• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Dalacin® C Capsules 150 mg, 300 mg
    / Pfizer


    Active Ingredient
    Clindamycin HCl 150 mg, 300 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    16 X 150 mg

    partial basket chart 8468 4007

    Capsules

    100 X 150 mg

    partial basket chart 35574 4006

    Capsules

    16 X 300 mg

    not in the basket chart 75856 4177

    Related information


    Dosage

    Dosage in Adults
    Clindamycin hydrochloride capsules (oral administration): 600-1800 mg/day divided in 2, 3 or 4 equal doses. To avoid the possibility of esophageal irritation, clindamycin HCl capsules should be taken with a full glass of water.
    Dosage in Children (over 1 month of age)
    Clindamycin hydrochloride capsules (oral administration): To avoid the possibility of esophageal irritation, clindamycin HCl capsules should be taken with a full glass of water. Doses of 8-25 mg/kg/day in 3 or 4 equal doses.
    Dosage in Elderly
    Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration. Therefore, dosage adjustments are not necessary in the elderly with normal hepatic function and normal (age-adjusted) renal function.
    Dosage in Renal Impairment
    Clindamycin dosage modification is not necessary in patients with renal insufficiency.
    Dosage in Hepatic Impairment
    Clindamycin dosage modification is not necessary in patients with hepatic insufficiency.
    Dosage in Specific Indications
    (a) Treatment of Beta-Hemolytic Streptococcal Infections: Refer to the dosage recommendations above. Treatment should be continued for at least 10 days.
    (b) Treatment of Chlamydia trachomatis Cervicitis: Clindamycin hydrochloride capsules orally 450-600 mg 4 times daily for 10-14 days.
    (c) Treatment of Toxoplasmic Encephalitis in Patients with AIDS: Clindamycin hydrochloride orally 600-1200 mg every 6 hours for 2 weeks followed by 300-600 mg orally every 6 hours. The usual total duration of therapy is 8 to 10 weeks. The dose of pyrimethamine is 25 to 75 mg orally each day for 8 to 10 weeks. Folinic acid 10 to 20 mg/day should be given with higher doses of pyrimethamine.
    (d) Treatment of Pneumocystis carinii Pneumonia in Patients with AIDS: Clindamycin hydrochloride 300 to 450 mg orally every 6 hours for 21 days, and Primaquine 15 to 30 mg dose orally once daily for 21 days.
    (e) Treatment of Acute Streptococcal Tonsillitis/Pharyngitis: Clindamycin hydrochloride capsules 300 mg orally twice daily for 10 days.
    (f) Dosage for Additional Therapeutic Activity – Treatment of Malaria:
    Uncomplicated Malaria/P falciparum
    Adults: Quinine sulfate: 650 mg orally three times daily for 3 or 7 days plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days.
    Children: Quinine sulfate: 10 mg/kg orally three times daily for 3 or 7 days plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days.
    Severe malaria
    Adults: Quinidine gluconate: 10 mg/kg loading dose IV over 1-2 hrs, then 0.02 mg/kg/min continuous infusion for at least 24 hours (for alternative dosing regimen please refer to quinidine label). Once parasite density <1% and patient can take oral medication, complete treatment with oral quinine, dose as above, plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg clindamycin loading dose IV followed by 5 mg base/kg IV every 8 hours. Avoid rapid IV administration. Switch to oral clindamycin (oral dose as above) as soon as patient can take oral medication. Treatment course = 7 days.
    Children: Quinidine gluconate: Same mg/kg dosing and recommendations as for adults plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg clindamycin loading dose IV followed by 5 mg base/kg IV every 8 hours. Avoid rapid IV administration. Switch to oral clindamycin (oral dose as above) as soon as patient can take oralmedication. Treatment course = 7 days.
    (g) Prophylaxis of Endocarditis in Patients Sensitive to Penicillin
    Clindamycin hydrochloride capsules (oral administration). Adults: 600 mg 1 hour before procedure; children: 20 mg/kg 1 hour before procedure.


    Indications

    Treatment of infections caused by susceptible strains of anaerobic microorganisms.


    Contra-Indications

    Individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin or to any of the excipients.


    Special Precautions

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Dalacin C Capsules and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficle.
    Because Dalacin C Capsules therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
    C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
    If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
    Clostridium difficile Associated Diarrhea: Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Dalacin C Capsules, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.
    C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
    If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
    Anaphylactic and Severe Hypersensitivity Reactions: Anaphylactic shock and anaphylactic reactions have been reported.
    Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported.
    In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy.
    A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
    Usage in Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
    General: Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
    Dalacin C Capsules should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
    Dalacin C Capsules should be prescribed with caution in atopic individuals.
    Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
    The use of Dalacin C Capsules occasionally results in overgrowth of nonsusceptible organisms—particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
    Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease.
    Prescribing Dalacin C Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
    Laboratory Tests: During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.
    Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.
    Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human dose based on mg/m²) revealed no effects on fertility or mating ability.
    Important information regarding some of the ingredients of the medicine: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.


    Side Effects

    The following reactions have been reported with the use of clindamycin.
    Infections and Infestations: Clostridium difficile colitis
    Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). Esophageal ulcer has been reported. An unpleasant or metallic taste has been reported after oral administration.
    Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions.
    Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy.
    Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported. Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported.
    Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions.)
    Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
    Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed.
    Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.
    Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.
    Musculoskeletal: Cases of polyarthritis have been reported.
    Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.


    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.
    Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strongCYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
    In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.


    Pregnancy and Lactation

    Pregnancy: Teratogenic effects.
    In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.
    Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.
    Lactation: Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL. Clindamycin has the potential to cause adverse effects on the breast-fed infant’s gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.
    The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.
    See prescribing information for full details.


    Overdose

    Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed.
    Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.


    Important notes

    Storage: Store at room temperature, below 25°C.


    Manufacturer
    Fareva Amboise, Poce-sur-Cisse, France
    CLOSE