Diamox Powder for Solution for Injection 500 mg/vial

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

ACETAZOLAMIDE SODIUM

Beszerezhető a:

Amdipharm Limited

ATC-kód:

S01EC; S01EC01

INN (nemzetközi neve):

ACETAZOLAMIDE SODIUM

Adagolás:

500 milligram/vial

Gyógyszerészeti forma:

Powder for solution for injection

Terápiás terület:

Carbonic anhydrase inhibitors; acetazolamide

Engedélyezési státusz:

Not marketed

Engedély dátuma:

1978-04-01

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIAMOX® POWDER FOR SOLUTION FOR INJECTION
500MG/VIAL
(Acetazolamide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS
IN THIS LEAFLET:
1. What DIAMOX® is and what it is used for
2. What you need to know before you are given DIAMOX®
3. How you are given DIAMOX®
4. Possible side effects
5. How to store DIAMOX®
6. Contents of the pack and other information
1. WHAT DIAMOX® IS AND WHAT IT IS USED FOR
DIAMOX® Powder for Solution for Injection 500mg/viaI belongs to a
group of drugs called
carbonic anhydrase inhibitors. DIAMOX® is used to treat the eye
condition glaucoma, and also
fluid retention and epilepsy.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DIAMOX®
YOU SHOULD NOT BE GIVEN DIAMOX® IF:
• you are allergic to acetazolamide or any of the other ingredients
of this medicine (listed in section
6).
• are you pregnant, breast feeding or trying for a baby.
• are you allergic to sulphonamides or sulphonamide derivatives.
• you have or have ever had severe liver disease (problems).
• you have or have ever had severe kidney problems.
• you have a particular type of glaucoma known as chronic non
congestive angle closure glaucoma.
• you have reduced function of the adrenal glands - glands above the
kidneys (also known as
Addison’s disease).
• you have low blood levels of sodium and/or potassium or high blood
levels of chlorine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given DIAMOX® if:
• you have liver problems.
• you have or ever had kidney problems such as kidney stones.
• you have trouble passing urine.
• you have lung problems such as chronic bronchitis or emphysema.
•
•

Termékjellemzők

Health Products Regulatory Authority
03 February 2020
CRN0095YR
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamox Powder for Solution for Injection 500 mg/vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Acetazolamide Sodium equivalent to Acetazolamide
500mg.
Excipient(s) with known effect
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
Sterile, white, lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DIAMOX is an enzyme inhibitor which acts specifically on carbonic
anhydrase. It is indicated in the treatment of:
i) GLAUCOMA: DIAMOX is useful in glaucoma (chronic simple (open angle)
glaucoma, secondary glaucoma, and perioperatively
in acute angle closure glaucoma where delay of surgery is desired in
order to lower intraocular pressure) because it acts on
inflow, decreasing the amount of aqueous secretion.
ii) ABNORMAL RETENTION OF FLUIDS: DIAMOX is a diuretic whose effect is
due to the effect on the reversible hydration of carbon
dioxide and dehydration of carbonic acid reaction in the kidney. The
result is renal loss of HCO
3-
ion which carries out sodium,
water and potassium.
DIAMOX can be used in conjunction with other diuretics when effects on
several segments of the nephron are desirable in the
treatment of fluid retaining states.
iii) EPILEPSY: In conjunction with other anticonvulsants best results
with DIAMOX have been seen in petit mal in children.
Good results, however, have been seen in patients, both children and
adults, with other types of seizures such as grand mal,
mixed seizure patterns, myoclonic jerk patterns etc.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
I. GLAUCOMA (SIMPLE ACUTE CONGESTIVE AND SECONDARY): ADULTS: 250
-1,000mg per 24 hours, usually in divided doses.
CHILDREN: The usual total daily dose is 125-750mg in divided doses.
ii. ABNORMAL RETENTION OF FLUID: Congestive heart failure,
drug-induced oedema.
ADULTS:
For diuresis, the starting dose is usu