VesiBeta ER 50mg (Mirabegron)

VesiBeta ER 50 mg (Mirabegron) – Complete Product Information

Brand Name: VesiBeta ER
Generic Name: Mirabegron
Dosage Form: Extended Release Tablets
Strength: 50 mg
Therapeutic Class: Beta-3 Adrenergic Agonist
Indications: Overactive Bladder (OAB) with symptoms of urgency, frequency, and urge urinary incontinence

Overview

VesiBeta ER 50 mg is an extended-release tablet that contains Mirabegron, which is a specific beta-3 adrenergic agonist utilized to control the symptoms of overactive bladder (OAB). OAB is a frequent condition that is characterized by an intense desire to urinate and frequent urination, frequent nighttime urine (nighttime urinary frequency), or even an urge to urinate. It can also cause incontinence (involuntary loss).

VesiBeta ER works by relaxing the muscle detrusor of the bladder in the phase of storage, which increases bladder capacity while reducing anxiety and frequency. In contrast to antimuscarinic medications traditionally employed to treat OAB, Mirabegron offers an alternative mechanism for action, usually with less anticholinergic adverse consequences, such as constipation or dry mouth.

Composition and Mechanism of Action

Active Ingredient:

• Mirabegron 50 mg (Extended Release)

Mechanism:

Mirabegron is a selective stimulator of beta-3 receptors for adrenergic stimulation located in the bladder’s detrusor muscle. In the case of activation, these receptors lead to relaxation of the muscle during the phase of filling the bladder, enhancing bladder capacity and decreasing the involuntary contractions. This helps alleviate symptoms of frequency, urgency, and incontinence.

Indications

VesiBeta ER 50 mg is indicated for the treatment of:

• Overactive bladder (OAB) with symptoms of frequent, urgent, as well as urge urinary incontinence among adults.
• It can be utilized as a monotherapy or with other drugs like antimuscarinics if it is appropriate.

Dosage and Administration

Recommended Dose:

• The recommended dosage for adults is 50 mg every day to be taken orally, and without or with food.
• If you have a patient who suffers from moderate renal impairment, moderate or slight liver impairment, or has a sedentary lifestyle, taking 25 mg per day is recommended for the first time, but it is possible to increase this number by 50 mg, based on the tolerability.
• Tablets are best swallowed whole, with water. Do not chew or crush them.

Treatment Duration:

• The length of treatment depends on the individual reaction; long-term therapy could be required.
• A regular check-up by a health care professional is recommended to assess the efficacy of the treatment and ensure its safety.

Who Should Take VesiBeta ER?

• Adults suffering from signs of excessive bladder activity.
• Patients who are intolerant or not suitable for treatment with antimuscarinics.
• People are looking for a substitute that has fewer anticholinergic-related side effects.

Who Should NOT Take VesiBeta ER?

• Patients who suffer from uncontrolled and severe hypertension (high blood pressure).
• There is a known hypersensitivity reaction to Mirabegron or other components that are part of the tablet.
• End-stage renal patients need dialysis.
• Pregnant women or breastfeeding, unless advised otherwise by a medical professional.

Warnings and Precautions

• Blood pressure monitoring: Mirabegron can raise blood pressure. It is important to monitor blood pressure regularly for those with already-existing hypertension.
• Urinary retention risk: Take care when administering this medicine to patients who have urinary obstruction or who are at risk of developing urinary retention.
• Heart rate: Mirabegron may cause a slightly increased heart rate. Be cautious when using it in patients suffering from serious cardiovascular diseases.
• Kidney and liver function: Dosage adjustments may be required to treat moderate impairment, but avoid them when you are suffering from severe impairment.
• Drug interactions: Mirabegron’s metabolism occurs through CYP450 enzymes. Inform your physician about any other medications.

Possible Side Effects

Common Side Effects:

• Hypertension (increased blood pressure)
• Nasopharyngitis (common cold symptoms)
• Headache
• Dizziness
• Urinary tract infection (UTI)
• Constipation

Less Common Side Effects:

• Tachycardia (fast heart rate)
• Blurred vision
• Palpitations
• Fatigue

Serious Side Effects:

• Severe allergic reactions (rash, itching, swelling)
• Significant increase in blood pressure
• Urinary retention requiring medical attention

If you experience any serious adverse reactions that are serious and are noticed, it is imperative to seek immediate medical treatment.

Drug Interactions

• Mirabegron is able to interact with drugs that are metabolized by liver enzymes CYP2D6 and CYP3A4.
• Could increase the plasma concentration of some drugs like digoxin, metoprolol, and desipramine.
• Use with caution when combined with other drugs for hypertension or those that affect the heart rate.
• Your healthcare professional should be informed of any medications you take, even over-the-counter medications, as well as supplements.

Use in Special Populations

• Elderly: The majority of patients tolerate it well, but it could require more frequent checking to monitor blood pressure.
• Renal impairment: Lower doses are recommended for moderate impairment. Avoid severe impairment.
• Hepatic impairment: Take lower doses for moderate to mild impairment. Stay clear of extreme impairment.
• Pregnancy and lactation: Limited data. Use only when clearly required and deemed necessary by a medical professional.

Patient Counseling Information

• It is recommended to take VesiBeta ER exactly as prescribed and at the same time throughout the day.
• Don’t crush, break, or chew tablets.
• Check your blood pressure frequently.
• Tell your doctor if you have symptoms that include chest pain, severe headaches, or discomfort with urination.
• Do not drive or operate heavy machines until you are aware of what the effects of the medication are on your body, particularly if you notice dizziness.
• Keep taking medication even if your symptoms get better, unless instructed not to by your physician.

Storage Instructions

• Maintain at a room temperature between 20°C to 25°C (68°F to 77°F).
• Be sure to shield yourself from light and moisture.
• Be sure to keep away from children.
• Do not use after the expiry date.

Frequently Asked Questions (FAQs)

Q1: How soon will VesiBeta ER start working?

It could take between 4 and 8 weeks before you notice an improvement in the symptoms.

Q2: Can I take VesiBeta ER with food?

Yes, it is consumed either with or without meals.

Q3: What should I do if I miss a dose?

You should take the dose you missed when you remember. However, skip the dose when it’s near the timing of your next dose. Don’t double-dose your medication.

Q4: Can I stop taking VesiBeta ER suddenly?

Don’t stop taking the medicine without consulting your doctor. If you stop abruptly, it could cause your symptoms to return.

Summary

VesiBeta ER 50 mg (Mirabegron) is an innovative and highly effective method to manage the overactive bladder symptoms through relaxing bladder muscles and increasing the bladder’s capacity. It is a viable alternative to the traditional antimuscarinic drugs, which may cause fewer side effects associated with constipation and dry mouth.

It is a once-a-day dosing regimen and has an overall favorable safety record. VesiBeta ER helps improve the quality of life of patients with urgency, frequency, and urinary incontinence.

Always speak with your doctor prior to introducing or stopping the medicine to confirm that it’s appropriate for you and also to reduce any potential risk.