Product image of Miktan Combi (Tamsulosin Hydrochloride, Dutasteride) supplied by GNH India

Miktan Combi

Active Ingredient:
Tamsulosin Hydrochloride, Dutasteride
Origin:
EU

Miktan Combi (Tamsulosin Hydrochloride, Dutasteride)

Tamsulosin Hydrochloride/Dutasteride, the active ingredient in Miktan Combi, is an Alpha-1 adrenergic blocker and 5-alpha-reductase inhibitor presented as a tablet for oral use. It is indicated for the treatment of benign prostatic hyperplasia in adult male patients. The combination therapy targets both dynamic and static components of prostate enlargement, improving urinary flow and reducing symptom severity.

GNH India supplies Miktan Combi as a licensed, GDP-compliant international pharmaceutical supplier, ensuring quality and regulatory compliance while serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Lek Pharmaceuticals D.D. Ljubljana

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Indications & Clinical Uses

Miktan Combi is used to manage conditions related to benign prostatic hyperplasia and its associated urinary symptoms.

  • Benign prostatic hyperplasia (BPH): reduces prostate volume and alleviates urinary obstruction.
  • Lower urinary tract symptoms (LUTS) due to BPH: improves urinary flow rate and decreases frequency and urgency.
  • Prostate enlargement: helps shrink the gland and relieve bladder outlet obstruction.

How It Works

  • Tamsulosin selectively blocks α1‑adrenergic receptors in prostatic smooth muscle, causing relaxation and decreasing urethral resistance. Dutasteride irreversibly inhibits both type 1 and type 2 5‑alpha‑reductase enzymes, lowering conversion of testosterone to dihydrotestosterone, which leads to gradual reduction of prostate size. The combined action addresses both dynamic (muscle tone) and static (gland volume) components of BPH, resulting in improved urinary flow and symptom relief.

Side Effects

Miktan Combi may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Dizziness: sensation of lightheadedness, especially after standing.
  • Ejaculation disorders: reduced volume or retrograde ejaculation.
  • Decreased libido: lowered sexual desire.
  • Nasal congestion: stuffy or runny nose.
  • Diarrhea: loose stools.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Orthostatic hypotension: marked drop in blood pressure upon standing, leading to fainting.
  • Severe liver injury: jaundice, elevated liver enzymes, or hepatitis.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Priapism: prolonged painful erection.
  • Breast tenderness or enlargement.

Precautions & Warnings

Before prescribing Miktan Combi, clinicians should consider several precautionary measures.

  • Cardiovascular assessment: evaluate for history of hypotension or syncopal episodes.
  • Liver function monitoring: check baseline enzymes and repeat if clinically indicated.
  • Drug selection in elderly: start with lowest effective dose due to increased sensitivity.
  • Concomitant α‑blockers: avoid combining with other agents that may cause additive blood pressure lowering.
  • Surgery planning: discontinue the medication several weeks before prostate surgery to reduce bleeding risk.
  • Store at ambient temperature: keep tablets below 25 °C in the original container, protected from moisture and light.

Avoid Interactions

Miktan Combi can interact with other medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Potassium‑sparing diuretics: may enhance risk of severe hypotension.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase dutasteride plasma levels.
  • Alpha‑adrenergic agonists (e.g., midodrine): antagonize tamsulosin’s effect, causing unpredictable blood pressure changes.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may increase bleeding tendency.
  • Antihypertensives: additive blood pressure lowering; monitor BP.
  • CYP2C9 substrates (e.g., warfarin, phenytoin): possible altered metabolism of dutasteride.

Frequently Asked Questions

Miktan Combi is prescribed for the treatment of benign prostatic hyperplasia (BPH) in adult men. The combination of tamsulosin and dutasteride helps reduce prostate size and relaxes smooth muscle, improving urinary flow and relieving symptoms such as urgency, frequency, and weak stream.

Tamsulosin blocks α1‑adrenergic receptors in prostatic smooth muscle, causing relaxation and lowering urethral resistance. Dutasteride inhibits both type 1 and type 2 5‑alpha‑reductase enzymes, decreasing conversion of testosterone to dihydrotestosterone, which reduces prostate volume over time. Together they address both dynamic and static components of BPH.

The dosage of Miktan Combi is determined by the prescribing physician based on the patient’s clinical condition, age, and response to therapy. The prescriber will select the appropriate strength and frequency in accordance with approved labeling and individual patient needs.

Miktan Combi is classified as pregnancy category X, indicating it is contraindicated in pregnancy because it may cause fetal harm. It is also not recommended for breastfeeding women, as the active ingredients can be excreted in breast milk and may affect the infant.

To order Miktan Combi, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Miktan Combi combines an α1‑blocker and a 5‑alpha‑reductase inhibitor, offering both rapid symptom relief and long‑term reduction of prostate size. Single‑agent α‑blockers provide quicker relief but do not shrink the gland, while 5‑alpha‑reductase inhibitors alone act more slowly. The combination can be more effective for men with larger prostates.

Store Miktan Combi tablets at ambient temperature, below 25 °C, in the original packaging. Keep the container tightly closed, protect from moisture and light, and keep out of reach of children. Do not store in a refrigerator or freezer.

Miktan Combi is taken orally, usually once daily, with or without food as directed by the prescriber. Swallow the tablet whole with a glass of water and follow any specific timing instructions provided by the healthcare professional.

Serious risks include orthostatic hypotension leading to fainting, severe liver injury, allergic reactions such as anaphylaxis, and priapism. Patients should seek immediate medical attention if they experience sudden dizziness, jaundice, rash with swelling, or a prolonged painful erection.

Miktan Combi should not be used by women, especially during pregnancy or breastfeeding, and is contraindicated in patients with known hypersensitivity to tamsulosin, dutasteride, or any excipients. Caution is advised in individuals with severe liver impairment, low blood pressure, or those undergoing prostate surgery.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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