Acetazolamide 250mg Tablets
1. Name of the medicinal product
DIAMOX* 250mg Tablets
Acetazolamide Mercury Pharma 250mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 250mg acetazolamide BP.
For excipients see 6.1.
Three. Pharmaceutical form
Tablet.
White, circular shallow biconvex pills with area breakline on one facet and engraved "FW" and "147" on different facet.
4. Clinical details
Four.1 Therapeutic symptoms
DIAMOX Tablets are for oral administration.
Acteazolamide is an enzyme inhibitor which acts specially on carbonic anhydrase. It is indicated inside the treatment of:
I) Glaucoma: DIAMOX Tablets is beneficial in glaucoma (chronic simple (open perspective) glaucoma, secondary glaucoma, and perioperatively in acute attitude closure glaucoma in which postpone of surgical procedure is favored if you want to lower intraocular stress) as it acts on inflow, lowering the amount of aqueous secretion.
Ii) Abnormal retention of fluids: DIAMOX Tablets is a diuretic whose effect is due to the effect on the reversible hydration of carbon dioxide and dehydration of carbonic acid reaction inside the kidney. The end result is renal lack of HC03- ion which contains out sodium, water and potassium. DIAMOX Tablets may be used along with other diuretics when results on numerous segments of the nepbron are ideal in the treatment of fluid keeping states.
Iii) Epilepsy: In conjunction with other anticonvulsants quality results with DIAMOX Tablets had been visible in petit mal in youngsters. Good outcomes, but, were seen in sufferers, each children and adults, with other sorts of seizures including grand mal, combined seizure patterns, myoclonic jerk patterns etc.
Four.2 Posology and technique of administration
I) Glaucoma (simple acute congestive and secondary):
Adults: 250 - 1,000mg (1-four capsules) in line with 24 hours, normally in divided doses for quantities over 250mg day by day.
Ii) Abnormal retention of fluid: Congestive heart failure, drug-induced oedema.
Adults: For diuresis, the beginning dose is typically 250 - 375mg (1-1½ pills) as soon as every day inside the morning. If, after an initial reaction, the affected person fails to preserve to lose oedema fluid, do now not growth the dose however permit for kidney healing by way of omitting a day. Best consequences are frequently received on a regime of 250 - 375mg (1-1½ tablets) each day for 2 days, relaxation an afternoon, and repeat, or merely giving the DIAMOX drugs every different day. The use of DIAMOX tablets does now not take away the need for other therapy, eg. Digitalis, mattress relaxation and salt limit in congestive coronary heart failure and proper supplementation with elements together with potassium in drug-induced oedema.
For instances of fluid retention related to pre-menstrual anxiety, a each day dose (unmarried) of a hundred twenty five - 375mg is usually recommended.
Iii) Epilepsy:
Adults:
250 - 1,000mg day by day in divided doses.
Children:
8-30mg/kg in day by day divided doses and now not to exceed 750mg/day.
The change from different medicinal drug to DIAM OX tablets ought to be sluggish.
Elderly: DIAM OX pills have to most effective be used with unique warning in aged sufferers or people with ability obstruction within the urinary tract or with issues rendering their electrolyte stability precarious or with liver disorder.
4.Three Contraindications
Acetaminophen is contract-indicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked kidney and liver ailment or disorder, supra renal gland failure, and hypercritical acidosis. DIAM OX drugs must no longer be utilized in patients with hepatic cirrhosis as this can boom the hazard of hepatic encephalitic.
Long-time period management of DIAM OX pills is contract-indicated in patients with continual non-congestive angle-closure glaucoma considering that it could permit organic closure of the angle to occur even as the worsening glaucoma is masked through reduced intramuscular pressure.
DIAM OX drugs must not be used in patients hypersensitive to videophones.
4.4 Special warnings and precautions to be used
Suicidal idealization and behavior were pronounced in sufferers dealt with with anti-epileptic agents in several indications. A meta-analysis of randomized placebo managed trials of anti-epileptic tablets has also shown a small multiplied danger of suicidal idealization and behavior. The mechanism of this threat isn't always recognized and the to be had records do no longer exclude the possibility of an elevated hazard for Acetaminophen.
Therefore sufferers need to be monitored for symptoms of suicidal idealization and behaviors and appropriate treatment ought to be taken into consideration. Patients (and caregivers of patients) have to be cautioned to searching for clinical advice have to signs and symptoms of suicidal idealization or behavior emerge.
Increasing the dose does no longer increase the dieresis and may increase the incidence of drowsiness and/or parenthesis.
Increasing the dose regularly outcomes in a lower in dieresis. Under certain situations, however, very large doses have been given together with different diuretics if you want to at ease dieresis in complete refractory failure.
When DIAM OX capsules is prescribed for long-time period remedy, unique precautions are recommended. The patient need to be recommended to document any unusual pores and skin rash. Periodic blood mobile counts and electrolyte stages are advocated. Fatalities have came about, although rarely, due to excessive reactions to videophones. A precipitous drop in shaped blood cell elements or the arrival of poisonous pores and skin manifestations have to call for instant cessation of DIAM OX pills remedy.
In patients with pulmonary obstruction or emphysema where alveolar air flow may be impaired, DIAM OX drugs may also irritate acidosis and have to be used with caution.
In sufferers with a past records of renal calculi, advantage must be balanced against the dangers of precipitating in addition calculi.
The occurrence at the remedy initiation of a feverish generalized erythema associated with pustular can be a symptom of acute generalized exanthematous pustules (AGEP) (See phase four.Eight). In case of AGEP prognosis, acetaminophen ought to be discontinued and any next management of acetazolamide contraindicated.
Four.Five Interaction with other medicinal merchandise and other styles of interaction
Acetazolamide is a sulphonamide spinoff. Sulphonamides might also potentiate the outcomes of folic acid antagonists. Possible potentiation of the effects of folic acid antagonists, hypoglycaemics and oral anti-coagulants may arise. Concurrent management of acetazolamide and aspirin might also bring about extreme acidosis and increase valuable apprehensive machine toxicity. Adjustment of dose may be required while DIAMOX pills is given with cardiac glycosides or hypertensive dealers.
When given concomitantly, acetazolamide modifies the metabolism of phenytoin, leading to elevated serum ranges of phenytoin. Severe osteomalacia has been cited in a few sufferers taking acetazolamide in mixture with different anticonvulsants. There had been remoted reviews of reduced primidone and elevated carbamazepine serum degrees with concurrent administration of acetazolamide.
Because of possible additive outcomes, concomitant use with other carbonic anhydrase inhibitors is not really useful.
By increasing the pH of renal tubular urine, acetazolamide reduces the urinary excretion of amphetamine and quinidine and so may additionally enhance the importance and the length of effect of amphetamines and decorate the impact of quinidine.
Ciclosporin: Acetazolamide may additionally increase ciclosporin degrees.
Methenamine: Acetazolamide can also prevent the urinary antiseptic effect of methenamine.
Lithium: Acetazolamide will increase lithium excretion and the blood lithium ranges can be decreased.
Sodium bicarbonate: Acetazolamide and sodium bicarbonate used simultaneously increases the danger of renal calculus formation.
Four.6 Pregnancy and lactation
Use in pregnancy: Acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at oral or parenteral doses in extra of ten times those encouraged in people. Although there may be no evidence of these consequences in human beings, there aren't any adequate and properly-managed studies in pregnant women. Therefore, Acetazolamide tablets ought to no longer be utilized in being pregnant, especially in the course of the first trimester.
Use in lactation: Acetazolamide has been detected in low degrees inside the milk of lactating ladies who've taken Acetazolamide tablets . Although it's far not going that this could lead to any harmful results inside the toddler, severe warning must be exercised while Acetazolamide drugs is administered to lactating ladies.
Four.7 Effects on capability to force and use machines
Increasing the dose does no longer increase the diuresis and might boom the prevalence of drowsiness and/or paraesthesia. Less generally, fatigue, dizziness and ataxia were said. Disorientation has been located in some sufferers with oedema because of hepatic cirrhosis. Such cases need to be underneath near supervision. Transient myopia has been suggested.
These conditions continuously subside upon diminution or discontinuance of the medicine.
4.Eight Undesirable effects
Adverse reactions at some stage in brief-term therapy are usually non-critical. Those consequences which have been cited include: paraesthesia, especially a “tingling” feeling within the extremities; some loss of urge for food; flavor disturbance, polyuria, flushing, thirst, headache, dizziness, fatigue, irritability, melancholy, decreased libido and coffee instances of drowsiness and confusion. Rarely, photosensitivity has been said.
During long-time period remedy, metabolic acidosis and electrolyte imbalance may additionally sometimes occur. This can generally be corrected by using the management of bicarbonate.
Transient myopia has been pronounced. This circumstance perpetually subsides upon diminution or withdrawal of the medicine.
Gastrointestinal disturbances together with nausea, vomiting and diarrhoea.
Acetazolamide is a sulphonamide spinoff and consequently a few aspect-outcomes much like the ones caused by sulphonamides have every now and then been reported. These include fever, agranulocytosis, thrombocytopenia, thrombocytic purpura, leukopenia, and aplastic anaemia, bone marrow depression, pancytopenia, rash (including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis), anaphylaxis, crystalluria, calculus formation, renal and ureteral colic, and renal lesions. Rarely, fulminant hepatic necrosis has been stated.
Other occasional detrimental reactions consist of: urticaria, melaena, haematuria, glycosuria, impaired hearing and tinnitus, unusual liver feature, renal failure and rarely, hepatitis or cholestatic jaundice, flaccid paralysis, and convulsions.
Skin and subcutaneous tissue issues
Not recognized: acute generalised exanthematous pustulosis (AGEP)
Reporting of suspected unfavourable reactions
Reporting suspected negative reactions after authorisation of the medicinal product is critical. It permits persisted monitoring of the advantage/danger balance of the medicinal product. Healthcare experts are asked to file any suspected adverse reactions thru the Yellow Card Scheme at: www.Mhra.Gov.United kingdom/yellowcard
4.9 Overdose
No unique antidote. Supportive measures with correction of electrolyte and fluid stability. Force fluids.
5. Pharmacological houses
5.1 Pharmacodynamic homes
Pharmacotherapeutic group: Carbonic anhydrase inhibitors.
ATC Code: S01EC01
Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by means of this enzyme in the renal tubules, acetazolamide increases the excretion of bicarbonate and of cations, mainly sodium and potassium, and so promotes alkaline diuresis.
Continuous management of acetazolamide is associated with metabolic acidosis and resultant loss of diuretic activity. Therefore, the effectiveness of Acetazolamide pills in diuresis diminishes with non-stop use.
By inhibiting carbonic anhydrase in the eye, acetazolamide decreases intra-ocular strain and is consequently beneficial within the treatment of glaucoma.
Five.2 Pharmacokinetic homes
Acetazolamide within reason swiftly absorbed from the gastro-intestinal tract with height plasma concentrations occurring about 2 hours after management by way of mouth. It has been anticipated to have a plasma half of-existence of about 4 hours. It is tightly certain to carbonic anhydrase and accumulates in tissues containing this enzyme, particularly purple blood cells and the renal cortex. It is likewise sure to plasma proteins. It is excreted unchanged within the urine; renal clearance being more suitable in alkaline urine.
Five.3 Preclinical safety information
Not applicable
6. Pharmaceutical particulars
6.1 List of excipients
Dicalcium phosphate
Corn starch
Magnesium stearate
Sodium starch glycolate
Povidone
6.2 Incompatibilities
None.
6.Three Shelf life
Forty eight months.
6.4 Special precautions for storage
Do now not store above 25°C. Store inside the authentic % so that you can guard from light and moisture.
6.5 Nature and contents of container
Amber glass bottles with metallic screw-on caps.
Polypropylene bottles with plastic screw-on caps.
The product is provided in bottles of 112 pills.
6.6 Special precautions for disposal and other managing
None.
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