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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Clindamycin and tretinoin: Pediatric drug information

Clindamycin and tretinoin: Pediatric drug information
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For additional information see "Clindamycin and tretinoin: Drug information" and "Clindamycin and tretinoin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Veltin [DSC];
  • Ziana
Brand Names: Canada
  • Biacna
Therapeutic Category
  • Acne Products;
  • Antibiotic, Miscellaneous;
  • Retinoic Acid Derivative
Dosing: Pediatric
Acne vulgaris

Acne vulgaris: Topical: Children ≥12 years and Adolescents: Topical: Apply pea-size amount to entire face once daily in the evening or at bedtime; Note: Higher dosages (larger amount or more frequent use) have not been shown to improve efficacy and are associated with increased adverse effects (eg, skin irritation).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Adult

(For additional information see "Clindamycin and tretinoin: Drug information")

Acne vulgaris

Acne vulgaris: Topical: Apply to the affected area once daily in the evening or at bedtime.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.

1% to 10%:

Dermatologic: Xeroderma (1%)

Local: Application-site dermatitis (1%), application-site erythema (4%), application-site irritation (5%), application-site pruritus (2%), application-site scaling (5%), local dryness of skin (6%)

Respiratory: Nasopharyngitis (4%)

Frequency not defined:

Dermatologic: Stinging of the skin (application site)

Local: Application-site burning

Contraindications

Regional enteritis, ulcerative colitis, history of antibiotic-associated colitis

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to clindamycin, tretinoin, or any component of the formulation; hypersensitivity to lincomycin

Warnings/Precautions

Concerns related to adverse effects:

• Photosensitivity: Tretinoin use is associated with increased susceptibility/sensitivity to ultraviolet (UV) light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Use is not recommended in patients with sunburn.

• Skin irritation: Treatment can increase skin sensitivity to weather extremes of wind or cold. Also, concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be used with caution due to increased skin irritation.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: For external use only; not for ophthalmic, oral, or intravaginal use; avoid mucous membranes, eyes, mouth, and angles of nose.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, External:

Veltin: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g [DSC], 60 g [DSC]) [contains edetate (edta) disodium, methylparaben, propylene glycol]

Ziana: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g) [contains methylparaben, propylparaben]

Generic: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g)

Generic Equivalent Available: US

Yes

Pricing: US

Gel (Clindamycin-Tretinoin External)

1.2-0.025% (per gram): $13.20 - $17.63

Gel (Ziana External)

1.2-0.025% (per gram): $14.68

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Biacna: Clindamycin phosphate 1.2% and tretinoin 0.025% (2 g, 30 g, 60 g) [contains edetate (edta) disodium, methylparaben, polysorbate 80, propylparaben]

Administration: Pediatric

For topical administration only; not for oral, ophthalmic, or intravaginal use. At bedtime, wash face with mild soap, rinse with water, and pat skin dry. Place pea-size amount on one fingertip and then dot on affected areas including chin, cheeks, nose, and forehead. Gently rub over entire face or entire affected area while avoiding eyes, lips, mouth, angles of nose, and mucous membranes. Wash hands after use. Apply sunscreen every morning and reapply throughout the day as needed. Avoid exposure to sunlight (including sunlamps) and wear protective clothing.

Administration: Adult

For external use only. Not for ophthalmic, oral, or intravaginal use. Prior to application, gently wash face with a mild soap and pat dry. Apply in the evening or at bedtime. Apply a pea-size amount to one fingertip and then dotted on chin, cheeks, nose, and forehead. Avoid contact with sunburned skin. Gently rub over entire face or entire affected area while avoiding eyes, mouth, angles of nose, and mucous membranes.

Hazardous Drugs Handling Considerations

Tretinoin is a hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect from heat and light.

Use

Treatment of acne vulgaris (FDA approved in ages ≥12 years and adults)

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Erythromycin (Systemic): May decrease therapeutic effects of Clindamycin (Topical). Management: Consider avoiding the concomitant use of systemic erythromycin and topical clindamycin when treating acne vulgaris. This recommendation does not appear to apply to intravaginal use of clindamycin for the treatment of bacterial vaginosis. Risk D: Consider Therapy Modification

Erythromycin (Topical): May decrease therapeutic effects of Clindamycin (Topical). Management: Consider avoiding use of topical erythromycin and topical clindamycin at the same application site when treating acne vulgaris. This recommendation does not appear to apply to intravaginal use of clindamycin for the treatment of bacterial vaginosis. Risk D: Consider Therapy Modification

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Neuromuscular-Blocking Agents: Clindamycin (Topical) may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Pregnancy Considerations

Adverse events were observed in animal reproduction studies using this combination topically. See individual agents.

Monitoring Parameters

Observe for changes in bowel frequency (diarrhea and/or bloody diarrhea)

Mechanism of Action

Clindamycin reversibly binds to 50S ribosomal subunits preventing peptide chain elongation thus inhibiting bacterial protein synthesis. Clindamycin exhibits in vitro activity against Cutibacterium acnes, an organism associated with acne vulgaris. Topical tretinoin is believed to decrease follicular epithelial cells cohesiveness and increase follicular epithelial cell turnover resulting in decreased microcomedone formation and increased expulsion of comedones.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Topical: Tretinoin: Minimal systemic absorption; Clindamycin: Low, but variable systemic absorption

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Acretin c;
  • (AR) Argentina: Clinoina;
  • (AT) Austria: Acnatac;
  • (AU) Australia: Acnatac;
  • (BD) Bangladesh: Cinamycin Plus | Clinacyn t | Clindacin plus | Clindax plus | Clinex Plus | Clinface | Dalacin plus | Trunac;
  • (BE) Belgium: Treclinax;
  • (BG) Bulgaria: Acnatac;
  • (BR) Brazil: Vitacid Acne;
  • (CH) Switzerland: Acnatac;
  • (CL) Chile: Taripel;
  • (CZ) Czech Republic: Acnatac;
  • (DE) Germany: Acnatac;
  • (EE) Estonia: Treclinac;
  • (EG) Egypt: Clindagram;
  • (ES) Spain: Treclinac;
  • (FI) Finland: Acnatac;
  • (FR) France: Zanea;
  • (GB) United Kingdom: Treclin;
  • (GR) Greece: Acnatac | Treticlin;
  • (IE) Ireland: Treclinac;
  • (IN) India: Acnon c | Acsolve-c | Mytret c | Nexret tc | Supatret c | Treclin | Tretin c | Tyret c;
  • (IT) Italy: Acnatac;
  • (JO) Jordan: Acticare;
  • (KE) Kenya: Clear t | Clindar t plus;
  • (LB) Lebanon: Cliniderm t;
  • (LT) Lithuania: Acnatac | Retino ac | Supratet c | Treclinac;
  • (LU) Luxembourg: Treclinax;
  • (LV) Latvia: Treclinac;
  • (MX) Mexico: Retin a forte;
  • (NL) Netherlands: Treclinac;
  • (NO) Norway: Acnatac | Zalna;
  • (PK) Pakistan: Acdermin | Acnex | Acnicot gel | Cleret | Clin | Clinda t gel | Clindasol t | Clinoin | Olinderm t | Safderm | Treclin | Ziana;
  • (PL) Poland: Acnatac;
  • (PR) Puerto Rico: Clindamycin phosphate 1.2% and tretinoin 0.025% | Clindamycin phosphate and tretinoin | Clindamycin phosphate and tretinoin gel | Veltin;
  • (PT) Portugal: Acnatac;
  • (RO) Romania: Acnatac;
  • (SE) Sweden: Acnatac;
  • (SI) Slovenia: Zalna;
  • (SK) Slovakia: Acnatac;
  • (TR) Turkey: Clindatre;
  • (UG) Uganda: Clear t;
  • (UY) Uruguay: Treclinda
  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Biacna (clindamycin phosphate and tretinoin) [product monograph]. Laval, Quebec, Canada: Bausch Health, Canada Inc; October 2020.
  3. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  4. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  5. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.
  6. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  7. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  8. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  9. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  10. Veltin (clindamycin phosphate and tretinoin) [prescribing information]. Exton, PA: Almirall, LLC; June 2019.
  11. Ziana (clindamycin phosphate and tretinoin) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; March 2017.
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