Overdose of Clindoxyl ADV in details
Excessive application of Clindoxyl ADV Gel may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
Topically applied Benzoyl Peroxide (Clindoxyl ADV) is not generally absorbed in sufficient amounts to produce systemic effects.
Excessive application of topically applied Clindamycin (Clindoxyl ADV) may result in absorption of sufficient amounts to produce systemic effects.
In the event of accidental ingestion of Clindoxyl ADV Gel, gastrointestinal adverse reactions similar to those seen with systemically administered Clindamycin (Clindoxyl ADV) may be seen.
Appropriate symptomatic measures should be taken to provide relief from irritation due to excessive application.
Accidental ingestion should be managed clinically.
Clindoxyl ADV warnings
ORALLY AND PARENTERALLY ADMINISTERED Clindamycin (Clindoxyl ADV) HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF Clindamycin (Clindoxyl ADV) RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC Clindamycin (Clindoxyl ADV). STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH Clindamycin (Clindoxyl ADV).
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
What should I discuss with my healthcare provider before taking Clindoxyl ADV?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Benzoyl Peroxide (Clindoxyl ADV) and Clindamycin (Clindoxyl ADV) combination in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of Duac® gel have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
No information is available on the relationship of age to the effects of Benzaclin® gel in geriatric patients.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Erythromycin
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Stomach or bowel problems (eg, antibiotic-associated colitis, pseudomembranous colitis, regional enteritis, ulcerative colitis), history of—Should not be used in patients with these conditions.
Clindoxyl ADV precautions
Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water. Clindoxyl ADV Gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Clindoxyl ADV Gel should be used with caution in atopic patients, in whom further skin drying may occur.
During the first weeks of treatment, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non-comedogenic moisturiser, temporarily reduce the frequency of application of Clindoxyl ADV Gel or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.
If severe local irritancy (e.g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, patients should be advise to discontinue Clindoxyl ADV Gel and consult their doctor.
As Benzoyl Peroxide (Clindoxyl ADV) may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.
If a patient has sunburn, this should be resolved before using Clindoxyl ADV Gel. If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Clindoxyl ADV Gel should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered.
The product may bleach hair or coloured fabrics. Avoid contact with hair, fabrics, furniture or carpeting.
Resistance to Clindamycin (Clindoxyl ADV): Patients with a recent history of systemic or topical Clindamycin (Clindoxyl ADV) or erythromycin use are more likely to have pre-existing anti-microbial resistant Propionibacterium acnes and commensal flora.
Cross-Resistance: Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.
Fertility: There are no data on the effect of Clindoxyl ADV Gel on fertility in humans.
References
- DailyMed. "BENZOYL PEROXIDE; ERYTHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Benzoyl peroxide". http://www.drugbank.ca/drugs/DB09096 (accessed September 17, 2018).
- DrugBank. "clindamycin". http://www.drugbank.ca/drugs/DB01190 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
