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GYNOTRIM KIT:

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  1 tablet of: Fluconazole… 150 mg
1 tablet of: Azithromycin dihydrate Equivalent to azithromycin base…1000 mg
2 tablets each of Secnidazole…1000 mg
   
   
  Therapeutic Indications & Usage
   
  GYNOTRIM is indicated for treatment of mixed vaginal infections or as empirical cure of suspected mixed vaginal infections such as vulvovaginitis, bacterial vaginosis and trichomoniasis; it is also indicated in syndromic management of pelvic inflammatory disease.
   
   
  Contraindications
   
  GYNOTRIM is contraindicated in patients with known hypersensitivity to this product or any of its ingredients, or to nitroimidazoles or macrolides. Co-administration of terfenadine and cisapride with fluconazole (in GYNOTRIM) is contraindicated.
   
  GYNOTRIM is not advocated during pregnancy, lactation and in children.
   
   
  Precautions
   
  GYNOTRIM is to be advocated with due precaution in hepatic and renal disease, and potentially proarrhythmic conditions in view potential of fluconazole and azithromycin to induce liver and kidney dysfunction, and cardiac conduction abnormalities.
   
  GYNOTRIM should be advocated with care in diarrhea since azithromycin usage could be associated with pseudomembranous colitis.
   
   
  Warnings
   
  Those who develop rashes due to fluconazole (in GYNOTRIM) must be monitored closely. Fluconazole (in GYNOTRIM) needs to be advocated with due precaution along with oral hypoglycemics, coumarins, phenytoin, cyclosporine, rifampicin, theophylline, astemizole, rifabutin, tacrolimus and short-acting benzodiazepines.
   
  As azithromycin interacts with aluminium and magnesium-containing antacids, digoxin, ergot derivatives, triazolam and drugs metabolized by cytochrome P450 such as carbamazepine, cyclosporine, phenytoin, GYNOTRIM must be coadministered with care.
   
  Secnidazole also has potential to interact with coumarins and hence GYNOTRIM must be coadministered with care alongwith such anticoagulants.
   
  Alcohol beverages must be avoided whilst taking GYNOTRIM, and for three days thereafter since simultaneous intake of nitroimidazoles like secnidazole could result in abdominal cramps, flushing, nausea, vomiting, headaches and even psychotic reactions.
   
   
  Adverse Reactions
   
  Single dose of 150 mg fluconazole (in GYNOTRIM) can cause mild to moderate headache, nausea, abdominal pain, diarrhea, dyspepsia, dizziness and taste perversion. Other rare side effects due to fluconazole (in GYNOTRIM) include vomiting, seizures, cardiac conduction abnormalities, skin lesions, hematopoietic disturbances, electrolyte and lipid changes.
   
  Azithromycin (in GYNOTRIM) can cause gastrointestinal side effects such as nausea, vomiting, diarrhea and abdominal pain. Other adverse reactions due to azithromycin (in GYNOTRIM) include fatigue, asthenia, paresthesia, malaise, hypersensitivity and skin eruptions. Cholestatic jaundice, palpitations, chest pain and arrhythmias, genitourinary affections such as monilia, vaginitis, nephritis and acute renal failure, nervous system manifestations like dizziness, headache, vertigo, somnolence, hyperactivity, nervousness, agitation, syncope, aggressive reaction and anxiety, as well as hearing disturbances and taste perversion can occur with azithromycin (in GYNOTRIM). Azithromycin (in GYNOTRIM), like other antimicrobials, can cause pseudomembranous colitis.
   
  Secnidazole (in GYNOTRIM) can cause mild side effects of gastrointestinal disturbances, and dizziness.
   
  Rarely, angioedema and anaphylactic reactions can occur with GYNOTRIM ingredients.
   
   
  Drug Interactions
   
  Fluconazole (in GYNOTRIM) can interact with oral hypoglycemics, coumarins, phenytoin, cyclosporine, rifampicin, theophylline, astemizole, rifabutin, tacrolimus, terfenadine, cisapride and short-acting benzodiazepines.
   
  Azithromycin (in GYNOTRIM) absorption can be reduced by antacids having magnesium or aluminium. Elevation of serum levels of digoxin, ergot derivatives, Triazolam and drugs metabolized by liver cytochrome P450 can occur with azithromycin (in GYNOTRIM).
   
  Secnidazole (in GYNOTRIM) can potentiate the action of anticoagulants.
   
   
  Recommended Dosage & Administration
   
  ADULTS:
  1 GYNOTRIM Combikit as single oral dose, or as prescribed. Both the partners should preferably be treated simultaneously.
   
   
  Presentations
   
  GYNOTRIM Combikit: Blisters of 4s.
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
   
 
         
 
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