No-Spa Ampułki (Drotaverine Hydrochloride)

Drotaverine Hydrochloride is employed to manage smooth‑muscle spasm across several gastrointestinal and genitourinary disorders.

• Abdominal and gastrointestinal spasm: reduces painful contractions and facilitates normal motility.
• Biliary colic: relaxes the sphincter of Oddi and eases bile duct pain.
• Menstrual cramps: alleviates uterine muscle cramps during dysmenorrhea.
• Urological spasm: eases bladder neck and ureteral smooth‑muscle tension.

• Drotaverine Hydrochloride inhibits phosphodiesterase‑4, leading to accumulation of cyclic AMP within smooth‑muscle cells. Elevated cAMP reduces intracellular calcium availability, causing relaxation of smooth‑muscle fibers in the gastrointestinal, biliary, uterine and urinary tracts without significant anticholinergic activity.

Adverse reactions may occur following administration of No-Spa Ampułki.

Common Side Effects

• Dizziness: transient sensation of light‑headedness.
• Headache: mild to moderate intensity.
• Nausea: occasional upset stomach.
• Flushing: temporary reddening of skin.
• Hypotension: mild drop in blood pressure.
• Injection site pain: local discomfort at the puncture site.

Serious or Rare Side Effects

• Allergic reactions: rash, pruritus, or urticaria.
• Anaphylaxis: severe, potentially life‑threatening hypersensitivity.
• Severe hypotension: marked blood pressure fall requiring intervention.
• Cardiac arrhythmia: irregular heart rhythm.
• Hematologic abnormalities: rare blood‑cell disturbances.
• Hepatic dysfunction: uncommon liver enzyme elevation.

Prior to using No-Spa Ampułki, clinicians should consider several safety aspects.

• Cardiovascular assessment: evaluate blood pressure and heart status.
• Hepatic impairment: use with caution in patients with liver disease.
• Renal impairment: monitor renal function and adjust if necessary.
• Allergic history: avoid in individuals with known hypersensitivity to drotaverine.
• Concomitant hypotensive agents: watch for additive blood‑pressure lowering effects.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Drotaverine Hydrochloride may interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may increase drotaverine plasma levels.
• Co‑administration with other antispasmodics: risk of excessive smooth‑muscle relaxation.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic effect.
• Antihypertensive drugs: potential additive hypotensive effect.
• Diuretics: may enhance blood‑pressure lowering and electrolyte shifts.
• Antihistamines: possible increase in sedation or dizziness.
• NSAIDs: monitor for gastrointestinal irritation when combined.