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Clindamycin

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Overview

What is Clindamycin?

Clindamycin Injection, USP a clear colorless to pale yellow sterile solution, contains clindamycin phosphate, USP a water soluble ester of clindamycin and phosphoric acid. Each mL contains clindamycin phosphate, USP equivalent of 150 mg clindamycin, 0.5 mg edetate disodium and 9.45 mg benzyl alcohol added as preservative in each mL. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH between 5.5 and 7.0. Clindamycin phosphate, USP 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, USP is L--α-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 CHClNOPS and the molecular weight is 504.96.

The structural formula is represented below:



What does Clindamycin look like?



What are the available doses of Clindamycin?

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What should I talk to my health care provider before I take Clindamycin?

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How should I use Clindamycin?

Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin Injection, USP products 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 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 Injection, USP 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 injection, USP and other antibacterial drugs, clindamycin injection, 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.

If diarrhea occurs during therapy, this antibiotic should be discontinued (see box).

Clindamycin phosphate Intramuscular administration should be used undiluted.

Clindamycin phosphate Intravenous administration should be diluted (see

Dilution for Intravenous use and Intravenous infusion rates

).


What interacts with Clindamycin?

This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.



What are the warnings of Clindamycin?

There is evidence that tolerance develops to the sedative effects of benzodiazepines. Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

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Clostridium difficile

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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.

Benzyl Alcohol Toxicity in Pediatric Patients (“Gasping Syndrome”)

This product contains benzyl alcohol as a preservative. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.

The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys’ capacity to detoxify the chemical. Premature and low birth weight infants may be more likely to develop toxicity.

Usage in Meningitis-


What are the precautions of Clindamycin?

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 injection products should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin 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 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 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 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 injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin 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 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


What are the side effects of Clindamycin?

The following reactions have been reported with the use of clindamycin.

Infections and Infestations

Clostridium difficile

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

Injection site irritation, pain, induration and sterile abscess have been reported after intramuscular injection and thrombophlebitis after intravenous infusion. Reactions can be minimized or avoided by giving deep intramuscular injections and 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?

This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

See .


What might happen if I take too much Clindamycin?

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?

Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.Each mL of clindamycin injection, USP sterile solution contains clindamycin phosphate, USP equivalent to 150 mg of clindamycin, 0.5 mg edetate disodium; and 9.45 mg benzyl alcohol added as a preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Clindamycin Injection, USP is as available in the following packages: Clindamycin Injection, USP Pharmacy Bulk Package is also available as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Do not refrigerate.This container closure is not made with natural rubber latex.Sterile, Nonpyrogenic.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Biologically inactive clindamycin phosphate is converted to active clindamycin. By the end of short-term intravenous infusion, peak serum levels of active clindamycin are reached.

After intramuscular injection of clindamycin phosphate, peak levels of active clindamycin are reached within 3 hours in adults and 1 hour in pediatric patients. Serum level curves may be constructed from IV peak serum levels as given in Table 1 by application of elimination half-lives (see ).

Serum levels of clindamycin can be maintained above the minimum inhibitory concentrations for most indicated organisms by administration of clindamycin phosphate every 8 to 12 hours in adults and every 6 to 8 hours in pediatric patients, or by continuous intravenous infusion. An equilibrium state is reached by the third dose.

No significant levels of clindamycin are attained in the cerebrospinal fluid even in the presence of inflamed meninges.

Non-Clinical Toxicology
This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

See .

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.

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 injection products should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin 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 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 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 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.

The following reactions have been reported with the use of clindamycin.

Infections and Infestations

Clostridium difficile

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

Injection site irritation, pain, induration and sterile abscess have been reported after intramuscular injection and thrombophlebitis after intravenous infusion. Reactions can be minimized or avoided by giving deep intramuscular injections and 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 .)

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).