Hyoscine N Butylbromide (Spasmoson) 20mg/ml Solution for Injection (IM/IV) 10 Ampoules x 1 ml

20mg/ml Solution for Injection (IM/IV)

Certainly! Here is the detailed information for Hyoscine N-Butylbromide (Spasmoson) 20mg/ml Solution for Injection (IM/IV) 10 Ampoules x 1 ml:

Product Description:

Spasmoson 20mg/ml Solution for Injection contains Hyoscine N-Butylbromide, a muscarinic antagonist (anticholinergic agent) that is used primarily to relieve smooth muscle spasms. It is available in 10 ampoules of 1 ml each, each containing 20mg of Hyoscine N-Butylbromide per ml.

Hyoscine N-Butylbromide works by blocking the action of acetylcholine, a neurotransmitter that causes smooth muscle contraction. By inhibiting this action, it helps to relax smooth muscles in the gastrointestinal tract, urinary tract, and other areas, providing relief from spasms and associated discomfort.

Spasmoson is typically administered via intramuscular (IM) or intravenous (IV) injection, depending on the clinical situation.

Indications:

Spasmoson (Hyoscine N-Butylbromide) is used for the following indications:

1. Gastrointestinal Spasms: To treat and relieve spasms in the stomach and intestines, including those caused by conditions like irritable bowel syndrome (IBS), colic, and gastritis.

2. Urinary Tract Spasms: To manage spasms in the bladder and urethra, particularly in conditions like urinary retention and dysuria (painful urination).

3. Biliary Spasms: To relieve gallbladder or bile duct spasms, which can be associated with conditions like gallstones or cholecystitis.

4. Post-Operative Use: To relieve abdominal cramping or spasms following surgeries, especially those involving the gastrointestinal or urinary tracts.

5. Invasive Diagnostic Procedures: To reduce discomfort or spasms during certain diagnostic procedures, such as endoscopy or laparoscopy, where smooth muscle relaxation is required.

Dosage:

The dosage of Spasmoson will depend on the specific condition being treated and the patient's overall health. The typical dosage for adults is as follows:

For Adults:

• Intramuscular (IM) or Intravenous (IV) Injection:

  • The usual dose is 20mg (1ml), which can be administered once or twice daily.

  • IV administration should be done slowly to avoid rapid onset of effects.

  • The dose can be adjusted depending on the severity of symptoms and the patient's response to treatment.

For Children:

• Not typically recommended for children under 12 years, unless specifically prescribed by a doctor. If used, a lower dose is required based on body weight, with pediatric dosages being carefully determined by a healthcare professional.

Note: Always follow the specific recommendations of your healthcare provider regarding the appropriate dose and frequency for your individual needs.

Side Effects:

Hyoscine N-Butylbromide (Spasmoson) is generally well-tolerated, but like all medications, it can cause side effects, especially if used incorrectly or in excessive doses.

Common Side Effects:

• Dry mouth: A common effect of anticholinergic medications.

• Blurred vision: Due to pupil dilation, leading to difficulty focusing on close objects.

• Dizziness: Some individuals may feel lightheaded or dizzy, especially with rapid intravenous administration.

• Constipation: As smooth muscles in the digestive tract are relaxed, normal bowel movements may be affected.

• Urinary retention: Difficulty urinating due to relaxation of the urinary tract muscles.

Serious Side Effects (Less Common):

• Tachycardia (rapid heart rate): Due to inhibition of parasympathetic nerve activity.

• Severe allergic reactions: Including symptoms such as rash, itching, swelling, or difficulty breathing (anaphylaxis).

• Confusion or agitation: Particularly in elderly patients or those with a history of cognitive impairments.

• Nausea or vomiting: Could be related to gastrointestinal effects.

Very Rare Side Effects:

• Paralytic ileus (intestinal obstruction due to a lack of movement in the intestines).

• Glaucoma: This can occur in patients who are predisposed to angle-closure glaucoma.

If any of the above side effects become severe or persistent, or if you experience signs of an allergic reaction (e.g., swelling of the face or throat, difficulty breathing), you should seek immediate medical attention.

Contraindications:

Spasmoson (Hyoscine N-Butylbromide) is contraindicated in certain conditions and should be used cautiously or avoided altogether in the following cases:

1. Hypersensitivity: Patients who have an allergy to Hyoscine N-Butylbromide or any other component of the formulation should not use this medication.

2. Glaucoma: Patients with narrow-angle glaucoma should avoid the use of Hyoscine N-Butylbromide, as it may worsen the condition by increasing intraocular pressure.

3. Myasthenia Gravis: This medication should be avoided in patients with myasthenia gravis, a condition that affects the neuromuscular junction and can be aggravated by anticholinergic agents.

4. Severe Gastrointestinal Obstruction: If there is a risk of bowel perforation or in cases of severe bowel obstruction, this drug should be avoided, as it can exacerbate the condition.

5. Severe Hepatic or Renal Impairment: Hyoscine N-Butylbromide should be used with caution or avoided in patients with significant liver or kidney dysfunction due to potential for altered drug metabolism or excretion.

6. Prostatic Hypertrophy: Men with enlarged prostate or urinary retention due to benign prostatic hyperplasia (BPH) should be cautious when using this drug as it can exacerbate urinary retention.

7. Pregnancy and Lactation: Hyoscine N-Butylbromide should only be used during pregnancy or breastfeeding if the potential benefits outweigh the risks. Always consult with a healthcare provider before use during these periods.

Precautions:

• Elderly Patients: Older adults may be more susceptible to anticholinergic side effects such as confusion, urinary retention, and dry mouth. They should be monitored closely.

• Renal and Hepatic Dysfunction: Patients with liver or kidney problems may need dose adjustments and close monitoring, as impaired liver or kidney function may slow the metabolism or clearance of the drug.

• Avoid Rapid IV Administration: If administering intravenously, the injection should be given slowly to minimize the risk of adverse effects such as dizziness or tachycardia.

• Caution in Hot Climates: Since Hyoscine N-Butylbromide can impair sweating, patients should be cautious when exposed to high temperatures, as the drug may increase the risk of heatstroke or overheating.

Summary:

Hyoscine N-Butylbromide (Spasmoson) is a muscle relaxant that is effective in treating smooth muscle spasms in various parts of the body, such as the gastrointestinal tract, urinary tract, and biliary system. It is typically administered via IM or IV injection, providing rapid relief for patients suffering from conditions like irritable bowel syndrome, urinary spasms, gastrointestinal cramping, and other spastic disorders.

As with any medication, it is important to follow dosing recommendations and to be aware of possible side effects and contraindications. Spasmoson should not be used in patients with certain medical conditions like glaucoma, myasthenia gravis, or severe gastrointestinal obstruction. Always consult a healthcare provider before use, especially in elderly patients, pregnant or breastfeeding women, or those with pre-existing health conditions.