Cleocin Phosphate

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• If diarrhea occurs during therapy, this antibacterial drug should be discontinued (see WARNING box ).
• Clindamycin phosphate IM administration should be used undiluted.
• Clindamycin phosphate IV administration should be diluted (see Dilution for IV use and IV infusion rates below).
• Adults:
• Parenteral (IM or IV Administration):
• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis , Peptococcus species and Clostridium species other than Clostridium perfringens ):
• 600–1200 mg/day in 2, 3 or 4 equal doses.
• More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens :
• 1200–2700 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 Dilution for IV use and IV Infusion Rates section below.
• Single intramuscular injections of greater than 600 mg are not recommended.
• Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:
• Table 2:
• Serum Clindamycin Levels Maintained, Rapid Infusion Rate and Maintenance Infusion Rate To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min Pediatric Patients 1 month of age to 16 years:
• Parenteral (IM or IV) Administration:
• 20 to 40 mg/kg/day in 3 or 4 equal doses.
• The higher doses would be used for more severe infections.
• Clindamycin should be dosed based on total body weight regardless of obesity.
• 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 2 /day for serious infections and 450 mg/m 2 /day for more severe infections.
• Parenteral therapy may be changed to oral CLEOCIN PEDIATRIC ® Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCl ® Capsules (clindamycin hydrochloride) 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.
• Pediatric Patients less than 1 month:
• The recommended dosage is 15 to 20 mg/kg/day in 3 to 4 equal doses.
• See Table 3 regarding the dosing regimen for pediatric patients with post-menstrual age (PMA) less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks.
• Table 3:
• Dosing Regimens for Pediatric Patients with PMA less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks PMA (weeks) Dose (mg/kg) Dosing Interval (hours) PMA:
• Post-Menstrual age Less than or equal to 32 5 8 Greater than or equal to 32 to less than or equal to 40 7 8 Dilution for IV use and IV Infusion Rates:
• The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.
• Infusion rates should not exceed 30 mg per minute.
• The usual infusion dilutions and rates are as follows:
• Dose Diluent Time 300 mg 50 mL 10 min 600 mg 50 mL 20 min 900 mg 50–100 mL 30 min 1200 mg 100 mL 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Dilution and Compatibility:
• Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of CLEOCIN PHOSPHATE Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.
• No incompatibility has been demonstrated with the antibacterial drugs cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.
• The following drugs are physically incompatible with clindamycin phosphate:
• ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.
• The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.
• Physico-Chemical Stability of Diluted Solutions of CLEOCIN PHOSPHATE Room Temperature:
• 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or Mini-Bag containers, demonstrated physical and chemical stability for at least 16 days at 25°C.
• Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in Mini-Bag containers, demonstrated physical and chemical stability for at least 16 days at 25°C.
• Refrigeration:
• 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or Mini-Bag containers, demonstrated physical and chemical stability for at least 32 days at 4°C.
• IMPORTANT:
• This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.
• Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.
• Frozen:
• 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in Mini-Bag containers demonstrated physical and chemical stability for at least eight weeks at -10°C.
• Frozen solutions should be thawed at room temperature and not refrozen.
• DIRECTIONS FOR DISPENSING Pharmacy Bulk Package — Not for Direct Infusion The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only under a laminar flow hood.
• Entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique.
• Multiple entries with a needle and syringe are not recommended.
• AFTER ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY.
• ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS AFTER INITIAL ENTRY.
• DIRECTIONS FOR USE CLEOCIN PHOSPHATE IV Solution in GALAXY Plastic Container Premixed CLEOCIN PHOSPHATE IV Solution is for intravenous administration using sterile equipment.
• Check for minute leaks prior to use by squeezing bag firmly.
• If leaks are found, discard solution as sterility may be impaired.
• Do not add supplementary medication.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
• Do not use unless solution is clear and seal is intact.
• Caution: Do not use plastic containers in series connections.
• Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
• Preparation for Administration : 1.
• Suspend container from eyelet support. 2.
• Remove protector from outlet port at bottom of container. 3.
• Attach administration set.
• Refer to complete directions accompanying set.
• Preparation of CLEOCIN PHOSPHATE in ADD-Vantage System For IV Use Only.
• CLEOCIN PHOSPHATE 300 mg, 600 mg and 900 mg may be reconstituted in 50 mL (for 300 mg and 600 mg) or 100 mL (for 900 mg) of dextrose injection 5% or sodium chloride injection 0.9% in the ADD-diluent container.
• Refer to separate instructions for ADD-Vantage System.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

When CLEOCIN PHOSPHATE Sterile Solution is administered to the pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ) .

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 antibacterial drug-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most antibacterial drugs 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following reactions have been reported with the use of clindamycin.
• Infections and Infestations:
• Clostridioides difficile colitis Gastrointestinal:
• Antibacterial drug-associated colitis (see WARNINGS ), pseudomembranous colitis, abdominal pain, nausea, and vomiting.
• The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ).
• 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 WARNINGS ).
• Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin.
• Anaphylactic shock, anaphylactic reaction, hypersensitivity, and acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction have also been reported (see WARNINGS ).
• Cutaneous vasculitis and symmetrical drug-related intertriginous and flexural exanthema have also been reported.
• Skin and Mucous Membranes:
• Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions ).
• Liver:
• Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
• Renal: Acute kidney injury (See WARNINGS ).
• 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 DOSAGE AND ADMINISTRATION ).

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Patients should be counseled that antibacterial drugs including CLEOCIN PHOSPHATE should only be used to treat bacterial infections.
• They do not treat viral infections (e.g., the common cold).
• When CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued.
• Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug.
• If this occurs, patients should contact their physician as soon as possible.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

• Each mL of CLEOCIN PHOSPHATE Sterile Solution contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate, 9.45 mg benzyl alcohol added as preservative.
• When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
• CLEOCIN PHOSPHATE is available in the following packages:
• 25-2 mL vials NDC 0009-0870-26 25-4 mL vials NDC 0009-0775-26 25-6 mL vials NDC 0009-0902-18 5-60 mL Pharmacy Bulk Package NDC 0009-0728-09 CLEOCIN PHOSPHATE is supplied in ADD-Vantage vials as follows:
• NDC Vial Size Total Clindamycin Phosphate/vial 0009-6582-01 25-2 mL Vials 300 mg 0009-3124-03 25-4 mL Vials 600 mg 0009-3447-03 25-6 mL Vials 900 mg
• Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
• CLEOCIN PHOSPHATE IV Solution in GALAXY plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose.
• The single dose GALAXY plastic containers are available as follows:
• 24-300 mg/50 mL containers NDC 0009-3381-02 24-600 mg/50 mL containers NDC 0009-3375-02 24-900 mg/50 mL containers NDC 0009-3382-02 Exposure of pharmaceutical products to heat should be minimized.
• It is recommended that GALAXY plastic containers be stored at room temperature (25°C).
• Avoid temperatures above 30°C.
• CLEOCIN PHOSPHATE IV Solution in GALAXY plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose.
• The single dose GALAXY plastic containers are available as follows:
• 24-300 mg/50 mL containers NDC 0009-3381-02 24-600 mg/50 mL containers NDC 0009-3375-02 24-900 mg/50 mL containers NDC 0009-3382-02 Exposure of pharmaceutical products to heat should be minimized.
• It is recommended that GALAXY plastic containers be stored at room temperature (25°C).
• Avoid temperatures above 30°C.

Quoted from the official label, section “How Supplied”.

How to store it

• Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
• Exposure of pharmaceutical products to heat should be minimized. It is recommended that GALAXY plastic containers be stored at room temperature (25°C).
• Avoid temperatures above 30°C.

Quoted from the official label, section “Storage and Handling”.

What is in it

• CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid.
• Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL.
• Clindamycin is a semisynthetic antibacterial drug 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- threo -α-D- galacto- Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2 S-trans )-.
• The molecular formula is C 18 H 34 ClN 2 O 8 PS and the molecular weight is 504.96.
• The structural formula is represented below:
• CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use ) .
• CLEOCIN PHOSPHATE IV Solution in the GALAXY 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.
• The plastic container is fabricated from a specially designed multilayer plastic, PL 2501.
• 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.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Clindamycin Phosphate