Spasmofen Ampoules – Antispasmodic & pain reliever

Spasmofen is Indicated for: acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem, e.g. gastro-duodenal endoscopy.

Dosage and Administration

For adults: 1-2 ampoules daily according to the condition, injected deep intramuscularly.

Composition

  • Each 2 ml ampoule contains Active Ingredients: 100 mg Ketoprofen, 20 mg Hyoscine butylbromide.
  • Inactive Ingredients: Arginine, Benzyl alcohol, Propylene glycol, Anhydrous citric acid, and Water for injections.

Pharmacology

Ketoprofen is a pharmacopoeial non-steroidal anti-inflammatory drug (NSAID). It is a strong inhibitor of prostaglandin synthetase and potent analgesic agent. Studies in vitro and in vivo show that ketoprofen possesses powerful anti-inflammatory, antipyretic, antibradykinin and lysosomal membrane stabilising properties.

Hyoscine butylbromide is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

Contraindications

  • Hypersensitivity to ketoprofen, hyoscine butylbromide or to any of the excipients.
  • Active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation.
  • Severe heart failure, hepatic failure and renal failure.
  • Spasmofen Ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.
  • Spasmofen Ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachychardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of gastrointestinal tract or paralytic ileus.

Pregnancy, Nursing Mothers & Pediatric Use

Do not administer injections preserved with benzyl alcohol to premature infants, neonates, children below 13 years, pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients (it may cause Gasping syndrome). Injections that are preservative free should be used in these populations.

Side Effects

  • Accommodation disorders, tachycardia, dizziness, flushing, dry mouth, dyshidrosis, urinary retention and injection site pain or burning sensation.
  •  Hyoscine butylbromide does not readily pass the blood-brain barrier. However, it cannot totally be ruled out that under certain circumstances psychiatric disorders (e.g. confusion) may also occur.

Precautions And Warnings

This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue.

Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Spasmofen Ampoules should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac Surgery where it may further accelerate the heart rate.

Because of the possibility that anticholinergics may reduce sweating, Spasmofen should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents.

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

NSAIDs are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDS cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or Intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.

Other Information

  • Trade Name: Spasmofen Ampoules.
  • Generic Name: Ketoprofen, Hyoscine butylbromide.

Pharmaceutical Form

Ampoules for intramuscular injection

Drug Interactions

Avoid the concomitant use of two or more NSAIDs (including aspirin) or the use of NSAIDs with anti-coagulants (as warfarin), cardiac glycosides, quinoline antibiotics or zidovudine.

NSAIDS decrease the elimination of lithium and methotrexate. The anticholinergic effect of drugs such as tricyclic antidepressants, antihistamines and anticholinergics may be intensified by hyoscine.

The tachycardiac effects of beta-adrenergic agents may be enhanced by hyoscine. Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

Package

A carton box containing 3 amber glass (type 1) ampoules, each of 2 ml plus an inner leaflet.

Storage

Store at a temperature not exceeding 30 °C.

The product contains benzyl alcohol. Not for use in neonates and infants.

نشرة حقن سبازموفين
نشرة حقن سبازموفين

Spasmofen Ampoules – Other Information Resources

SPASMOFEN AMPOULE – PATIENT INFORMATION LEAFLET

سبازموفين أمبول – النشرة الداخلية.

سبازموفين أمبولات للحقن العضلي – مضاد للتقلصات ومسكن للآلام

سبازموفين للحقن العضلي – مضاد للتقلص، خافض للحرارة ومسكن للألم