Lidocaine Hydrochloride Solution

Adult:

The maximum recommended single dose of lidocaine hydrochloride oral topical solution, 2% (viscous) for healthy adults should be such that the dose of lidocaine HCl does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Pediatric:

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of lidocaine hydrochloride oral topical solution 2% (viscous)).

For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine hydrochloride oral topical solution 2% (viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

Gabapentin tablets are given orally with or without food. Patients should be informed that, should they break the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of breaking the scored tablet should be discarded.

If gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

In adults with postherpetic neuralgia, gabapentin tablets therapy may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Gabapentin tablets are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.

Patients 12 years of age and above: The starting dose is 300 mg three times a day. The effective dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Gabapentin tablets should be administered three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.

Pediatric Patients Age 3 to 11 years: The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The effective dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin tablets therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin tablets and other commonly used antiepileptic drugs, the addition of gabapentin tablets does not alter the plasma levels of these drugs appreciably.

If gabapentin tablets are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage adjustment in patients 12 years of age and older with compromised renal function or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):

                                        TABLE 1. Gabapentin Tablets Dosage Based on Renal Function 

Renal Function Creatinine Clearance (mL/min)

Total Daily
Dose Range
(mg/day)

Dose Regimen
(mg)

≥ 60

900 to 3600

300 TID

400 TID

600 TID

800 TID

1200 TID

>30 to 59

400 to 1400

200 BID

300 BID

400 BID

500 BID

700 BID

>15 to 29

200 to 700

200 QD

300 QD

400 QD

500 QD

700 QD

15a

100 to 300

100 QD

125 QD

150 QD

200 QD

300 QD

Post-Hemodialysis Supplemental Dose (mg)b

Hemodialysis

125b

150b

200b

250b

350b

Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:



The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

The optimal daily dose of calcitriol must be carefully determined for each patient. Calcitriol Capsules should be administered orally. Calcitriol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

The effectiveness of calcitriol therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

Because of improved calcium absorption from the gastrointestinal tract, some patients on calcitriol may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplements at all.

During the titration period of treatment with calcitriol, serum calcium levels should be checked at least twice weekly. When the optimal dosage of calcitriol has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

The recommended initial dose of calcitriol is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

Patients with normal or only slightly reduced serum calcium levels may respond to calcitriol doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral calcitriol may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral calcitriol may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

The recommended initial dosage of calcitriol is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2- to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, calcitriol should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of calcitriol may be needed.

The recommended initial dosage of calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

For pediatric patients less than 3 years of age, the recommended initial dosage of calcitriol is 10 to 15 ng/kg/day.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of lidocaine hydrochloride oral topical solution, 2% (viscous) for healthy adults should be such that the dose of lidocaine HCl does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of lidocaine hydrochloride oral topical solution 2% (viscous)).

For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine hydrochloride oral topical solution 2% (viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

The maximum recommended single dose of lidocaine hydrochloride oral topical solution, 2% (viscous) for healthy adults should be such that the dose of lidocaine HCl does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of lidocaine hydrochloride oral topical solution 2% (viscous)).

For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine hydrochloride oral topical solution 2% (viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.

The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide may be associated with either or both dose-independent or dose-dependent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.

To minimize dose-dependent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, depending on current monotherapy dose. Further increases of either or both components should depend on clinical response with blood pressure measured at the interdosing interval to ensure that there is an adequate antihypertensive effect at that time. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. After addition of the diuretic it may be possible to reduce the dose of lisinopril. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control without electrolyte disturbance if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). If the patient's blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg of lisinopril should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).

Concomitant administration of lisinopril and hydrochlorothiazide with potassium supplements, potassium salt substitutes or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).

The combination may be substituted for the titrated individual components.

Regimens of therapy with lisinopril and hydrochlorothiazide tablets need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.7 m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See ). PRECAUTIONS

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

When lidocaine hydrochloride topical solution 4% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with lidocaine hydrochloride topical solution 4% is quite low, caution should be exercised particularly when employing large volumes since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of lidocaine hydrochloride topical solution is 1-5 mL (40-200 mg of lidocaine hydrochloride), i.e., 0.6-3.0 mg/kg or 0.3-1.5 mg/lb of body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after use and never reused under any circumstances. When spraying, transfer the solution from the original container to an atomizer.

Maximum Recommended Dosages:

The maximum recommended dose of lidocaine hydrochloride topical solution should be such that the dose of lidocaine hydrochloride is kept below 300 mg and in any case should never exceed 4.5 mg/kg (2 mg/lb) of body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum dose of lidocaine hydrochloride and epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of lidocaine hydrochloride administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, 2% (Viscous) for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (¾ to 1 teaspoonful).

For infants and in children under 3 years of age, ¼ teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, 2% (Viscous) for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (¾ to 1 teaspoonful).

For infants and in children under 3 years of age, ¼ teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

DOSAGE AND ADMINISTRATION
Adult:
The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.
For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.
The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Pediatric:
Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing. It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).
For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCI, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCI), i.e., 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use. When spraying, transfer the solution from the original container to an atomizer.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, 2% (Viscous) for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (¾ to 1 teaspoonful).

For infants and in children under 3 years of age, ¼ teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See ). PRECAUTIONS

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCI, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCI), i.e., 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use. When spraying, transfer the solution from the original container to an atomizer.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCI, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCI), i.e., 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use. When spraying, transfer the solution from the original container to an atomizer.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3.7 to 5 mL of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%).

For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, 2% (Viscous) for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (¾ to 1 teaspoonful).

For infants and in children under 3 years of age, ¼ teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, 2% (Viscous) for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight, and physical condition (see PRECAUTIONS).

Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (¾ to 1 teaspoonful).

For infants and in children under 3 years of age, ¼ teaspoon of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCI, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCI), i.e., 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use. When spraying, transfer the solution from the original container to an atomizer.

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs. the dose of lidocaine HCI should not exceed 75 to 100 mg when calculated according to Clark's rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

There is currently no dosage information available for this product. We apologize for any inconvenience.

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCl, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia.  The lowest dosage needed to provide effective anesthesia should be administered.  Dosages should be reduced for children and for elderly and debilitated patients.  The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight.  Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

The dosages recommended below are for normal, healthy adults:

When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCl), ie, 0.6 to 3 mg/kg or 0.3 to 1.5 mg/lb body weight.

NOTE: The solution may be applied with a sterile swab which is discarded after a single use.  When spraying, transfer the solution from the original container to an atomizer.

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)

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 obstructive pulmonary disease (mild to moderate) 500 mg QD x 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 QD x 3 days
Genital ulcer disease (chancroid) One single 1 gram dose
Non-gonoccocal 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.)Azithromycin tablets can be taken with or without food.

Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)

Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.

Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)

Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight
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
Total mL per Treatment Course Total mg per
Treatment Course
Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5

5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)

7.5 mL

150 mg

10
22
5 mL (1 tsp)
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 (3/4tsp) 22.5 mL
900 mg
40
88

10 mL (2 tsp)

5 mL (1tsp)

30 mL
1200 mg
50 and above

12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.

Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course
Kg Lbs. Day 1-3 Day 1-3

5
11

2.5 mL (½ 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
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight

200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1

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 (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 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, eight 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 PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight

200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5

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 (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg

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 obstructive pulmonary disease (mild to moderate) 500 mg QD x 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 QD x 3 days
Genital ulcer disease (chancroid) One single 1 gram dose
Non-gonoccocal 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.)Azithromycin tablets can be taken with or without food.

Renal Insufficiency:
No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)

Hepatic Insufficiency:
The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

Pediatric Patients:
Azithromycin for oral suspension can be taken with or without food.

Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

Acute bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days.(See chart below.)

Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA,ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS-Pediatric Use.) Based on Body Weight
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
Total mL per Treatment Course Total mg per
Treatment Course
Kg Lbs. Day 1
Days 2-5
Day 1 Days 2-5

5
11
2.5 mL (½ tsp)
1.25 mL (¼ tsp)

7.5 mL

150 mg

10
22
5 mL (1 tsp)
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 (3/4tsp) 22.5 mL
900 mg
40
88

10 mL (2 tsp)

5 mL (1tsp)

30 mL
1200 mg
50 and above

12.5 mL (2 ½ tsp)
6.25 mL (1¼ tsp) 37.5 mL
1500 mg
*Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.

Weight
100 mg/5 mL 200 mg/5 mL Total mL per
Treatment Course Total mg per
Treatment Course
Kg Lbs. Day 1-3 Day 1-3

5
11

2.5 mL (½ 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
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight

200 mg/5 mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day1

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 (4 ½ tsp) 22.5 mL
900 mg
40
88
30 mL (6tsp) 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, eight 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 PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days
Weight

200mg/5mL
Total mL per Treatment course
Total mg per Treatment course
Kg Lbs.
Day 1-5

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 (1 ½ tsp) 37.5 mL
1500 mg
33
73
10 mL (2 tsp) 50 mL
2000 mg
40
88
12.5 mL (2 ½ tsp) 62.5 mL
2500 mg