CLIN Single Use Kit

See WARNINGbox.

Clostridium difficile associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, 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 Meningitis

Since 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.

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

Gastrointestinal

Antibiotic-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 occasionally 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. Anaphylactoid reactions have also been reported. If a hypersensitivity reaction occurs, the drug should be discontinued. The usual agents (epinephrine, corticosteroids, antihistamines) should be available for emergency treatment of serious reactions.

Skin and Mucous Membranes

Pruritus, vaginitis, 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

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 have been reported.

Cardiovascular

Cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration. (See DOSAGE AND ADMINISTRATIONsection.)

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.

• Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.
• CLSI. Performance Standards for Antimicrobial Susceptibility Testing: Twenty-fourth Informational Supplement. CLSI document M 100-S24. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
• CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition. CLSI document M07-A9. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
• CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests;Approved Standard – Eleventh Edition. CLSI document M02-A11. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
• CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Eighth Edition. CLSI document M11-A8. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.

Revised: 8/2014

EN-3625

Hospira, Inc., Lake Forest, IL 60045 USA

NDC 69101-715-01 Rx-Only

CLIN Single Use Kit

Kit Contains:
1 Clindamycin Injection, USP 150 mg/ mL (2 mL)
6 Isopropyl Alcohol 70% Prep Pads
1 Pair Nitrile Powder Free Sterile Gloves (Size: Large)
1 Syringe (1 mL)
Sterile 4x4 Gauze

Distributed by:
Burke Therapeutics
Hot Springs, AR 71913

Get emergency medical help if you have any signs of an allergic reaction to clindamycin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, clindamycin may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have: new or worsening symptoms of fever, facial swelling, a red or blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes), weight loss, pain or burning when you urinate, lower back pain, swelling in your legs or feet, cough, chest pain, or trouble breathing.

Clindamycin can cause diarrhea, which may be severe or lead to serious, life-threatening intestinal problems. If you have diarrhea that is watery or bloody, stop using clindamycin and call your doctor.

Call your doctor at once if you have:

• any change in bowel habits;

• severe stomach pain, diarrhea that is watery or bloody;

• little or no urination;

• a metallic taste in your mouth (after clindamycin injection);

• signs of inflammation in your body - swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing; or

• severe skin reaction- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common clindamycin side effects may include:

• nausea, vomiting, stomach pain;

• mild skin rash; or

• vaginal itching or discharge;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with clindamycin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Abdominal pain, pain in the esophagus, nausea, vomiting, an unpleasant or metallic taste, skin rashes, and liver function test abnormalities.
• All antibiotics carry a risk of severe diarrhea caused by an overgrowth of Clostridium difficile bacteria. The risk may be higher with clindamycin compared with some other antibiotics. Further investigations are warranted with severe diarrhea that occurs within several months of clindamycin administration. Symptoms include watery or bloody stools, with or without stomach cramps or fever.
• Not suitable for the treatment of meningitis because it does not reach high enough concentrations in the cerebrospinal fluid (the fluid around the brain and spinal cord).
• May not be suitable for some people including those with a history of gastrointestinal disease (such as colitis) or a history of allergic reactions.
• Be cautious when using in patients with kidney or liver disease. Although dosage reductions are not specifically recommended, liver and kidney function should be monitored.
• May interact with a number of different drugs including neuromuscular blocking agents (such as succinylcholine, vecuronium), those that inhibit or induce CYP3A4 hepatic enzymes, and erythromycin.
• Clindamycin needs to be administered every six hours.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Clindamycin is an antibiotic that is usually reserved for treating anaerobic infections or other serious infections caused by gram positive bacteria in penicillin-allergic people. The risk of C. difficile-associated diarrhea may be higher with clindamycin compared with some other antibiotics.