Azithromycin Monohydrate

Directions

Adults and children (12 years and older): Take one to four tablets, one to four times daily, or as recommended by your

healthcare practitioner.

Children (6-11 years): Take one to three tablets, one to four times daily, or as recommended by your healthcare practitioner.

Children (1-5 years): Take 1/2 to three tablets, one to three times daily, or as recommended by your healthcare practitioner.

Infants (0-11 months): Take 1/2 to three tablets, one to two times daily, or as recommended by your healthcare practitioner.

For children 0-2 years old, dissolve tablet in a small amount of water.

Acute Dosing: Follow the above age recommended tablet amounts and take every 15 to 60 minutes (up to 12 times per day)

or until symptoms improve, then resume general dosing.

Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under tongue.

Directions
Adults and children (12 years and older): Take one to four tablets, one to four times daily, or as recommended by your
healthcare practitioner.

Children (6-11 years): Take one to three tablets, one to four times daily, or as recommended by your healthcare practitioner.

Children (1-5 years): Take 1/2 to three tablets, one to three times daily, or as recommended by your healthcare practitioner.

Infants (0-11 months): Take 1/2 to three tablets, one to two times daily, or as recommended by your healthcare practitioner.

For children 0-2 years old, dissolve tablet in a small amount of water.

Acute Dosing: Follow the above age recommended tablet amounts and take every 15 to 60 minutes (up to 12 times per day)
or until symptoms improve, then resume general dosing.

Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under tongue.

Directions
Adults and children (12 years and older): Take one to four tablets, one to four times daily, or as recommended by your
healthcare practitioner.

Children (6-11 years): Take one to three tablets, one to four times daily, or as recommended by your healthcare practitioner.

Children (1-5 years): Take 1/2 to three tablets, one to three times daily, or as recommended by your healthcare practitioner.

Infants (0-11 months): Take 1/2 to three tablets, one to two times daily, or as recommended by your healthcare practitioner.

For children 0-2 years old, dissolve tablet in a small amount of water.

Acute Dosing: Follow the above age recommended tablet amounts and take every 15 to 60 minutes (up to 12 times per day)
or until symptoms improve, then resume general dosing.

Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under tongue.

2.1 Recommended Dosing

The recommended dose of NESINA is 25 mg once daily.

NESINA may be taken with or without food.

2.2 Patients with Renal Impairment

No dose adjustment of NESINA is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min).

The dose of NESINA is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min).

The dose of NESINA is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis). NESINA may be administered without regard to the timing of dialysis. NESINA has not been studied in patients undergoing peritoneal dialysis [see Clinical Pharmacology (12.3)].

Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of NESINA therapy and periodically thereafter.

Sodium Pertechnetate Tc99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc99m Injection is instilled aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose.

The suggested dose ranges employed for various diagnostic indications in average ADULT patients (70 kg) are:

Indication Megabecquerels (MBq) Millicuries (mCi) Vesico-ureteral imaging 18.5 - 37 0.5 - 1 Thyroid gland imaging 37 - 370 1 - 10 Salivary gland imaging 37 - 185 1 - 5 Nasolacrimal drainage system imaging 3.70 (max.) 0.100 (max.) The recommended dosage ranges in PEDIATRIC PATIENTS are: Vesico-ureteral imaging 18.5 - 37 MBq (0.5 - 1 mCi) Thyroid gland imaging 2.2 - 2.96 MBq (60 - 80 µCi) per kg body weight.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

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

The solution to be administered as the patient dose should be crystal clear and contain no particulate matter.

RADIATION DOSIMETRY

The estimated absorbed radiation doses to an average ADULT and PEDIATRIC patient from an intravenous injection of a maximum dose of 1110 MBq (30 mCi) of Sodium Pertechnetate Tc99m Injection distributed uniformly in the total body are shown in Tables 5 and 6.

Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous Administration Organ Absorbed Radiation Dose Per Unit Activity Administered (mGy/mCi) NOTE: To obtain radiation absorbed dose in rads from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose). Adrenals 0.14 Urinary Bladder Wall 0.67 Bone Surfaces 0.20 Brain 0.07 Breasts 0.07 Gallbladder Wall 0.27 Stomach Wall 0.96 Small Intestine 0.59 ULI Wall 2.11 LLI Wall 7.77 Heart Wall 0.12 Kidneys 0.19 Liver 0.14 Lungs 0.09 Muscle 0.12 Ovaries 0.37 Pancreas 0.21 Red Marrow 0.13 Skin 0.07 Spleen 0.16 Testes 0.10 Thymus 0.09 Thyroid 0.81 Uterus 0.30 Remaining Tissues 0.13 Effective Dose (mSv/mCi) 0.48 Table 6. Pediatric Absorbed Radiation Doses Per Unit Activity (mGy/mCi) from Intravenous Injection Age 15 years 10 years 5 years 1 year Organ NOTE: To obtain radiation absorbed dose in rads from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose). Adrenals 0.17 0.27 0.41 0.70 Urinary Bladder Wall 0.85 1.11 1.22 2.22 Bone Surfaces 0.24 0.36 0.52 0.96 Brain 0.09 0.15 0.24 0.44 Breasts 0.09 0.13 0.21 0.41 Gallbladder Wall 0.37 0.59 0.85 1.30 Stomach Wall 1.26 1.78 2.89 5.92 Small Intestine 0.74 1.15 1.74 3.03 ULI Wall 2.70 4.44 7.40 14.06 LLI Wall 1.04 1.67 2.66 4.81 Heart Wall 0.15 0.23 0.34 0.63 Kidneys 0.22 0.32 0.48 0.78 Liver 0.18 0.30 0.48 0.81 Lungs 0.13 0.19 0.29 0.52 Muscle 0.15 0.22 0.33 0.59 Ovaries 0.37 0.67 0.96 1.67 Pancreas 0.27 0.41 0.59 1.00 Red Marrow 0.17 0.24 0.33 0.56 Skin 0.08 0.13 0.21 0.37 Spleen 0.20 0.30 0.44 0.78 Testes 0.14 0.22 0.32 0.59 Thymus 0.12 0.17 0.28 0.52 Thyroid 1.33 2.04 4.44 8.14 Uterus 0.37 0.56 0.81 1.37 Remaining Tissues 0.13 0.24 0.36 0.63 Effective Dose (mSv/mCi) 0.63 0.96 1.55 2.92

The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc99m Injection for imaging the nasolacrimal drainage system are shown in Table 7.

Table 7. Absorbed Radiation Doses from Dacryoscintigraphy Absorbed Radiation Dose Organ mGy/3.7 MBq rad/100 µCi * Assuming no blockage of drainage system. Eye Lens:   If lacrimal fluid turnover is 16%/min. 0.140 0.014   If lacrimal fluid turnover is 100%/min. 0.022 0.002   If drainage system is blocked 4.020 0.402 Total Body 0.011 0.001 Ovaries* 0.030 0.003 Testes* 0.009 0.001 Thyroid* 0.130 0.013

In pediatric patients, an average 30 minute exposure to 37 MBq (1 mCi) of Sodium Pertechnetate Tc99m Injection following instillation for direct cystography, results in an estimated absorbed radiation dose shown in Table 8.

Table 8. Pediatric Absorbed Radiation Dose from Cystography Age Bladder wall dose, mGy (rad) Gonadal dose, mGy (rad) 1 year 3.6 (0.36) 0.15 (0.015) 5 years 2.0 (0.2) 0.095 (0.0095) 10 years 1.3 (0.13) 0.066 (0.0066) 15 years 0.92 (0.092) 0.046 (0.0046)