ClindaMax

Last updated on RxList: 7/12/2018
ClindaMax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/12/2018

Clindamax Vaginal Cream (clindamycin phosphate vaginal cream, 2%) is an antibiotic indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). ClindaMax Vaginal Cream can be used to treat non-pregnant women and pregnant women during the second and third trimester. Common side effects of ClindaMax Vaginal Cream include:

The recommended dose is one applicatorful of ClindaMax Vaginal Cream (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. ClindaMax Vaginal Cream may interact with other neuromuscular blocking agents. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Clindamax Vaginal Cream. Clindamax Vaginal Cream should be used during the first trimester of pregnancy only if prescribed. It is unknown if topical Clindamax Vaginal Cream passes into breast milk. Oral forms of clindamycin pass into breast milk. Breastfeeding while using Clindamax Vaginal Cream is not recommended.

Our Clindamax Vaginal Cream (clindamycin phosphate vaginal cream, 2%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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ClindaMax Consumer Information

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

Stop using clindamycin topical and call your doctor at once if you have:

  • severe redness, itching, or dryness of treated skin areas; or
  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose).

Common side effects may include:

  • burning, itching, dryness, peeling or redness of treated skin; or
  • oily skin.

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.

Read the entire detailed patient monograph for ClindaMax (Clindamycin Phosphate)

SLIDESHOW

Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
ClindaMax Professional Information

SIDE EFFECTS

Clinical Trials

Non-Pregnant Women

In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.

Table 1- Events Occurring in ≥1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%

Event Clindamycin Phosphate Vaginal Cream
3 Day
n=600
7 Day
n=1325
Urogenital    
  Vaginal moniliasis 7.7 10.4
  Vulvovaginitis 6.0 4.4
  Vulvovaginal disorder 3.2 5.3
  Trichomonal vaginitis 0 1.3
Body as a Whole    
  Moniliasis (body) 1.3 0.2

Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:

Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain.

Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial infection, inflammatory swelling, allergic reaction, and fungal infection.

Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder.

Endocrine system: hyperthyroidism.

Central nervous system: dizziness and vertigo.

Respiratory system: epistaxis.

Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria.

Special senses: taste perversion.

Pregnant Women

In a clinical trial involving pregnant women during the second trimester, 1.7% of 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 22.8% of pregnant patients. Events occurring in ≥1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2.

Table 2- Events Occurring in ≥1% of Preg nant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo

Event Clindamycin Placebo
7 Day
n=180
7 Day
n=184
Urogenital    
  Vaginal moniliasis 13.3 7.1
  Vulvovaginal disorder 6.7 7.1
  Abnormal labor 1.1 0.5
Body as a Whole    
  Fungal infection 1.7 0
Skin    
Pruritus, non-application site   0

Other events occurring in <1% of the clindamycin vaginal cream 2% group include:

Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis.

Body as a whole: upper respiratory infection.

Skin: pruritus (topical application site) and erythema.

Other clindamycin formulations:

Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

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

Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea. (See WARNINGS.)

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 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. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.

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

Read the entire FDA prescribing information for ClindaMax (Clindamycin Phosphate)

© ClindaMax Patient Information is supplied by Cerner Multum, Inc. and ClindaMax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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