clindamycin vaginal

Action and Spectrum

Actions and spectrum: 

Action: 

• Protein Synthesis Inhibition: clindamycin binds to the 50S subunit of bacterial ribosome and inhibits the protein synthesis. This disruption in protein production prevents bacterial growth and replication. 

Spectrum: 

• Gram-Positive Bacteria: clindamycin is particularly effective against various Gram-positive bacteria, including Streptococci (e.g., Streptococcus agalactiae, Streptococcus pneumoniae), Staphylococci (including Staphylococcus aureus, including methicillin-resistant strains, MRSA), Clostridium species (some, not all) 
• Anaerobic Bacteria: clindamycin also exhibits activity against anaerobic bacteria, such as Bacteroides species. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Cleocin vaginal cream 

Vulvovaginal disorder (3.2-7.1%) 

Moniliasis, body (0.2-1.3%) 

Vulvovaginitis (4.4-6%) 

Trichomonal vaginitis (1.3%) 

Pruritus, nonapplication site (1.1%) 

Xaciato 

Vulvovaginal candidiasis (17%) 

Clindesse vaginal cream 

Back pain (5%) 

Urinary tract infection (2%) 

Headache (7%) 

Constipation (2%) 

Cleocin vaginal suppository 

Vaginal pain (1.9%) 

Fungal infection (1%) 

Vulvovaginal disorder (3.4%) 

Vaginal moniliasis (1.5%)  

>10% 

Xaciato 

Vulvovaginal candidiasis (17%) 

Clindesse vaginal cream 

Cleocin vaginal cream H4 

Fungal vaginosis (14%) 

Vaginal moniliasis (7.1-13.3%)  

<1% 

Dermatologic: pruritus, Pruritic rash, erythema 

General: Fatigue 

Nervous System: Dizziness 

Whole body: Upper respiratory tract infection 

Gastrointestinal: vomiting, Diarrhea 

Immune System: Hypersensitivity 

Reproductive System: dysuria, Dysfunctional uterine bleeding, dysmenorrhea, menorrhagia, intermenstrual bleeding, pelvic pain, vaginal irritation, vaginal burning, vulvar erythema, vulvovaginitis, vulvovaginal discomfort, vulvitis, vulvovaginal dryness  

Postmarketing Reports 

Drug reaction with the eosinophilia systemic symptoms (DRESS) 

Pseudomembranous colitis 

Black Box Warning

Black Box Warning: 

There is no specific black box warning associated with clindamycin vaginal. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Individuals with a known hypersensitivity or allergy to clindamycin or other components of the vaginal product should avoid its use. 
• History of Colitis: clindamycin use has been associated with the development of colitis, including pseudomembranous colitis. Individuals with a history of colitis should exercise caution, and the benefits and risks of clindamycin use should be carefully assessed. 
• Known History of Regional Enteritis, Ulcerative Colitis, or Crohn’s Disease: clindamycin should be used with caution in individuals with a history of inflammatory bowel diseases such as regional enteritis, ulcerative colitis, or Crohn’s disease. 
• Use with Erythromycin: Concomitant use of clindamycin and erythromycin is not recommended due to potential antagonism of their effects.

Caution: 

• Pseudomembranous Colitis: clindamycin use has been associated with the development of pseudomembranous colitis, a severe inflammation of the colon. Patients should be monitored for symptoms such as diarrhea, abdominal pain, and fever. If pseudomembranous colitis is suspected, discontinuation of clindamycin and appropriate medical intervention are necessary. 
• Renal and Hepatic Impairment: Caution is advised in individuals with renal or hepatic impairment. Adjustments to the dosage of clindamycin may be necessary based on the severity of impairment. 
• History of Gastrointestinal Disease: Individuals with a history of gastrointestinal disease, particularly colitis, should use clindamycin with caution. The potential risk of exacerbating gastrointestinal conditions should be weighed against the benefits of treatment.

Comorbidities: 

• Immunocompromised States: Individuals with compromised immune systems, whether due to conditions such as HIV/AIDS, immunosuppressive therapies, or other immunodeficiencies, may be more susceptible to infections.  
• Allergies and Hypersensitivity Reactions: Individuals with a history of allergies or hypersensitivity reactions to clindamycin or related drugs should be cautious, as they may have an increased risk of adverse reactions. 
• Pregnancy and Lactation: The safety of clindamycin vaginal products during pregnancy and lactation may need careful consideration. The risks and benefits should be assessed, and the use of the medication should be determined in consultation with healthcare providers. 

Pregnancy / Lactation

Pregnancy consideration: US FDA pregnancy category: B 

Lactation: Excreted into human milk: Yes 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

clindamycin is an antibiotic with a mechanism of action that involves inhibiting bacterial protein synthesis. The vaginal formulation of clindamycin is used to treat bacterial infections affecting the vaginal area. It works by binding to 50S subunit of bacterial ribosome, thereby blocking the synthesis of bacterial proteins.

This disruption in protein synthesis impedes bacterial growth and replication. clindamycin exhibits a spectrum of activity primarily against Gram-positive bacteria, including pathogens such as Streptococcus and Staphylococcus species. The use of clindamycin vaginal products is indicated in conditions like bacterial vaginosis, where there is an imbalance in the normal vaginal flora.

The antibiotic’s pharmacological properties contribute to its efficacy in combating bacterial infections in the vaginal region, and its application is guided by healthcare professionals based on the specific clinical context. As with any medication, the appropriate use of clindamycin vaginal products involves a careful assessment of the patient’s condition and consideration of potential risks and benefits.  

Pharmacodynamics: 

• Protein Synthesis Inhibition: clindamycin binds to the 50S subunit of the bacterial ribosome, disrupting the synthesis of bacterial proteins. By interfering with this essential cellular process, clindamycin prevents the production of proteins necessary for bacterial growth and replication. 
• Bacteriostatic and Bactericidal Effects: clindamycin exhibits both bacteriostatic (inhibits bacterial growth) and bactericidal (kills bacteria) effects, depending on the concentration of drug at the site of infection and susceptibility of the target bacteria. In some cases, particularly against certain Gram-positive bacteria, it may act as bactericidal. 
• Spectrum of Activity: clindamycin is effective against a range of bacteria, primarily Gram-positive cocci, including Staphylococcus and Streptococcus species. It is also active against certain anaerobic bacteria, making it suitable for treating infections caused by these organisms. 
• Treatment of Bacterial Vaginosis: In the case of the vaginal formulation, clindamycin is used to treat bacterial vaginosis, a condition characterized by an imbalance in the normal vaginal flora. By targeting the responsible bacteria and inhibiting their protein synthesis, clindamycin helps restore the balance of the vaginal microbiota. 
• Impact on Anaerobic Bacteria: clindamycin’s activity against anaerobic bacteria is relevant in the context of bacterial vaginosis, where anaerobic organisms may contribute to the infection. 

Pharmacokinetics: 

Absorption 

clindamycin vaginal cream or suppositories are designed for local application in the vaginal area. Absorption of the drug occurs through the vaginal mucosa. The extent of systemic absorption is low compared to oral or intravenous administration. 

Distribution 

clindamycin distributes within the vaginal tissues after local administration. The drug primarily exerts its effects at the site of application, targeting the bacteria causing the infection in the vaginal area. Limited systemic distribution occurs. 

Metabolism 

clindamycin is not extensively metabolized in the body. The drug’s primary form is the active compound clindamycin, and it undergoes minimal hepatic metabolism. 

Elimination and excretion 

clindamycin and its metabolites are excreted from the body, with the majority of elimination occurring through renal excretion. Some unchanged drug may be excreted in the urine. 

Adminstartion

Administration: 

• Wash Hands: Before handling the medication, wash your hands thoroughly to minimize the risk of introducing bacteria. 
• Prepare the Applicator: If the product comes with an applicator, prepare it according to the instructions. This may involve attaching a prefilled applicator or filling the applicator with the prescribed amount of clindamycin. 
• Positioning: Find a comfortable position, such as lying on your back with knees bent or standing with one foot elevated on a surface. Choose the position that allows for easy insertion of the applicator. 
• Insert the Applicator: the applicator inserted into the vagina as directed by your healthcare provider. It is important to avoid inserting it too deep. If you have any concerns or difficulty with insertion, consult your healthcare provider. 
• Administer the Medication: If using a prefilled applicator, push the plunger to release the medication. If using a cream or ovule, follow the specific instructions provided with the product. 
• Dispose of the Applicator: After administration, dispose of the applicator as instructed. Some applicators may be single-use and should be discarded after each application. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: clindamycin vaginal 

Pronounced: (klin-duh-MY-sin va-JY-nuhl) 

Why do we use clindamycin vaginal? 

clindamycin vaginal products, such as clindamycin vaginal cream or suppositories, are used for the treatment of specific infections in the vaginal area. The primary indication for the use of clindamycin in the vaginal form is the management of bacterial vaginosis (BV).

BV is often associated with an overgrowth of harmful bacteria, leading to symptoms such as vaginal discharge, odor, and discomfort. clindamycin helps to eliminate the overgrowth of these bacteria, restoring a healthier balance to the vaginal microbiota.