Drez V

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin 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 clindamycin, 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 clindamycin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Topical (Drez V) HCl and other antibacterial drugs, Clindamycin Topical (Drez V) 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.

Clotrimazole Topical (Drez V) Cream: Clotrimazole Topical (Drez V) cream is an antifungal cream used to treat skin infections caused by dermatophytes, fungi, yeasts, moulds, etc [eg, athlete's foot, jock itch, ringworm of the body, cutaneous candidiasis (candida infection of the skin which may occur in diaper areas in babies, in armpits, groins or areas under the breasts)], pityriasis versicolor (commonly called white spots).

Clotrimazole Topical (Drez V) cream can also be used for erythrasma (a skin infection caused by the bacteria Corynebacterium minutissimum and usually affects areas with skin folds eg, the groin, armpits, between toes).

Clotrimazole Topical (Drez V) cream can also be used for female fungal infections of the vaginal area. It can also be used in males where inflammation is present in the penis, caused by yeast fungi (Candida vulvitis and Candida balanitis).

Clotrimazole Topical (Drez V)

Topical Powder:

Clotrimazole Topical (Drez V) powder may be used as an adjuvant to the previously mentioned treatment or as a follow-up treatment (prevention of reinfection) of the previously mentioned fungal infections (dermatomycoses) and erythrasma.

Clindamycin Topical (Drez V) is a single-dose therapy used to treat vaginal infections (bacterial vaginosis) caused by certain bacteria in non-pregnant women.

Clindamycin Topical (Drez V) 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.

Clindamycin Topical (Drez V) may also be used for purposes other than those listed in this medication guide.

Clotrimazole Topical (Drez V) is an antifungal medication that fights infections caused by fungus.

Clotrimazole Topical (Drez V) (for the skin) is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Clotrimazole Topical (Drez V) may also be used for purposes not listed in this medication guide.

Clindamycin Topical (Drez V) is for topical use only, and not for oral, ophthalmic, or intravaginal use.

Apply Clindamycin Topical (Drez V) 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 Clindamycin Topical (Drez V) 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 Clindamycin Topical (Drez V) contains, as dispensed, 12 mg (1.2%) of clindamycin phosphate, equivalent to 10 mg (1%) of clindamycin.

Clindamycin Topical (Drez V) containing clindamycin phosphate equivalent to 10 mg clindamycin 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

Usual Adult Dose for Tinea Corporis:

Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Cruris:

Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Pedis:

Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 to 8 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Cutaneous Candidiasis:

Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Tinea Versicolor:

Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Vaginal Candidiasis:

Regimen 1: 100 mg (one 100 mg vaginal suppository) intravaginally once a day for 7 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 2: 200 mg (one 200 mg vaginal suppository) intravaginally once a day for 3 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 3: 500 mg (one 500 mg vaginal suppository) intravaginally once.

Regimen 4: One applicatorful of 1% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 7 consecutive days.

Regimen 5: One applicatorful of 2% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 3 consecutive days.

Studies have shown the three and seven day courses of clotrimazole to be equally effective. Patient compliance may be increased with a three day course. Patients who fail to achieve a cure with a single 500 mg dose should be treated with a 3 or 7 day course of clotrimazole.

Weekly or monthly clotrimazole vaginal suppositories appear to be effective topical regimens for chronic suppressive therapy in female patients with HIV.

Usual Pediatric Dose for Tinea Corporis:

> 3 years: Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Cruris:

> 3 years: Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Pedis:

> 3 years: Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 to 8 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Cutaneous Candidiasis:

> 3 years: Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Tinea Versicolor:

> 3 years: Apply Clotrimazole Topical (Drez V) in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Vaginal Candidiasis:

> 12 years: Regimen 1: 100 mg (one 100 mg vaginal suppository) intravaginally once a day for 7 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 2: 200 mg (one 200 mg vaginal suppository) intravaginally once a day for 3 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 3: 500 mg (one 500 mg vaginal suppository) intravaginally once.

Regimen 4: One applicatorful of 1% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 7 consecutive days.

Studies have shown the three and seven day courses of clotrimazole to be equally effective. Patient compliance may be increased with a three day course. Patients who fail to achieve a cure with a single 500 mg dose should be treated with a 3 or 7 day course of clotrimazole.

Weekly or monthly clotrimazole vaginal suppositories appear to be effective topical regimens for chronic suppressive therapy in female patients with HIV.

See also:
What is the most important information I should know about Clindamycin Topical (Drez V)?

Hypersensitivity

Do not administer Clindamycin Topical (Drez V) (clindamycin phosphate) to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions.

History of Bowel Disease

Do not administer Clindamycin Topical (Drez V) (clindamycin phosphate) to patients with regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea.

See also:
What is the most important information I should know about Clotrimazole Topical (Drez V)?

Clotrimazole Topical (Drez V) Cream: Hypersensitivity to clotrimazole, cetostearyl alcohol or to any other components of Clotrimazole Topical (Drez V) Cream.

Clotrimazole Topical (Drez V)

Topical Powder:

Use Clindamycin Topical (Drez V) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clindamycin Topical (Drez V) is for vaginal use only.
• Wash your hands before and after using Clindamycin Topical (Drez V). 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 Clindamycin Topical (Drez V) at bedtime. This will help keep the medicine in the vagina and reduce leaking.
• Clindamycin Topical (Drez V) works best if it is used at the same time each day.
• To clear up your infection completely, use Clindamycin Topical (Drez V) for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Clindamycin Topical (Drez V) 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 Clindamycin Topical (Drez V).

Use Clotrimazole Topical (Drez V) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Clotrimazole Topical (Drez V). Talk to your pharmacist if you have questions about this information.
• Clotrimazole Topical (Drez V) is for vaginal use only. Do not use it rectally or take by mouth.
• Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days.
• Clotrimazole Topical (Drez V) comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use.
• External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging.
• Wash your hands immediately after using Clotrimazole Topical (Drez V).
• To clear up your infection completely, use Clotrimazole Topical (Drez V) for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Clotrimazole Topical (Drez V), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clotrimazole Topical (Drez V).

Clindamycin Topical (Drez V) is used to treat severe acne (acne vulgaris) and vaginal infections caused by certain bacteria.

Clotrimazole Topical (Drez V) is used for the treatment of fungal infections of the vagina, mouth, ear and skin, such as athlete's foot, jock itch, ringworm, thrush, or otitis externa (inflammation of outer ear).

See also:
What other drugs will affect Clindamycin Topical (Drez V)?

Erythromycin

Clindamycin Topical (Drez V) should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin 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

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Topical (Drez V) should be used with caution in patients receiving such agents.

See also:
What other drugs will affect Clotrimazole Topical (Drez V)?

Simultaneous administration of Clotrimazole Topical (Drez V) with amphotericin B, nystatin, natamycin activity of clotrimazole decreases.

See also:
What are the possible side effects of Clindamycin Topical (Drez V)?

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 Clindamycin Topical (Drez V) in 368 patients. Clindamycin Topical (Drez V) 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 clindamycin phosphate cream intravaginally in a single dose.

Of the 368 women treated with a single dose of Clindamycin Topical (Drez V), 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindamycin Topical (Drez V) and in 32 of 85 patients (38%) treated with placebo.

Adverse reactions occurring in ≥2% of patients receiving Clindamycin Topical (Drez V) in the placebo-controlled clinical trial are shown in Table 1.

Table 1. Adverse Reactions Occurring in ≥2% of Clindamycin Topical (Drez V)-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 Clindamycin Formulations

Clindamycin Topical (Drez V) affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:

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 clindamycin 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 clindamycin. A few cases of anaphylactoid reactions have been reported.

Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Musculoskeletal: Cases of polyarthritis have been reported.

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 in rare instances.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Clindamycin Topical (Drez V). 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

See also:
What are the possible side effects of Clotrimazole Topical (Drez V)?

Applies to Clotrimazole Topical (Drez V): topical cream, topical lotion, topical solution

In addition to its needed effects, some unwanted effects may be caused by Clotrimazole Topical (Drez V) (the active ingredient contained in Clotrimazole Topical (Drez V)). In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Clotrimazole Topical (Drez V), check with your doctor or nurse as soon as possible:

• Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

An antibacterial agent that is a semisynthetic analog of lincomycin.

Each gram of cream and topical powder contains clotrimazole 0.01 g.

Clotrimazole Topical (Drez V) Cream is odourless, can be washed off and does not stain.