commonly used in combination with other antiviral medications, such as interferon or direct-acting antivirals (DAAs), for the treatment of chronic hepatitis C virus (HCV) infection. This combination therapy is intended to suppress the replication of the virus, reduce liver inflammation, and prevent the progression of liver disease. The specific treatment regimen and duration can vary depending on the genotype of the hepatitis C virus and individual patient factors.

Ribavirin Capsule USP should only be used under the supervision and guidance of a qualified healthcare professional, as it may have side effects and interactions with other medications. Additionally, its use may be contraindicated in certain medical conditions, so individualized medical advice is essential when considering this medication.

How does Ribavirin Capsule USP work?

Ribavirin Capsule USP works as an antiviral medication by interfering with the replication and spread of certain viruses, primarily the hepatitis C virus (HCV). Its precise mechanism of action is not fully understood, but it is thought to affect the virus in several ways:

  • Inhibition of Viral RNA Synthesis: Ribavirin is a nucleoside analog, which means it is structurally similar to the building blocks of RNA and DNA. When HCV replicates, it needs to synthesize new viral RNA. Ribavirin is incorporated into the viral RNA during replication, leading to errors in the RNA strand. These errors can disrupt the normal functioning of the virus and reduce its ability to replicate accurately.
  • Immunomodulatory Effects: Ribavirin may also have immunomodulatory effects, meaning it can influence the body’s immune response. Chronic HCV infection can suppress the immune system’s ability to fight the virus effectively. Ribavirin may help boost the immune response, making it more effective at combating the virus.
  • Synergy with Other Antiviral Medications: Ribavirin is often used in combination with other antiviral medications, such as interferon or direct-acting antivirals (DAAs), for the treatment of chronic hepatitis C. In these combination therapies, the different medications work together to target various stages of the HCV lifecycle, ultimately suppressing viral replication and promoting clearance of the virus from the body.

Ribavirin Capsule USP in hepatitis C treatment is often guided by clinical protocols and individual patient factors. The specific treatment regimen and choice of medications may vary depending on the genotype of the hepatitis C virus and the patient’s medical history. Ribavirin is not effective against all viruses, and its use is primarily limited to certain viral infections, including hepatitis C. The exact mechanisms of action against other viruses may differ, and its use in those cases would be determined by specific viral characteristics and clinical guidelines.

Benefits of Ribavirin Capsule USP:

  • Treatment of Chronic Hepatitis C: Ribavirin, when used in combination with other antiviral medications such as interferon or direct-acting antivirals (DAAs), has been effective in treating chronic hepatitis C. It helps suppress the replication of the hepatitis C virus, reduce liver inflammation, and prevent the progression of liver disease.
  • Improved Sustained Virologic Response (SVR): Treatment with Ribavirin in combination with other antiviral agents can lead to a sustained virologic response (SVR) in many patients. SVR means that the virus is undetectable in the blood six months after completing treatment, indicating a cure for hepatitis C.

Side Effects of Ribavirin Capsule USP:

  • Anemia: Ribavirin can reduce the number of red blood cells in the body, leading to anemia. Anemia can cause fatigue, weakness, and pale skin.
  • Fatigue: Many people taking Ribavirin report feeling tired or fatigued as a side effect.
  • Irritability and Mood Changes: Some individuals may experience mood swings, irritability, or depression while taking Ribavirin.
  • Nausea and Vomiting: Nausea and vomiting are common side effects of Ribavirin.
  • Headache: Headaches are another possible side effect of this medication.
  • Skin Reactions: Skin reactions such as rash or itching may occur.
  • Cough or Shortness of Breath: Some individuals may experience coughing or shortness of breath.
  • Dizziness: Dizziness can occasionally occur.
  • Thyroid Function Abnormalities: Ribavirin can affect thyroid function in some individuals, leading to hypothyroidism (underactive thyroid) or hyperthyroidism (overactive thyroid).
  • Birth Defects: Ribavirin is known to cause birth defects and should not be used by pregnant women or their male partners who are trying to conceive.

These are not all possible side effects, and other less common side effects can occur. It’s important for patients to discuss any side effects they experience with their healthcare provider. The decision to use Ribavirin should be based on a thorough assessment of the potential benefits and risks, and patients should be monitored closely during treatment to manage any side effects or adverse reactions effectively.

Frequently asked questions (FAQs) about Ribavirin Capsule USP:

  1. What is Ribavirin Capsule USP used for?

Ribavirin Capsule USP is primarily used in the treatment of chronic hepatitis C, often in combination with other antiviral medications.

  1. How does Ribavirin work?

Ribavirin interferes with the replication and spread of certain viruses, including hepatitis C, by inhibiting viral RNA synthesis and potentially modulating the immune response.

  1. What is the recommended dosage of Ribavirin Capsule USP for hepatitis C treatment?

The dosage can vary depending on the specific treatment regimen and patient factors. It is typically taken orally, and the exact dose should be determined by a healthcare provider.

  1. How long do I need to take Ribavirin Capsule USP for hepatitis C treatment?

The duration of treatment can vary depending on factors such as the genotype of the hepatitis C virus and individual patient response. It is typically taken for several weeks to months.

  1. What are the common side effects of Ribavirin Capsule USP?

Common side effects can include anemia, fatigue, irritability, nausea, vomiting, headache, skin reactions, cough, and more. However, not everyone will experience these side effects.

  1. Is Ribavirin Capsule USP safe during pregnancy?

No, Ribavirin can cause birth defects and should not be used by pregnant women or by male partners trying to conceive. Effective contraception is necessary during and after treatment.

  1. Can Ribavirin Capsule USP be used alone to treat hepatitis C?

Ribavirin is usually used in combination with other antiviral medications for hepatitis C treatment. The specific treatment plan should be determined by a healthcare provider.

  1. Can Ribavirin Capsule USP cure hepatitis C?

Ribavirin, when used in combination therapy, can lead to a sustained virologic response (SVR), which is considered a cure for hepatitis C in many cases. SVR means that the virus is undetectable in the blood six months after completing treatment.

  1. Is it safe to consume alcohol while taking Ribavirin Capsule USP?

Alcohol consumption should be avoided or limited during hepatitis C treatment, as it can worsen liver damage. Patients should follow their healthcare provider’s recommendations regarding alcohol.

  1. Are there any drug interactions with Ribavirin Capsule USP?

Ribavirin may interact with other medications, so it’s important to inform your healthcare provider about all the medications you are taking, including overthecounter drugs and supplements.

As Ribavirin Capsule USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Ribavirin 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

Ribavirin 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 Ribavirin 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:

Ribavirin Capsule USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Ribavirin Capsule USP 200mg
Each Hard-gelatin capsules contains:
Ribavirin USP…………………200mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.

THERAPEUTIC INDICATIONS:

Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 3 years.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: Ribavirin capsule are to be administered orally each day in two divided doses (morning & evening) with food.
In the cases in which no specific dose recommendation is made, the following dose should be used. Patient weight: <75 kg = 1000mg and >75 kg = 1200mg.
Attach dispensing label as per end country.