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Symbiotrin Oral Gel


  • Product Code: Miconazole Nitrate 2%w/w
  • Availability: In Stock

  • 57.00Tk.



Indications

Miconazole Nitrate oral gel is indicated-

  • For the treatment of oral and gastrointestinal candidiasis.
  • For eradication of fungal colonization in the mouth and gastrointestinal tract.
  • For the treatment of super infections due to gram-positive bacteria.

 

Pharmacology

Pharmacodynamics: Miconazole has antifungal activity against common dermatophytes and yeasts, as well as certain gram-positive bacilli and cocci. Its activity is based on inhibiting the demethylation step in the biosynthesis of ergosterol. Ergosterol, the end product of the biosynthetic pathway and the main sterol in yeast and fungi. The interruption of ergosterol production destroys the cell membrane of the fungus and causes holes to appear in it. These holes allow the essential components of the fungal cell to leak and eventually cause the fungal cell to die.

Pharmacokinetics: The oral bioavailability of miconazole is low (25-30%), because miconazole is less absorbed from the intestine. Miconazole is absorbed systemically after administration as an oral gel. Absorbed miconazole is bound to plasma proteins (88.2%), mainly serum albumin and red blood cells (10.6%). Most of the absorbed portion of miconazole oral gel is metabolized; less than 1% of the administered dose is excreted in the urine in its original form. The terminal plasma half-life of most patients is 20-25 hours. The elimination half-life of miconazole is similar in any patient with renal failure.

 

Dosage & Administration

Oropharyngeal candidosis-

  • Infants 4-24 months: 1.25 ml (1⁄4 measuring spoon) of gel, applied 4 times day after meals.
  • Adult and children 2 years of age and older: 2.5 ml (1⁄2 measuring spoon) of gel, applied 4 times a day after meals.

Gastrointestinal tract candidosis-

  • Infants (4 months of age or above): Children and adults who have difficulty swallowing tablets: 20 mg per kg body weight per day, in four divided doses. The daily dose should not exceed 250 mg (10 ml gel) four times daily.

Missed Dose: Apply the missed dose as soon as you remember. In case of next dosing time, omit the missed
dose and continue your usual course.

In case of localized lesions of the mouth, a small amount of gel may be applied 2-4 times a day directly to the affected area with a clean finger. For best results, Miconazole oral gel should be kept in contact with the affected area as long as possible. The treatment should be continued for at least a week after symptoms have disappeared. For oral candidosis, dental prosthesis should be removed at night and brushed with the gel

 

Interaction

  • Concurrent therapy with Terfenadine, Astemizole, and Cisapride should be avoided since Miconazole may impede their metabolism, causing these products to precipitate, according to in vitro investigations.
  • Miconazole may cause a delay in the metabolism of phenytoin and cyclosporine, which might lead to phenytoin and cyclosporine toxicity, respectively.

 

Contraindications

Miconazole should not be used in patients who have a history of hypersensitivity to the active component.

 

Side Effects

Occasionally nausea and vomiting, diarrhea with long term use and rarely allergic reactions.

 

Pregnancy & Lactation

There is no information regarding the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible or the potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.

 

Precautions & Warnings

If Miconazole and an anticoagulant are used together, the anticoagulant impact should be monitored and titrated. When using miconazole and phenytoin at the same time, blood levels should be checked. In babies and young children, care must be taken to avoid obstructing the throat with the gel.

 

Therapeutic Class

Aural Anti-fungal preparations

 

Storage Conditions

keep in a dry place away from light and heat. Keep out of the reach of children.

 

Pharmaceutical Name

NIPRO JMI Pharma Ltd.

Tags: Symbiotrin Oral Gel