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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 17.05.2022
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Cleocin T Gel is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Cleocin T Gel is 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 colitis, as described in the BOXED WARNING, before selecting Cleocin T Gel, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes
Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intraabdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci
Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci
Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci
Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to Cleocin T Gel.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cleocin T Gel HCl and other antibacterial drugs, Cleocin T Gel HCl 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.
Cleocin T Gel is a single-dose therapy used to treat vaginal infections (bacterial vaginosis) caused by certain bacteria in non-pregnant women.
Cleocin T Gel Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria. The recommended dose is a single applicatorful at any time of the day.
Cleocin T Gel may also be used for purposes other than those listed in this medication guide.
Cleocin T Gel is for topical use only, and not for oral, ophthalmic, or intravaginal use.
Apply Cleocin T Gel once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.
If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued.
The contents of Cleocin T Gel are flammable; avoid fire, flame and/or smoking during and immediately following application.
How supplied
Dosage Forms And Strengths
White to off-white thermolabile foam. Each gram of Cleocin T Gel contains, as dispensed, 12 mg (1.2%) of Cleocin T Gel phosphate, equivalent to 10 mg (1%) of Cleocin T Gel.
Cleocin T Gel containing Cleocin T Gel phosphate equivalent to 10 mg Cleocin T Gel per gram, is white to off-white in color and thermolabile. It is available in the following sizes:
100 gram aerosol can - NDC 0145-0061-00
50 gram aerosol can - NDC 0145-0061-50
Storage and Handling
Store at controlled room temperature between 68°F to 77°F (20°C to 25°C).
Flammable. Avoid fire, flame or smoking during and immediately following application.
Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C).
Keep out of reach of children.
Manufactured for: Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. Revised: 1/2012
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What is the most important information I should know about Cleocin T Gel?
Hypersensitivity
Do not administer Cleocin T Gel (Cleocin T Gel phosphate) to individuals with a history of hypersensitivity to Cleocin T Gel or other lincosamides. Reported reactions to other formulations of Cleocin T Gel include rashes, urticaria, erythema multiforme, and anaphylactoid reactions.
History of Bowel Disease
Do not administer Cleocin T Gel (Cleocin T Gel phosphate) to patients with regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.
Use Cleocin T Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Cleocin T Gel is for vaginal use only.
- Wash your hands before and after using Cleocin T Gel. To use, remove the cap from the tube. Screw the plastic applicator on the threaded end of the tube. Rolling the tube from the bottom, squeeze gently and force the medicine into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point.
- Unscrew the applicator from the tube and replace the cap. While lying on your back, firmly grasp the applicator barrel and insert into the vagina as far as it will possibly go without causing discomfort. Slowly push the plunger until it stops. Carefully remove the applicator from the vagina and throw the applicator away.
- Use Cleocin T Gel at bedtime. This will help keep the medicine in the vagina and reduce leaking.
- Cleocin T Gel works best if it is used at the same time each day.
- To clear up your infection completely, use Cleocin T Gel for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Cleocin T Gel and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Cleocin T Gel.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Cleocin T Gel is used to treat severe acne (acne vulgaris) and vaginal infections caused by certain bacteria.
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What other drugs will affect Cleocin T Gel?
Erythromycin
Cleocin T Gel should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its Cleocin T Gel component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.
Neuromuscular Blocking Agents
Cleocin T Gel has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Cleocin T Gel should be used with caution in patients receiving such agents.
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What are the possible side effects of Cleocin T Gel?
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Cleocin T Gel in 368 patients. Cleocin T Gel was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg Cleocin T Gel phosphate cream intravaginally in a single dose.
Of the 368 women treated with a single dose of Cleocin T Gel, 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Cleocin T Gel and in 32 of 85 patients (38%) treated with placebo.
Adverse reactions occurring in ≥2% of patients receiving Cleocin T Gel in the placebo-controlled clinical trial are shown in Table 1.
Table 1. Adverse Reactions Occurring in ≥2% of Cleocin T Gel-Treated Patients and at a Higher Rate than Placebo-Treated Patients
N = number of patients in intent-to-treat population
n (%) = number and percentage of patients with reported adverse reaction
NOS = not otherwise specified
Other Cleocin T Gel Formulations
Cleocin T Gel affords minimal peak serum levels and systemic exposure (AUCs) of Cleocin T Gel compared to an oral or intravenous dose of Cleocin T Gel. Data from well-controlled trials directly comparing Cleocin T Gel administered orally to Cleocin T Gel administered vaginally are not available.
The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of Cleocin T Gel:
Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridium difficile-associated diarrhea.
Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent Cleocin T Gel therapy could be made in any of these reports.
Hypersensitivity Reactions: Maculopapular rash, vesiculobullous 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. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with Cleocin T Gel. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during Cleocin T Gel therapy.
Musculoskeletal: Cases of polyarthritis have been reported.
Renal: Although no direct relationship of Cleocin T Gel to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Cleocin T Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: Rash
Gastrointestinal: Hematochezia
Reproductive System: Vaginal erythema, vulvovaginal pruritis, vaginal discharge, vaginal swelling, vaginal bleeding, vaginal pain
An antibacterial agent that is a semisynthetic analog of lincomycin.