Indications : התוויות

1. INDICATIONS AND USAGE
Therapeutic Indication
Treatment of infections caused by susceptible strains of anaerobic microorganisms.

Additional Therapeutic Activity
Treatment of Malaria

2. DOSAGE AND ADMINISTRATION
Administer Dalacin C Capsules with a full glass of water (approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (See section 6).


Dosage in Adults
Clindamycin hydrochloride capsules (oral administration):
600-1800 mg/day divided in 2, 3 or 4 equal doses.
Dosage in Children (over 1 month of age)
Clindamycin hydrochloride capsules (oral administration):
To avoid the possibility of esophageal irritation, clindamycin HCl capsules should be taken with a full glass of water and no less than 30 minutes before lying down.Doses of 8-25 mg/kg/day in 3 or 4 equal doses.

Dosage in Elderly
Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration. Therefore, dosage adjustments are not necessary in the elderly with normal hepatic function and normal (age-adjusted) renal function (see Section 4.2 Pharmacokinetic Properties).


Dosage in Renal Impairment
Clindamycin dosage modification is not necessary in patients with renal insufficiency.
Dosage in Hepatic Impairment
Clindamycin dosage modification is not necessary in patients with hepatic insufficiency.

Dosage in Specific Indications
(a) Treatment of Beta-Hemolytic Streptococcal Infections
Refer to the dosage recommendations above. Treatment should be continued for at least 10 days.

(b) Treatment of Chlamydia trachomatis Cervicitis
Clindamycin hydrochloride capsules orally 450-600 mg 4 times daily for 10-14 days .

(c) Treatment of Toxoplasmic Encephalitis in Patients with AIDS
Clindamycin hydrochloride orally 600-1200 mg every 6 hours for 2 weeks followed by 300-600 mg orally every 6 hours. The usual total duration of therapy is 8 to 10 weeks.
The dose of pyrimethamine is 25 to 75 mg orally each day for 8 to 10 weeks. Folinic acid 10 to 20 mg/day should be given with higher doses of pyrimethamine.

(d) Treatment of Pneumocystis carinii Pneumonia in Patients with AIDS Clindamycin hydrochloride 300 to 450 mg orally every 6 hours for 21 days, and Primaquine 15 to 30 mg dose orally once daily for 21 days.

(e) Treatment of Acute Streptococcal Tonsillitis/Pharyngitis
Clindamycin hydrochloride capsules 300 mg orally twice daily for 10 days.

(f) Dosage for   Additional Therapeutic Activity - Treatment of Malaria: 
Uncomplicated Malaria/P falciparum

Adults:
Quinine sulfate: 650 mg orally three times daily for 3 or 7 days plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days.

Children:

Quinine sulfate: 10 mg/kg orally three times daily for 3 or 7 days plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days.

Severe malaria

Adults:
Quinidine gluconate: 10 mg/kg loading dose IV over 1-2 hrs, then 0.02 mg/kg/min continuous infusion for at least 24 hours (for alternative dosing regimen please refer to quinidine label). Once parasite density <1% and patient can take oral medication, complete treatment with oral quinine, dose as above, plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg clindamycin loading dose IV followed by 5 mg base/kg IV every 8 hours. Avoid rapid IV administration. Switch to oral clindamycin (oral dose as above) as soon as patient can take oral medication. Treatment course = 7 days.

Children:

Quinidine gluconate: Same mg/kg dosing and recommendations as for adults plus clindamycin: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg clindamycin loading dose IV followed by 5 mg base/kg IV every 8 hours. Avoid rapid IV administration. Switch to oral clindamycin (oral dose as above) as soon as patient can take oral medication. Treatment course = 7 days.


(g) Prophylaxis of Endocarditis in Patients Sensitive to Penicillin Clindamycin hydrochloride capsules (oral administration). Adults: 600 mg 1 hour before procedure; children: 20 mg/kg 1 hour before procedure.

3. CONTRAINDICATIONS
Dalacin C Capsules is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin or to any of the excipients listed in the section 8.

4. WARNINGS

4.1 See BOXED WARNING
Clostridioides difficile Associated Diarrhea

Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Dalacin C Capsules, 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.

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, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

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