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Spironolactone

INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY SPIRONOLACTONE Available CompositionVELACTONE-100 Each film coated tablet contains Spironolactone USP 100mg PHARMACOLOGICAL CLASSIFICATION

Diuretic (Aldosterone antagonist)

VELACTONE inhibits the effect of aldosterone by competing for intracellular aldosterone receptor in the distal tubule cells (it actually works on aldosterone receptors in the collecting duct). This increases the excretion of water and sodium, while decreasing the excretion of potassium. Spironolactone has a fairly slow onset of action, taking several days to develop and similarly the effect diminishes slowly. Spironolactone has anti-androgen activity by binding to the androgen receptor and preventing it interacting with dihydrotestosterone.

PHARMACOKINETICS

VELACTONE is fairly rapidly absorbed from the gastrointestinal tract. It is also rapidly metabolised and bound in plasma proteins. Many of its metabolites are also active and one of them, canrenone as potassium canrenoate, is used parenterally when rapid effect is needed. Spironolactones half-life is 85 minutes, but canrenones half-life is 10 to 35 hours, depending on the dose. The main elimination route is in the urine and some also in the bile

INDICATIONS

VELACTONE is indicated for the treatment of

congestive heart failure
nephrotic syndrome (a kidney disorder)
oedema (fluid retention) associated with liver cirrhosis
dropsy or swelling of the abdomen
diagnosis and treatment of a hormone condition called primary aldosteronism which may affect your electrolyte balance or cause muscle cramps or tetany.

                    PATIENT INFORMATION: BEFORE YOU TAKE VELACTONE
Do not take VELACTONE Tablets if you have:
Ever had an allergic reaction to Spironolactone Tablets or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
difficulty passing water
kidney disease
too much potassium in the blood (hyperkalaemia)
Addison’s disease
Diabetes mellitus with or without kidney problems.
HOW TO TAKE VELACTONE You must take your medicine as the doctor tells you. It is important to take VELACTONE Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. This medicine should be taken once a day with food.
The adult dose varies from 25mg to 200mg VELACTONE a day. If you are not sure how much to take, ask your doctor or pharmacist.
ElderlyYour doctor will start you on a low starting dose and gradually increase the dosage as needed to obtain the desired effect.ChildrenIf you are giving VELACTONE to a child, the number of tablets you give will depend on the childs weight. Your doctor will work out the number of tablets that you should give. IF YOU MISS A DOSETake it as soon as you remember. If it is nearly time for the next dose, do not take the one you missed. Take the next dose at the usual time. Do not take a double dose to make up for the dose that you missed. If you miss more than one dose, or you are not sure what to do, ask your doctor or pharmacist.
WHAT TO DO IF AN OVERDOSE IS TAKEN
  If you accidentally take too many tablets, contact your doctor or nearest hospital accident department immediately. The symptoms of an overdose are feeling drowsy and dizzy. You may also feel or be sick or may suffer from diarrhoea.

TAKING OTHER MEDICINEPlease tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of VELACTONE if you are taking any of the following:

digoxin or carbenoxolone;
medicines for high blood pressure;
other diuretics;
non-steroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen,
potassium supplements

SIDE EFFECTS Like all medicines, VELACTONE can cause side effects in some people. You may experience:• Nausea• HeadachesIn men, swelling or tenderness of the breasts can occur.

STORING

Keep out of the reach and sight of children.
Keep your tablets in a dry place, below 30°C.
Don’t take VELACTONE after the ‘expiry’ date shown on the pack,

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.