Acetazolamide (Page 2 of 2)
OVERDOSAGE
No data are available regarding acetazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that acetazolamide is remarkably nontoxic. No specific antidote is known. Treatment should be symptomatic and supportive.
Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate.
Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide may be dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.
DOSAGE AND ADMINISTRATION
Glaucoma
Acetazolamide should be used as an adjunct to the usual therapy. The dosage employed in the treatment of
chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g of acetazolamide per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 1 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension. Continuous supervision by a physician is advisable.
In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma , the preferred dosage is 250 mg every four hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 mg or 250 mg every four hours depending on the individual case. A complementary effect has been noted when acetazolamide has been used in conjunction with miotics or mydriatics as the case demanded.
Epilepsy
It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adult, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 mg to 30 mg per kg in divided doses. Although some patients respond to a low dose, the optimum range appears to be from 375 mg to 1,000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When acetazolamide tablets are given in combination with other anticonvulsants, it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications. This can be increased to levels as indicated above.
The change from other medications to acetazolamide should be gradual and in accordance with usual practice in epilepsy therapy.
Congestive Heart Failure
For diuresis in congestive heart failure, the starting dose is usually 250 mg to 375 mg once daily in the morning (5 mg/kg). If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day.
Acetazolamide tablets yield best diuretic results when given on alternate days, or for two days alternating with a day of rest.
Failures in therapy may be due to overdosage or too frequent dosage. The use of acetazolamide does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction.
Drug-Induced Edema
Recommended dosage is 250 mg to 375 mg of acetazolamide once a day for one or two days, alternating with a day of rest.
Acute Mountain Sickness
Dosage is 500 mg to 1,000 mg daily, in divided doses. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1,000 mg is recommended. It is preferable to initiate dosing 24 hours to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.
Note: The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the kidney which requires intermittent dosage if it is to recover from the inhibitory effect of the therapeutic agent.
HOW SUPPLIED
Acetazolamide Tablets USP are supplied as follows:
250 mg – White to off-white, round, standard convex tablets debossed with E and 2 on one side and scored in quarters on the other side.
Unit dose packages of 100 (10 x 10) NDC 60687-619-01
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
PACKAGING INFORMATION
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Eywa Pharma Inc. as follows:
(250 mg / 100 UD) NDC 60687-619-01 packaged from NDC 71930-009
Distributed by:
American Health Packaging
Columbus, OH 43217
8461901/0322F
Package/Label Display Panel – Carton – 250 mg
NDC 60687- 619 -01
acetaZOLAMIDE
Tablets, USP
250 mg
100 Tablets (10 x 10) Rx Only
Each Tablet Contains:
Acetazolamide, USP……………………………………………………… 250 mg
Usual Dosage: See package insert for full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep this and all drugs out of reach of children.
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from
NDC # 71930-009, Eywa Pharma Inc.
Distributed by:
American Health Packaging
Columbus, Ohio 43217
761901 0461901/0521
Package/Label Display Panel – Blister – 250 mg
acetaZOLAMIDE Tablet, USP
250 mg
| ACETAZOLAMIDE acetazolamide tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| Labeler — American Health Packaging (929561009) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| American Health Packaging | 929561009 | repack (60687-619) | |
Revised: 10/2022 American Health Packaging
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.