ALFUZOSIN HCL,DUTASTERIDE

Background and Date of Approval

Alfuzosin Hcl Dutasteride contains two active ingredients in one tablet. One of the active substances is Alfuzosin Hcl, which belongs to the group of medications called alpha-adrenoreceptor antagonists. The other active substance is Dutasteride belonging to the group of medications called 5-alpha-reductase inhibitors. The FDA approved this combination to treat Benign prostatic hyperplasia (BPH).

Uses

Alfuzosin Hcl + Dutasteride is used to treat symptoms associated with benign prostatic hyperplasia in men (enlarged prostate). It refers to a non-cancerous prostate gland growth, which can result in urinary problems such as difficulty in passing urine, frequent or urgent need to urinate, and urinary dribbling.

How is it administered?

Your doctor will decide the dose and duration of Alfuzosin Hcl + Dutasteride based on the disease condition and other factors. Always take this medicine as prescribed by your doctor. Take the tablet at the same time every day, with or without food. Do not break, chew, crush, or break the tablet. Swallow the whole tablet with water.

Side Effects

The common side effects of Alfuzosin Hcl + Dutasteride are impotence, decreased libido, ejaculation disorder, headache, nausea, abdominal pain, upper respiratory tract infection, breast enlargement in male, and breast tenderness in male.

Warnings

Do not take Alfuzosin Hcl + Dutasteride if you have severe liver disease or hepatic impairment. This drug is metabolized in the liver, so severe liver dysfunction can affect the clearance of these medications and potentially lead to adverse effects. This tablet should be used cautiously in individuals with moderate to severe kidney impairment. Dose adjustments may be necessary in these cases, and close monitoring of renal function is advised. If you are scheduled for cataract surgery or any other eye procedure, notify your ophthalmologist that you are taking this tablet. The medication has been associated with intraoperative floppy iris syndrome (IFIS), which can complicate the surgical procedure.

Precautions

Alfuzosin Hcl + Dutasteride can cause a drop in blood pressure, leading to orthostatic hypotension (a sudden drop in blood pressure upon standing up). If a person has a history of orthostatic hypotension or is prone to low blood pressure, this drug should be used with caution. It is not recommended for adolescents and children under the age of 18. This drug is specifically indicated for use in men and should not be taken by women.

Word of Advice

This medicine may lower blood pressure, which could cause dizziness or fainting, particularly when changing position (such as moving from lying down to standing up). To reduce this risk, rise slowly and gradually when moving from a seated or lying position. Maintaining adequate hydration is important while taking Alfuzosin HCl + Dutasteride. Drink sufficient water throughout the day unless your healthcare provider advises otherwise. If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

References

Sanofi, Electronic medicines compendium (EMC), [Revised on Sept 2020] [ Accessed on 13th June 2023], https://www.medicines.org.uk/emc/files/pil.1475.pdf Rivopharm UK Ltd, US Food and Drug Administration, [Revised on March 2017] [ Accessed on 13th June 2023], https://www.medicines.org.uk/emc/files/pil.8988.pdf Ciplamed; Accessed on 13th June 2023; https://ciplamed-library.com/content/alfusin-d-tablets Package leaflet: Information for the user -Xatral 10mg tablets. www.hpra.ie . [Revised on Dec 2019], [ Accessed on 13th June 2023], https://www.hpra.ie/img/uploaded/swedocuments/2205503.PPA0465_138_002.856a0b73-285a-41e8-9b98-7a162579cd59.000001Xatral%20PIL.180515.pdf Package leaflet: Information for the user -Xatral 10mg tablets. www.hpra.ie . [Revised on Feb 2019], [ Accessed on 13th June 2023], https://www.hpra.ie/img/uploaded/swedocuments/b9581434-1b99-4640-806c-e9dd8a3531dc.pdf KD Tripathi, Essentials of Medical Pharmacology, Antiadrenergic Drugs (Adrenergic Receptor Antagonists) and Drugs for Glaucoma, 7th edition, 2013, 142. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Androgens, 12th edition, 2011, 1205.

Frequently Asked Questions

Can Alfuzosin Hcl + Dutasteride be taken at any time of the day?

Yes, Alfuzosin Hcl + Dutasteride can be taken at any time of the day. However, taking it at the same time each day is generally recommended for better medication adherence. It can be taken with or without food, as directed by your healthcare provider.

Can Alfuzosin Hcl + Dutasteride be taken with certain supplements or herbal products?

Certain supplements or herbal products may interact with Alfuzosin Hcl + Dutasteride, affecting its effectiveness or increasing the risk of side effects. It is important to inform your healthcare provider about all your supplements or herbal products before starting or modifying your medication regimen.

What are the long-term effects of taking Alfuzosin Hcl + Dutasteride?

The long-term effects of taking Alfuzosin Hcl + Dutasteride can vary from person to person. There have been some reports of hepatotoxicity (liver damage) associated with alfuzosin use, although this is considered rare. It is essential to monitor liver function through regular blood tests if you take alfuzosin for an extended period.

How long does it take for Alfuzosin Hcl + Dutasteride to work?

During the initial treatment period, some individuals may experience a more rapid response, while others may require more time to see significant improvements. It is essential to continue taking Alfuzosin Hcl + Dutasteride as your healthcare provider prescribes, even if you do not see immediate results.

Whether women can take Alfuzosin Hcl + Dutasteride?

No, Alfuzosin Hcl + Dutasteride is specifically indicated for use in men and should not be taken by women.

Can I drive while taking Alfuzosin Hcl + Dutasteride?

Alfuzosin Hcl + Dutasteride may cause dizziness or drowsiness in some individuals, affecting your ability to drive or operate machinery safely. If you experience these side effects, avoiding activities requiring alertness is advisable.

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS