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  • DALACIN® 2% 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

    Before or after initiation of therapy with clindamycin, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.
    The use of clindamycin may result in the overgrowth of non-susceptible 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. Therefore, it is 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 contraindicated in this situation.
    Caution is advised in patients when prescribing clindamycin to individuals with inflammatory bowel disease such as Crohn’s disease or ulcerative colitis.
    As with all vaginal infections, sexual intercourse during treatment with clindamycin vaginal cream is not recommended. Latex condoms and diaphragms may be weakened if exposed to the suppository base used in clindamycin vaginal cream. The use of such products within 72 hours following treatment with clindamycin vaginal cream 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 with clindamycin vaginal cream is not recommended.
    Paediatric population
    Safety and efficacy in paediatric 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 human breast milk following the use of vaginally administered clindamycin vaginal cream. See prescribing information for full details.


    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.


    Important notes

    Excipient information
    Dalacin Cream contains propylene glycol, cetostearyl alcohol and benzyl alcohol.
    Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
    Benzyl alcohol may cause allergic reactions and mild local irritation.


    Manufacturer
    Pharmacia & Upjohn Company
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