clindamycin palmitate hydrochloride (redirected from Dalacin C Flavored Granules)

clindamycin palmitate hydrochloride

Cleocin Pediatric, Dalacin C Flavored Granules (CA)

Pharmacologic class: Lincosamide

Therapeutic class: Anti-infective

Pregnancy risk category B

FDA Boxed Warning

• To reduce development of bacterial resistance and maintain drug efficacy, use only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
• Drug may cause pseudomembranous colitis, ranging from mild to life-threatening. Consider this diagnosis in patients who develop diarrhea after drug administration.
• If diagnosis of pseudomembranous colitis has been established, initiate therapeutic measures. Mild cases usually respond to drug withdrawal alone. In moderate to severe cases, consider giving fluids and electrolytes, protein supplements, and antibacterial drug effective against Clostridium difficile colitis.
• Diarrhea, colitis, and pseudomembranous colitis may first appear up to several weeks after clindamycin therapy ends.
• Reserve drug for serious infections when less toxic antimicrobials are inappropriate. Don't use for nonbacterial infections, such as most upper respiratory tract infections.

Action

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

Availability

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.

Route	Onset	Peak	Duration
P.O.	Rapid	45 min	6-8 hr
I.V.	Rapid	End of infusion	6-8 hr
I.M.	Rapid	1-3 hr	6-8 hr
Topical, vaginal	Unknown	Unknown	Unknown

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.