Dalacin Vaginal Ovules

/ Pfizer

The recommended dose is one clindamycin vaginal ovule intravaginally, preferably at bedtime, for three consecutive days.

3-day treatment of bacterial vaginosis in non-pregnant women.

Hypersensitivity to clindamycin or lincomycin. History of regional enteritis, ulcerative colitis, history of “antibiotic-associated” colitis.

Before or after initiation of therapy , other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.
The use of this antibiotic may result in the overgrowth of nonsusceptible organisms, particularly yeasts.
Onset of symptoms suggestive of pseudomembranous colitis may occur during or after antimicrobial treatment. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. It is therefore, important that this is considered in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Moderate cases may improve following withdrawal of the drug.
Clindamycin treatment must be stopped if pseudomembranous diarrhoea occurs. An adequate antibacterial therapy should be prescribed. Drugs inhibiting peristalsis are contra-indicated in this situation.
Caution is advised in patients when prescribing these Ovules to individuals with Inflammatory Bowel Disease such as Crohn’s Disease or Ulcerative Colitis.
As with all vaginal infections, sexual intercourse during treatment with this Ovule is not recommended. Latex condoms and diaphragms may be weakened if exposed to the ovule base used in drug. The use of such products within 72 hours following treatment with these Ovules is not recommended as such use could be associated with diminished contraceptive efficacy or protection against sexually transmitted disease.
The use of other vaginal products (such as tampons and douches) during the treatment  is not recommended.
Safety and efficacy studies have not been performed with this Vaginal Ovule in the following populations: pregnant women, lactating women, patients with impaired hepatic function, immunodeficient or colitis.
Clindamycin treatment must be stopped if pseudomembranous diarrhea occurs. An adequate antibacterial therapy should be prescribed. Drugs inhibiting peristalsis are contra-indicated in this situation.
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Clinical Trials
The safety of clindamycin vaginal ovules was evaluated in non-pregnant patients. The following treatment-related adverse events were reported by less than 10% of patients:
Gastrointestinal disorders: Abdominal cramps, localized abdominal pain, diarrhea, nausea, vomiting.
General disorders and administration site conditions: Fever, generalized pain, localized edema, applicationsite pain, pruritus (topical application site).
Infections and infestations: Vaginal candidiasis, pyelonephritis, vaginitis/vaginal infection, fungal infection, candidiasis (body) vulvovaginal pain.
Musculoskeletal and connective tissue disorders: Flank pain.
Nervous system disorders: Headache.
Renal and urinary disorders: Dysuria.
Reproductive system and breast disorders: Vulvovaginal disorder, vaginal pain, menstrual disorder, vaginal discharge.
Skin and subcutaneous tissue disorders: Pruritus (non-application site), rash.

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.

Pregnancy: This drug is not recommended during the first trimester, it may be used to treat pregnant women if clearly necessary during the second and third trimester of pregnancy. Digital application of the vaginal ovule is recommended during pregnancy.
Lactation :
It is unknown whether clindamycin is excreted in human breast milk following vaginal administration, but it is used in much lower doses than systemic clindamycin, and approximately 30% (range: 6% to 70%) is systemically absorbed. Following systemic administration, clindamycin has been reported to appear in human breast milk in ranges from < 0.5 to 3.8 μg/mL.
If clindamycin is administered systemically to a breastfeeding mother, there is a risk of adverse reactions on the breastfed infant’s gastrointestinal flora such as diarrhoea or blood in the stool, or rash. Use of this drug in a breastfeeding woman can be considered if the expected benefit to the mother outweighs the risks for the child.

Vaginally applied clindamycin phosphate contained in DALACIN Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects In the event of overdose, general symptomatic and supportive measures are indicated as required.