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  • Dalacin Vaginal Cream
    / Pfizer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    40 gr

    not in the basket chart 8990 4066

    Dosage

    The recommended dose is one applicatorful of clindamycin vaginal cream 2% intravaginally, preferably at bedtime, for three or seven consecutive days.


    Indications

    Bacterial vaginosis, only if bacteria susceptible to clindamycin are present.


    Contra-Indications

    This product is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin or any of the components of this product.
    This product is also contraindicated in individuals with a history of antibiotic-associated colitis.


    Special Precautions

    The use of clindamycin vaginal products may result in the overgrowth of nonsusceptible organisms, particularly yeasts. Orally and parenterally administered clindamycin, similar to virtually all other antibiotics, has been associated with diarrhea, and in some cases, antibiotic-associated colitis. If significant or prolonged diarrhea occurs during the use of any clindamycin vaginal product, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with clindamycin vaginal cream. Clindamycin vaginal cream contains ingredients which may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of these products during treatment with clindamycin vaginal cream is not recommended. Pediatric Use Safety and efficacy in pediatric patients have not been established.


    Side Effects

    Clinicl Trials: The safety of clindamycin vaginal cream was evaluated in both nonpregnant patients and patients during their second and third trimesters of pregnancy. The following treatment-related adverse events were reported by less than 10% of patients.
    Ear and labyrinth disorders: Vertigo
    Endocrine disorders: Hyperthyroidism
    Gastrointestinal disorders: Generalized abdominal pain, localized abdominal pain, abdominal cramps, halitosis, abdominal distension, diarrhea, nausea, vomiting, constipation, dyspepsia, flatulence, gastrointestinal disorder.
    General disorders & administration site conditions: Inflammatory swelling, generalized pain
    Infections & infestations: Vaginal candidiasis , vulvovaginitis, trichomonal vaginitis, vaginitis/vaginal infection, urinary tract infection, candidiasis (body), fungal infection, bacterial infection, upper respiratory infection, candidiasis (skin).
    Immune system disorders: Allergic reaction.
    Investigations: Abnormal microbiological test.
    Musculoskeletal & connective tissue disorders: Back pain.
    Nervous system disorders: Headache, dizziness, taste perversion.
    Pregnancy, puerperium & perinatal conditions: Abnormal labor Reproductive system and breast disorders: Vulvovaginal disorder, menstrual disorder, vaginal pain, metrorrhagia, vaginal discharge, endometriosis, pelvic pain.
    Renal & urinary disorders: Dysuria, glycosuria, proteinuria.
    Respiratory, thoracic & mediastinal disorders: Epistaxis.
    Skin & subcutaneous tissue disorders: Pruritus (non-application site), rash, maculopapular rash, erythema, urticaria.


    Drug interactions

    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 and Lactation

    In clinical trials, the use of clindamycin vaginal products in pregnant women in their second and third trimesters, and systemically administered clindamycin during their second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. If clindamycin vaginal cream is used during the second or third trimester, the possibility of fetal harm appears remote. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clindamycin vaginal cream should be used during the first trimester of pregnancy only if clearly needed.
    Lactation: It is not known if clindamycin is excreted in breast milk following the use of vaginally administered clindamycin vaginal cream. Orally and parenterally administered clindamycin have been reported to appear in breast milk. Therefore, a full benefit-risk assessment should be done when considering the use of clindamycin vaginal cream in a nursing mother.


    Overdose

    Vaginally applied clindamycin phosphate vaginal cream 2%, could be absorbed in sufficient amounts to produce systemic effects.In the event of overdose, general symptomatic and supportive measures are indicated as required.


    Manufacturer
    Pharmacia Upjohn
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