Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Clindamycin in 5 Percent Dextrose
Overview
What is Clindamycin in 5 Percent Dextrose?
Clindamycin in 5% Dextrose Injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
The chemical name of clindamycin phosphate is L--D-- Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2)-.
The molecular formula is CHCIN0PS and the molecular weight is 504.97.
The structural formula is represented below:
The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
What does Clindamycin in 5 Percent Dextrose look like?
What are the available doses of Clindamycin in 5 Percent Dextrose?
Sorry No records found.
What should I talk to my health care provider before I take Clindamycin in 5 Percent Dextrose?
Sorry No records found
How should I use Clindamycin in 5 Percent Dextrose?
Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin in 5% Dextrose Injection is 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 antibiotic-associated pseudomembranous colitis, as described in the , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, , other streptococci (except ), and .
Skin and skin structure infections caused by, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by , streptococci (except ), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin in 5% Dextrose Injection and other antibacterial drugs, Clindamycin in 5% Dextrose Injection 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.
If diarrhea occurs during therapy, this antibiotic should be discontinued (see box).
Adults
Parenteral (IV Administration)
Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including species and species other than ):
600 to 1200 mg/day in 2, 3 or 4 equal doses.
More severe infections, particularly those due to proven or suspected species, or species other than :
1200 to 2700 mg/day in 2, 3 or 4 equal doses.
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 daily have been given intravenously to adults. See IV section below.
Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:
Neonates
(less than 1 month)
15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.
Pediatric patients 1 month of age to 16 years
Parenteral (IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m/day for serious infections and 450 mg/m/day for more severe infections.
Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride flavored granules or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.
In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
What interacts with Clindamycin in 5 Percent Dextrose?
This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
What are the warnings of Clindamycin in 5 Percent Dextrose?
Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
See .
Clostridium difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Anaphylactic and Severe Hypersensitivity Reactions
Anaphylactic shock and anaphylactic reactions have been reported (see
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 (see
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.
What are the precautions of Clindamycin in 5 Percent Dextrose?
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.
Clindamycin in 5% Dextrose Injection should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Clindamycin in 5% Dextrose Injection should be prescribed with caution in atopic individuals.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy.
The use of Clindamycin in 5% Dextrose Injection may result in overgrowth of nonsusceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Clindamycin in 5% Dextrose Injection should not be injected intravenously undiluted as a bolus, but should be infused over at least 10 to 60 minutes as directed in the section.
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 Clindamycin in 5% Dextrose Injection 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.
Information for Patients
Patients should be counseled that antibacterial drugs including Clindamycin in 5% Dextrose Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Clindamycin in 5% Dextrose Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Clindamycin in 5% Dextrose Injection or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Laboratory Tests
During prolonged therapy periodic liver and kidney function tests and blood counts should be performed.
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 strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro
Antagonism has been demonstrated between clindamycin and erythromycin. Because of possible clinical significance, the two drugs should not be administered concurrently.
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 1.1 times the highest recommended adult human dose based on mg/m) revealed no effects on fertility or mating ability.
Pregnancy
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.
Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (2.1 and 1.1 times the highest recommended adult human dose based on mg/m, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (0.9 and 0.5 times the highest recommended adult human dose based on mg/m, respectively) revealed no evidence of teratogenicity.
Nursing Mothers
Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously. Clindamycin has the potential to cause adverse effects on the breastfed 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 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 breastfed child from clindamycin or from the underlying maternal condition.
Pediatric Use
When Clindamycin in 5% Dextrose Injection sterile solution is administered to the pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable.
Usage in Newborns and Infants
The potential for the toxic effect in the pediatric population from chemicals that may leach from the single dose premixed IV preparation in plastic has not been evaluated. See .
Geriatric Use
Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to ) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.
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.
What are the side effects of Clindamycin in 5 Percent Dextrose?
The following reactions have been reported with the use of clindamycin.
Infections and Infestations
Clostridium difficile colitis
Gastrointestinal
Antibiotic-associated colitis (see ), pseudomembranous colitis, abdominal pain, nausea, and vomiting. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see ).
An unpleasant or metallic taste has been reported after intravenous administration of the higher doses of clindamycin phosphate.
Hypersensitivity Reactions
Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions.
Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (See ). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. Anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported (see )
Skin and Mucous Membranes
Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported (see ).
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.
Local Reactions
Thrombophlebitis has been reported after intravenous infusion. Reactions can be minimized by avoiding prolonged use of indwelling intravenous catheters.
Musculoskeletal
Polyarthritis cases have been reported.
Cardiovascular
Cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration. (See .)
What should I look out for while using Clindamycin in 5 Percent Dextrose?
This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
See .
Clostridium difficile
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What might happen if I take too much Clindamycin in 5 Percent Dextrose?
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.
How should I store and handle Clindamycin in 5 Percent Dextrose?
Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.Manufactured by:PAR PHARMACEUTICAL Chestnut Ridge, NY 10977Patent No.:6,028,0656,268,3566,593,3186,593,320Revised: 12/2016Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 300 mg, 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C. Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 300 mg, 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C.
