Clindamycin and Benzoyl Peroxide

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Overview

What is Clindamycin and Benzoyl Peroxide?

For Dermatological Use Only - Not for Ophthalmic Use

*Reconstitute Before Dispensing*

Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

Chemically, clindamycin phosphate is (CHClNOPS). The structural formula for clindamycin is represented below:

Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate).

Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (CHO). It has the following structural formula:

Benzoyl peroxide has a molecular weight of 242.23.

Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.

What does Clindamycin and Benzoyl Peroxide look like?

What are the available doses of Clindamycin and Benzoyl Peroxide?

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What should I talk to my health care provider before I take Clindamycin and Benzoyl Peroxide?

Sorry No records found

How should I use Clindamycin and Benzoyl Peroxide?

Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

Clindamycin and Benzoyl Peroxide Gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

What interacts with Clindamycin and Benzoyl Peroxide?

Clindamycin and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

What are the warnings of Clindamycin and Benzoyl Peroxide?

8. OATP1B1 substrates – Gemfibrozil is an inhibitor of organic anion-transporter polyprotein (OATP) 1B1 and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see ). Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see ).

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN 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. 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 AND STOOL ASSAY FOR 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.

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 colitis.

What are the precautions of Clindamycin and Benzoyl Peroxide?

General

For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.

Avoid contact with eyes and mucous membranes.

Clindamycin and erythromycin containing products should not be used in combination. studies have shown antagonism between these two antimicrobials. The clinical significance of this antagonism is not known.

Information for Patients

Clindamycin and benzoyl peroxide gel, 1%/5% is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.
This medication should not be used for any disorder other than that for which it was prescribed.
Patients should not use any other topical acne preparation unless otherwise directed by physician.
Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using clindamycin and benzoyl peroxide gel, 1%/5%. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used.
Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue clindamycin and benzoyl peroxide gel, 1%/5% and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician.
Clindamycin and benzoyl peroxide gel, 1%/5% may bleach hair or colored fabric.
Clindamycin and benzoyl peroxide gel, 1%/5% can be stored at room temperature up to 25°C (77°F) for 3 months. Do not freeze. Discard any unused product after 3 months.
Before applying clindamycin and benzoyl peroxide gel, 1%/5% to affected areas wash the skin gently, then rinse with warm water and pat dry.

Patients using clindamycin and benzoyl peroxide gel, 1%/5% should receive the following information and instructions:

Carcinogenesis, Mutagenesis, Impairment of Fertility

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown.

Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of clindamycin and benzoyl peroxide gel, 1%/5% with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).

In a 2-year dermal carcinogenicity study in rats, treatment with clindamycin and benzoyl peroxide gel, 1%/5% at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide gel, 1%/5%, based on mg/m) was statistically significantly higher than that in the sham- and vehicle-controls.

Genotoxicity studies were not conducted with clindamycin and benzoyl peroxide gel, 1%/5%. Clindamycin phosphate was not genotoxic in or in a rat micronucleus test. Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with clindamycin and benzoyl peroxide gel, 1%/5% or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide gel, 1%/5%, based on mg/m) revealed no effects on fertility or mating ability.

Pregnancy: Teratogenic Effects: Pregnancy Category C:

Animal reproductive/developmental toxicity studies have not been conducted with clindamycin and benzoyl peroxide gel, 1%/5% or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m, respectively) revealed no evidence of teratogenicity.

There are no well-controlled trials in pregnant women treated with clindamycin and benzoyl peroxide gel, 1%/5%. It also is not known whether clindamycin and benzoyl peroxide gel, 1%/5% can cause fetal harm when administered to a pregnant woman.

Nursing Women

It is not known whether clindamycin and benzoyl peroxide gel, 1%/5% is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

What are the side effects of Clindamycin and Benzoyl Peroxide?

During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide gel, 1%/5% and vehicle groups.

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.



Application site reaction	13 (3%)	1 (<1%)
Dry skin	50 (12%)	10 (6%)
Pruritus	8 (2%)	1 (<1%)
Peeling	9 (2%)	-
Erythema	6 (1%)	1 (<1%)
Sunburn	5 (1%)	-

What should I look out for while using Clindamycin and Benzoyl Peroxide?

Clindamycin and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN 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. 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 AND STOOL ASSAY FOR 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.

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 colitis.

What might happen if I take too much Clindamycin and Benzoyl Peroxide?

Sorry No Records found

How should I store and handle Clindamycin and Benzoyl Peroxide?

Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17Prior to dispensing, Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Prescribing Information as of July 2017. Rx OnlyManufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 0854044849 Rev. 3 07/17

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The pharmacokinetics (plasma and urine) of clindamycin from clindamycin and benzoyl peroxide gel, 1%/5% was studied in male and female patients (n=13) with acne vulgaris. Clindamycin and benzoyl peroxide gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5. Peak plasma concentrations (C) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. The AUC (0-12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5.

The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5. The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04).

A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of clindamycin and benzoyl peroxide gel, 1%/5%. The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.

Non-Clinical Toxicology

Clindamycin and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN 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. 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 AND STOOL ASSAY FOR 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.

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 colitis.

Flecainide acetate has been administered to patients receiving preparations or without adverse effects. During administration of multiple oral doses of flecainide acetate to healthy subjects stabilized on a maintenance dose of , a 13% to 19% increase in plasma levels occurred at six hours postdose.

In a study involving healthy subjects receiving flecainide acetate and concurrently, plasma flecainide levels were increased about 20% and levels were increased about 30% compared to control values. In this formal interaction study, flecainide acetate and were each found to have negative inotropic effects; when the drugs were administered together, the effects were additive. The effects of concomitant administration of flecainide acetate and on the PR interval were less than additive. In flecainide acetate clinical trials, patients who were receiving concurrently did not experience an increased incidence of side effects. Nevertheless, the possibility of additive negative inotropic effects of and flecainide should be recognized.

Flecainide is not extensively bound to plasma proteins. studies with several drugs which may be administered concomitantly showed that the extent of flecainide binding to human plasma proteins is either unchanged or only slightly less. Consequently, interactions with other drugs which are highly protein bound (e.g., ) would not be expected. Flecainide acetate has been used in a large number of patients receiving without apparent interaction. Limited data in patients receiving known enzyme inducers (, , ) indicate only a 30% increase in the rate of flecainide elimination. In healthy subjects receiving (1 gm daily) for one week, plasma flecainide levels increased by about 30% and half-life increased by about 10%.

When is added to flecainide therapy, plasma flecainide levels may increase two-fold or more in some patients, if flecainide dosage is not reduced. (See).

Drugs that inhibit cytochrome P450IID6, such as , might increase the plasma concentrations of flecainide in patients that are on chronic flecainide therapy; especially if these patients are extensive metabolizers.

There has been little experience with the coadministration of flecainide acetate and either or . Because both of these drugs have negative inotropic properties and the effects of coadministration with flecainide acetate are unknown, neither nor should be administered concurrently with flecainide unless, in the judgment of the physician, the benefits of this combination outweigh the risks. There has been too little experience with the coadministration of flecainide acetate with or to recommend concomitant use.

For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.

Avoid contact with eyes and mucous membranes.

Clindamycin and erythromycin containing products should not be used in combination. studies have shown antagonism between these two antimicrobials. The clinical significance of this antagonism is not known.

During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide gel, 1%/5% and vehicle groups.

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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