Trade Name: Clindamycin hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: CAPSULE, HUMAN PRESCRIPTION DRUG

Strength: 150 mg/1

Storage and handling

CLINDAMYCIN HYDROCHLORIDE Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Clostridium difficilen- C. difficile
  • Because clindamycin hydrochloride 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 n n n section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.n nn
  • C. difficilen- C. difficile
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against n n n may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of n n n , and surgical evaluation should be instituted as clinically indicated.n nn
  • Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
  • Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin.
  • Inactive ingredients: n n n - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; n n n - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide.n nn
  • The structural formula is represented below:
  • Cn n n Hn n n ClNn n n On n n Su2022HCl t ttt M.W. 461.45n nn
  • The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-n n n -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-n n n -u03b1-D-n n n -octopyranoside monohydrochloride.n nn
  • Human Pharmacology
  • Absorption
  • Serum level studies with a 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. 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.
  • Distribution
  • 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). No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.
  • Excretion
  • 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 bioinactive metabolites.
  • Special Populations
  • Renal Impairment
  • 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.
  • Use in Elderly
  • Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 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 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 4.2 h) in younger adults. The extent 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 inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome. It has activity against Gram-positive aerobes and anaerobes as well as some Gram-negative anaerobes. Clindamycin is bacteriostatic. Cross-resistance between clindamycin and lincomycin is complete. Antagonism n n n has been demonstrated between clindamycin and erythromycin. Clindamycin inducible resistance has been identified in macrolide-resistant staphylococci and beta-hemolytic streptococci. Macrolide-resistant isolates of these organisms should be screened for clindamycin inducible resistance using the D-zone test.n nn
  • Clindamycin has been shown to be active against most of the isolates of the following microorganisms, both n n n and in clinical infections, as described in the n n n section.n nn
  • Gram-positive aerobes
  • Staphylococcus aureus
  • Streptococcus pneumoniae
  • Streptococcus pyogenes
  • Anaerobes
  • Prevotella melaninogenica
  • Fusobacterium necrophorum
  • Fusobacterium nucleatum
  • Peptostreptococcus anaerobius
  • Clostridium perfringens
  • At least 90% of the microorganisms listed below exhibit n n n minimum inhibitory concentrations (MICs) less than or equal to the clindamycin susceptible MIC breakpoint for organisms of a similar type to those shown in Table 1. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms n n n established in adequate and well-controlled clinical trials.n nn
  • Gram-positive aerobes
  • Staphylococcus epidermidis
  • Streptococcus agalactiae
  • Streptococcus anginosus
  • Streptococcus oralis
  • Streptococcus mitis
  • Anaerobes
  • Prevotella intermedia
  • Prevotella bivia
  • Propionibacterium acnes
  • Micromonas (u201cPeptostreptococcusu201d) micros
  • Finegoldia (u201cPeptostreptococcusu201d) magna
  • Actinomyces israelii
  • Clostridium clostridioforme
  • Eubacterium lentum
  • Susceptibility Testing Methods
  • When available, the clinical microbiology laboratory should provide cumulative n n n susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.n nn
  • Dilution Techniques
  • Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure based on dilution method (broth, agar, or microdilution)n n n or equivalent using standardized inoculum and concentrations of clindamycin. The MIC values should be interpreted according to the criteria provided in Table 1.n nn
  • Diffusion Techniques
  • Quantitative methods that require the measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The standardized proceduren n n n requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 2 mcg of clindamycin to test the susceptibility of microorganisms to clindamycin. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 2 mcg clindamycin disk should be interpreted according to the criteria in Table 1.n nn
  • NA = not applicable
  • A report of u201cSusceptibleu201d indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of u201cIntermediateu201d indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation.
  • A report of u201cResistantu201d indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
  • Quality Control
  • Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test.n n n Standard clindamycin powder should provide the MIC ranges in Table 2. For the disk diffusion technique using the 2 mcg clindamycin disk the criteria provided in Table 2 should be achieved.n nn
  • NA = Not applicable
  • ATCCn n n is a registered trademark of the American Type Culture Collectionn nn
  • Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
  • Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the n n n box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).n nn
  • Anaerobes:
  • Streptococci:
  • Staphylococci:
  • Pneumococci:
  • Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
  • See n n n box.n nn
  • Clostridium difficilen- C. difficile
  • C. difficilen- C. difficile
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against n n n may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment ofn n n , and surgical evaluation should be instituted as clinically indicated.n nn
  • A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
  • Usage in Meningitis-
  • No data
  • The following reactions have been reported with the use of clindamycin.
  • Gastrointestinaln- WARNING n- WARNINGS
  • Hypersensitivityn- Reactions
  • Skin and Mucous Membranes:n- Hypersensitivity Reactionsn- .
  • Liver
  • Renal
  • Hematopoietic
  • Musculoskeletal
  • 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.
  • If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see n box).n
  • strong>Adults: n u2014150 to 300 mg every 6 hours. n - 300 to 450 mg every 6 hours. n n - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. n - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.n
  • To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.
  • Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
  • In cases of u03b2-hemolytic streptococcal infections, treatment should continue for at least 10 days.
  • Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes:
  • strong>Clindamycin hydrochloride capsules, USP, 150 mg are size u20181u2019 capsules with turquoise blue opaque cap and light green body imprinted with n on cap and body in black ink containing white to off white powder. They are supplied as follows:n
  • NDC 66267-774-06 Bottles of 6
  • Store at 20u00b0 - 25u00b0 C (68u00b0 - 77u00b0 F) [See USP Controlled Room Temperature].
  • TO report SUSPECTED ADVERSE REACTIONS, contact the FDA at n or n .n
  • One-year oral toxicity studies in Spartan Sprague-Dawley rats and beagle dogs at dose levels up to 300 mg/kg/day (approximately 1.6 and 5.4 times the highest recommended adult human dose based on mg/mn n n , respectively) have shown clindamycin to be well tolerated. No appreciable difference in pathological findings has been observed between groups of animals treated with clindamycin and comparable control groups. Rats receiving clindamycin hydrochloride at 600 mg/kg/day (approximately 3.2 times the highest recommended adult human dose based on mg/mn n n ) for 6 months tolerated the drug well; however, dogs dosed at this level (approximately 10.8 times the highest recommended adult human dose based on mg/mn n n ) vomited, would not eat, and lost weight.n nn
  • Manufactured for:
  • Ranbaxy Pharmaceuticals Inc.
  • Jacksonville, FL 32257 USA
  • March 2013 FDA-05
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Clindamycin hydrochloride (Clindamycin hydrochloride) which is also known as Clindamycin hydrochloride and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 150 mg/1.

Clindamycin hydrochloride (Clindamycin hydrochloride) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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