Silotime 4

SILOTIME 4

SILOTIME 4 is a medication manufactured by Intas Pharmaceuticals Ltd. used primarily for the management of benign prostatic hyperplasia (BPH).

• Name:

  • Brand Name: SILOTIME 4 (also seen as SILOTIME 4MG CAP or SILOTIME 4 Tablet)
  • Common Name (Active Ingredient): Silodosin

• Composition:

  • Each unit of SILOTIME 4 contains 4 mg of Silodosin. Silodosin belongs to a class of drugs known as alpha-1 blockers.

• Uses: SILOTIME 4 is prescribed to treat the symptoms of an enlarged prostate gland (benign prostatic hyperplasia - BPH) in men. It works by relaxing the muscles of the bladder and prostate gland, which helps to alleviate urinary symptoms such as:

  • Difficulty initiating urination.
  • Weak urine flow.
  • Frequent urination.
  • Urgent need to urinate.
  • Increased nighttime urination frequency.
  • Sensation of incomplete bladder emptying. It helps to improve overall urinary flow and output.

• Dosage and Administration:

  • Typically, SILOTIME 4 should be taken orally once daily, with food, or as advised by a doctor.
  • Capsules or tablets should be swallowed whole with water; they should not be crushed, chewed, or broken.
  • The dose and duration of treatment are determined by the physician based on the severity of the condition and individual response.
  • It's important not to discontinue the medication without consulting a doctor. For patients with moderate kidney impairment, a dose adjustment may be necessary.

• Side Effects: Common side effects may include:

  • Dizziness
  • Diarrhoea
  • Stuffy nose (nasal congestion, nasopharyngitis)
  • Orthostatic hypotension (sudden lowering in blood pressure upon standing, leading to dizziness)
  • Headache
  • Retrograde ejaculation (orgasm with reduced or no semen)
  • Increased prostate-related protein Most common side effects are usually temporary and resolve over time, but persistent or severe symptoms should be reported to a doctor.

• Precautions:

  • Allergies: Do not take if allergic to Silodosin or any components of the medicine.
  • Cardiovascular: Caution is advised if you have low blood pressure, as SILOTIME 4 can cause further lowering of blood pressure and dizziness.
  • Liver/Kidney Impairment: Inform your doctor if you have liver or kidney disease. Severe liver or kidney impairment may require dose adjustments or contraindicate use.
  • Eye Surgery: Inform your eye doctor if you are scheduled for cataract or glaucoma surgery, as SILOTIME 4 can cause Intraoperative Floppy Iris Syndrome (IFIS).
  • Alcohol: Avoid or limit alcohol consumption as it can increase dizziness.
  • Driving/Operating Machinery: May cause dizziness or weakness; exercise caution when driving or operating machinery.
  • Drug Interactions: Inform your doctor about all other medications, including herbal supplements, as some drugs (e.g., other alpha-blockers, strong CYP3A4 inhibitors like ketoconazole, or PDE-5 inhibitors like sildenafil) can interact, potentially leading to increased side effects or excessively low blood pressure.
  • Gender/Age: Intended for men only; not for use in women, especially pregnant or breastfeeding women, or children.

• Storage:

  • Store in a cool and dry place, away from direct sunlight.
  • Keep out of sight and reach of children.
  • Maintain storage temperatures between 10ºC to 25ºC or below 30ºC.

Here are frequently asked questions about SILOTIME 4 by INTAS PHARMACEUTICALS LTD, providing concise and accurate answers:

What is SILOTIME 4 used for?

SILOTIME 4 is primarily used to treat the symptoms of an enlarged prostate gland, a medical condition known as Benign Prostatic Hyperplasia (BPH), in adult men. It helps alleviate urinary difficulties such as trouble initiating urination, weak urine flow, frequent urination (especially at night), the persistent feeling of incomplete bladder emptying, and urgent urges to urinate.

How does SILOTIME 4 work?

SILOTIME 4 contains Silodosin as its active ingredient, which belongs to a class of drugs called alpha-blockers. It works by selectively blocking alpha-1A adrenergic receptors located in the prostate gland, bladder neck, and urethra. This action relaxes the smooth muscles in these areas, improving urine flow and relieving the symptoms associated with BPH.

What is the usual dosage for SILOTIME 4?

The recommended daily dose of SILOTIME 4 is usually one 0.4 mg capsule, taken once daily. It should be taken with a meal to aid absorption and reduce potential stomach upset. Your doctor will determine the exact dosage and duration of treatment based on your condition and response.

What are the possible side effects of SILOTIME 4?

Common side effects can include dizziness, headache, diarrhea, nasal congestion (stuffy nose), and retrograde ejaculation (orgasm with less or no semen). Some individuals may also experience orthostatic hypotension, a sudden drop in blood pressure when changing posture (e.g., standing up), which can lead to dizziness or fainting. If these side effects persist or worsen, consult your doctor.

Is SILOTIME 4 safe during pregnancy or breastfeeding?

No, SILOTIME 4 is not intended for use in women. It is specifically contraindicated for pregnant and breastfeeding women, as its safety and efficacy have not been established in these populations.

Can SILOTIME 4 be taken with other medications?

SILOTIME 4 can interact with other medications. Inform your doctor about all medicines, supplements, or herbal products you are currently taking, especially strong CYP3A4 inhibitors (like ketoconazole, itraconazole, clarithromycin, ritonavir), strong P-glycoprotein inhibitors (like cyclosporine), and other alpha-blockers, as these can increase silodosin levels or cause excessive blood pressure lowering. Taking it with medications for erectile dysfunction, such as sildenafil, can also lead to a significant drop in blood pressure.

What precautions should be taken while using SILOTIME 4?

Avoid consuming alcohol while taking SILOTIME 4, as it can increase dizziness and the risk of low blood pressure. Due to the potential for dizziness or fainting, avoid driving or operating heavy machinery until you know how the medicine affects you. Inform your doctor if you have severe kidney or liver disease, low blood pressure, or are planning to undergo cataract or glaucoma eye surgery, as special precautions or dose adjustments may be needed.

What happens if a dose of SILOTIME 4 is missed?

If you miss a dose of SILOTIME 4, 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 SILOTIME 4 be stored?

SILOTIME 4 should be stored in a cool and dry place, ideally below 30°C, and protected from light and moisture. Keep the medicine in its original packaging and out of the reach of children and pets. Always check the expiration date and use the medicine before it expires.