Author: druginteractionchecker_lgaiz4

DOSAGE AND ADMINISTRATION

2 AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal.

To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of a meal.

Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours.

( 2.1 , 2.2 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.

(2.2) Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.

Use of the 125 mg/5 mL oral suspension is recommended.

(2.2) 2.1 Adults The usual adult dose is one 500-mg tablet of AUGMENTIN every 12 hours or one 250-mg tablet of AUGMENTIN every 8 hours.

For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours or one 500-mg tablet of AUGMENTIN every 8 hours.

Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500-mg tablet.

The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875-mg tablet.

Two 250-mg tablets of AUGMENTIN should not be substituted for one 500-mg tablet of AUGMENTIN.

Since both the 250-mg and 500-mg tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets are not equivalent to one 500-mg tablet of AUGMENTIN.

The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet should not be substituted for each other, as they are not interchangeable.

The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt).

The 250-mg tablet of AUGMENTIN contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.

2.2 Pediatric Patients Based on the amoxicillin component, AUGMENTIN should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months) : The recommended dose of AUGMENTIN is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.

Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older : See dosing regimens provided in Table 1.

The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)] .

However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.

[see Warnings and Precautions (5.6) ] Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/5 mL or 400 mg/5 mL oral suspension a 125 mg/5 mL or 250 mg/5 mL oral suspension a Otitis media b , sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours a Each strength of suspension of AUGMENTIN is available as a chewable tablet for use by older children.

b Duration of therapy studied and recommended for acute otitis media is 10 days.

Patients Weighing 40 kg or More : Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.

The 250-mg tablet of AUGMENTIN should not be used until the child weighs at least 40 kg,due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of AUGMENTIN (250/125) versus the 250-mg chewable tablet of AUGMENTIN (250/62.5).

2.3 Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.

Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875‑mg dose.

Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.

Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,depending on severity of the infection.

They should receive an additional dose both during and at the end of dialysis.

2.4 Directions for Mixing Oral Suspension Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely.

Add approximately 2/3 of the total amount of water for reconstitution (see Table 2 below) and shake vigorously to suspend powder.

Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water for Reconstitution Contents of Each Teaspoonful (5 mL) 125 mg/5 mL 75 mL100 mL150 mL 67 mL90 mL134 mL 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt 200 mg/5 mL 50 mL75 mL100 mL 50 mL75 mL95 mL 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt 250 mg/5 mL 75 mL100 mL150 mL 65 mL87 mL130 mL 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt 400 mg/5 mL 50 mL75 mL100 mL 50 mL70 mL90 mL 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt Note: Shake oral suspension well before using.

Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

DOSAGE AND ADMINISTRATION

Accurate diagnosis of infecting organism is essential.

Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination.

Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months.

General measures in regard to hygiene should be observed to control sources of infection or reinfection.

Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis.

In some forms of athlete’s foot, yeasts and bacteria may be involved as well as fungi.

Griseofulvin will not eradicate the bacterial or monilial infection.

Gris-PEG ® tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Adults: Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis.

For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.

Pediatric Use: Approximately 7.3 mg per kg of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients.

On this basis, the following dosage schedule is suggested: 16-27 kg: 125 mg to 187.5 mg daily over 27 kg: 187.5 mg to 375 mg daily Children and infants 2 years of age and younger – dosage has not been established.

Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective.

Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

DOSAGE AND ADMINISTRATION

If diarrhea occurs during therapy, this antibiotic should be discontinued.

(See WARNING box).

Adults: Parenteral (I.M.

or I.V.

Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis , Peptococcus species and Clostridium species other than Clostridium perfringens ): 600 to 1200 mg/day in 2, 3 or 4 equal doses.

More severe infections, particularly those due to proven or suspected Bacteroides fragilis , Peptococcus species, or Clostridium species other than Clostridium perfringens : 1200 to 2700 mg/day in 2, 3 or 4 equal doses.

For more serious infections, these doses may have to be increased.

In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.

Doses of as much as 4800 mg daily have been given intravenously to adults.

See Dilution and Infusion Rates section below.

Single I.M.

injections of greater than 600 mg are not recommended.

Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous I.V.

infusion as follows: To maintain serum clindamycin levels Above 4 mcg/mL Above 5 mcg/mL Above 6 mcg/mL Rapid infusion rate 10 mg/min for 30 min 15 mg/min for 30 min 20 mg/min for 30 min Maintenance infusion rate 0.75 mg/min 1 mg/min 1.25 mg/min Neonates (less than 1 month): 15 to 20 mg/kg/day in three to four equal doses.

The lower dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years): Parenteral (I.M.

or I.V.) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses.

The higher doses would be used for more severe infections.

As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m 2 /day for serious infections and 450 mg/m 2 /day for more severe infections.

Parenteral therapy may be changed to clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Dilution and Infusion Rates: Clindamycin phosphate must be diluted prior to I.V.

administration.

The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL.

Infusion rates should not exceed 30 mg per minute.

The usual infusion dilutions and rates are as follows: Dose Diluent Time 300 mg 600 mg 900 mg 1200 mg 50 mL 50 mL 50-100 mL 100 mL 10 min 20 min 30 min 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in I.V.

solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically.

No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

Physico-Chemical Stability of Diluted Solutions of Clindamycin: Room temperature: 6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time.

Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer’s Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

Frozen solutions should be thawed at room temperature and not refrozen.

Caution: Do not use plastic containers in series connections.

Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

DOSAGE AND ADMINISTRATION

Streptococcal (Group A) Upper Respiratory Infections (for example, pharyngitis) Adults—a single injection of 1,200,000 units; older pediatric patients—a single injection of 900,000 units; infants and pediatric patients under 60 lbs.—300,000 to 600,000 units.

Syphilis Primary, secondary, and latent—2,400,000 units (1 dose).

Late (tertiary and neurosyphilis)—2,400,000 units at 7-day intervals for three doses.

Congenital—under 2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust dosage based on adult dosage schedule.

Yaws, Bejel, and Pinta —1,200,000 units (1 injection).

Prophylaxis —for rheumatic fever and glomerulonephritis.

Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks.

METHOD OF ADMINISTRATION BICILLIN L-A IS INTENDED FOR INTRAMUSCULAR INJECTION ONLY.

DO NOT INJECT INTO OR NEAR AN ARTERY OR NERVE, OR INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS.

(SEE WARNINGS SECTION.) Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site.

In neonates, infants and small children, the midlateral aspect of the thigh may be preferable.

Administration in the anterolateral thigh is not recommended due to the adverse effects observed (see WARNINGS section), and vascularity of this region.

When doses are repeated, vary the injection site.

Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Adults: Serious infections—150 to 300 mg every 6 hours.

More severe infections—300 to 450 mg every 6 hours.

Pediatric Patients: Serious infections—8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses.

More severe infections—16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.

To avoid the possibility of esophageal irritation, Clindamycin HCl Capsules, USP should be taken with a full glass of water.

Serious infections due to anaerobic bacteria are usually treated with clindamycin injection.

However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clindamycin HCl Capsules, USP.

In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

DOSAGE AND ADMINISTRATION

The optimum daily dosage of SINEMET must be determined by careful titration in each patient.

SINEMET tablets are available in a 1:4 ratio of carbidopa to levodopa (SINEMET 25-100) as well as 1:10 ratio (SINEMET 25-250 and SINEMET 10-100).

Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.

Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day.

Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

Usual Initial Dosage Dosage is best initiated with one tablet of SINEMET 25-100 three times a day.

This dosage schedule provides 75 mg of carbidopa per day.

Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of SINEMET 25-100 a day is reached.

If SINEMET 10-100 is used, dosage may be initiated with one tablet three or four times a day.

However, this will not provide an adequate amount of carbidopa for many patients.

Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.

How to Transfer Patients from Levodopa Levodopa must be discontinued at least twelve hours before starting SINEMET.

A daily dosage of SINEMET should be chosen that will provide approximately 25% of the previous levodopa dosage.

Patients who are taking less than 1500 mg of levodopa a day should be started on one tablet of SINEMET 25-100 three or four times a day.

The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one tablet of SINEMET 25-250 three or four times a day.

Maintenance Therapy should be individualized and adjusted according to the desired therapeutic response.

At least 70 to 100 mg of carbidopa per day should be provided.

When a greater proportion of carbidopa is required, one tablet of SINEMET 25-100 may be substituted for each tablet of SINEMET 10-100.

When more levodopa is required, SINEMET 25-250 should be substituted for SINEMET 25-100 or SINEMET 10-100.

If necessary, the dosage of carbidopa and levodopa 25-250 may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day.

Experience with total daily dosages of carbidopa greater than 200 mg is limited.

Because both therapeutic and adverse responses occur more rapidly with SINEMET than with levodopa alone, patients should be monitored closely during the dose adjustment period.

Specifically, involuntary movements will occur more rapidly with SINEMET than with levodopa.

The occurrence of involuntary movements may require dosage reduction.

Blepharospasm may be a useful early sign of excess dosage in some patients.

Addition of Other Antiparkinsonian Medications Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while SINEMET is being administered, although dosage adjustments may be required.

Interruption of Therapy Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of SINEMET.

Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET is required, especially if the patient is receiving neuroleptics.

(See WARNINGS .) If general anesthesia is required, SINEMET may be continued as long as the patient is permitted to take fluids and medication by mouth.

If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

DOSAGE AND ADMINISTRATION

Patients should prime QVAR by actuating into the air twice before using for the first time or if QVAR has not been used for over ten days.

Avoid spraying in the eyes or face when priming QVAR.

QVAR is a solution aerosol, which does not require shaking.

Consistent dose delivery is achieved, whether using the 40 or 80 mcg strengths, due to proportionality of the two products (i.e., two actuations of 40 mcg strength should provide a dose comparable to one actuation of the 80 mcg strength).

QVAR should be administered by the oral inhaled route in patients 5 years of age and older.

Use of QVAR with a spacer device in children less than 5 years of age is not recommended (see PRECAUTIONS, Pediatric Use ).

The onset and degree of symptom relief will vary in individual patients.

Improvement in asthma symptoms should be expected within the first or second week of starting treatment, but maximum benefit should not be expected until 3-4 weeks of therapy.

For patients who do not respond adequately to the starting dose after 3-4 weeks of therapy, higher doses may provide additional asthma control.

The safety and efficacy of QVAR when administered in excess of recommended doses has not been established.

Recommended Dosage for QVAR: Previous Therapy Recommended Starting Dose Highest Recommended Dose Adults and Adolescents: Bronchodilators Alone 40 to 80 mcg twice daily 320 mcg twice daily Inhaled Corticosteroids 40 to 160 mcg twice daily 320 mcg twice daily Children 5 to 11 years: Bronchodilators Alone 40 mcg twice daily 80 mcg twice daily Inhaled Corticosteroids 40 mcg twice daily 80 mcg twice daily As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR downward over time to the lowest level that maintains proper asthma control.

This is particularly important in children since a controlled study has shown that QVAR has the potential to affect growth in children.

Patients should be instructed on the proper use of their inhaler.

Patients Not Receiving Systemic Corticosteroids Patients who require maintenance therapy of their asthma may benefit from treatment with QVAR at the doses recommended above.

In patients who respond to QVAR, improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy.

Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.

Patients Maintained on Systemic Corticosteroids QVAR may be effective in the management of asthmatics maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient’s asthma should be reasonably stable before treatment with QVAR is started.

Initially, QVAR should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroids.

After approximately one week, gradual withdrawal of the systemic corticosteroids is started by reducing the daily or alternate daily dose.

Reductions may be made after an interval of one or two weeks, depending on the response of the patient.

A slow rate of withdrawal is strongly recommended.

Generally these decrements should not exceed 2.5 mg of prednisone or its equivalent.

During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g.

joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function.

Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency.

If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

DIRECTIONS FOR USE Illustrated Patient’s Instructions for proper use accompany each package of QVAR.

DOSAGE AND ADMINISTRATION

2 Adult Patients ( 2.1 ) Infection Recommended Dose / Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.

Acute bacterial sinusitis 500 mg once daily for 3 days.

Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose.

Gonococcal urethritis and cervicitis One single 2 gram dose.

Pediatric Patients ( 2.2 ) Infection Recommended Dose / Duration of Therapy Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis 10 mg/kg once daily for 3 days.

Community-acquired pneumonia 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days.

2.1 Adult Patients [see INDICATIONS AND USAGE ( 1.1 ) and CLINICAL PHARMACOLOGY ( 12.3 )] Infection * Recommended Dose / Duration of Therapy Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial exacerbations of chronic obstructive pulmonary disease 500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial sinusitis 500 mg-once daily for 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose *DUE TO THE INDICATED ORGANISMS [see INDICATIONS AND USAGE ( 1.1 )] Azithromycin tablets can be taken with or without food.

2.2 Pediatric Patients Infection * Recommended Dose / Duration of Therapy Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis 10 mg/kg once daily for 3 days.

Community-acquired pneumonia 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.

Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days.

*DUE TO THE INDICATED ORGANISMS [see INDICATIONS AND USAGE ( 1.2 )] 1 see dosing tables below for maximum doses evaluated by indication Azithromycin for oral suspension can be taken with or without food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA(Age 6 months and above, [see USE IN SPECIFIC POPULATIONS (8.4)])Based on Body Weight * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

OTITIS MEDIA AND COMMUNITY – ACQUIRED PNEUMONIA : ( 5 – Day Regimen )* Dosing Calculated on 10 mg / kg / day Day 1 and 5 mg / kg / day Days 2 to 5 .

Weight 100 mg / 5 mL 200 mg / 5 mL Kg Lbs .

Day 1 Days 2 to 5 Day 1 Days 2 to 5 Total mL per Treatment Course Total mg per Treatment Course 5 11 2.5 mL; (½ tsp) 1.25 mL; (¼ tsp) 7.5 mL 150 mg 10 22 5 mL; (1tsp) 2.5 mL; (½ tsp) 15 mL 300 mg 20 44 5 mL; (1 tsp) 2.5 mL; (½ tsp) 15 mL 600 mg 30 66 7.5 mL; (1½ tsp) 3.75 mL; (¾ tsp) 22.5 mL 900 mg 40 88 10 mL; (2 tsp) 5 mL; (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL; (2½ tsp) 6.25 mL; (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.

OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS : ( 3 – Day Regimen )* Dosing Calculated on 10 mg / kg / day .

Weight 100 mg / 5 mL 200 mg / 5 mL Kg Lbs .

Days 1 to 3 Days 1 to 3 Total mL per Treatment Course Total mg per Treatment Course 5 11 2.5 mL; (1/2 tsp) 7.5 mL 150 mg 10 22 5 mL; (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA : ( 1 – Day Regimen ) Dosing Calculated on 30 mg / kg as a single dose .

Weight 200 mg / 5 mL Kg Lbs .

1 – Day Regimen Total mL per Treatment Course Total mg per Treatment Course 5 11 3.75 mL;(3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL;(1½ tsp) 7.5 mL 300 mg 20 44 15 mL;(3 tsp) 15 mL 600 mg 30 66 22.5 mL;(4½ tsp) 22.5 mL 900 mg 40 88 30 mL;(6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL;(7½ tsp) 37.5 mL 1500 mg The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established.

In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days.

(See chart below.) PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS(Age 2 years and above, [see USE IN SPECIFIC POPULATIONS (8.4)])Based on Body Weight PHARYNGITIS / TONSILLITIS : ( 5 – Day Regimen ) Dosing Calculated on 12 mg / kg / day for 5 days .

Weight 200 mg / 5 mL Kg Lbs .

Day 1 to 5 Total mL per Treatment Course Total mg per Treatment Course 8 18 2.5 mL; (½ tsp) 12.5 mL 500 mg 17 37 5 mL; (1 tsp) 25 mL 1000 mg 25 55 7.5 mL; (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL; (2 tsp) 50 mL 2000 mg 40 88 12.5 mL; (2½ tsp) 62.5 mL 2500 mg Constituting instructions for azithromycin oral suspension 300, 600, 900, 1200 mg bottles.

The table below indicates the volume of water to be used for constitution: Amount of water to be added Total volume after constitution ( azithromycin content ) Azithromycin concentration after constitution 9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL 9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL 12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL 15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mL Shake well before each use.

Oversized bottle provides shake space.

Keep tightly closed.

After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days.

Discard after full dosing is completed.

DOSAGE AND ADMINISTRATION

Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products mL = milliliter Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours children under 4 years do not use

DOSAGE AND ADMINISTRATION

Directions • adults and children 12 years of age and over: chew and swallow 2-3 chews as symptoms occur, or as directed by a doctor • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor