Dalavag

 

Category:

Anti-infective(vaginal).

 

  Indications:

Vaginosis, bacterial (treatment).

 

Mechanism of action/Effect:

Clindamycin phosphate is hydrolyzed in vivo to clindamycin, which inhibits protein synthesis in susceptible bacteria by binding to the 50 s sub until of bacterial ribosomes and prevents peptide bond formation.

 

Pharmacokinetics:

Approximately 2 to 8 % of the administered does (100 mg) is absorbed systemically.

 

Side Effects:

Those indicating need for medical attention:

Incidence less frequent Hypersensitivity (itching, burning, skin rash, redness, swelling, or other sign of irritation not present before therapy)

Incidence rate:

Skin reaction, local (burning at site of application) those indicating need for medical attention only if the continue or are bothersome:

Incidence less frequent or rate:

Rash or irritation of sexual partner

 

Contraindications:

This medication should not be used when the following medical problem exists:

Antibiotic-associated colitis, history of, or regional enteritis, ulcerative colitis, or a history of  "antibiotic-associated" colitis

 

Drug interaction:

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.

Therefore, it should be used with caution in patients receiving such agents.

 

Usual adult and adolescent does:

Anti-infective (vaginal):

Nonpregnant females:

Intravaginal,100 mg (one applicatorful) into vagina once a day, preferably at bedtime, for three or seven consecutive days.

Pregnant females (second or third timesters):

Intravaginal, 100 mg (one applicatorful) into vagina once a day, preferably at bedtime, for seven consecutive days.

Single-does prefilled applicator:

Intravaginal, recommended does of 100 mg (a single applicatorful) once at anytime of the day.

 

Usual pediatric does:

Safety and efficacy have not been established.

 

Pregnancy:

FDA pregnancy Category B.

 

Breast-feeding:

It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

 

Reference: USP DI®   27th Edition-2007.