What are the ingredients of the Drotin (drotaverine) tablet and is it safe to use during the first trimester of pregnancy?

Drotin (Drotaverine) Composition and First Trimester Safety

Direct Answer

Drotin tablets contain drotaverine hydrochloride (typically 40-80 mg per tablet) as the active ingredient, and while this antispasmodic has been studied extensively during active labor, there is insufficient safety data to recommend its use during the first trimester of pregnancy for non-labor indications.

Composition of Drotin

• Active ingredient: Drotaverine hydrochloride, typically available as 40 mg or 80 mg tablets 1, 2
• Drug class: Antispasmodic agent (smooth muscle relaxant) 1, 3

Safety Profile During First Trimester

Critical Timing Considerations

• The first trimester (weeks 1-12) is the period of highest risk for medication-induced teratogenicity due to organogenesis, and medications should be avoided during this time whenever possible 4
• The available research on drotaverine focuses exclusively on its use during active labor at term, not during early pregnancy 1, 2, 3, 5

Evidence Limitations

• No published studies specifically evaluate drotaverine safety during the first trimester for typical indications like abdominal cramping or spasms 1, 2, 3, 5
• All available trials administered drotaverine to women in active labor (cervical dilation ≥3-4 cm) at term gestation, not during early pregnancy 1, 2, 3, 5
• Studies demonstrate efficacy in shortening labor duration by accelerating cervical dilation, but provide no information about first trimester exposure risks 1, 3

Clinical Algorithm for First Trimester Spasmodic Pain

Step 1: Non-Pharmacological Approaches First

• Prioritize conservative management including rest, hydration, and heat application before considering any medication during the first trimester 4

Step 2: If Medication Required

• Avoid drotaverine during the first trimester due to lack of safety data in this critical developmental period 4
• Consider acetaminophen as the safest analgesic option if pain relief is necessary 6
• For gastrointestinal spasms, address underlying causes (constipation, dietary factors) with bulk-forming agents like psyllium if needed 4

Step 3: Specialist Consultation

• Refer to obstetrics for persistent symptoms requiring pharmacological intervention during the first trimester 6, 4

Important Caveats and Pitfalls

Common Misconceptions

• Do not assume that safety during labor translates to safety during the first trimester - these are entirely different clinical contexts with different risk profiles 1, 2, 3
• The fact that drotaverine shows no adverse effects when given during active labor at term does not provide reassurance about organogenesis-period exposure 1, 3, 5

Specific Concerns

• One study noted increased atonic postpartum hemorrhage with drotaverine use during labor, suggesting effects on smooth muscle that could theoretically impact early pregnancy 5
• The absence of evidence is not evidence of safety - lack of teratogenicity data means the drug should be avoided during the first trimester 4

Documentation Requirements

• If drotaverine was inadvertently taken during the first trimester, document the exposure and ensure appropriate prenatal monitoring, though no specific malformations have been reported 1, 2, 3