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Nindanib 100 Mg

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10 CAPSULEProduct code 255127

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Product information

Manufacturer
Glenmark Laboratories
Category
Allopathy
Composition
Not provided
Packaging
10 CAPSULE
Box / case pack
1 / —
Description

NINDANIB 100 MG

Name

  • Brand Name: Nindanib 100 mg
  • Common Name: Nintedanib

Composition

  • Active Ingredient: Nintedanib 100 mg

Uses

Nindanib 100 mg is prescribed for the treatment of various medical conditions, primarily involving lung diseases:

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease characterized by progressive scarring of the lungs.
  • Chronic Fibrosing Interstitial Lung Diseases (ILDs): Specifically those with a progressive phenotype.
  • Systemic Sclerosis-Associated Interstitial Lung Disease.
  • Non-Small Cell Lung Cancer (NSCLC): Particularly advanced, metastatic, or recurrent adenocarcinoma, sometimes in combination with docetaxel, especially after the failure of first-line chemotherapy.

Dosage and Administration

  • Typical Dosage: The usual recommended dosage is 100 mg taken twice daily, approximately 12 hours apart. Your doctor may adjust the dose based on tolerance and side effects.
  • Administration: Nindanib 100 mg capsules should be swallowed whole with food and a liquid. Do not chew, crush, or open the capsules.
  • Timing: Take the medicine at the same time every day for optimal benefits.
  • Missed Dose: If a dose is missed, skip it and continue with the next scheduled dose at the regular time. Do not take a double dose to make up for the missed one.
  • Maximum Dose: Do not exceed 300 mg of Nintedanib in one day.

Side Effects

Common Side Effects:

  • Diarrhea (very common), nausea, vomiting, and stomach/abdominal pain.
  • Decreased or loss of appetite, headache, and weight loss.
  • High blood pressure (hypertension).

Serious Side Effects:

  • Liver problems, indicated by symptoms such as yellowing of skin/eyes (jaundice), dark urine, upper right abdominal pain, unusual bleeding or bruising, fatigue, or loss of appetite.
  • Bleeding problems.
  • Heart attack or stroke symptoms like chest pain, pressure, or numbness/weakness on one side of the body.
  • Gastrointestinal perforation or severe stomach cramps.
  • Increased protein in the urine (proteinuria).

Precautions

  • Medical History: Inform your doctor about any history of bleeding problems, liver disease, kidney issues, or recent stomach surgery before starting treatment.
  • Drug Interactions: Disclose all medications, supplements, and herbal products you are currently taking, as Nindanib can interact with other drugs, including blood thinners, certain anti-infectives (e.g., erythromycin, rifampicin), and medicines for brain-related disorders (e.g., phenytoin, carbamazepine, St. John's wort).
  • Pregnancy and Breastfeeding: Nindanib is not recommended during pregnancy or breastfeeding due to potential harm to the unborn baby or infant. Effective contraception must be used during treatment and for at least three months after the last dose by both male and female patients.
  • Monitoring: Regular blood tests to monitor liver function are essential before and during treatment.
  • Lifestyle: Avoid alcohol consumption and smoking, as they can reduce the effectiveness of the medicine or increase side effects.
  • Diet: Do not consume grapefruit or grapefruit juice while taking Nindanib.
  • Hydration: Stay well-hydrated, especially if experiencing diarrhea.

Storage

  • Store Nindanib 100 mg capsules at room temperature, ideally between 20°C to 25°C (68°F to 77°F), but generally below 25°C or 30°C.
  • Keep the medicine dry and protect it from light, moisture, and high heat.
  • Keep all medicines out of the reach and sight of children and pets.
Frequently asked questions

Here are frequently asked questions about NINDANIB 100 MG (Nintedanib):

What is NINDANIB 100 MG used for?

NINDANIB 100 MG, which contains the active ingredient Nintedanib, is an anti-fibrotic medicine primarily used to treat adults with certain chronic lung conditions. These include idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) to help slow the rate of decline in lung function. It can also be used in combination with docetaxel to treat specific types of non-small cell lung cancer (NSCLC).

How does NINDANIB 100 MG work?

NINDANIB 100 MG is a tyrosine kinase inhibitor (TKI). It works by blocking multiple receptor tyrosine kinases (RTKs) such as platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and vascular endothelial growth factor receptor (VEGFR) 1-3. By inhibiting these specific enzymes, Nintedanib helps to reduce the formation of fibrous tissue in the lungs and can also hinder the growth and spread of abnormal cells in certain cancers.

What is the usual dosage of NINDANIB 100 MG?

The typical recommended dosage of Nintedanib is 150 mg taken orally twice daily, approximately 12 hours apart, with food. Your doctor may prescribe NINDANIB 100 MG (100 mg twice daily) if the higher dose is not well tolerated, particularly in patients with mild liver impairment. It is crucial to swallow the capsules whole with liquid and not to chew, crush, or open them, as this can cause a bitter taste. Do not exceed a total dose of 300 mg in one day.

What are the possible side effects of NINDANIB 100 MG?

Common side effects of NINDANIB 100 MG include diarrhea (which is very common), nausea, vomiting, stomach pain, decreased appetite, headache, weight loss, and high blood pressure. More serious side effects can include liver problems (manifested by yellowing skin or eyes, dark urine, or upper right abdominal pain), bleeding problems, heart attack, stroke, a tear in the stomach or intestinal wall (perforation), and increased protein in your urine (proteinuria). You should contact your doctor immediately if you experience any severe or persistent side effects.

Is NINDANIB 100 MG safe during pregnancy or breastfeeding?

NINDANIB 100 MG is not recommended during pregnancy as it can cause harm to an unborn baby. Females who are able to become pregnant should use highly effective contraception before starting, during treatment, and for at least 3 months after the last dose. A pregnancy test should be performed before and at regular intervals during treatment. Breastfeeding is also not recommended while taking NINDANIB 100 MG, as it is unknown if the drug passes into human milk and could potentially harm a nursing infant.

Can NINDANIB 100 MG be taken with other medications?

NINDANIB 100 MG can interact with other medications, potentially altering its effectiveness or increasing the risk of side effects. It is important to inform your doctor about all medicines you are taking, including prescription, over-the-counter drugs, vitamins, and herbal supplements. For example, concomitant use with certain P-glycoprotein (P-gp) and CYP3A4 inducers (like rifampin, carbamazepine, phenytoin, and St. John's wort) can decrease Nintedanib's levels. Nintedanib can also increase the risk of bleeding when taken with anticoagulants (blood thinners) such as warfarin, dabigatran, apixaban, or aspirin, requiring close monitoring by your doctor.

What precautions should be taken while on NINDANIB 100 MG?

Your doctor will monitor your progress with regular visits, including blood tests to check liver function before starting and during treatment (monthly for the first three months, then periodically). Be sure to inform your doctor if you have a history of bleeding problems, liver or heart disease, blood clots, recent abdominal surgery, or gastrointestinal perforation. If you experience diarrhea, nausea, or vomiting, your doctor may recommend supportive treatment, a dose reduction, or temporary interruption of the medication. Smoking should be avoided as it can reduce the effectiveness of Nintedanib.

What happens if a dose of NINDANIB 100 MG is missed?

If you miss a dose of NINDANIB 100 MG, skip the missed dose and take your next dose at its regularly scheduled time. Do not take extra capsules or a double dose to make up for a missed one.

How should NINDANIB 100 MG be stored?

NINDANIB 100 MG capsules should be stored at room temperature, typically between 20°C to 25°C (68°F to 77°F). It is important to keep the medicine dry and protect it from high heat and moisture. Keep the capsules in their original container, tightly closed, and out of the reach of children.