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VALOSIN:

 
 
 
   
   
   
 
    
 
 
   Abridged Prescribing Information
     
     
 
  Composition
   
  Each 1 ml of VALOSIN Injection contains:
  Valethamate bromideNF XII. . .8 mg Sodium chloride. . .8 mg
  Water for Injection IP...... Q.s.
   
   
  Therapeutic Indications & Usage
   
 
VALOSIN is indicated for cervical dilatation in the first stage of labor, as well as in symptomatic relief of intestinal, ureteric and biliary colics.
   
   
  Contraindications
   
 
VALOSIN is contraindicated in presence of enlarged prostate, paralytic ileus, pyloric stenosis, ulcerative colitis, toxic megacolon, myasthenia gravis, closed angle glaucoma, hypertension, cardiovascular disease and hypersensitivity to its ingredients. It is also not to be used during pregnancy.
   
  Precautions & Warnings
   
 
VALOSIN must be advocated with caution in thyrotoxicosis, cardiac insufficiency, cardiac failure and cardiac surgery wherein the heart rate may further accelerate.
   
  Concomitant use of VALOSIN with antihistamines, butyrophenones, phenothiazines and tricyclic antidepressants is to be advocated with caution. The reduction in gastric motility with VALOSIN can affect the absorption of other drugs co-administered. Safety of VALOSIN in children is not known
   
   
  Adverse Reactions
   
 
The adverse reactions with valethamate (VALOSIN) include anticholinergic effects such as dryness of mouth, thirst, reduced bronchial secretions, dilatation of pupils with loss of accommodation, flushing and dryness of skin and palpitations. Rarely, there may be hypersensitivity reactions, and central nervous symptoms such as nervousness and giddiness.
   
   
  Drug Interactions:
   
 
The effects of VALOSIN are enhanced when given along with other drugs with antimuscarinic properties such as antihistamines, Butyrophenones, phenothiazines and tricyclic antidepressants is to be advocated with caution. The reduction in gastric motility with VALOSIN can affect the absorption of other drugs co-administered.
   
   
  Recommended Dosage & Administration
   
 
ADULTS: 4-8 mg (½-1 ml) VALOSIN deep intramuscular (IM) or slow IV.
   
   
  Presentations
   
  VALOSIN Injections: 1 ml ampoules.
   
 
 
 
   
 
         
 
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