Clindamycin hydrochloride (injection)

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# Overview
Clindamycin hydrochloride (injection) is a antibiotic that is FDA approved for the treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci, and staphylococci.   Common adverse reactions include abdominal pain,  pseudomembranous colitis,  esophagitis,  nausea, vomiting, and  diarrhea.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
CLEOCIN PHOSPHATE 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 WARNING box, 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.
CLEOCIN PHOSPHATE 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, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.
Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, 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 Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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.

### Dosage
If diarrhea occurs during therapy, this antibiotic should be discontinued.
Clindamycin phosphate IM administration should be used undiluted.
Clindamycin phosphate IV administration should be diluted
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):
6001200 mg/day in 2, 3 or 4 equal doses.
More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcusspecies, or Clostridium species other than Clostridium perfringens:
12002700 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:

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin hydrochloride (injection) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Clindamycin hydrochloride (injection) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Dosage
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 (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. 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/m2/day for serious infections and 450 mg/m2/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 -hemolytic streptococcal infections, treatment should be continued for at least 10 days.
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.
There is limited information regarding FDA-Labeled Use of Clindamycin hydrochloride (injection) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin hydrochloride (injection) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Clindamycin hydrochloride (injection) in pediatric patients.

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

# Warnings
- Clostridium difficile associated diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Severe Skin Reactions
Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported. In case of such an event, treatment should be permanently discontinued.
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 hepatic capacity to detoxify the chemical. Premature and low birth weight infants may be more likely to develop toxicity.
Usage in MeningitisSince clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN AND INTRAVENOUS CORTICOSTEROIDS SHOULD ALSO BE ADMINISTERED AS INDICATED.

### Precautions
- 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.
- CLEOCIN PHOSPHATE products should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
- CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE may result in overgrowth of nonsusceptible organismsparticularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
CLEOCIN PHOSPHATE should not be injected intravenously undiluted as a bolus, but should be infused over at least 1060 minutes as directed in the DOSAGE AND ADMINISTRATION 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 CLEOCIN PHOSPHATE 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.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Clindamycin hydrochloride (injection) in the drug label.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Clindamycin hydrochloride (injection) in the drug label.

# Drug Interactions
There is limited information regarding Clindamycin hydrochloride (injection) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
There is no FDA guidance on usage of Clindamycin hydrochloride (injection) in women who are pregnant.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin hydrochloride (injection) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Clindamycin hydrochloride (injection) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clindamycin hydrochloride (injection) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Clindamycin hydrochloride (injection) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Clindamycin hydrochloride (injection) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Clindamycin hydrochloride (injection) in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Clindamycin hydrochloride (injection) in the drug label.

# Pharmacology
There is limited information regarding Clindamycin hydrochloride (injection) Pharmacology in the drug label.

## Mechanism of Action
- Clindamycin has a primarily bacteriostatic effect. It is a bacterial protein synthesis inhibitor by inhibiting ribosomal translocation, in a similar way to macrolides. It does so by binding to the 50S rRNA of the large bacterial ribosome subunit.
- The structures of the complexes between several antibiotics (including clindamycin) and a Deinococcus radiodurans ribosome have been solved by X-ray crystallography by a team from the Max Planck Working Groups for Structural Molecular Biology, and published in the journal Nature.

## Structure
There is limited information regarding Clindamycin hydrochloride (injection) Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Clindamycin hydrochloride (injection) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Clindamycin hydrochloride (injection) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Clindamycin hydrochloride (injection) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Clindamycin hydrochloride (injection) in the drug label.

# How Supplied
- 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

## Storage
There is limited information regarding Clindamycin hydrochloride (injection) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Clindamycin hydrochloride (injection) in the drug label.

# Precautions with Alcohol
- Alcohol-Clindamycin hydrochloride (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
There is limited information regarding Clindamycin hydrochloride (injection) Brand Names in the drug label.

# Look-Alike Drug Names
There is limited information regarding Clindamycin hydrochloride (injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price