Odaplex SR

Odaplex SR - Precautions | Dosage | Effects

This article was medically reviewed by M.Pharm, Marko Tanaskovic on August 12, 2018. To read more about an author, click here.

Odaplix SR is a drug that contains an active substance called indapamide and belongs to a group of medicines used to treat high blood pressure (hypertension). Odaplix SR is classified as a diuretic (as per its pharmacological effects) because it works by increasing urination, which decreases blood volume, which consequently leads to a reduction in pressure on the blood vessels.

According to the chemical classification, this medicine is classified in indoline group.

Most of the Odaplix SR is metabolized through the liver and only 7% of the drug can be found in unchanged form in the urine. About 75% of the drug is bound to protein plasma.

Odaplix SR is used to treat essential hypertension, alone or in combination with other drugs. According to the FDA, indapamide can also be used to treat fluid / salt retention that occurs in patients with congestive heart failure.

Precautions

Odaplix SR is contraindicated in patients with anuria (inability to urinate) as well as in patients who are allergic to the active substance or other drugs from the indoline group and sulfonamides (such as Bactrim).

Hyponatremia has been reported in patients taking this medicine (sodium concentration below healthy normal range) and hypokalemia (potassium concentration below healthy normal range). Symptoms that indicate the occurrence of hyponatremia include: nausea, vomiting, muscle cramps, muscle weakness, confusion, irritability, seizures and coma, while signs indicating the occurrence of hypokalemia include malaise, constipation and arrhythmias.

If you notice any of the above signs, contact your doctor immediately, as hyponatremia and hypokalemia must be treated immediately.

Patients who have or have recently had hypokalemia and hyponatremia should not use this medicine. Patients who are vomiting and / or have diarrhea while on therapy with this medicine must be carefully monitored because these conditions further increase the risk of hypokalemia and hyponatremia. Periodic blood tests done to measure levels of sodium and potassium (and other electrolytes) are highly recommended while taking this medicine.

Odaplix SR should not be used in patients with severe renal impairment (as its efficacy depends on kidney function), as well as in patients with severe hepatic impairment (e.g. hepatic encephalopathy) because most of the drug is metabolized by the liver.

The concomitant use of this medicine with lithium (antipsychotic) is contraindicated because it increases the risk of lithium toxic effects.

Odaplix SR should be used with caution in patients with gout, as this drug may lead to increased serum concentrations of uric acid.

Patients with diabetes should use this medicine cautiously because it might increase blood levels of glucose. The blood glucose levels should be monitored regularly in diabetic patients who are on therapy with this medicine.

Dosage

Odaplix SR is available in the form of modified release tablets at a dose of 1.5 mg. The usual dose in the treatment of hypertension is one tablet daily (usually in the morning, immediately after getting up). Swallow the tablet with a glass of water. Do not crush or chew the tablet as this may affect the effect of the drug.

The use of higher doses usually does not increase the antihypertensive effect, but increases the risk of hypokalemia and hyponatremia.

Use of Odaplix SR During Pregnancy and Breastfeeding

In a Michigan Medicaid surveillance study on 46 infants who were exposed to this drug during first three months of pregnancy 6.5% (3 out of 46) infants were born with major birth defects (2 were expected).

Diuretics are not recommended to be routinely used in pregnancy if women is otherwise healthy. These drugs do not prevent or treat toxemia in pregnancy.

FDA places this drug in Pregnancy Category B, because studies on animals (rats, rabbits and mice) in doses that are up to 6,250 times higher than recommended dose in humans have shown that indapamide does not cause any harm to the fetus. However, there are no studies in pregnant women and studies on animals cannot always predict effects in humans. Therefore, Odaplix SR should be used with precaution in pregnancy.

There are no data on whether Odaplix SR passes into breast milk. If your doctor recommends you to use Odaplix SR then you might need to stop breastfeeding while on therapy.

Interactions

Odaplix SR is not recommended to be used concomitantly with following drugs:

  • Lithium - an antipsychotic. Odaplix SR might increase blood levels of lithium which may lead to serious adverse events.
  • Amiodarone, dronedarone, dofetilide and other anti-arrhythmic agents. Taking any of these drugs concomitantly with Odaplix SR increases the risk of serious arrhythmias (irregular heartbeat).
  • Cisapride - drug used to treat gastroesophageal reflux disease. Cisapride has potential to cause arrhythmia and concomitant use with Odaplix SR should therefore be avoided.
  • Sodium bisphosphate - drug used for bowel cleansing. This drug might cause kidney failure, even up to few months after its use, and concomitant use of Odaplix SR increases risk of kidney damage.
  • Pimozide and droperidol - antipsychotic drugs. Concomitant use should be avoided due to an increased risk of arrhythmia.
  • Dolasetron - drug used to prevent nausea in patients on chemotherapy. Concomitant use with this drug increases risk of irregular heartbeat.

Inform your doctor about all medicines you are taking.

Side Effects

Studies on long-term use (up to 36 months) of Odaplix SR in patients with mild and moderate hypertension have shown that this drug is safe and effective for long-term treatment of hypertension. However, as any other drug, Odaplix SR can also cause side effects.

Odaplix may cause following side effects:

  • Headache.
  • Respiratory tract infections (sinusitis and pharyngitis).
  • Gastrointestinal side effects (diarrhea, nausea, vomiting, constipation, abdominal pain and dyspepsia).
  • Cough.
  • Asthenia.
  • Peripheral edema.
  • Drowsiness.
  • Vasculitis.
  • Impotence.
  • Hyperglycemia.
  • Changes in electrolyte levels in the blood.
  • Dry mouth.
  • Nocturia or polyuria.
  • Arrhythmia.

Inform your doctor should you notice any side effects.

Reference

  1. FDA
  2. Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. NICE Clinical Guidelines, No. 107. National Collaborating Centre for Women's and Children's Health (UK). 2010.
  3. Beling S, Vukovich RA, Neiss ES, et all. Long-term experience with indapamide. Am Heart J. 1983. 106(1 Pt 2): 258-262.

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