Dyspas-R

Dicyclomine (10mg) + Ranitidine (150mg)
Price: Discontinued/Not available in legitimate market
Mfr: Dr. Reddy's Laboratories Ltd. | Form: Tablet

📋 Clinical Overview

A fixed-dose combination (FDC) of an antispasmodic (Dicyclomine) and an H2-receptor antagonist (Ranitidine). Dicyclomine relieves smooth muscle spasm in the gastrointestinal tract, while Ranitidine reduces gastric acid secretion. This combination is primarily used for the symptomatic relief of acid-related disorders accompanied by visceral colic and spasms. Note: The FDC of Dicyclomine and Ranitidine was banned by the Indian government in 2018 under Gazette Notification G.S.R. 72(E) due to an unfavorable risk-benefit ratio. However, individual components are still available separately and the combination may be found in some contexts, though its prescription is strongly discouraged.

💊 Dosage & Administration

Adult: One tablet (Dicyclomine 10mg + Ranitidine 150mg) twice daily, preferably before meals or at bedtime. Maximum: Two tablets per day. Note: This is historical data; the combination is banned.

Note: Take orally with a glass of water. Can be taken before food or at bedtime. Do not crush or chew unless advised. Avoid concomitant antacids within 1-2 hours of Ranitidine dose as they may impair absorption.

⚠️ Contraindications

  • Hypersensitivity to Dicyclomine, Ranitidine, or other components
  • Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy)
  • Obstructive disease of the gastrointestinal tract (e.g., paralytic ileus, pyloric stenosis)
  • Unstable cardiovascular status in acute hemorrhage
  • Myasthenia gravis
  • Glaucoma (angle-closure)
  • Severe renal impairment (for Ranitidine)
  • Porphyria

🔬 Mechanism of Action

Dicyclomine exerts a direct relaxant effect on visceral smooth muscle and possesses antimuscarinic (anticholinergic) activity, relieving colic and spasms. Ranitidine competitively inhibits histamine at H2 receptors of gastric parietal cells, leading to a marked reduction in basal and stimulated gastric acid secretion, volume, and hydrogen ion concentration.

🤕 Side Effects

  • Dry mouth
  • Constipation
  • Blurred vision
  • Dizziness
  • Drowsiness
  • Headache
  • Nausea
  • Diarrhea (paradoxical)

🤰 Special Populations

Pregnancy: Category B (US FDA) for both. Use only if clearly needed. Dicyclomine may cause neonatal intestinal atony. Ranitidine crosses the placenta. Safer alternatives exist.

Driving: May impair mental and/or physical abilities. Drowsiness, dizziness, and blurred vision are common. Do not drive or operate machinery until effect is known.

🔄 Drug Interactions

Antacids (Aluminum/Magnesium hydroxide)Decreased absorption of RanitidineModerate
Ketoconazole, ItraconazoleDecreased absorption of azole antifungals due to increased gastric pHMajor
DigoxinIncreased bioavailability of Digoxin (theoretical)Moderate
WarfarinPotential increased anticoagulant effect (rare, disputed)Moderate
Metoprolol, PropranololIncreased plasma levels of beta-blockers due to reduced hepatic blood flow (Ranitidine)Moderate
Midazolam, TriazolamIncreased sedation and prolonged effect (CYP3A4 inhibition by Ranitidine is weak)Moderate
Other Anticholinergics (e.g., Amitriptyline, Atropine)Additive anticholinergic side effectsMajor
AlcoholEnhanced sedative effect with DicyclomineModerate
MetforminIncreased Metformin exposure (reduced renal clearance by Ranitidine)Moderate
PhenytoinIncreased Phenytoin levels (Ranitidine inhibits metabolism)Major

🔁 Alternatives to Dyspas-R

Same composition (Dicyclomine (10mg) + Ranitidine (150mg)), different brands:

Drotin-R Spasmonil-R Colimex-R Rantif-D