Y.S.P. Industries


Y.S.P. Industries
Full Prescribing Info
Clindamycin (Cap: HCl; Inj: Phosphate)
Each ml contains Clindamycin (as Clindamycin Phosphate) 150 mg.
9.45 mg Benzyl Alcohol (as preservative).
Pharmacology: Pharmacokinetics: Serum level studies with 150 mg oral dose of clindamycin hydrochloride in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak serum level of 2.50 mcg/ml was reached in 45 minutes; serum levels averaged 1.51 mcg/ml at 3 hours and 0.70 mcg/ml at 6 hours. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose. Serum level studies following multiple doses of clindamycin hydrochloride for up to 14 days show no evidence of accumulation or altered metabolism of drug.
Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Concentrations of clindamycin in the serum increased linearly with increased dose. Serum levels exceed the MIC (Minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses.
Clindamycin is widely distributed in body fluids and tissues (including bones). The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; The remainder is excreted as bio-inactive metabolites. Doses of up to 2 grams of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. Pharmacokinetic studies in elderly volunteers (61-79 years) and younger adults (18-39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4-5.1h) in the elderly compared to 3.2 hours (range 2.1-4.2h) in younger adults. The extend of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function.
Microbiology: Clindamycin has been shown to have in vitro activity against isolates of the following organisms: Aerobic gram-positive cocci, including: Staphylococcus aureus; Staphylococcus epidermidis (penicillinase and nonpenicillinase producing strains); when tested by in vitro methods some staphylococcal strains originally resistant to erythromycin rapidly develop resistance to clindamycin; Streptoccoci (except Streptococcus faecalis); Pneumococci.
Anaerobic gram-negative bacilli, including: Bacteriodes species (including Bacteroides fragilis group and Bacteroides melaninogenicus group); Fusobacterium species.
Anaerobic gram-positive non-sporeforming bacilli, including: Propionibacterium, Eubacterium, Actinomyces species.
Anaerobic and microaerophilic gram-positive cocci, including: Peptococcus species; Peptostreptococcus species, Microaerophilic streptococci.
Clostridia: Clostridia are more resistant than most anaerobes to Clindamycin. Most Clostridium perfringens are susceptible, but other species, e.g., Clostridium sporogenes and Clostridium tertium are frequently resistant to clindamycin.
Susceptibility testing should be done.
Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.
Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria; susceptible strains of gram positive aerobic bacteria such as streptococci, staphylococci and pneumococci; and susceptible strains of Chlamydia trachomatis.
Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.
Lower respiratory infection including bronchitis, pneumonia, empyema and lung abscess.
Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses, and wound infections, specific skin and soft tissue infections caused by susceptible organisms like erysipelas and paranychia (panaritium).
Bone and joint infections including osteomyelitis and septic arthritis.
Gynecological infections including endometritis, cellulitis, vaginal cuff infection and tubo-ovarian abscess, salpingitis, and pelvic inflammatory disease when given in conjunction with an antibiotic of appropriate gram negative spectrum. In cases of cervicitis due to Chlamydia trachomatis, single drug therapy with clindamycin has been shown to be effective in eradicating the organism.
Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum.
Septicemia and endocarditis–the effectiveness of clindamycin in the treatment of selected cases of endocarditis has been documented when clindamycin is determined to be bactericidal to the infecting organism by in vitro testing of appropriate achievable serum concentrations.
Dental infections such as periodontal abscess and periodontitis.
Toxoplasmic encephalitis in patients with AIDS. In patients who are intolerant to conventional treatment, clindamycin in combination with pyrimethamine has been shown to be efficacious.
Pneumocystis jiroveci (previously classified as Pneumocystis carinii) pneumonia in patients with AIDS. In patients who are intolerant to, or do not respond adequately to conventional treatment, clindamycin may be used in combination with primaquine.
Clindamycin phosphate, when used concurrently with an aminoglycoside antibiotic such as gentamicin or tobramycin, has been shown to be effective in preventing peritonitis or intra-abdominal abscess after bowel perforation and bacterial contamination secondary to trauma.
In-vitro susceptibility to clindamycin has been shown for the following organisms: B. melaninogenicus, B. disiens, B. bivius, Peptostreptococcus spp., G.vaginalis, M.mulieris, M.curtisii and Mycoplasma hominis.
Dosage/Direction for Use
Dosage in Adult: The usual daily adult dosage of clindamycin phosphate for infections of the intraabdominal area, female pelvis and other complicated or serious infections is 2400-2700 mg given in 2, 3, or 4 equal doses. Less complicated infections due to more susceptible microorganisms may respond to lower doses such as 1200-1800 mg/day administered in 3 or 4 equal doses.
Doses of up to 4800 mg daily have been used successfully.
Single IM doses of greater than 600 mg are not recommended.
Dosage in Children (over 1 month of age): 20-40 mg/kg/day in 3 or 4 equal doses.
Dosage in Neonates (under 1 month of age): 15-20 mg/kg/day in 3 or 4 equal doses. The lower dosage may be adequate for small premature infants.
Dosage in Elderly: Pharmacokinetic studies with clindamycin have shown no clinical 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 Indication: Treatment of Beta-Hemolytic Streptococcal Infections: Treatment should be continued for at least 10 days.
Inpatient treatment of Pelvic Inflammatory Disease: Clindamycin Phosphate 900mg (IV) every 8 hours daily plus an antibiotic with an appropriate gram negative aerobic spectrum administered IV, e.g., gentamicin 2.0 mg/kg followed by 1.5 mg/kg every 8 hours daily in patients with normal renal function. Continue (IV) drugs for at least 4 days and at least 48 hours after patient improves. Then continue oral clindamycin hydrochloride treatment.
Treatment of Toxoplasmic Encephalitis in patients with AIDS: Clindamycin Phosphate IV or 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.
Treatment of Pneumocystis jiroveci (previously classified as Pneumocystis carinii) Pneumonia in patient with AIDS: Clindamycin phosphate IV 600 to 900 mg every 6 hours or 900 mg IV every 8 hours or 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.
Mode of Administration: IM or IV.
Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or lincomycin or to any component of the formulation.
As this preparation contains benzyl alcohol, its use should be avoided in children under two years of age. Not to be used in neonates.
Special Precautions
Clindamycin 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.
It should not be used in patients with nonbacterial infections, such as most upper respiratory tract infections.
Its use in newborns is contraindicated.
Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
If therapy is prolonged, liver and kidney function tests should be performed.
The use of clindamycin phosphate may result in overgrowth of non-susceptible organisms, particularly yeasts.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, 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.
Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10-60 minutes as directed.
Effects on ability to drive and use machines: The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.
Use In Pregnancy & Lactation
Use in pregnancy: Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Clindamycin should be used in pregnancy only if clearly needed.
Use in nursing mother: Clindamycin has been reported to appear in human breast milk in ranges from 0.7 to 3.8 mcg/ml.
Adverse Reactions
Blood and lymphatic system disorders: Transient neutropenia (leucopenia) 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 disorders: A few cases of anaphylactoid reactions have been reported.
Nervous system disorders: Dysgeusia.
Cardiac disorders: Rare instances of cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration.
Vascular disorders: Thrombophlebitis has been reported with IV injection. These reactions can be minimized by deep IM injection and avoidance of indwelling intravenous catheters.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting and diarrhea, esophagitis and esophageal ulcer with oral preparations.
Hepatobiliary disorders: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
Skin and subcutaneous tissue disorders: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbiliform-like skin rashes are the most frequently reported reactions. Rare instances of erythema multiforme have been associated with clindamycin. Pruritus, vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported. Rare cases of toxic epidermal necrolysis and cases of Stevens-Johnson syndrome have been reported during post-marketing surveillance.
General disorders and administration site conditions: Local irritation, pain, abscess formation have been seen with IM injection.
Drug Interactions
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently. 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 patient receiving such agents.
Caution For Usage
Incompatibilities: When combined with clindamycin phosphate in an infusion solution, ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, ceftriaxone sodium, and ciprofloxacin are each physically incompatible with clindamycin phosphate.
Store at temperature below 30°C.
Shelf-Life: 2 years from the date of manufacture.
MIMS Class
ATC Classification
J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.
Cap 150 mg x 50 x 10's. 300 mg x 50 x 10's. Inj (clear colorless to slightly yellowish solution in vial) 150 mg/mL x 2 mL x 10's, 50's.
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