Dicardplus (Tablets) Instructions for Use

Marketing Authorization Holder

Ipca Laboratories Ltd. (India)

ATC Code

C03BA04 (Chlorthalidone)

Active Substance

Chlorthalidone (USAN)

Dosage Forms

	Dicardplus	Tablets 12.5 mg: 30 pcs.
		Tablets 25 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets are yellow, round, flat-cylindrical, with beveled edges, smooth on both sides.

Excipients: microcrystalline cellulose (type 101) – 52.9 mg, pregelatinized starch – 1.875 mg, quinoline yellow lake (D&C Yellow No.10) – 0.1 mg, microcrystalline cellulose (type 102) – 5 mg, sodium carboxymethyl starch – 1.5 mg, colloidal silicon dioxide – 0.375 mg, stearic acid – 0.75 mg.

10 pcs. – blisters (3) – cardboard packs.

Tablets are yellow, round, flat-cylindrical, with beveled edges, smooth on both sides.

Excipients: microcrystalline cellulose (type 101) – 105.8 mg, pregelatinized starch – 3.75 mg, quinoline yellow lake (D&C Yellow No.10) – 0.2 mg, microcrystalline cellulose (type 102) – 10 mg, sodium carboxymethyl starch – 3 mg, colloidal silicon dioxide – 0.75 mg, stearic acid – 1.5 mg.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Diuretic

Pharmacotherapeutic Group

Diuretics; thiazide-like diuretics, sulfonamides

Pharmacological Action

A thiazide-like diuretic with a long-lasting effect. It impairs the reabsorption of sodium, chloride ions, and equivalent amounts of water in the distal renal tubules.

Furthermore, it increases the excretion of potassium, magnesium, bicarbonate ions from the body, delays the excretion of uric acid and calcium ions. It belongs to diuretics of moderate efficacy. The diuretic effect begins within 2 hours, reaches its maximum in 12 hours, and lasts up to 72 hours.

It causes a reduction in elevated blood pressure. The antihypertensive effect develops gradually, reaching its maximum 2-4 weeks after the start of treatment.

In addition, Chlorthalidone reduces polyuria in patients with diabetes insipidus, although its mechanism of action is not clear.

Pharmacokinetics

After oral administration, Chlorthalidone is absorbed from the gastrointestinal tract. Absorption is variable.

It is highly bound to erythrocytes, with much less binding to plasma proteins.

The elimination half-life (T_1/2) is long, amounting to 40-60 hours.

It is excreted mainly unchanged in the urine.

In elderly patients, excretion is slowed compared to young and middle-aged patients, while absorption remains unchanged.

Indications

Arterial hypertension. Edematous syndrome of various etiologies (chronic heart failure, nephrotic syndrome, liver cirrhosis).

ICD codes

Dosage Regimen

The dosage is established individually. For arterial hypertension – 25 mg once daily. If necessary, the dose can be increased to 50-100 mg/day.

After the effect is achieved, switch to maintenance therapy at the minimum effective dose. For edematous syndrome, it is used at a dose of 50-100 mg once daily, if necessary – up to 200 mg, after achieving the effect, switch to maintenance therapy.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, constipation, loss of appetite are possible.

From the CNS and peripheral nervous system: headache, weakness, paresthesia, dizziness are possible.

From the water-electrolyte balance: hypokalemia, hypomagnesemia, hyponatremia, hypochloremic alkalosis, hypercalcemia are possible.

From metabolism: hyperuricemia, hyperglycemia are possible.

From the hematopoietic system: rarely – thrombocytopenia, leukopenia.

Dermatological reactions: skin rashes are possible.

Contraindications

Anuria, severe renal and hepatic insufficiency, hypokalemia, hyponatremia, hypercalcemia, hyperuricemia, hypochloremic alkalosis, arterial hypertension in pregnancy, hypersensitivity to chlorthalidone and sulfonamides.

Use in Pregnancy and Lactation

It crosses the placental barrier. It is contraindicated in pregnancy for arterial hypertension. In other cases, use is possible only for strict indications at the minimum effective dose and when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Chlorthalidone is excreted in breast milk. If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency. Use with caution in cases of impaired renal excretory function.

Geriatric Use

Use with caution in elderly persons.

Special Precautions

Use with caution in patients with diabetes mellitus, gout, severe atherosclerosis of coronary and cerebral vessels, impaired renal excretory function, and in elderly persons.

During treatment, monitoring of blood count, blood electrolyte composition, uric acid level, and blood glucose is necessary.

Effect on ability to drive vehicles and operate machinery

Chlorthalidone, especially at the beginning of treatment, may impair the ability to drive vehicles and operate machinery.

Drug Interactions

With simultaneous use with corticosteroids, amphotericin B, carbenoxolone, the risk of severe hypokalemia increases.

With simultaneous use with NSAIDs, a decrease in the diuretic and antihypertensive effect of chlorthalidone is possible.

With simultaneous use with digitalis preparations, the risk of toxic effects of digitalis preparations may increase due to hypokalemia caused by chlorthalidone.

With simultaneous use of lithium carbonate, the plasma concentration of lithium and the risk of lithium intoxication increase.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.