Dalacin T


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Related to Dalacin T: Dalacin C

clindamycin phosphate

Cleocin Phosphate, Cleocin T,Clindagel, ClindaMax, Clindesse,Clindets, Dalacin C Phosphate (CA),Dalacin T (CA) (UK), Evoclin, Zindaclin (UK)

Pharmacologic class: Lincosamide

Therapeutic class: Anti-infective

Pregnancy risk category B

FDA Box Warning

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.

• Because Cleocin therapy has been associated with severe colitis that may be fatal, it should be reserved for serious infections for which less toxic antimicrobials are inappropriate. It shouldn't be used in patients with non-bacterial infections such as most upper respiratory tract infections.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality because these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has occurred more than 2 months after administration of antibacterial agents.

• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Action

Inhibits protein synthesis in susceptible bacteria at level of 50S ribosome, thereby inhibiting peptide bond formation and causing cell death

Availability

Aerosol foam: 1%

Capsules: 75 mg, 150 mg, 300 mg

Granules for oral suspension: 75 mg/5 ml

Injection: 150 mg base/ml

Topical: 1% gel, lotion, single-use applicators, solution, and suspension

Vaginal cream: 2%

Vaginal suppositories (ovules): 100 mg

Indications and dosages

Severe infections caused by sensitive organisms (such as Bacteroides fragilis, Clostridium perfringens, Fusobacterium, pneumococci, staphylococci, and streptococci)

Adults: 300 to 450 mg P.O. q 6 hours, or (for other than C. perfringens) 1.2 to 2.7 g/day I.M. or I.V. in two to four equally divided doses

Children: 16 to 20 mg/kg/day P.O. (hydrochloride) in three to four equally divided doses, or 13 to 25 mg/kg/day P.O. (palmitate hydrochloride) in three to four equally divided doses

Neonates younger than 1 month: 15 to 20 mg/kg/day I.M. or I.V. in three to four equally divided doses

Acute pelvic inflammatory disease

Adults: 900 mg I.V. q 8 hours (given with gentamicin)

Acne vulgaris

Adults and children older than age 12:

Apply a thin film of topical gel, lotion, or solution locally to affected area b.i.d.

Off-label uses

• Bacterial vaginosis (phosphate)
Chlamydia trachomatis infection in females
• CNS toxoplasmosis in AIDS patients (given with pyrimethamine)
Pneumocystis jiroveci pneumonia (given with primaquine)
• Rosacea (lotion)

Contraindications

• Hypersensitivity to drug or lincomycin

Precautions

Use cautiously in:
• renal or hepatic impairment
• known alcohol intolerance
• pregnant patients
• neonates.

Administration

• Give oral doses with full glass of water, with or without food.

Don't give as I.V. bolus injection.
• Dilute I.V. solution to a concentration of 18 mg/ml using normal saline solution, dextrose 5% in water, or lactated Ringer's solution. Infuse no faster than 30 mg/minute.
• Don't administer I.M. dosages above 600 mg.
• Inject I.M. doses deep into large muscle mass to prevent induration and sterile abscess.

Adverse reactions

GI: nausea, vomiting, diarrhea, abdominal pain, esophagitis, pseudomembranous colitis

Hematologic: neutropenia, leukopenia, agranulocytosis, thrombocytopenia purpura

Hepatic: jaundice, hepatic dysfunction

Skin: maculopapular rash, generalized morbilliform-like rash

Other: bitter taste (with I.V. use), phlebitis at I.V. site, induration and sterile abscess (with I.M. use), anaphylaxis

Interactions

Drug-drug.Erythromycin: antagonistic effect

Kaolin/pectin: decreased GI absorption of clindamycin

Hormonal contraceptives: decreased contraceptive efficacy

Neuromuscular blockers: enhanced neuromuscular blockade

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, creatine kinase: increased levels

Platelets, white blood cells: transient decrease in counts

Patient monitoring

• Monitor creatinine level closely in patients with renal insufficiency.
• Monitor hepatic enzyme levels in patients with hepatic disease.
• Assess for signs and symptoms of hypersensitivity reactions, including anaphylaxis.
• Assess for diarrhea and signs and symptoms of colitis.

Patient teaching

• Tell patient to take drug with food if it causes stomach upset.

Urge patient to contact prescriber immediately if he develops rash, unusual fatigue, or yellowing of skin or eyes or if diarrhea occurs during or after treatment.
• Tell patient that I.V. use may cause bitter taste. Reassure him that this effect will resolve on its own.
• Caution patient not to rely on condoms or diaphragm for contraception for 72 hours after using vaginal preparation; drug may weaken latex products and cause breakage.
• Instruct patient taking hormonal contraceptives to use supplemental birth control method, such as condoms (unless she's using a vaginal preparation); drug may reduce hormonal contraceptive efficacy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

clindamycin

(klin-da-mye-sin) ,

Cleocin

(trade name),

Cleocin T

(trade name),

Clinda-Derm

(trade name),

Clinda-T

(trade name),

Clindagel

(trade name),

Clindesse

(trade name),

Clindets

(trade name),

Dalacin C

(trade name),

Dalacin T

(trade name),

Evoclin

(trade name)

Classification

Therapeutic: anti infectives
Pregnancy Category: B

Indications

Oral: Intramuscular: Intravenous: Treatment of:
  • Skin and skin structure infections,
  • Respiratory tract infections,
  • Septicemia,
  • Intra-abdominal infections,
  • Gynecologic infections,
  • Osteomyelitis,
  • Endocarditis prophylaxis.
Topical: Severe acne. Vaginal: Bacterial vaginosis. Oral: Intramuscular: Intravenous: Treatment of Pneumocystis carinii pneumonia, CNS toxoplasmosis, and babesiosis.

Action

Inhibits protein synthesis in susceptible bacteria at the level of the 50S ribosome.

Therapeutic effects

Bactericidal or bacteriostatic, depending on susceptibility and concentration.
Active against most gram-positive aerobic cocci, including:
  • Staphylococci,
  • Streptococcus pneumoniae,
  • other streptococci, but not enterococci.
Has good activity against those anaerobic bacteria that cause bacterial vaginosis, including Bacteroides fragilis, Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, and Corynebacterium.Also active against Pneumocystis jirovecii and Toxoplasma gondii.

Pharmacokinetics

Absorption: Well absorbed following PO/IM administration. Minimal absorption following topical/vaginal use.
Distribution: Widely distributed. Does not significantly cross blood-brain barrier. Crosses the placenta; enters breast milk.
Protein Binding: 94%.
Metabolism and Excretion: Mostly metabolized by the liver.
Half-life: Neonates: 3.6–8.7 hr; Infants up to 1 yr: 3 hr; Children and adults: 2–3 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POrapid 60 min6–8 hr
IMrapid 1–3 hr6–8 hr
IVrapid end of infusion6–8 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Regional enteritis or ulcerative colitis (topical foam)Previous pseudomembranous colitis;Severe liver impairment;Diarrhea;Known alcohol intolerance (topical solution, suspension).
Use Cautiously in: Obstetric: Safety not established for systemic and topical; approved for vaginal use in 3rd trimester of pregnancy; Lactation: Has been used safely but appears in breast milk and exposes infant to drug and its side effects.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • vertigo

Cardiovascular

  • arrhythmias
  • hypotension

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • bitter taste (IV only)
  • nausea
  • vomiting

Dermatologic

  • rash

Local

  • local irritation (topical products)
  • phlebitis at IV site

Interactions

Drug-Drug interaction

Kaolin/pectin may ↓ GI absorption.May enhance the neuromuscular blocking action of other neuromuscular blocking agents. Topical: Concurrent use with irritants, abrasives, or desquamating agents may result in additive irritation.

Route/Dosage

Oral (Adults) Most infections—150–450 mg q 6 hr. P. carinii pneumonia—1200–1800 mg/day in divided doses with 15–30 mg Primaquine/day (unlabeled). CNS toxoplasmosis—1200–2400 mg/day in divided doses with pyrimethamine 50–100 mg/day (unlabeled); Bacterial endocarditis prophylaxis—600 mg 1 hr before procedure.
Oral (Children >1 mo) 10–30 mg/kg/day divided q 6–8 hr; maximum dose 1.8 g/day. Bacterial endocarditis prophylaxis—20 mg/kg 1 hr before procedure.
Intramuscular Intravenous (Adults) Most infections—300–600 mg q 6–8 hr or 900 mg q 8 hr (up to 4.8 g/day IV has been used; single IM doses of >600 mg are not recommended). P. carinii pneumonia—2400–2700 mg/day in divided doses with Primaquine (unlabeled). Toxoplasmosis—1200–4800 mg/day in divided doses with pyrimethamine. Bacterial endocarditis prophylaxis—600 mg 30 min before procedure.
Intramuscular Intravenous (Children >1 mo) 25–40 mg/kg/day divided q 6–8 hr; maximum dose: 4.8 g/day. Bacterial endocarditis prophylaxis—20 mg/kg 30 min before procedure; maximum dose: 600 mg.
Intramuscular Intravenous (Infants <1 mo and <2 kg) 5 mg/kg q 8–12 hr; ≥2 kg—20–30 mg/kg/day divided q 6–8 hr.
Vaginal (Adults and Adolescents) Cleocin, Clindamax—1 applicatorful (5 g) at bedtime for 3 or 7 days (7 days in pregnant patients); Clindesse—one applicatorful (5 g) single dose; or 1 suppository (100 mg) at bedtime for 3 nights.
Topical (Adults and Adolescents) Solution—1% solution/suspension applied twice daily (range 1–4 times daily). Foam, gel—1% foam or gel applied once daily.

Availability (generic available)

Capsules: 75 mg, 150 mg, 300 mg
Oral suspension: 75 mg/5 mL
Injection: 150 mg/mL
Premixed infusion: 300 mg/50 mL, 600 mg/50 mL, 900 mg/50 mL
Topical: 1% lotion, gel, foam, solution, suspension, single-use applicators
In combination with: benzoyl peroxide (Acanya, BenzaClin, Duac); (see combination drugs).
Vaginal cream: 2%
Vaginal suppositories (ovules): 100 mg
In combination with: tretinoin (Ziana); (see combination drugs).

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
  • Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving results.
  • Monitor bowel elimination. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. This may begin up to several weeks following the cessation of therapy.
  • Assess patient for hypersensitivity (skin rash, urticaria).
  • Lab Test Considerations: Monitor CBC; may cause transient ↓ in leukocytes, eosinophils, and platelets.
    • May cause ↑ alkaline phosphatase, bilirubin, CPK, AST, and ALT concentrations.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Diarrhea (Side Effects)

Implementation

  • Do not confuse Clindesse with Clindets.
  • Oral: Administer with a full glass of water. May be given with or without meals. Shake liquid preparations well. Do not refrigerate. Stable for 14 days at room temperature.
  • Intramuscular: Do not administer >600 mg in a single IM injection.
  • Intravenous Administration
  • pH: 5.5–7.0.
  • Intermittent Infusion: Diluent: Vials must be diluted before use. Dilute a dose of 300 mg or 600 mg in 50 mL and a dose of 900 mg or 1200 mg in 100 mL. Compatible diluents include D5W, 0.9% NaCl, D5/0.9% NaCl, D5/0.45% NaCl, or LR. Admixed solution stable for 16 days at room temperature. Premixed infusion is already diluted and ready to use.Concentration: Not to exceed 18 mg/mL.
  • Rate: Not to exceed 30 mg/min. Hypotension and cardiopulmonary arrest have been reported following rapid IV administration.
  • Y-Site Compatibility: amiodarone, ampicillin, atracurium, bumetanide, cefepime, ciprofloxacin, dobutamine, dopamine, gentamicin, hydrocortisone sodium phosphate, insulin, lidocaine, metoclopramide, metronidazole, penicillin G, potassium chloride, prochlorperazine, ranitidine, ticarcillin/clavulanate, vancomycin, vecuronium, verapamil.
  • Y-Site Incompatibility: aminophylline, ceftazidime, cefuroxime, furosemide, heparin, phenytoin, quinupristin/dalfopristin, trastuzumab, trimethoprim/sulfamethoxazole
  • Vaginal: Applicators are supplied for vaginal administration. When treating bacterial vaginosis, concurrent treatment of male partner is not usually necessary.
  • Topical: Contact with eyes, mucous membranes, and open cuts should be avoided during topical application. If accidental contact occurs, rinse with copious amounts of cool water.
    • Wash affected areas with warm water and soap, rinse, and pat dry prior to application. Apply to entire affected area.

Patient/Family Teaching

  • Instruct patient to take medication around the clock at evenly spaced times and to finish the drug completely as directed, even if feeling better. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous.
    • Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professional.
    • Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal or anal itching or discharge).
    • Notify health care professional if no improvement within a few days.
    • Patients with a history of rheumatic heart disease or valve replacement need to be taught the importance of antimicrobial prophylaxis before invasive medical or dental procedures.
  • Intravenous: Inform patient that bitter taste occurring with IV administration is not clinically significant.
  • Vaginal: Instruct patient on proper use of vaginal applicator. Insert high into vagina at bedtime. Instruct patient to remain recumbent for at least 30 min following insertion. Advise patient to use sanitary napkin to prevent staining of clothing or bedding. Continue therapy during menstrual period.
    • Advise patient to refrain from vaginal sexual intercourse during treatment.
    • Caution patient that mineral oil in clindamycin cream may weaken latex or rubber contraceptive devices. Such products should not be used within 72 hr of vaginal cream.
  • Topical: Caution patient applying topical clindamycin that solution is flammable (vehicle is isopropyl alcohol). Avoid application while smoking or near heat or flame.
    • Advise patient to notify health care professional if excessive drying of skin occurs.
    • Advise patient to wait 30 min after washing or shaving area before applying.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
  • Endocarditis prophylaxis.
  • Improvement in acne vulgaris lesions. Improvement should be seen in 6 wk but may take 8–12 wk for maximum benefit.

Dalacin T

A brand name for CLINDAMYCIN.