Irovel 300 mg Tablet

Manufactured bySun Pharma Laboratories Ltd.
ContainsIrbesartan
Description

Irovel 300 mg Tablet is used alone or in combination with other medicines for the treatment of high blood pressure in adults and children above the age of 16 years. It is also used to treat kidney disease associated with diabetes mellitus. Patients are advised to follow a strict exercise and diet regimen along with this medicine to get the best possible effect.

Side effects

Major & minor side effects for Irovel 300 mg Tablet

  • Increased potassium levels
  • Dizziness
  • Swelling of face, lips, eyelids, tongue, hands and feet
  • Difficulty in breathing
  • Orthostatic Hypotension
  • Increased heart beat
  • Rash
  • Pharyngitis
  • Heartburn
  • Headache
  • Indigestion
  • Diarrhea
  • Dark colored urine
  • Stomach pain

Uses of Irovel 300 mg Tablet

What is it prescribed for?

  • Hypertension
  • Diabetic Nephropathy
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Concerns

Commonly asked questions

  • Onset of action
    The effect of this medicine can be observed within 1-2 hours of administration of the dose.
  • Duration of effect
    The effect of this medicine lasts for an average duration of 24 hours.
  • Safe with alcohol?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is it habit forming?
    No habit forming tendency has been reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. Discuss all the risks and benefits with your doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. Discuss all the risks and benefits with your doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to irbesartan or any other medicines of the same class.

Aliskiren

Coadministration of Irovel 300 mg Tablet and aliskiren is not recommended in diabetic or renal impaired patients with creatinine clearance less than 60 ml/min due to the increased risk of severe side effects. These side effects may include hypotension, increased potassium levels, and worsening of renal disorders.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. Discuss all the risks and benefits with your doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. Discuss all the risks and benefits with your doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.
General warnings

Hypotension

Symptomatic hypotension may occur in patients with volume depletion or patients who are treated with high doses of diuretics. It is advised to correct the condition before starting Irovel 300 mg Tablet or to start the treatment at reduced doses.

Hyperkalemia

Irovel 300 mg Tablet may significantly increase the potassium levels in the blood (hyperkalemia). This may cause serious adverse effects. Report any unusual symptoms to the doctor immediately. Close monitoring of potassium levels and kidney functions is recommended during treatment with this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Pediatric dose

The safety and efficacy of this medicine have not been established in children under the age of 16 years.

Missed Dose

If a dose of Irovel 300 mg Tablet is missed, take the missed dose as soon as you remember it. If it is almost time for the next dose, skip the missed dose. Do not double the dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Aliskiren

Insulin

Angiotensin converting enzyme inhibitors (ACEI's)

Diclofenac

Potassium sparing diuretics

Trimethoprim

Disease interactions

Hypotension

Irovel 300 mg Tablet should be used with caution in patients who are sodium depleted and/or volume depleted since it may increase the risk of hypotension. The volume depleted and/or sodium depleted state should be corrected before starting the therapy or the treatment should be started at a lower dose. Vital signs should be monitored closely during therapy with this medicine.

Angioedema

This medicine is not recommended for use in patients with a known history of angioedema due to the increased risk of worsening of the patient's condition. Report any symptoms such as swelling of the face or lips, difficulty swallowing, or difficulty breathing to the doctor immediately. Stop the medicine if any of the above signs appear and seek emergency medical treatment. Discontinue the therapy if angioedema is associated with Irovel 300 mg Tablet. Your doctor may prescribe an alternative medicine based on the clinical condition.

Congestive heart failure

Irovel 300 mg Tablet should be used with caution in patients with congestive heart failure, especially in volume or sodium depletion states, due to the increased risk of life-threatening side effects. These side effects may include renal failure, myocardial ischemia, and death. Close monitoring of kidney and heart function is necessary during treatment with this medicine. Your doctor may prescribe an alternative medicine based on the clinical condition.
Food interactions
It is recommended to avoid a high potassium diet during treatment with this medicine due to the increased risk of serious adverse effects. Your doctor/dietitian will suggest appropriate changes in your diet to avoid high intake of potassium.
Lab interactions
Information not available.
Take Irovel 300 mg Tablet with or without food. Do not take in larger amounts than advised. Inform the doctor if you experience any undesirable side effects. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Does not cause sleepiness

How it works
This medicine works by relaxing the blood vessels. This allows the blood to flow smoothly and decreases the blood pressure.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Angiotensin receptor blockers

Schedule

Schedule H

[Internet]. Toxnet.nlm.nih.gov. 2017 [cited 8 August 2017]. Available from:

https://toxnet.nlm.nih.gov/cgi-bin/sis/search2

Irbesartan: irbesartan tablet [Internet]. Dailymed.nlm.nih.gov. 2017 [cited 8 August 2017]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ddca7d7c-07fe-4df6-83ae-a9c05048b66e

Irbesartan - DrugBank [Internet]. Drugbank.ca. 2017 [cited 8 August 2017]. Available from:

https://www.drugbank.ca/drugs/DB01029

Irbesartan: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2017 [cited 8 August 2017]. Available from:

https://medlineplus.gov/druginfo/meds/a698009.html

Prescribing medicines in pregnancy database [Internet]. Therapeutic Goods Administration (TGA). 2017 [cited 8 August 2017]. Available from:

http://www.tga.gov.au/prescribing-medicines-pregnancy-database
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