Flotral D

FLOTRAL D

FLOTRAL D is a combination medication developed by Sun Pharma (originally Ranbaxy) that is primarily used to manage the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate gland, in adult men. This medication helps improve overall urinary function and enhances the quality of life for individuals with BPH.

Composition

FLOTRAL D contains two active ingredients:

• Alfuzosin (10 mg): An alpha-1 adrenergic blocker that relaxes the smooth muscles in the prostate and bladder neck, improving urine flow.
• Dutasteride (0.5 mg): A 5-alpha reductase inhibitor that reduces the size of the prostate gland by lowering the production of dihydrotestosterone (DHT), a hormone contributing to prostate growth.

Uses

FLOTRAL D is prescribed for:

• Treatment of benign prostatic hyperplasia (BPH) or enlarged prostate gland.
• Alleviation of urinary symptoms associated with BPH, such as frequent urination, urgency, weak urine stream, difficulty starting urination, and the sensation of incomplete bladder emptying.
• Improvement of urine flow and reduction of discomfort related to urinary retention.
• Reducing the need for prostate surgery and the risk of acute urinary retention.

Dosage and Administration

• FLOTRAL D Tablet should be taken orally, precisely as prescribed by your doctor.
• It is typically recommended to take the medication once daily, immediately after the same meal each day.
• The tablet should be swallowed whole with a glass of water; do not crush, chew, or break it, as this could alter the way the medicine is absorbed.
• The dosage and duration of treatment will be determined by your doctor based on your specific condition and response. Do not stop taking it abruptly, even if symptoms improve.

Side Effects

Common side effects may include:

• Dizziness, lightheadedness, or drowsiness.
• Sexual problems such as decreased sex drive (libido), difficulty with ejaculation, or impotence (erectile dysfunction).
• Runny or stuffy nose (nasal congestion).
• Increased breast size or breast tenderness (gynecomastia), and testicle pain/swelling.
• Headache, fatigue, nausea, abdominal pain, or diarrhea. Serious, less common side effects can include low blood pressure (orthostatic hypotension), especially when standing up, leading to dizziness or fainting. In rare cases, persistent painful penile erection (priapism) can occur, requiring immediate medical attention.

Precautions

• Allergies: Do not take FLOTRAL D if you are allergic to alfuzosin, dutasteride, or any other ingredients.
• Low Blood Pressure: Inform your doctor if you have low blood pressure, as it can worsen dizziness or lightheadedness. Rise slowly from a sitting or lying position to minimize dizziness.
• Liver/Kidney Disease: Use with caution in patients with liver or kidney disease; dose adjustments may be required. Regular monitoring of liver and kidney function is recommended.
• Heart Conditions: Inform your doctor if you have a history of heart disease.
• Surgery: Consult your doctor before undergoing cataract surgery, as FLOTRAL D may cause complications.
• Pregnancy/Breastfeeding: FLOTRAL D is contraindicated for women, especially during pregnancy, as dutasteride can harm a developing fetus. It is also not indicated for breastfeeding women, as dutasteride can pass into breast milk.
• Children: FLOTRAL D is not recommended for use in children or adolescents under 18 years of age.
• Driving/Operating Machinery: Avoid driving or operating machinery if you experience drowsiness, dizziness, or blurred vision.
• Drug Interactions: Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and vitamins, to avoid potential interactions. Certain medications, such as strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) and PDE-5 inhibitors (e.g., sildenafil), can interact with FLOTRAL D.
• Blood Donation: Men taking FLOTRAL D should not donate blood for at least six months after their last dose to prevent exposure to pregnant women.
• Prostate Cancer: FLOTRAL D does not cure prostate cancer and may increase the risk of high-grade prostate cancer.

Storage

• Store FLOTRAL D Tablet at room temperature, ideally between 20°C and 25°C.
• Protect it from light and moisture.
• Keep the container tightly closed when not in use.
• Always keep this medicine out of the sight and reach of children.

What is FLOTRAL D used for?

FLOTRAL D is primarily used to manage the signs and symptoms of benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate gland, in adult men. It helps alleviate urinary problems associated with BPH, such as difficulty initiating urination, frequent urination (especially at night), a weak urine stream, and the sensation of incomplete bladder emptying. It also works to reduce the overall size of the enlarged prostate gland.

How does FLOTRAL D work?

FLOTRAL D is a combination medication containing two active ingredients: Alfuzosin (10 mg) and Dutasteride (0.5 mg). Alfuzosin is an alpha-1 adrenergic blocker that relaxes the smooth muscles in the prostate and bladder neck, which improves urine flow and reduces discomfort. Dutasteride is a 5-alpha reductase inhibitor that reduces the production of dihydrotestosterone (DHT), a hormone responsible for prostate growth, thereby helping to shrink the prostate gland over time.

What is the usual dosage of FLOTRAL D?

The typical dosage for adults is one tablet (containing 10 mg of Alfuzosin and 0.5 mg of Dutasteride) taken orally once daily. It should be swallowed whole with a glass of water, immediately after the same meal each day, to ensure consistent absorption and effectiveness. Always follow your doctor's specific instructions regarding dosage and duration of treatment.

What are the possible side effects of FLOTRAL D?

Common side effects can include dizziness, lightheadedness (especially when standing up), headache, nasal congestion, fatigue, ejaculation disorders, impotence (erectile dysfunction), decreased libido, and breast disorders such as enlargement or tenderness (gynecomastia). Low blood pressure (hypotension) may also occur. If any side effects are bothersome or persistent, consult your doctor.

Is FLOTRAL D safe during pregnancy or breastfeeding?

No, FLOTRAL D is contraindicated during pregnancy and breastfeeding. It should not be used by women. Pregnant women or those who could become pregnant should avoid handling the medicine or being exposed to the semen of men taking FLOTRAL D, as it contains dutasteride which can cause serious abnormalities to a developing fetus. Condom use is recommended for men taking FLOTRAL D during sexual intercourse.

Can FLOTRAL D be taken with other medications?

FLOTRAL D can interact with several other medications. It should be used with caution or avoided with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), PDE-5 inhibitors (e.g., sildenafil, tadalafil), which can further lower blood pressure, and anticoagulants like warfarin, which may increase the risk of bleeding. Always inform your doctor about all medications, including over-the-counter drugs, herbal supplements, and vitamins, you are currently taking to avoid potential interactions.

What precautions should be taken while using FLOTRAL D?

Patients with a history of low blood pressure, liver impairment, kidney disease, or certain heart conditions should use FLOTRAL D with caution. This medicine may cause dizziness or fainting, so caution is advised when driving or operating machinery until you know how it affects you. Inform your doctor if you are planning cataract surgery, as FLOTRAL D can cause complications. Men taking FLOTRAL D should not donate blood for at least six months after their last dose.

What happens if a dose of FLOTRAL D is missed?

If you miss a dose of FLOTRAL D, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should FLOTRAL D be stored?

FLOTRAL D should be stored at room temperature, ideally between 20°C and 25°C. It should be protected from light and moisture. Keep the medicine in its original container and always out of the reach of children.