Romilast (500mcg) 30 Tablets

Romilast (500mcg) 30 Tablets

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  • Manufacturer SCILIFE PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Roflumilast

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Roflumilast, a medication available as a 500mcg tablet, exhibits its therapeutic effect through a targeted mechanism of action. It is a potent and selective inhibitor of the enzyme phosphodiesterase-4 (PDE4), which plays a crucial role in various inflammatory processes. By blocking PDE4, roflumilast increases intracellular levels of cyclic adenosine monophosphate (cAMP), a key signaling molecule. This elevation in cAMP leads to a cascade of events that result in the suppression of pro-inflammatory mediators, such as cytokines and chemokines, produced by immune cells. This mechanism contributes to the anti-inflammatory and immunomodulatory effects of roflumilast, making it effective in managing certain inflammatory conditions.

  • Ingredients

    Roflumilast
  • Drug Class

    Phosphodiesterase-4 inhibitor

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Roflumilast 500mcg Tablet:

    • Used for treating chronic obstructive pulmonary disease (COPD), reducing inflammation in the lungs and improving breathing difficulties.
    • Used for managing symptoms of severe COPD, including chronic bronchitis and emphysema.
    • Used to prevent exacerbations (sudden worsening) of COPD symptoms.
    • Used for long-term maintenance treatment, helping to control and manage the disease.
    • Used for reducing mucus production and improving lung function in COPD patients.
    • Used to enhance the overall quality of life for individuals with COPD.
    • Used for patients who have experienced recurrent exacerbations, providing better control of the condition.
  • In case of Overdose

    In the case of an overdose of Roflumilast 500mcg Tablets, it is crucial to remain calm and take immediate action. Seek medical assistance promptly by contacting emergency services or a healthcare professional. Inform them about the overdose and provide details such as the amount ingested and the time of consumption. They will guide you on the necessary steps, which may include inducing vomiting or administering activated charcoal to prevent further absorption. Quick response and medical intervention are vital in managing the situation effectively.

  • Missed Dose

    In the case of a missed dose of Roflumilast 500mcg Tablet, it is recommended to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, it is best to skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one, as this may increase the risk of side effects. If you miss several doses, consult your healthcare professional for advice on how to safely resume your medication. It is important to maintain a consistent dosing schedule for the medication's effectiveness.

  • How To Use

    To take Roflumilast 500mcg Tablet, swallow the tablet whole with a full glass of water, preferably in the morning, as directed by your healthcare professional, and it can be taken with or without food.

  • When Not to Use

    Following are the conditions/situations when Roflumilast 500mcg Tablet should not be taken:

    • Avoid using if you have a known allergy to Roflumilast or other related medications.
    • Do not take this medication if you have severe liver problems or severe kidney disease.
    • Contraindicated in patients with a history of severe depression or suicidal thoughts/attempts.
    • Should not be used in individuals with a history of seizures or epilepsy.
    • Not suitable for those with a rare genetic problem of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.
    • Avoid if you are currently taking other medications that may interact with Roflumilast, such as anticoagulants or certain antidepressants.
    • Do not use this medication if you are pregnant or breastfeeding, unless advised by your doctor.
  • Side Effects

    The side effects of Roflumilast 500mcg Tablet may include:

    • Diarrhea
    • Weight loss
    • Nausea
    • Headache
    • Insomnia (difficulty sleeping)
    • Decreased appetite
    • Back pain
    • Flu-like symptoms
  • Precautions & Warnings

    Following are the precautions and warnings for Roflumilast 500mcg Tablet:

    • Not recommended for individuals with a known hypersensitivity or severe allergic reaction to Roflumilast or any of its inactive ingredients.
    • Patients with a history of psychiatric disorders should be closely monitored as this medication may exacerbate these conditions.
    • Caution is advised for patients with moderate to severe liver impairment, as dosage adjustments may be necessary.
    • Patients with a history of suicidal thoughts or behavior should be closely observed, as this medication may increase these risks.
    • It may cause weight loss, so regular monitoring of weight is recommended.
    • Patients should be advised to immediately report any worsening respiratory symptoms or persistent fever.
    • Roflumilast may increase the risk of infections; patients should be instructed to seek medical attention for any signs or symptoms of infection.
  • Drug Interactions

    Following are the drug interactions for Roflumilast 500mcg Tablet:

    • Strong inhibitors of CYP3A4 and CYP1A2 (e.g., ritonavir, ciprofloxacin) can increase roflumilast plasma concentrations, potentially leading to increased side effects.
    • Inducers of CYP3A4 (e.g., rifampin, carbamazepine) may decrease roflumilast plasma levels, reducing its effectiveness.
    • Concomitant use with other phosphodiesterase-4 (PDE4) inhibitors is not recommended due to potential increased risk of adverse effects.
    • Roflumilast may increase the risk of bleeding when used with anticoagulants or antiplatelet drugs, such as warfarin or clopidogrel.
    • It can interact with certain anti-inflammatory medications, like corticosteroids, potentially reducing the effectiveness of these drugs.
    • The use of roflumilast with diuretics may increase the risk of electrolyte imbalances.
    • Caution is advised when combining with insulin or oral hypoglycemic agents, as it may affect blood glucose levels.
  • Food Interactions

    Following are the food interactions for Roflumilast 500mcg Tablet:

    • Avoid consuming grapefruit or grapefruit juice as it may increase the levels of the medication in the blood, potentially leading to an increased risk of side effects.
    • Alcohol intake should be minimized or avoided as it can increase the risk of gastrointestinal issues and may also enhance the chances of adverse effects.
    • Caffeine-rich beverages like coffee or energy drinks should be consumed in moderation as they can interact with Rofulumilast and affect its effectiveness.
    • High-fat meals can delay the absorption of Roflumilast, so it is advisable to take the medication on an empty stomach or with a light meal.
    • Avoid consuming tobacco products as they can reduce the therapeutic effects of Roflumilast and may lead to respiratory complications.
    • There is no significant interaction with dairy products, but if you have lactose intolerance, consider taking the medication with alternative sources of calcium.
    • Spicy foods may exacerbate gastrointestinal side effects, so it's best to moderate their consumption during treatment.
    • Always ensure you are well-hydrated, and drink plenty of water throughout the day to aid in the medication's absorption and overall well-being.
  • Storage/Disposal

    Roflumilast 500mcg Tablets should be stored in a secure and dry location, away from direct sunlight, moisture, and heat sources. Maintain the medication in its original packaging, ensuring the container is tightly sealed to maintain its integrity. It is crucial to keep the tablets at room temperature, avoiding extreme temperatures. Always verify the expiration date before use and never use the medication past its expiry. When disposing of unused or expired tablets, do not flush them or pour them down the drain. Instead, consult your pharmacist or local waste management guidelines for safe disposal practices to protect the environment. Keep the medication out of children's reach to prevent accidental consumption.

  • Quick Tips, if any

    Following are the quick tips for Roflumilast 500mcg Tablet:

    • Take the tablet as directed by your doctor, typically once daily in the morning.
    • Swallow the tablet whole with a full glass of water; do not crush, chew, or break it.
    • Ensure you take the medication regularly, even if you feel well, to maximize its effectiveness.
    • Roflumilast may take several weeks to show its full effect, so be patient and continue the medication as prescribed.
    • Avoid drinking alcohol as it may increase the risk of certain side effects.
    • Inform your doctor about all medications you're taking to prevent potential drug interactions.
    • Store the tablets at room temperature, away from moisture and light.

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