Clindamycin hydrochloride (injection)

Clindamycin hydrochloride (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Clindamycin hydrochloride (injection) is a antibiotic that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Clindamycin hydrochloride (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.

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.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

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 organisms—particularly 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 10–60 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

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

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

• Oral

• Intravenous

Monitoring

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

• Description

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

Structure

File:Clindamycin hydrochloride (injection)01.png

This image is provided by the National Library of Medicine.

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

Storage

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

Images

Drug Images

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Package and Label Display Panel

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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

References

The contents of this FDA label are provided by the National Library of Medicine.

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