Clindamycin Topical/Niacinamide

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 HCl and other antibacterial drugs, Clindamycin Topical 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.

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

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

Treating acne.

Niacinamide is a vitamin B supplement. Exactly how Niacinamide works is unknown.

• Niacinamide is for external use only. Avoid getting Niacinamide in your eyes. If you get Niacinamide in your eyes, rinse thoroughly with cool tap water.
• Follow up with your doctor after 8 to 12 weeks to monitor your progress.
• Do not use any other medicines or special cleansers on your skin unless your doctor instructs you otherwise. Makeup and other acne medicines may be applied over Niacinamide as directed by your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Niacinamide while you are pregnant. It is not known if Niacinamide is found in breast milk after topical use. If you are or will be breast-feeding while you use Niacinamide, check with your doctor. Discuss any possible risks to your baby.

Clindamycin Topical is for topical use only, and not for oral, ophthalmic, or intravaginal use.

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

Clindamycin Topical 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

Applies to the following strengths: 100 mg; 500 mg

Usual Adult Dose for:

• Niacin Deficiency
• Pemphigus

Usual Pediatric Dose for:

• Niacin Deficiency
• Pemphigus

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dialysis
• Other Comments

Usual Adult Dose for Niacin Deficiency

Recommended Daily Allowances (RDA):

Males: 19 mg orally each day

Females: 13 mg orally each day

Initial dose: 100 mg orally 3 times a day, with or after meals

Maintenance dose: 100 to 500 mg orally up to 3 times a day, with or after meals

Niacinamide has toxic potential at adult doses in excess of 3 g/day.

Niacinamide may also be administered parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products. All existing parenteral vitamin products for adults contain 40 mg/vial, which is the dose recommended by the American Medical Association/Nutrition Advisory Group for patients 11 years and older requiring parenteral vitamins.

Usual Adult Dose for Pemphigus

Recommended Daily Allowances (RDA):

Males: 19 mg orally each day

Females: 13 mg orally each day

Initial dose: 100 mg orally 3 times a day, with or after meals

Maintenance dose: 100 to 500 mg orally up to 3 times a day, with or after meals

Niacinamide has toxic potential at adult doses in excess of 3 g/day.

Niacinamide may also be administered parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products. All existing parenteral vitamin products for adults contain 40 mg/vial, which is the dose recommended by the American Medical Association/Nutrition Advisory Group for patients 11 years and older requiring parenteral vitamins.

Usual Pediatric Dose for Niacin Deficiency

Recommended Daily Allowances (RDA):

0 to 6 months: 5 mg orally each day

6 months to 1 year: 6 mg orally each day

1 to 3 years: 9 mg orally each day

4 to 6 years: 12 mg orally each day

7 to 10 years: 13 mg orally each day

Males:

11 to 14 years: 17 mg orally each day

15 to 18 years: 20 mg orally each day

19 to 50 years: 19 mg orally each day

Females:

11 to 50 years: 13 mg orally each day

Niacinamide may also be administered parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products. All existing parenteral vitamin products for children contain 17 mg/vial, which is the dose recommended by the American Medical Association/Nutrition Advisory Group for patients under 11 years of age.

Usual Pediatric Dose for Pemphigus

Recommended Daily Allowances (RDA):

0 to 6 months: 5 mg orally each day

6 months to 1 year: 6 mg orally each day

1 to 3 years: 9 mg orally each day

4 to 6 years: 12 mg orally each day

7 to 10 years: 13 mg orally each day

Males:

11 to 14 years: 17 mg orally each day

15 to 18 years: 20 mg orally each day

19 to 50 years: 19 mg orally each day

Females:

11 to 50 years: 13 mg orally each day

Niacinamide may also be administered parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products. All existing parenteral vitamin products for children contain 17 mg/vial, which is the dose recommended by the American Medical Association/Nutrition Advisory Group for patients under 11 years of age.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Because niacinamide is primarily metabolized by the liver and because of the risk of hepatotoxicity, niacinamide in not recommended in patients with liver dysfunction.

Dialysis

Data not available

Other Comments

Taking niacinamide with food may reduce stomach upset.

Niacinamide should not be taken with hot drinks.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about niacinamide

• Niacinamide Side Effects
• During Pregnancy
• Drug Interactions
• Support Group
• 1 Review
• Drug class: vitamins

Consumer resources

• Niacinamide
• Niacinamide Extended-Release Tablets

Related treatment guides

• Niacin Deficiency
• Pemphigus

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

Hypersensitivity

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

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

• Clindamycin Topical is for vaginal use only.
• Wash your hands before and after using Clindamycin Topical. 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 at bedtime. This will help keep the medicine in the vagina and reduce leaking.
• Clindamycin Topical works best if it is used at the same time each day.
• To clear up your infection completely, use Clindamycin Topical 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 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.

Use Niacinamide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash the affected area with a mild cleanser or other cleansing product prescribed by your doctor and completely dry.
• Apply a thin layer of the medicine to the affected area twice daily or as directed by your doctor. Gently rub the medicine in until it is evenly distributed.
• Wash your hands immediately after using Niacinamide.
• If you miss a dose of Niacinamide, 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 Niacinamide.

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

To treat Hartnup disease (light sensitive skin rashes), inflammatory skin disease, vitamin deficiency, anxiety and Alzheimer’s disease (disorder that causes mental confusion and forgetfulness). It is also used in combination with intravenous vitamin C therapy for cancer.

See also:
What other drugs will affect Clindamycin Topical?

Erythromycin

Clindamycin Topical 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 should be used with caution in patients receiving such agents.

See also:
What are the possible side effects of Clindamycin Topical?

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

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

Table 1. Adverse Reactions Occurring in ≥2% of Clindamycin Topical-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 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. 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 Niacinamide?

Applies to niacinamide: tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; itching; nausea; stomach upset; temporary feeling of warmth or flushing of the skin.

Seek medical attention right away if any of these SEVERE side effects occur while taking niacinamide:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; changes in vision; dark urine; decreased urination; fast or irregular heartbeat; loss of appetite; muscle pain or weakness; numbness or persistent tingling of the skin; persistent nausea, vomiting, or general "unwell" feeling; severe or prolonged flushing of the skin; stomach pain; swelling of the hands, legs, or feet; vomit that looks like coffee grounds; yellowing of the skin or eyes.

An antibacterial agent that is a semisynthetic analog of lincomycin.

Niacinamide, also called as nicotinamide (vitamin B3), is prescribed for the treatment of niacin deficiency disorders including pellagra. Niacinamide should not be used for treatment of hyperlipidemia.