Clindamycin

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials.

Store in tight container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.

Commercially available clindamycin phosphate vaginal cream should be stored in a tight container at 20-25 °C; freezing should be avoided. The vaginal suppositories and clindamycin phosphate vaginal cream should be stored at a controlled room temperature of 25 °C, but may be exposed to temperatures ranging from 15-30 °C; exposure to temperatures exceeding 30 °C or high humidity should be avoided. When stored as recommended, the commercially available vaginal cream is stable for 18 months following the date of manufacture. /Clindamycin phosphate/

The commercially available gel containing clindamycin phosphate (clindamycin 1%) in fixed combination with benzoyl peroxide 5% should be refrigerated at 2-8 °C until dispensed.178 Once dispensed, the gel may be stored at a room temperature up to 25 °C for up to 60 days. The gel should not be frozen. /Clindamycin phosphate/

Commercially available clindamycin phosphate 1% topical gel, lotion, and solution should be stored in tight containers at 20-25 °C; freezing should be avoided. /Clindamycin phosphate/

Wear approved respiratory protection, chemically compatible gloves, and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site.

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.

SRP: Wastewater from contaminant suppression, cleaning of protective clothing/equipment, or contaminated sites should be contained and evaluated for subject chemical or decomposition product concentrations. Concentrations shall be lower than applicable environmental discharge or disposal criteria. Alternatively, pretreatment and/or discharge to a permitted wastewater treatment facility is acceptable only after review by the governing authority and assurance that "pass through" violations will not occur. Due consideration shall be given to remediation worker exposure (inhalation, dermal and ingestion) as well as fate during treatment, transfer and disposal. If it is not practicable to manage the chemical in this fashion, it must be evaluated in accordance with EPA 40 CFR Part 261, specifically Subpart B, in order to determine the appropriate local, state and federal requirements for disposal.

As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly.

SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker.

As with all dry powders, it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.

SRP: The scientific literature for the use of contact lenses in industry is conflicting. The benefit or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place.

Respiratory protection: Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place. Gloves: Chemically compatible. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. Eye protection: Safety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area. Protective clothing: Protect exposed skin.

Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials.

Reversibility of antibiotic-induced paralysis of mouse phrenic nerve-hemidiaphragm preparation by calcium and by neostigmine.

Concurrent use of kaolin- or attapulgite-containing antidiarrheals with oral clindamycin may significantly delay the absorption of oral clindamycin; concurrent use should be avoided or patients should be advised to take adsorbent antidiarrheals not less than 2 hours before or 3 to 4 hours after oral lincomycins.

There is in vitro evidence of antagonism between erythromycin and clindamycin.

Clindamycin has been reported to antagonize the bactericidal activity of aminoglycosides in vitro, and some clinicians recommend that these drugs not be used concomitantly. However, in vivo antagonism has not been demonstrated, and clindamycin has been administered successfully in conjunction with an aminoglycoside with no apparent decrease in activity.

For more Interactions (Complete) data for CLINDAMYCIN (7 total), please visit the HSDB record page.

Clindamycin has been linked to two forms of hepatotoxicity: transient serum aminotransferase elevations usually occurring after several days of high intravenous doses; and, an acute, idiosyncratic liver injury that arises within 1 to 3 weeks of starting therapy and is typically mild and self-limited.

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 70(SRC), determined from a structure estimation method(2), indicates that clindamycin is expected to have high mobility in soil(SRC). The pKa of clindamycin is 7.79(3), indicating that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization of the neutral species clindamycin from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 2.9X10-22 atm-cu m/mole(SRC), using a fragment constant estimation method(3). Clindamycin is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 5.3X10-17 mm Hg at 25 °C(SRC), determined from a fragment constant method(4). Utilizing the Closed Bottle Test, 3% of the Theoretical BOD was reached in 4 weeks(3) indicating that biodegradation is not an important environmental fate process in soil(SRC).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 70(SRC), determined from a structure estimation method(2), indicates that clindamycin is not expected to adsorb to suspended solids and sediment(SRC). Volatilization of the neutral species from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 2.9X10-22 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). A pKa of 7.79(5) indicates clindamycin will exist partially in the cation form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process(SRC). According to a classification scheme(6), an estimated BCF of 12(SRC), from its log Kow of 2.16(7) and a regression-derived equation(8), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Utilizing the Closed Bottle Test, 3% of the Theoretical BOD was reached in 4 weeks(5) indicating that biodegradation is not an important environmental fate process in water(SRC).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), clindamycin, which has an estimated vapor pressure of 5.3X10-17 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase clindamycin may be removed from the air by wet or dry deposition(SRC). Clindamycin does not contain chromophores that absorb at wavelengths >290 nm(3) and, therefore, is not expected to be susceptible to direct photolysis by sunlight(SRC).

The adverse effects of clindamycin vary based on how its mode of administration. The most common adverse effects experienced with topical use include pruritis, xeroderma, erythema, burning, exfoliation, or oily skin. The most common side effects of intravaginal administration are vaginal candidiasis, pruritis, vulvovaginal disease, and vulvovaginitis. With systemic administration, the primary adverse effects of clindamycin are pseudomembranous colitis, nausea, vomiting, and diarrhea, resulting from clindamycin destroying much of the GI tract’s healthy flora. Clostridium difficile rapidly overgrows in this environment. The A and B toxins produced by C. difficile cause Clostridium difficile-associated diarrhea (CDAD). If suspected, a stool antigen test should be in order.

Oral; topical; parenteral (intramuscular, intravenous). Rapidly absorbed after oral administration with peak serum concentrations observed after about 45 minutes. Absorption of an oral dose is virtually complete (90%) and the concomitant intake of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose. Clindamycin does not penetrate the blood brain barrier.

Clindamycin is distributed into milk, achieving breast milk concentrations of 0.7-3.8 ug/mL at dosages of 150 mg orally to 600 mg IV.

/EXPTL/ Clindamycin readily crosses the placenta, and cord blood concentrations of the drug have been reported to be 46% of concurrent maternal blood concentrations. Clindamycin is distributed into milk.

The most common adverse effects due to clindamycin toxicity are gastrointestinal or allergic. There is no antidote for clindamycin toxicity, and the adverse effects will resolve with dose adjustment or discontinuation of the antibiotic. Treatment is supportive. The recommendation is to measure serum electrolytes in patients with vomiting and diarrhea. Vital signs need to be monitored along with CBC with differential, platelets, LFTs, and renal function in symptomatic patients. The clinical team must also obtain an EKG and maintain continuous cardiac monitoring as cardiac arrhythmias, although rare, may occur. Evaluation for Clostridium difficile toxin will be needed when colitis is suspected.

Systemic/vaginal clindamycin inhibits protein synthesis of bacteria by binding to the 50S ribosomal subunits of the bacteria. Specifically, it binds primarily to the 23s RNA subunit. Topical clindamycin reduces free fatty acid concentrations on the skin and suppresses the growth of Propionibacterium acnes (Corynebacterium acnes) , an anaerobe found in sebaceous glands and follicles.

Orally and parenterally administered clindamycin has been associated with severe colitis (pseudomembranous colitis) which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Clindamycin concentrations in sewage water effluents of the Netherlands in 2002 ranged from approximately 60 to 240 ng/L(1). Concentrations of up to 110 ng/L were reported in an unspecified sewage treatment effluent sample(2). Clindamycin concentrations of 30 and 1000 ng/L have also been reported. It was reported present in biosolids at a concentration of 1,540 ng/kg dry weight(3).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of clindamycin can be estimated to be 70(SRC). According to a classification scheme(2), this estimated Koc value suggests that clindamycin is expected to have high mobility in soil. However, the pKa of clindamycin is 7.79(3), indicating that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4).

/CASE REPORTS/ Clindamycin-related anaphylactic reaction is rarely reported. We report a male patient with buccal cancer who was undergoing radical neck dissection when life-threatening anaphylactic shock developed soon after intravenous infusion of clindamycin. Immediate cardiopulmonary resuscitation was performed, and the patient recovered uneventfully. Perioperative anaphylactic shock is a serious problem due to the difficulty of judgment and potentially disastrous outcome. Immediate diagnosis and halting of drug infusion should be the first actions taken.

/CASE REPORTS/ A 73-year-old woman developed erythroderma with intense pruritus, malaise, and chills 7 days after treatment with intravenous clindamycin. Two years later she experienced a similar reaction with more rapid onset (48 hours) after treatment with aztreonam. Resolution followed withdrawal of treatment in both instances, and intradermal tests proved positive at delayed reading for both drugs.

/CASE REPORTS/ Prolongation of QT time interval may be provoked by a limited number of drugs, especially macrolide antibiotics. We describe a case of QT time interval prolongation induced by clindamycin with subsequent repeated ventricular fibrillation and resuscitation; there is no previous report in the literature of QT time prolongation caused by lincosamides.

/CASE REPORTS/ Four cases of severe pseudomembranous colitis following the use of lincomycin and clindamycin are described; 2 required emergency total colectomy and 2 died. Cases of such gravity after the use of these drugs have not been previously reported. One hundred and fifty-six orthopedic cases where clindamycin and lincomycin were used postoperatively are reviewed; 34 had diarrhea (22 per cent), and 3 of the severe cases occurred in this group. The diagnosis of pseudomembranous colitis may be difficult as the latent period from initiation of drug therapy to commencement of diarrhea may be as much as 18 days, and that from cessation of drug therapy may be as much as 11 days. The value of early sigmoidoscopy in cases of diarrhea of obscure etiology is emphasized, and the characteristic sigmoidoscopic and histological appearances of pseudomembranous colitis are described. As these drugs may produce a lethal condition it is suggested that they should be used with appropriate discretion, especially in the elderly female who appears to be most at risk.

For more Human Toxicity Excerpts (Complete) data for CLINDAMYCIN (8 total), please visit the HSDB record page.

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl clindamycin palmitate hydrochloride, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Clindamycin palmitate hydrochloride/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl clindamycin hydrochloride, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Clindamycin hydrochloride/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl clindamycin phosphate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Clindamycin phosphate/

The Generic Animal Drug and Patent Restoration act requires that each sponsor of an approved animal drug must submit to the FDA certain information regarding patents held for the animal drug or its method of use. The Act requires that this information, as well as a list of all animal drug products approved for safety and effectiveness, be made available to the public. Clindamycin hydrochloride is included on this list. /Clindamycin hydrochloride/

For more FDA Requirements (Complete) data for CLINDAMYCIN (7 total), please visit the HSDB record page.

Semi-synthetic antibiotic prepared from lincomycin

Clindamycin has found use in the treatment of common infections caused by gram-positive cocci.

It is used as an orally-active lincomycin-group antibiotic with the same range of activity as lincomycin.

MEDICATION

MEDICATION (VET)

Use (kg) in Switzerland (2009): >500

(1972) No Data

(1975) No Data

(1972) No Data

(1975) No Data

(1972) GREATER THAN 4.54X10+5 G (FREE BASE)

(1975) PROBABLY GREATER THAN 4.54X10+5 GRAMS

Lincomycin is treated with a solution of Rydon reagent prepared from triphenylphosphine, acetonitrile, and chlorine. The base is ultimately reacted with hydrochloric acid.

First resulted from the reaction of lincomycin and thionyl chloride; improved synthetic methods involve the reaction of lincomycin and triphenylphosphine dichloride or triphenylphosphine in carbon tetrachloride.

Synthesized ... by introducing a chlorine atom at the 7 position of lincomycin.

Manufacturing Process: R.D. Birkenmeyer, Kagan, US 3475407(1969 to Upjohn).

Antibiotics are fermentation products and are isolated either as unfinished products or as intermediates, generally solid substances of limited stability. They are purified by methods normally employed in organic chemistry, which include chromatography, crystallization, and precipitation. /Antibiotics/

Oral: For solution: 75 mg (of clindamycin) per 5 mL, Cleocin Pediatric (Pfizer). /Clindamycin palmitate hydrochloride/

Table: Clindamycin Hydrochloride Preparations [Table#4359]

Table: Clindamycin Phosphate in Dextrose Preparations [Table#4360]

Table: Clindamycin Phosphate Preparations [Table#4361]

For more Formulations/Preparations (Complete) data for CLINDAMYCIN (6 total), please visit the HSDB record page.

Animal Drugs -> FDA Approved Animal Drug Products (Green Book) -> Active Ingredients

Pharmaceuticals -> Animal Drugs -> Approved in Taiwan

CLINDAMYCIN DIFFERS CHEMICALLY FROM LINCOMYCIN BY SUBSTITUTION OF CHLORINE ATOM FOR HYDROXYL GROUP ON PARENT COMPD. WITH THIS SLIGHT MOLECULAR MODIFICATION, CLINDAMYCIN IS...MORE POTENT THAN LINCOMYCIN.

Clindamycin is a derivative of the amino acid trans-L-4-n-propylhygrinic acid, attached to a sulfur-containing derivative of an octose. It is a congener of lincomycin ...