Asiclin 300 Capsule

Asiclin 300 Capsule is used for: Serious respiratory tract infections, empyema, anaerobic pneumonitis, lung abscess, serious skin and soft tissue infections, bone and joint Infections, septicemia, intra-abdominal infections, peritonitis, intra-abdominal abscess, gynecological Infections, endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infection, dental infections

Adult: Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Oral Serious Infections: 150 mg - 300 mg every 6 hours. More severe infections: 300 mg - 450 mg every 6 hours. Max: 1.8 g/day. Prophylaxis of endocarditis 600 mg 1 hr before dental procedure. IV/IM Injections Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridioides species other than Clostridium perfringens): 600–1200 mg/day in 2, 3 or 4 equal doses by IV/IM. More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200–2700 mg/day in 2, 3 or 4 equal doses by IV/IM. Surgical Prophylaxis 900 mg PO/IV 1 hr prior to procedure; may redose q6hr if necessary Single intramuscular injections of > 600 mg not recommended Alternatively, drug may be administered in the form of a single rapid infusion of first dose followed by continuous IV infusion as follows To maintain serum levels >4mcg/mL, administer a rapid infusion at 10 mg/min for 30 min followed by maintenance infusion of 0.75 mg/min To maintain serum levels >5 mcg/mL, administer a rapid infusion at 15 mg/min for 30 min followed by maintenance infusion of 1 mg/min To maintain serum levels >6 mcg/mL, administer a rapid infusion at 20 mg/min for 30 min followed by maintenance infusion of 1.25 mg/min

Child Oral Powder for oral solution: Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses. Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses. More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses. In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. IV/IM Injections Child 1 Month of Age to 16 Years: 20 to 40 mg/kg/day in 3 or 4 equal doses by IV/IM. Alternative Pediatric Patients Dosing: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections. Neonates (Less than 1 Month of Age): 15 to 20 mg/kg/day in 3 to 4 equal doses by IV/IM. The lower effective dosage may be adequate for small prematures. IM: No more than 600 mg per injection

Cap: May be taken with or without food. Swallow whole w/ a full glass of water & in an upright position. Granules: Should be taken with food. IV Preparation Dilute 300 and 600 mg in 50 mL of D5W Dilute 900 mg in 50-100 mL of D5W Dilute 1200 mg in 100 mL of D5W IV Administration Intermittent IV infusion Infuse over 10-60 min at a rate not exceeding 30 mg/min 300 mg doses infuse over 10 min 600 mg doses infuse over 20 min 900 mg doses infuse over 30 min 1200 mg doses infuse over 60 min; no more than 1200 mg of drug should be given by IV infusion in 1 hr Continuous IV infusion May give continuous IV infusion instead of intermittent after first dose has been given by rapid IV infusion

Hypersensitivity to clindamycin, lincomycin, or formulation components

Clostridium difficile-associated diarrhea (CDAD) has been reported and may range in severity from mild diarrhea to fatal colitis C difficile produces toxins A and B, which contribute to CDAD; hypertoxin-producing C difficile strains increase morbidity and mortality (more likely to be refractory to antimicrobial therapy and may require colectomy) If CDAD suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued Administration Images Patient Handout Formulary Dosing & Uses Adult Pediatric Dosage Forms & Strengths capsule 75mg 150mg 300mg injectable solution 150mg/mL oral solution 75mg/5mL intravenous ready-to-use solution 300 mg/50mL (5% dextrose) 600 mg/50mL (5% dextrose) 900 mg/50mL (5% dextrose) Infections Aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens) 600–1200 mg/day IV/IM divided BID/QID More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200–2700 mg/day IV/IM divided BID/QID For more serious infections, these doses may have to be increased; in life-threatening situations due to either aerobes or anaerobes these doses may be increased; doses of as much as 4800 mg qDay given IV to adults Single intramuscular injections of > 600 mg not recommended Alternatively, drug may be administered in the form of a single rapid infusion of first dose followed by continuous IV infusion as follows To maintain serum levels >4mcg/mL, administer a rapid infusion at 10 mg/min for 30 min followed by maintenance infusion of 0.75 mg/min To maintain serum levels >5 mcg/mL, administer a rapid infusion at 15 mg/min for 30 min followed by maintenance infusion of 1 mg/min To maintain serum levels >6 mcg/mL, administer a rapid infusion at 20 mg/min for 30 min followed by maintenance infusion of 1.25 mg/min Serious Infections Caused by Anaerobic Bacteria 150-450 mg PO q6-8hr; not to exceed 1.8 g/day, OR 1.2-2.7 g/day IV/IM divided q6-12hr; not to exceed 4.8 g/day Amnionitis 450-900 mg IV q8hr Inhalational & Gastrointestinal Anthrax (Off-label) 900 mg IV q8hr with ciprofloxacin 400 mg PO q12hr or doxycycline 150-300 mg PO q12hr Bacterial Vaginosis 300 mg PO q12hr for 7 days Surgical Prophylaxis 900 mg PO/IV 1 hr prior to procedure; may redose q6hr if necessary Bite Wounds (Human or Animal) 300 mg PO q6hr Gangrenous Pyomyositis 900 mg IV q8hr with penicillin G Group B Streptococcus Neonatal prophylaxis 900 mg IV q8hr until delivery Orofacial/Parapharyngeal Space Infections 150-450 mg PO q6hr for at least 7 days; not to exceed 1.8 g/day, OR 600-900 mg IV q8hr Pelvic Inflammatory Disease 900 mg IV q8hr with gentamicin 2 mg/kg; THEN 1.5 mg/kg q8hr; continue after discharge with doxycycline 100 mg PO q12hr to complete 14 days of therapy Toxic Shock Syndrome 900 mg IV q8hr plus oxacillin or nafcillin (2 g IV q4hr) or vancomycin (30 mg/kg/day IV divided q12hr Endocarditis Prophylaxis (Off-label) 600 mg PO/IV/IM 30-60 min before procedure Avoid IM injections in patients receiving anticoagulant therapy; administer PO in these circumstances; in general, administer IV only if patient does not tolerate or is unable to absorp oral medications Dosing considerations Recent AHA guidelines recommend only for high-risk patients undergoing invasive procedures CNS Toxoplasmosis, With Pyrimethamine or Leucovorin (Off-label) 600 mg IV or PO q6hr for at least 6 weeks Gardnerella Vaginalis (Off-label) PO: 300 mg PO q12hr for 7 days Pneumocystis (Carinii) Jiroveci (Off-label) 30 mg/kg/day divided q6-8hr 300-450 mg PO q6-8hr with primaquine for 21 days 600-900 mg IV q6-8hr with primaquine for 21 days Sarcoidosis (Orphan) Orphan indication sponsor Autoimmunity Research Foundation; 3423 Hill Canyon Avenue; Thousand Oaks, CA 91360 Administration PO: May take with food Interactions Interaction Checker Enter a drug name to check for any interactions. Type a drug, OTC, or herbal name and clindamycin All InteractionsSort By: Severity Contraindicated (0) Serious (11) atracurium BCG vaccine live cholera vaccine cisatracurium microbiota oral pancuronium rapacuronium rocuronium succinylcholine typhoid vaccine live vecuronium Monitor Closely (15) bazedoxifene/conjugated estrogens conjugated estrogens dienogest/estradiol valerate digoxin estradiol estrogens conjugated synthetic estropipate ethinylestradiol letermovir levonorgestrel oral/ethinylestradiol/ferrous bisglycinate mestranol mipomersen nitazoxanide ospemifene sodium picosulfate/magnesium oxide/anhydrous citric acid Minor (11) balsalazide biotin erythromycin base erythromycin ethylsuccinate erythromycin lactobionate erythromycin stearate food pantothenic acid pyridoxine pyridoxine (Antidote) thiamine Adverse Effects Frequency Not Defined Abdominal pain Agranulocytosis Eosinophilia (transient) Diarrhea Fungal overgrowth Pseudomembranous colitis Hypersensitivity Stevens-Johnson syndrome Rashes Urticaria Hypotension Nausea Vomiting Sterile abscess at IM site Thrombophlebitis Granulocytopenia Neutropenia Thrombocytopenia Polyarthritis Renal dysfunction Postmarketing reports Metallic taste Clostridium difficile colitis Acute generalized exanthematous pustulosis (AGEP) Erythema multiforme, some resembling Stevens-Johnson syndrome Acute kidney injury Drug reaction with eosinophilia and systemic symptoms (DRESS) Esophagitis and esophageal ulcer, particularly when taken in lying position or with small amount of water Warnings Black Box Warnings Clostridium difficile-associated diarrhea (CDAD) has been reported and may range in severity from mild diarrhea to fatal colitis C difficile produces toxins A and B, which contribute to CDAD; hypertoxin-producing C difficile strains increase morbidity and mortality (more likely to be refractory to antimicrobial therapy and may require colectomy) If CDAD suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued Contraindications Hypersensitivity to clindamycin, lincomycin, or formulation components Cautions Clindamycin is potentially nephrotoxic; acute kidney injury including acute renal failure reported; consider monitoring of renal function of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs; monitoring of renal function should be performed if therapy is prolonged Endocarditis prophylaxis: Use only for high-risk patients, per recent AHA guidelines Due to risk of esophagitis and esophageal ulcer, important to ensure adherence with administration guidance Risk of potentially fatal pseudomembranous colitis, fungal or bacterial superinfection on prolonged use; discontinue therapy if significant abdominal cramps, diarrhea, or passage of blood and mucus occurs May increase risk of drug-resistant bacteria if prescribed in the absence of proven or strongly suspected bacterial infection Use caution in hepatic impairment, monitor for hepatic abnormalities; periodic liver enzyme determinations should be made when treating patients with severe liver disease Not for use in meningitis due to inadequate penetration into CSF Severe skin reactions including toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, reported; permanently discontinue if reactions occur Parenteral product contains benzyl alcohol, which has been associated with gasping syndrome and death in newborns Use with caution in patients with history of gastrointestinal disease, especially colitis Not for administration as a bolus; infuse over 10-60 min Consider possibility of clostridium difficile in all patients who present with diarrhea following antibiotic use Serious anaphylactic reactions require immediate emergency treatment with epinephrine; oxygen and intravenous corticosteroids should also be administered as indicated Prescribe with caution in atopic individuals Indicated surgical procedures should be performed in conjunction with antibiotic therapy Clindamycin dosage modification may not be necessary in patients with renal disease Discontinue therapy permanently and institute appropriate therapy if anaphylactic or severe hypersensitivity reaction occurs When solution is administered to pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable MONITORING PARAMETERS Monitor liver and renal function if treatment exceeds 10 days. In children monitor liver and renal function in neonates and infants. Regular monitoring of blood counts, liver and kidney functions.

Pregnancy In clinical trials with pregnant women, systemic administration of clindamycin during the second and third trimesters, has not been associated with increased frequency of congenital abnormalities Clindamycin should be used during first trimester of pregnancy only if clearly needed; there are no adequate and well-controlled studies in pregnant women during 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 Clindamycin has been reported to appear in breast milk in range of 0.5 to 3.8 mcg/mL; clindamycin has potential to cause adverse effects on breastfed infant's gastrointestinal flora; if oral or intravenous clindamycin is required by nursing mother, it is not a reason to discontinue breastfeeding, but alternate drug may be preferred; monitor infant for possible adverse effects on gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in stool indicating possible antibiotic-associated colitis The developmental and health benefits of breastfeeding should be considered along with mother's clinical need for clindamycin and any potential adverse effects on breastfed child from clindamycin or from underlying maternal condition

May enhance the action of neuromuscular blocking agents (e.g. atracurium). May antagonise the effects of parasympathomimetics. May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. Increased coagulation tests (prothrombin time/INR) and/or bleeding w/ vit K antagonists (e.g. warfarin, acenocoumarol, fluindione). Neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Monitor for adverse reactions when strong CYP3A4 and/or CYP3A5 inhibitors are coadministered with clindamycin. In the presence of strong CYP3A4 and/or CYP3A5 inducers such as rifampicin, monitor for loss of effectiveness Contraindicated (0) Serious (11) atracurium BCG vaccine live cholera vaccine cisatracurium microbiota oral pancuronium rapacuronium rocuronium succinylcholine typhoid vaccine live vecuronium

Side effects of Clindamycin : Frequency Not Defined Abdominal pain Agranulocytosis Eosinophilia (transient) Diarrhea Fungal overgrowth Pseudomembranous colitis Hypersensitivity Stevens-Johnson syndrome Rashes Urticaria Hypotension Nausea Vomiting Sterile abscess at IM site Thrombophlebitis Granulocytopenia Neutropenia Thrombocytopenia Polyarthritis Renal dysfunction Potentially Fatal: Gasping syndrome (neonates); pseudomembranous colitis.

Clindamycin inhibits protein synthesis by reversibly binding to the 50S subunit of the ribosomal thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting to stunted cell growth.

Asiclin 300 300mg Capsule manufactured by Asiatic Laboratories Ltd.. Its generic name is Clindamycin. Asiclin 300 is availble in Bangladesh. Farmaco BD drug index information on Asiclin 300 Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.