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FLOXPRO CAPSULES

TRANSULOSIN HCL

FDA/SD.243-050868 TRANSULOSIN HCL 4000MCG

What it does

Transulosin is a medication used to help relieve urinary symptoms associated with an enlarged prostate.

Commonly used for: difficulty urinating due to an enlarged prostate (benign prostatic hyperplasia)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.243-050868
Registration date
2024-05-30
Expiry date
2027-06-01
Status
Valid
Active ingredient
TRANSULOSIN HCL
Dosage form
TRANSULOSIN HCL
Strength
4000MCG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Mvc Pharmaceuticals
Country of origin
-
Manufacturer location
2nd Floor, Prime Corporate Park, Sheraton Sahar Road, behind ITC Grand Maratha, Ashok Nagar, Andheri East, Mumbai, Maharashtra 400099, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:06 · updated 2026-10-20 04:00:09

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Transulosin is a medication used to help relieve urinary symptoms associated with an enlarged prostate.

What it treats

  • difficulty urinating due to an enlarged prostate (benign prostatic hyperplasia)

How it works

Transulosin works by relaxing the muscles in the prostate and the bladder neck, making it easier to urinate.

Who it's for

This medication is for adult men who have urinary problems caused by an enlarged prostate.

Cautions

  • • Consult your doctor if you have liver or kidney problems.
  • • Use with caution if you have low blood pressure.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: transulosin

Tamsulosin is an alpha-1 adrenergic receptor antagonist primarily used to treat benign prostatic hyperplasia (BPH). It helps alleviate urinary symptoms associated with BPH by relaxing the muscles in the prostate and bladder neck, improving urine flow and reducing urinary obstruction.

Indications

  • Benign prostatic hyperplasia (BPH)
  • Urinary symptoms associated with BPH

Dosage

Children: Not indicated for paediatric use.

Adults: Refer to the BNF for specific dosing information, typically starting with a low dose to assess tolerance.

Mechanism of action

Tamsulosin selectively blocks alpha-1A adrenergic receptors found predominantly in the prostate, leading to the relaxation of smooth muscle in the bladder neck and prostate. This action reduces resistance to urinary flow and facilitates urination.

Pharmacodynamics

The pharmacodynamic effects of tamsulosin include decreased urinary obstruction and improved urinary flow. Its selective action on the alpha-1A receptors results in fewer cardiovascular side effects compared to non-selective alpha blockers.

Pharmacokinetics

Tamsulosin is well-absorbed after oral administration, with peak plasma concentrations occurring approximately 6 to 8 hours post-dose. It undergoes extensive hepatic metabolism, primarily by cytochrome P450 enzymes, and has a half-life of about 9 to 13 hours. The drug is excreted mainly in urine, with a small percentage excreted in feces.

Contra-indications

  • Severe hepatic impairment
  • Hypersensitivity to tamsulosin or any of its components
  • Concomitant use with potent CYP3A4 inhibitors

Adverse effects

  • Dizziness
  • Headache
  • Nasal congestion
  • Abnormal ejaculation
  • Fatigue
  • Orthostatic hypotension

Interactions

  • Caution with other antihypertensive medications due to additive effects
  • Potential interactions with other alpha-adrenergic antagonists
  • Caution with PDE5 inhibitors, as they may increase the risk of hypotension
  • CYP3A4 inhibitors may increase tamsulosin levels

Precautions

  • Monitor for signs of hypotension, especially in patients taking antihypertensives
  • Caution in patients with a history of orthostatic hypotension
  • Evaluate for prostate cancer prior to initiation in older patients
  • Use with caution in patients with severe renal impairment

Pregnancy

Tamsulosin is not indicated for use in pregnancy. It is classified as Category B by the FDA, indicating no known risk in humans, but should be used only if clearly needed.

Breast-feeding

It is not known if tamsulosin is excreted in human milk. Caution is advised when administered to nursing mothers.

Storage

Store at room temperature, 20-25 degrees Celsius, in a tightly sealed container. Protect from moisture and light.

Formulations

  • Capsules (0.4 mg)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.