Formulation in Pharmacy Practice - eMixt

BETHANECHOL
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Bethanechol chloride is very soluble in water (1.17g per mL).
Bethanechol chloride injection has a pH of 5.5 - 7.5.  Optimum pH for stability is 6.5 - 7.0.


Formula 1

Bethanechol 1mg per mL
Bethanechol choride tablets 25mg
Sterile Water for Irrigation to   100  mL
Filter to remove insoluble excipients (optional).
Expiry:  30 days
Stability:   30 days
Storage:  Refrigerate (4°C).  Protect from light.  If available, store in amber glass bottles.
Shake well before use
 

 
NOTES
  1. A solution prepared from bethanechol chloride powder was more stable than that prepared from tablets.
  2. The injection can be given orally.  Dilute the injection to the desired concentration with sterile water and maintain pH between 5.5 - 7.5.
  3. As this preparation is unpreserved parabens 0.1% could be added.
  4. The dose can be added to flavoured cordial prior to administration.

Alternative:
Bethanechol chloride 5mg/mL can be formulated by suspending crushed tablets in the following vehicles.2
  • a 1:1 mixture of Ora Sweet and Ora Plus
  • a 1:1 mixture of Ora Sweet SF and Ora Plus
  • or a 1:4 dilution of Cherry Syrup concentrate with simple syrup
All formulations were stored in amber glass containers.
The stability was 60 days at both 5°C and 25°C.2

REFERENCES
  1. Schlatter J.L., Saulnier J.L.  Bethanechol chloride oral solution:  Stability and use in infants.
    Ann Pharmacother 1997; 31 (Mar): 294-296. [PubMed]
  2. Allen L.V., Erickson M.A.  Stability of bethanechol chloride, pyrazinamide, quinidine sulfate, rifampin, and tetracycline hydrochloride in extemporaneously compounded oral liquids.
    Am J Health-Syst Pharm 1998; 55 (Sep 1): 1804-1809 [PubMed]

 
Formulation in Pharmacy Practice
Page Updated September 2011