| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| Oral | Tablet, 250 mg and 600 mg azithromycin (as azithromycin dihydrate) | pregelatinized starch, sodium croscarmellose, sodium lauryl sulphate and lactose |
| Powder for oral suspension, azithromycin 100 mg/5 mL, 200 mg/5 mL when reconstituted (as azithromycin dihydrate) | sucrose and sodium phosphate | |
| Intravenous | Azithromycin for injection, 500 mg/vial, (100 mg/mL after reconstitution) (as azithromycin dihydrate) | sodium hydroxide for pH adjustment |
TABLETS 250 mg: Each pink, film-coated, unscored, modified capsule shaped ZITHROMAX tablet, engraved “ZTM 250” or “306” on one side and “Pfizer” on the other side, contains azithromycin dihydrate equivalent to 250 mg of azithromycin and the following inactive ingredients: pregelatinized starch (27 mg), anhydrous calcium phosphate dibasic, sodium croscarmellose (9 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose (tablet coating), titanium dioxide, triacetin and D&C Red #30 aluminum lake. The tablets are packaged in white plastic (high density polyethylene) bottles of 30 or in a single treatment package (Z-pak) of 6 blister packaged tablets per box.
TABLETS 600 mg: Each white, film-coated, unscored, modified oval shaped ZITHROMAX tablet, debossed with “PFIZER” on one side and “308” on the other side, contains azithromycin dihydrate equivalent to 600 mg azithromycin and the following non-medicinal ingredients: anhydrous calcium phosphate dibasic, pregelatinized starch (64.8 mg), sodium croscarmellose (21.6 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose (tablet coating), titanium dioxide and triacetin. These are packaged in HDPE bottles of 30 tablets.
POWDER FOR ORAL SUSPENSION: ZITHROMAX Powder for Oral Suspension, contains azithromycin dihydrate equivalent to: 300 mg; 600 mg; and 900 mg of azithromycin per bottle. After reconstitution, each bottle (high density polyethylene) contains a cherry flavoured suspension with azithromycin dihydrate equivalent to: 300 mg per 15 mL (100 mg/5 mL); 600 mg per 15 mL (200 mg/5 mL); 900 mg per 22.5 mL (200 mg/5 mL) azithromycin. The non-medicinal ingredients include: sucrose (3.86 g per 100 mg/5 mL and 3.87 g per 200 mg/5 mL); sodium phosphate (8.76 mg per 100 mg/5 mL and 17.50 mg per 200 mg/5 mL), tribasic hydroxypropyl cellulose; xanthan gum; FD&C Red #40 and artificial flavours (see 4.3 Reconstitution). The 300 mg bottle (100 mg/5 mL) is supplied with a plastic stopper and a calibrated syringe. The 600 mg bottle (200 mg/5 mL) and the 900 mg bottle (200 mg/5 mL) are supplied with a plastic stopper, and a calibrated syringe and dosing cup.
ZITHROMAX for Injection 500 mg: Each vial contains azithromycin dihydrate in a lyophilized form equivalent to 500 mg azithromycin for injection. The non-medicinal ingredients include: 384.6 mg anhydrous citric acid and 198.5 mg sodium hydroxide for pH adjustment. After reconstitution, each mL contains azithromycin dihydrate equivalent to 100 mg azithromycin (500 mg/5 mL) (see 4.3 Reconstitution). ZITHROMAX for Injection is supplied in cartons of 10 single dose vials.
)| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| Oral | Tablet, 250 mg and 600 mg azithromycin (as azithromycin dihydrate) | pregelatinized starch, sodium croscarmellose, sodium lauryl sulphate and lactose |
| Powder for oral suspension, azithromycin 100 mg/5 mL, 200 mg/5 mL when reconstituted (as azithromycin dihydrate) | sucrose and sodium phosphate | |
| Intravenous | Azithromycin for injection, 500 mg/vial, (100 mg/mL after reconstitution) (as azithromycin dihydrate) | sodium hydroxide for pH adjustment |
TABLETS 250 mg: Each pink, film-coated, unscored, modified capsule shaped ZITHROMAX tablet, engraved “ZTM 250” or “306” on one side and “Pfizer” on the other side, contains azithromycin dihydrate equivalent to 250 mg of azithromycin and the following inactive ingredients: pregelatinized starch (27 mg), anhydrous calcium phosphate dibasic, sodium croscarmellose (9 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose (tablet coating), titanium dioxide, triacetin and D&C Red #30 aluminum lake. The tablets are packaged in white plastic (high density polyethylene) bottles of 30 or in a single treatment package (Z-pak) of 6 blister packaged tablets per box.
TABLETS 600 mg: Each white, film-coated, unscored, modified oval shaped ZITHROMAX tablet, debossed with “PFIZER” on one side and “308” on the other side, contains azithromycin dihydrate equivalent to 600 mg azithromycin and the following non-medicinal ingredients: anhydrous calcium phosphate dibasic, pregelatinized starch (64.8 mg), sodium croscarmellose (21.6 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose (tablet coating), titanium dioxide and triacetin. These are packaged in HDPE bottles of 30 tablets.
POWDER FOR ORAL SUSPENSION: ZITHROMAX Powder for Oral Suspension, contains azithromycin dihydrate equivalent to: 300 mg; 600 mg; and 900 mg of azithromycin per bottle. After reconstitution, each bottle (high density polyethylene) contains a cherry flavoured suspension with azithromycin dihydrate equivalent to: 300 mg per 15 mL (100 mg/5 mL); 600 mg per 15 mL (200 mg/5 mL); 900 mg per 22.5 mL (200 mg/5 mL) azithromycin. The non-medicinal ingredients include: sucrose (3.86 g per 100 mg/5 mL and 3.87 g per 200 mg/5 mL); sodium phosphate (8.76 mg per 100 mg/5 mL and 17.50 mg per 200 mg/5 mL), tribasic hydroxypropyl cellulose; xanthan gum; FD&C Red #40 and artificial flavours (see 4.3 Reconstitution). The 300 mg bottle (100 mg/5 mL) is supplied with a plastic stopper and a calibrated syringe. The 600 mg bottle (200 mg/5 mL) and the 900 mg bottle (200 mg/5 mL) are supplied with a plastic stopper, and a calibrated syringe and dosing cup.
ZITHROMAX for Injection 500 mg: Each vial contains azithromycin dihydrate in a lyophilized form equivalent to 500 mg azithromycin for injection. The non-medicinal ingredients include: 384.6 mg anhydrous citric acid and 198.5 mg sodium hydroxide for pH adjustment. After reconstitution, each mL contains azithromycin dihydrate equivalent to 100 mg azithromycin (500 mg/5 mL) (see 4.3 Reconstitution). ZITHROMAX for Injection is supplied in cartons of 10 single dose vials.
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