Clindamycin Phosphate and Benzoyl Peroxide Gel - Indication, Dosage, Precautions, and Pharmacological Aspects

Overview:

Acne is often treated with fixed-combination medications comprising Clindamycin and Benzoyl peroxide (BPO). Clindamycin helps to significantly improve acne by lowering propionibacterium acne concentrations and inflammation. This assists in reducing the signs and stopping the growth of new acne lesions.

BPO is well-known for its speedy bactericidal abilities that successfully target and eradicate germs that cause acne. Additionally, it aids in avoiding the development of bacterial strains resistant to antibiotics, which is a major concern in the long-term care of acne. However, it is important to remember that BPO has a possible disadvantage: its concentration-dependent propensity to produce skin dryness and irritation. This might occasionally cause pain and reduce patient adherence to the recommended course of treatment. In some circumstances, the level of dryness and irritation may restrict how frequently or how much product may be applied without discomfort.

Due to their dual mechanisms of action, fixed-combination products containing Clindamycin and BPO are useful components in managing acne vulgaris. However, when prescribing these products, healthcare professionals should consider the possibility of skin dryness and irritation and work closely with patients to find a suitable harmony between efficacy and tolerability. The Food and Drug Administration (US FDA) approved the drug in 2000.

Drug Group:

• Clindamycin Phosphate: It is a water-soluble ester derived from the semi-synthetic antibiotic Lincomycin. It is created by introducing a 7(S)-chloro-substitution at the 7(R)-hydroxyl group of Lincomycin.

• Benzoyl Peroxide: It is an FDA-approved prescription drug and an over-the-counter (OTC) topical medicine for treating acne vulgaris. It clears skin, removes oil, and destroys the germs that cause acne. It works best when used in conjunction with other therapies and does not cause bacterial resistance.

Available Doses and Dosage Forms:

The color of Clindamycin and Benzoyl peroxide gel is opaque and ranges from white to slightly yellow. Each gram of Clindamycin and Benzoyl peroxide gel includes 50 mg (milligrams) of Benzoyl peroxide and 12 mg of Clindamycin phosphate, equal to 10 mg of Clindamycin.

For Patients:

What Is Acne?

Acne vulgaris is a common dermatological disorder that causes skin pores to get clogged, leading to different blemishes including blackheads, whiteheads, and other types of pimples. For those with the disorder, these pimples, which are frequently pus-filled, can be irritating and painful.

How Do Clindamycin Phosphate and Benzoyl Peroxide Gel Work?

Clindamycin and Benzoyl peroxide work well together as an acne therapeutic agent. These two ingredients are part of a class of drugs called topical antibiotics. Their coordinated efforts center on identifying and destroying the bacteria that cause acne, which increases the effectiveness of their therapeutic effects.

What Is the Dosage of Clindamycin Phosphate and Benzoyl Peroxide Gel?

The medication comes in gel form and includes Benzoyl peroxide at a concentration of five percent and Clindamycin Phosphate at 1.2 percent.

What Are the Things to Inform the Doctor Before Taking the Drug?

Individuals must take the following actions and notify their doctor and chemist before using Clindamycin and Benzoyl peroxide:

• Allergies: Notify the healthcare provider and pharmacist of any known allergies to medications, including Clindamycin.

• Medication and Supplement List: Provide a thorough list of all presently used prescription and over-the-counter drugs, vitamins, nutritional supplements, and herbal items. Mentioning any particular drugs, such as Erythromycin and any other topical acne treatments, is crucial. The doctor may require this information to modify drug dosages appropriately or to watch for any side effects carefully.

• Stomach Issues and Digestive Conditions: A history of stomach troubles, ulcerative colitis (a disease marked by inflammation and ulcers in the colon and rectum lining), or past bouts of severe diarrhea brought on by antibiotic usage should be disclosed to the healthcare professional.

• Nursing and Pregnancy: It is important to inform the doctor if an individual is nursing, trying to get pregnant, or already pregnant. It is advised to speak with the doctor right away if they become pregnant while taking Clindamycin and Benzoyl peroxide.

• Precautions for Sun Exposure: Reduce unnecessary or extended exposure to sunlight. Since Benzoyl peroxide and Clindamycin may make skin more sensitive to sunlight, it is advised to use protective clothes, sunglasses, and sunscreen.

• Recommendation for Moisturizer: Ask the doctor or chemist for the best moisturizer to keep the skin smooth during treatment.

How Are Clindamycin Phosphate and Benzoyl Peroxide Gel Administered?

Clindamycin and Benzoyl peroxide are combined as a gel intended to be used topically on the skin. It is often recommended to use this gel twice daily, in the morning and the evening. The efficacy of the application can be increased by being consistent with the time. People should carefully follow the directions on their prescription labels to ensure optimal usage. Ask a healthcare professional or chemist for clarification if any part of the guidelines is unclear. Clindamycin and Benzoyl peroxide gel must be applied exactly as directed; any variations, such as using more or less of the prescribed quantity or using it more frequently than recommended by a doctor, must be avoided. To use the gel, the individual should follow these steps:

• Wash the affected area with warm water and gently pat it dry with a clean towel.

• Use fingertips to apply a thin and even layer of the gel to the affected area. Avoid getting the gel into the eyes, nose, mouth, or other body openings. If accidental contact with the eyes occurs, rinse with warm water.

• Examine the treated area in a mirror. If a white film is visible on the skin, this indicates an excessive application of the medication.

• After application, remember to wash one’s hands thoroughly.

What Are the Side Effects of Clindamycin Phosphate and Benzoyl Peroxide Gel?

Common side effects are:

• Redness of the skin.

• Skin peeling.

• Dryness of the skin.

• Itching of the skin.

More serious side effects are:

• Pain in the stomach or cramps.

• The presence of blood or mucus in the stool.

• Diarrhea.

• Noticeable changes in the skin or nails that might indicate skin infections.

Dietary Considerations:

No special dietary considerations unless advised by the doctors.

Missed Dose:

On remembering, take the missing dosage right away. But if it is almost time for the next dosage, skip the missed dose and continue taking the medication according to schedule. Do not increase the dosage to make up for missing doses.

Storage

• The drug must be kept in its original container, which must be kept firmly closed, at room temperature, away from sources of extreme heat and moisture, and not in the bathroom.

• After ten weeks, all unused medicine should be thrown away.

• Dispose of unused prescriptions in a way that keeps animals, kids, and others from getting to them.

• The drug should not be flushed down the toilet. The best way to dispose of medications is through a medication take-back program; people may learn more by speaking with their chemist or the local waste management or recycling center.

Notably, many containers, such as weekly pill organizers and those for eye drops, creams, patches, and inhalers, may not have child-resistant characteristics, making them easily accessible to young children. This makes it vital to keep drugs out of sight and out of children's reach. Safety caps should always be fastened, and medicines should be quickly put in a safe position that is out of their sight and reach to prevent accidental poisoning in young children.

For Doctors:

Indications:

The topical usage of Clindamycin phosphate (1.2 percent) and Benzoyl peroxide gel (5 percent) is indicated for treating inflammatory acne vulgaris in individuals 12 years of age or older.

Dose and Administration:

Use a small amount of Clindamycin phosphate and Benzoyl peroxide gel to cover the face lightly once daily in the evening or according to the doctor's instructions. Gently wash the skin, rinse it warmly, and pat it dry before applying gel. Avoid touching damaged skin, lips, mouth, eyes, or mucous membranes. Please note that the gel is only meant to be applied topically and should not be ingested or applied to the eyes or intravaginally.

Dosing Considerations:

The color of Clindamycin phosphate and Benzoyl peroxide gel, which is opaque, ranges from white to slightly yellow. The gel contains 50 mg of Benzoyl peroxide and 12 mg of Clindamycin phosphate, comparable to 10 mg of Clindamycin. These active chemicals are crucial parts of the composition of the acne treatment product Clindamycin phosphate and Benzoyl peroxide gel.

What Are the Pharmacological Aspects of Clindamycin Phosphate and Benzoyl Peroxide Gel?

Description:

Clindamycin Phosphate:

• Molecular Formula - C18H34ClN2O8PS.

• Molecular Weight - 504.97.

Benzoyl Peroxide:

• Molecular Formula - C14H10O4.

• Molecular Weight - 242.23.

Each gram of Clindamycin phosphate and Benzoyl peroxide gel contains 50 mg (5 percent) Benzoyl peroxide and 10 mg (1 percent) Clindamycin as Clindamycin phosphate in a base of disodium lauryl sulfosuccinate, dimethicone, glycerin, edetate disodium, silicon dioxide, purified water, poloxamer 182, methylparaben, and sodium hydroxide.

Mechanism of Action:

• Clindamycin - The antibacterial compound Clindamycin belongs to the Lincosamide class.

• Benzoyl Peroxide - The oxidizing agent Benzoyl peroxide, on the other hand, possesses keratolytic and bactericidal characteristics. However, the precise mechanism by which Benzoyl peroxide works has yet to be entirely understood.

Pharmacokinetics:

Clindamycin blood levels were shown to be very low, less than 0.5 ng/mL (nanogram per milliliter), for both groups over the four-week treatment period in research comparing Clindamycin phosphate and Benzoyl peroxide gel with a one percent Clindamycin solution, comprising 78 patients. The skin can absorb Benzoyl peroxide, which is then transformed into Benzoic acid. Less than two percent, or very little, is absorbed as Benzoic acid into the blood. The majority of it, therefore, remains on the skin and does not go throughout the body.

Microbiology:

Clindamycin prevents bacteria from producing proteins by adhering to certain areas of the organism. By doing this activity, germs cannot develop and spread illnesses. The 50S ribosomal subunits of susceptible bacteria bind to Clindamycin. Interacting with peptidyl transfer stops peptide chains from lengthening, hence halting protein synthesis.

• In Vivo Activity - No microbial research was done in the clinical tests using this product. As a result, more is needed to know about how Clindamycin interacts with real living things.

• In Vitro Activity - Clindamycin and Benzoyl peroxide components have demonstrated in vitro action against Propionibacterium acnes, a bacterium linked to acne vulgaris. How useful this in vitro activity will be in actual clinical settings is still being determined because the therapeutic relevance of this activity is unknown.

• Drug Resistance - There have been instances of Propionibacterium acnes becoming more resistant to Clindamycin when it is used to treat acne. Clindamycin might not offer any further advantages over Benzoyl peroxide alone in people with Propionibacterium acnes resistance. This shows that Clindamycin's ability to cure acne may be constrained by medication resistance.

Toxicity:

• Benzoyl Peroxide and Tumor Promotion - Animal studies have demonstrated that the acne treatment ingredient, Benzoyl peroxide, advances and encourages the growth of tumors. In research on mice, applying high doses of Benzoyl peroxide twice a week for 20 weeks caused skin tumors to grow. Since the therapeutic relevance of these findings is unknown, it is unclear how this could apply to people.

• Fertility Research - There has been no research on how Clindamycin phosphate and Benzoyl peroxide gel affect fertility (the capacity to conceive children). Even at very high dosages, Clindamycin, when ingested as a separate drug and taken orally by rats, had no negative effects on their capacity to reproduce or mate.

• Genetic Damage - No particular testing was conducted to determine whether Clindamycin phosphate and Benzoyl peroxide gel can harm genetic material. In certain experiments, Clindamycin did not exhibit any genetic harm. At the same time, Benzoyl peroxide has been shown to damage DNA (deoxyribonucleic acid) in various cell types and may result in mutations.

• Effect of Ultraviolet Radiation - When mice using Clindamycin phosphate and Benzoyl peroxide gel were exposed to ultraviolet (UV) radiation, they developed skin tumors more quickly and in greater numbers than mice not using the gel.

• Carcinogenicity Studies - There was no rise in skin tumors in a mouse trial using Clindamycin phosphate and Benzoyl peroxide gel when administered at very high dosages. However, prolonged use of a different formulation involving Clindamycin and Benzoyl peroxide in male rats resulted in skin growths known as keratoacanthomas.

Clinical Studies (Safety and Efficacy):

According to several studies, clindamycin phosphate 1.2 percent and Benzoyl peroxide (BPO) five percent work together synergistically to treat skin disorders like acne more effectively than each active component alone. However, a significant downside of the BPO component in these fixed combinations is that, mostly because of its concentration-dependent effects, it may cause skin irritation and dryness in a fraction of individuals.

What Are the Contraindications of Clindamycin Phosphate and Benzoyl Peroxide Gel?

• Clindamycin phosphate and Benzoyl peroxide gel are not recommended for use in those with a history of pseudomembranous colitis, antibiotic-associated colitis, ulcerative colitis, or regional enteritis.

• People who have shown signs of hypersensitivity to Lincomycin, Benzoyl peroxide, any of the ingredients in the formulation, or Clindamycin should not use Clindamycin phosphate and Benzoyl peroxide gel since it is contraindicated in these circumstances. It is significant to highlight that cases of anaphylaxis and severe allergic reactions requiring hospitalization have been linked to postmarketing usage of the gel.

Warnings and Precautions:

• Colitis - Clindamycin is absorbed into the body when administered topically. Systemic and topical Clindamycin usage has been linked to reports of colitis, including pseudomembranous colitis, and diarrhea, including bloody diarrhea. It is advised to stop using Clindamycin phosphate and Benzoyl peroxide gel if there is a substantial episode of diarrhea. After receiving Clindamycin parenterally and orally, severe colitis has been reported; this condition can often manifest several weeks after the medication has been stopped. Antiperistaltic medications like opiates and Diphenoxylate combined with Atropine may make severe colitis worse and last longer. It is crucial to remember that severe colitis has the potential to be lethal.

• Ultraviolet Light and Environmental Exposure - Benzoyl peroxide, one of the gel's components, may make people more sensitive to sunlight. Precautions must be taken to reduce exposure to the sun, which includes refraining from using tanning beds or sunlamps after administering the drug. People who work in occupations involving a lot of sun exposure or who are naturally sensitive to the sun need to be very careful about following this advice.

What Are the Drug Interactions of Clindamycin Phosphate and Benzoyl Peroxide Gel?

• Erythromycin - Since Clindamycin in the gel may interact intensely with Erythromycin, as demonstrated in lab studies, do not take Clindamycin phosphate and Benzoyl peroxide gel with items that contain it. However, the precise effects that this combination will have on patients are not known, so caution should be maintained while mixing these treatments.

• Concomitant Topical Medications - Be cautious when using Clindamycin phosphate and Benzoyl peroxide gel with other topical acne treatments as they may cause skin irritation to worsen, especially if they contain peeling, desquamating, or abrasive ingredients. Consider lowering the frequency of Clindamycin phosphate and Benzoyl peroxide application or stopping treatment if dermatitis or irritation develops. It is advised to stop using Clindamycin phosphate and Benzoyl peroxide gel therapy if the irritation still exists despite these changes. This method aids in controlling skin irritation and guarantees that acne sufferers will have a comfortable and productive overall treatment experience. Always seek the advice of a healthcare professional for specific advice on how to treat and manage acne.

• Neuromuscular Blocking Agents - The neuromuscular blocking qualities of Clindamycin may enhance the effectiveness of other neuromuscular blocking medications. Therefore, using this gel with extreme caution while administering these medications to people is vital. When combined, the effect on muscular function might be increased, and difficulties could result. To protect patients' safety in these circumstances, medical professionals should thoroughly evaluate and monitor them. By taking this extra precaution, they may simultaneously avoid any negative effects or issues that could result from using Clindamycin phosphate and Benzoyl peroxide gel and neuromuscular blocking medications. When combining these drugs, always heed the advice of a healthcare provider.

Specific Considerations:

• Pregnancy - There has not been enough research on pregnant women, so it is unclear whether Clindamycin phosphate and Benzoyl peroxide gel are safe during pregnancy. Only if the advantages to the mother outweigh the hazards to the unborn child should it be utilized. Much greater doses of Clindamycin than those used in human trials were administered to rats and mice, yet no evidence of birth abnormalities was seen. It is crucial to remember that animal research results may translate to something other than similar effects in humans. Use Clindamycin phosphate and Benzoyl peroxide gel only if the doctor thinks it is very important for the skin condition if an individual is pregnant.

• Lactating Mothers - When administered to the skin, Clindamycin phosphate and Benzoyl peroxide gel may enter breast milk; however, this is unknown. Clindamycin has been discovered in breast milk after oral or intravenous administration. This could be harmful to a breastfeeding infant. In light of how crucial the medicine is to the mother, she should determine whether to quit nursing or stop using the drug. Care is advised when a breastfeeding woman takes Clindamycin phosphate and Benzoyl peroxide gel because many medications might end up in breast milk. It is best to seek advice from a healthcare expert in such circumstances.

• Pediatric Population - For children under 12, Clindamycin phosphate and Benzoyl peroxide gel have not been researched enough to demonstrate their effectiveness and safety. As a result, it is not advised for usage with this age group.

• Geriatric Population - There were not enough elderly participants (more than 65) in the Clindamycin phosphate and Benzoyl peroxide gel experiments (clinical studies) to determine whether they were affected differently than younger people.