Rouz Darou Pharmaceutical Company

CLARITHROMYCIN is generally effective in the eradication of S. pyrogenes from the nasopharynx; however, data establishing the efficacy of CLARITHROMYCIN in the subsequent prevention of rheumatic fever are not available at present.)

Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes. (Abscesses usually require surgical drainage.)

Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.

CLARITHROMYCIN tablets in combination with amoxicillin and lansoprazole or omeprazole delayed-release capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.

CLARITHROMYCIN Filmtab tablets in combination with omeprazole capsules or ranitidine bismuth citrate tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain CLARITHROMYCIN as the single antimicrobial agent are more likely to be associated with the development of CLARITHROMYCIN resistance among patients who fail therapy. CLARITHROMYCIN-containing regimens should not be used in patients with known or suspected CLARITHROMYCIN resistant isolates because the efficacy of treatment is reduced in this setting.

In patients who fail therapy, susceptibility testing should be done if possible. If resistance to CLARITHROMYCIN is demonstrated, a non-CLARITHROMYCIN-containing therapy is recommended. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.

Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.)

Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.

CLARITHROMYCIN tablets are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

CLARITHROMYCIN is contraindicated in patients with a known hypersensitivity to CLARITHROMYCIN, erythromycin, or any of the macrolide antibiotics.

Concomitant administration of CLARITHROMYCIN with cisapride, pimozide, or terfenadine is contraindicated. There have been post-marketing reports of drug interactions when CLARITHROMYCIN and/or erythromycin are co-administered with cisapride, pimozide, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of hepatic metabolism of these drugs by erythromycin and CLARITHROMYCIN. Fatalities have been reported.

CLARITHROMYCIN is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability of 250 mg CLARITHROMYCIN tablets was approximately 50%. For a single 500 mg dose of CLARITHROMYCIN, food slightly delays the onset of CLARITHROMYCIN absorption, increasing the peak time from approximately 2 to 2.5 hours. Food also increases the CLARITHROMYCIN peak plasma concentration by about 24%, but does not affect the extent of CLARITHROMYCIN bioavailability. Food does not affect the onset of formation of the antimicrobial active metabolite, 14-OH CLARITHROMYCIN or its peak plasma concentration but does slightly decrease the extent of metabolite formation, indicated by an 11% decrease in area under the plasma concentration-time curve (AUC). Therefore, CLARITHROMYCIN tablets may be given without regard to food. Steady-state peak plasma CLARITHROMYCIN concentrations were attained within 3 days and were approximately 1 to 2 mg/mL with a 250 mg dose administered every 12 hours and 3 to 4 mg/mL with a 500 mg dose administered every 8 to 12 hours. The elimination half-life of CLARITHROMYCIN was about 3 to 4 hours with 250 mg administered every 12 hours but increased to 5 to 7 hours with 500 mg administered every 8 to 12 hours. After a 250 mg tablet every 12 hours, approximately 20% of the dose is excreted in the urine as CLARITHROMYCIN, while after a 500 mg tablet every 12 hours, the urinary excretion of CLARITHROMYCIN is somewhat greater, approximately 30%. The major metabolite found in urine is 14-OH CLARITHROMYCIN, which accounts for an additional 10% to 15% of the dose with either a 250 mg or a 500 mg tablet administered every 12 hours. Steady-state CLARITHROMYCIN Cmax values ranged from 2 to 4 mg/mL and 5 to 10 mg/mL, respectively.

CLARITHROMYCIN and the 14-OH CLARITHROMYCIN metabolite distribute readily into body tissues and fluids. There are no data available on cerebrospinal fluid penetration. Because of high intracellular concentrations, tissue concentrations are higher than serum concentrations.

CLARITHROMYCIN 500 mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult males. The plasma levels of CLARITHROMYCIN and 14-hydroxy-CLARITHROMYCIN were increased by the concomitant administration of omeprazole. For CLARITHROMYCIN, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when CLARITHROMYCIN was administered with omeprazole than when CLARITHROMYCIN was administered alone. Similar results were seen for 14-hydroxy-CLARITHROMYCIN, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. CLARITHROMYCIN concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.

CLARITHROMYCIN exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.

CLARITHROMYCIN is active in vitro against a variety of aerobic and anaerobic gram-positive and gram-negative microorganisms as well as most Mycobacterium avium complex (MAC) microorganisms.

Additionally, the 14-OH CLARITHROMYCIN metabolite also has clinically significant antimicrobial activity. The 14-OH CLARITHROMYCIN is twice as active against Haemophilus influenzae microorganisms as the parent compound.

CLARITHROMYCIN has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections.

NOTE: Most strains of methicillin-resistant and oxacillin-resistant staphylococci are resistant to CLARITHROMYCIN.

Omeprazole/CLARITHROMYCIN dual therapy; ranitidine bismuth citrate/CLARITHROMYCIN dual therapy; omeprazole/CLARITHROMYCIN/amoxicillin triple therapy; and lansoprazole/CLARITHROMYCIN/amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections.

CLARITHROMYCIN pretreatment resistance rates were 3.5% (4/113) in the omeprazole/CLARITHROMYCIN dual therapy studies and 9.3% (41/439) in the omeprazole/CLARITHROMYCIN/ amoxicillin triple therapy studies. CLARITHROMYCIN pretreatment resistance was 12.6% (44/348) in the ranitidine bismuth citrate/CLARITHROMYCIN b.i.d. versus t.i.d. clinical study. CLARITHROMYCIN pretreatment resistance rates were 9.5% (91/960) by E-test and 11.3% (12/106) by agar dilution in the lansoprazole/CLARITHROMYCIN/amoxicillin triple therapy clinical trials.

CLARITHROMYCIN has demonstrated in vitro activity against Mycobacterium avium complex (MAC) microorganisms isolated from both AIDS and non-AIDS patients. While gene probe techniques may be used to distinguish M. avium species from M. intracellulare, many studies only reported results on M. avium complex (MAC) isolates.

CLARITHROMYCIN was also shown to be active against phagocytized M. avium complex (MAC) in mouse and human macrophage cell cultures as well as in the beige mouse infection model.

CLARITHROMYCIN activity was evaluated against Mycobacterium tuberculosis microorganisms.

CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE. IF PREGNANCY OCCURS WHILE TAKING THIS DRUG, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. CLARITHROMYCIN HAS DEMONSTRATED ADVERSE EFFECTS OF PREGNANCY OUTCOME AND/OR EMBRYO-FETAL DEVELOPMENT IN MONKEYS, RATS, MICE, AND RABBITS AT DOSES THAT PRODUCED PLASMA LEVELS 2 TO 17 TIMES THE SERUM LEVELS ACHIEVED IN HUMANS TREATED AT THE MAXIMUM RECOMMENDED HUMAN DOSES.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including CLARITHROMYCIN, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug 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 Clostridium difficile colitis.

CLARITHROMYCIN is principally excreted via the liver and kidney. CLARITHROMYCIN may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.

CLARITHROMYCIN in combination with ranitidine bismuth citrate therapy is not recommended in patients with creatinine clearance less than 25 ml/min.

CLARITHROMYCIN in combination with ranitidine bismuth citrate should not be used in patients with a history of acute porphyria.

It is not known whether CLARITHROMYCIN is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CLARITHROMYCIN is administered to a nursing woman. It is known that CLARITHROMYCIN is excreted in the milk of lactating animals and that other drugs of this class are excreted in human milk.

In a steady-state study in which healthy elderly subjects (age 65 to 81 years old) were given 500 mg every 12 hours, the maximum serum concentrations and area under the curves of CLARITHROMYCIN and 14-OH CLARITHROMYCIN were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse events when compared to younger patients. Dosage adjustment should be considered in elderly patients with severe renal impairment.

CLARITHROMYCIN use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range. In two studies in which theophylline was administered with CLARITHROMYCIN (a theophylline sustained-release formulation was dosed at either 6.5 mg/kg or 12 mg/kg together with 250 or 500 mg q12h CLARITHROMYCIN), the steady-state levels of Cmax, Cmin, and the area under the serum concentration time curve (AUC) of theophylline increased about 20%.

Concomitant administration of single doses of CLARITHROMYCIN and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine may be considered.

When CLARITHROMYCIN and terfenadine were coadministered, plasma concentrations of the active acid metabolite of terfenadine were threefold higher, on average, than the values observed when terfenadine was administered alone. The pharmacokinetics of CLARITHROMYCIN and the 14-hydroxy-CLARITHROMYCIN were not significantly affected by coadministration of terfenadine once CLARITHROMYCIN reached steady-state conditions. Concomitant administration of CLARITHROMYCIN with terfenadine is contraindicated.

CLARITHROMYCIN 500 mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult subjects. The steady-state plasma concentrations of omeprazole were increased (Cmax, AUC0?24, and T½ increases of 30%, 89%, and 34%, respectively), by the concomitant administration of CLARITHROMYCIN. The mean 24?hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with CLARITHROMYCIN.

Co-administration of CLARITHROMYCIN with ranitidine bismuth citrate resulted in increased plasma ranitidine concentrations (57%), increased plasma bismuth trough concentrations (48%), and increased 14-hydroxy-CLARITHROMYCIN plasma concentrations (31%). These effects are clinically insignificant.

Simultaneous oral administration of CLARITHROMYCIN and zidovudine to HIV-infected adult patients resulted in decreased steady-state zidovudine concentrations. When 500 mg of CLARITHROMYCIN were administered twice daily, steady-state zidovudine AUC was reduced by a mean of 12% (n=4). Individual values ranged from a decrease of 34% to an increase of 14%. Based on limited data in 24 patients, when CLARITHROMYCIN was administered two to four hours prior to oral zidovudine, the steady-state zidovudine Cmax was increased by approximately 2?fold, whereas the AUC was unaffected.

Simultaneous administration of CLARITHROMYCIN and didanosine to 12 HIV-infected adult patients resulted in no statistically significant change in didanosine pharmacokinetics.

Concomitant administration of fluconazole 200 mg daily and CLARITHROMYCIN 500 mg twice daily to 21 healthy volunteers led to increases in the mean steady-state CLARITHROMYCIN Cmin and AUC of 33% and 18%, respectively. Steady-state concentrations of 14OH CLARITHROMYCIN were not significantly affected by concomitant administration of fluconazole.

Concomitant administration of CLARITHROMYCIN and ritonavir (n=22) resulted in a 77% increase in CLARITHROMYCIN AUC and a 100% decrease in the AUC of 14-OH CLARITHROMYCIN. CLARITHROMYCIN may be administered without dosage adjustment to patients with normal renal function taking ritonavir. However, for patients with renal impairment, the following dosage adjustments should be considered. For patients with CLCR 30 to 60 mg/min, the dose of CLARITHROMYCIN should be reduced by 50%. For patients with CLCR < 30 ml/min, the dose of CLARITHROMYCIN should be decreased by 75%.

Spontaneous reports in the post-marketing period suggest that concomitant administration of CLARITHROMYCIN and oral anticoagulants may potentiate the effects of the oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving CLARITHROMYCIN and oral anticoagulants simultaneously.

Elevated digoxin serum concentrations in patients receiving CLARITHROMYCIN and digoxin concomitantly have also been reported in post-marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin levels should be carefully monitored while patients are receiving digoxin and CLARITHROMYCIN simultaneously.

The following drug interactions, other than increased serum concentrations of carbamazepine and active acid metabolite of terfenadine, have not been reported in clinical trials with CLARITHROMYCIN; however, they have been observed with erythromycin products and/or with CLARITHROMYCIN in post-marketing experience.

Concurrent use of erythromycin or CLARITHROMYCIN and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Erythromycin has been reported to decrease the clearance of triazolam and, thus, may increase the pharmacologic effect of triazolam. There have been post-marketing reports of drug interactions and CNS effects (e.g., somnolence and confusion) with the concomitant use of CLARITHROMYCIN and triazolam.

There have been reports of an interaction between erythromycin and astemizole resulting in QT prolongation and torsades de pointes. Concomitant administration of erythromycin and astemizole is contraindicated. Because CLARITHROMYCIN is also metabolized by cytochrome P450, concomitant administration of CLARITHROMYCIN with astemizole is not recommended.

As with other macrolides, CLARITHROMYCIN has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin), through inhibition of cytochrome P450 metabolism of these drugs. Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

The use of erythromycin and CLARITHROMYCIN in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin and/or CLARITHROMYCIN with carbamazepine, cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine, cisapride, pimozide, rifabutin, and astemizole. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving these drugs.

The most frequently reported events in adults were diarrhea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), and headache (2%). In pediatric patients, the most frequently reported events were diarrhea (6%), vomiting (6%), abdominal pain (3%), rash (3%), and headache (2%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, only 1% was described as severe.

In pneumonia studies conducted in adults comparing CLARITHROMYCIN to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in CLARITHROMYCIN-treated patients compared to erythromycin-treated patients (13% vs. 32%; p<0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of CLARITHROMYCIN-treated patients.

In two U.S. studies of acute otitis media comparing CLARITHROMYCIN to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in CLARITHROMYCIN-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p<0.001). One-third as many CLARITHROMYCIN-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.

Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis and Stevens-Johnson syndrome have occurred. Other spontaneously reported adverse events include glossitis, stomatitis, oral moniliasis, vomiting, tongue discoloration, thrombocytopenia, leukopenia, neutropenia, and dizziness. There have been reports of tooth discoloration in patients treated with CLARITHROMYCIN. Tooth discoloration is usually reversible with professional dental cleaning. There have been isolated reports of hearing loss, which is usually reversible, occurring chiefly in elderly women. Reports of alterations of the sense of smell, usually in conjunction with taste perversion have also been reported.

Transient CNS events including anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor and vertigo have been reported during post-marketing surveillance. Events usually resolve quickly with discontinuation of the drug.

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with CLARITHROMYCIN. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.

There have been rare reports of hypoglycemia, some of which have occurred in patients taking oral hypoglycemic agents or insulin.

As with other macrolides, CLARITHROMYCIN has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

Changes in laboratory values with possible clinical significance were as follows:

Hepatic: Elevated SGPT (ALT) <1%; SGOT (AST) <1%; GGT <1%; alkaline phosphatase <1%; LDH <1%; total bilirubin <1%.

GGT, alkaline phosphatase, and prothrombin time data are from adult studies only.

Overdosage with ATENOLOL has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely.

The predominant symptoms reported following ATENOLOL overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in ATENOLOL overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia.

Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. ATENOLOL can be removed from the general circulation by hemodialysis. Other treatment modalities should be employed at the physician's discretion and may include:

BRADYCARDIA: Atropine intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated.

HEART BLOCK (SECOND OR THIRD DEGREE): Isoproterenol or transvenous cardiac pacemaker.

CARDIAC FAILURE: Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful.

HYPOTENSION: Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously.

BRONCHOSPASM: A beta2 stimulant such as isoproterenol or terbutaline and/or aminophylline.

Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

TABLE 29 Adult Dosage Guidelines
Infection	Dosage (q12h)	Normal Duration (days)
Pharyngitis/Tonsillitis	250 mg	10
Acute maxillary sinusitis	500 mg	14
Acute exacerbation of chronic bronchitis due to:
S. pneumoniae	250 mg	7 to 14
M. catarrhalis	250 mg	7 to 14
H. influenzae	500 mg	7 to 14
Pneumonia due to:
S. pneumoniae	250 mg	7 to 14
M. pneumoniae	250 mg	7 to 14
Uncomplicated skin and skin structure	250 mg	7 to 14

Triple Therapy: CLARITHROMYCIN/Lansoprazole/Amoxicillin: The recommended adult dose is 500 mg CLARITHROMYCIN, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days.

Triple Therapy: CLARITHROMYCIN/Omeprazole/Amoxicillin The recommended adult dose is 500 mg CLARITHROMYCIN, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: CLARITHROMYCIN/Omeprazole The recommended adult dose is 500 mg CLARITHROMYCIN given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy: CLARITHROMYCIN/Ranitidine Bismuth Citrate The recommended adult dose is 500 mg CLARITHROMYCIN given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. CLARITHROMYCIN and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 ml/min.

CLARITHROMYCIN may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL < 30 ml/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Prophylaxis: The recommended dose of CLARITHROMYCIN for the prevention of disseminated Mycobacterium avium disease is 500 mg bid. In children, the recommended dose is 7.5 mg/kg bid up to 500 mg bid. No studies of CLARITHROMYCIN for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment: CLARITHROMYCIN is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. CLARITHROMYCIN should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. The recommended dose for mycobacterial infections in adults is 500 mg bid. In children, the recommended dose is 7.5 mg/kg bid up to 500 mg bid. Dosing recommendations for children are in the table above.

CLARITHROMYCIN therapy should continue for life if clinical and mycobacterial improvements are observed.

stotage: Store at controlled room temperature 15-30° C (59-86° F) in a well-closed container. Protect from light.