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Components:
Indapamid
Method of action:
Antihypertensive, Diuretic, Hypotensive, Vasodilator
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.09.20

Name of the medicinal product

Actapam

Qualitative and quantitative composition

Indapamid

Therapeutic indications

The information provided in Therapeutic indications of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Actapam hemihydrate tablets are indicated for the oral treatment of essential hypertension.

Actapam hemihydrate tablets may be used as sole therapy or combined with other antihypertensive agents.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Posology

Adults

The dosage is one tablet, containing 2.5 mg Actapam hemihydrate, daily to be taken in the morning.

Patients with renal failure

In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated. Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.

Older people

In the older people, the plasma creatinine must be adjusted in relation to age, weight and gender. Older people can be treated with Actapam when renal function is normal or only minimally impaired.

Patients with hepatic impairment

In severe hepatic impairment, treatment is contraindicated.

Paediatric population

Actapam is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

The action of Actapam is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5 mg Actapam daily is not recommended as there is no appreciable additional antihypertensive effect but a diuretic effect may become apparent.

If a single daily tablet of Actapam does not achieve a sufficient reduction in blood pressure, another antihypertensive agent may be added; those which have been used in combination with Actapam include beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. The co-administration of Actapam with diuretics may cause hypokalaemia and, therefore, is not recommended.

There is no evidence of rebound hypertension on withdrawal of Actapam.

Method of administration

Actapam tablets are for oral administration only.

Contraindications

The information provided in Contraindications of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Severe renal failure

Hepatic encephalopathy, severe impairment of liver function, severe hepatic failure

Hypokalaemia

Recent cerebrovascular accident.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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In case of hepatic impairment, thiazide-related diuretics may cause hepatic encephalopathy, particularly in case of electrolyte imbalance. Administration of the diuretic must be stopped immediately if this occurs.

Photosensitivity

Cases of photosensitivity reactions have been reported with thiazides and thiazide-related diuretics. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that photosensitivity leading to exaggerated sunburn may occur and treatment should be discontinued at the first sign of skin erythema.

Angioneurotic oedema

Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported infrequently in patients receiving treatment with Actapam. In such cases, treatment with Actapam should be stopped immediately and the patient should be monitored until the oedema has disappeared.

Water and electrolyte balance

Plasma sodium

Plasma sodium must be measured before treatment is initiated and subsequently at regular intervals. Any kind of treatment with diuretics may cause hyponatraemia, sometimes with very serious consequences. A drop in plasma sodium may be asymptomatic in the beginning. Therefore, regular monitoring is essential and should be carried out even more frequently in elderly patients and in cirrhotic patients. Hyponatraemia with hypovolaemia may be responsible for dehydration and orthostatic hypotension. Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: the incidence and degree of this effect are slight.

Plasma potassium

Potassium depletion with hypokalaemia constitutes the greatest risk in the treatment with thiazides and related diuretics. The risk of onset of hypokalaemia (< 3.4 mmol/l) must be prevented in certain high risk populations, i.e. the elderly, malnourished and/or polymedicated , cirrhotic patients with oedema and ascites, coronary artery disease, cardiac failure patients, patients with hyperaldosteronism, patients predisposed to or suffering from gout.

In cardiac patients, hypokalaemia increases the cardiac toxicity of digitalis preparations (e.g. digoxin) and the risks of arrhythmias.

Individuals with a long QT interval are also at risk, whether the origin is congenital or iatrogenic. Hypokalaemia, as well as bradycardia, is then a predisposing factor to the onset of severe arrhythmias, in particular, potentially fatal torsades de pointes.

More frequent monitoring of plasma potassium is required in all the situations indicated above. The first measurement of plasma potassium should be obtained during the first week following the start of treatment and subsequently at regular intervals, especially in the mentioned risk patients.

If hypokalaemia (< 3.4 mmol potassium) is detected, it must be corrected and it should be prevented in risk patients.

Plasma calcium

Thiazides and related diuretics may decrease urinary calcium excretion and cause a slight and transitory increase in plasma calcium. Frank hypercalcaemia may be due to previously unrecognised hyperparathyroidism.

Treatment with Actapam hemihydrate should be stopped if hypercalcaemia occurs in patients with hyperparathyroidism.

Treatment should be withdrawn before the investigation of parathyroid function.

Blood glucose

Monitoring of blood glucose is important in diabetic patients, especially in the presence of hypokalaemia.

Uric acid

Serum urate should be monitored in patients with gout. Tendency to gout attacks may be increased in hyperuricaemic patients.

Renal function and diuretics

Caution should be exercised when administering Actapam hemihydrate to patients with severe renal impairment. However, the drug has been safely given to patients with impaired renal function.

However, if renal insufficiency worsens, treatment should be stopped.

Thiazides and related diuretics are fully effective at normal or only minimally impaired renal function (plasma creatinine below levels of the order of 25 mg/l, i.e. < 220 µmol/l in an adult). In elderly patients, the plasma creatinine values must be adjusted according to age, body weight and sex.

Secondary hypovolaemia, as a result of loss of water and sodium induced by the diuretic at the start of treatment results in reduced glomerular filtration which, may increase plasma concentrations of blood urea and creatinine. This temporary impairment of renal function is harmless to patients with normal renal function but may exacerbate pre-existing renal insufficiency.

Athletes

The attention of athletes is drawn to the fact that this medicinal product contains a drug substance, which may give a positive result in doping tests.

Lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Actapam hemihydrate does not affect vigilance but different reactions in relation with the decrease in blood pressure may occur in individual cases, especially at the start of the treatment or when another antihypertensive agent is added. As a result, the ability to drive vehicles or to operate machinery may be impaired.

Undesirable effects

The information provided in Undesirable effects of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Summary of safety profile

The most commonly reported adverse reactions are hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.

During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/l) was seen in 25 % of patients and < 3.2 mmol/l in 10 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.41 mmol/l.

The majority of adverse reactions concerning clinical or laboratory parameters are dose-dependent.

Tabulated summary of adverse reactions

The following undesirable effects have been observed with Actapam during treatment ranked under the following frequencies:

Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class

Adverse Event

Frequency

Blood and lymphatic system disorders

Thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia

Very rare

Metabolism and nutrition disorders

Hypercalcaemia

Very rare

Potassium depletion with hypokalaemia, particularly serious in certain high risk populations , hyponatraemia , loss of weight

Not known

Nervous system disorders

Fatigue, headache, paraesthesia, vertigo

Rare

Dizziness, syncope

Not known

Eye disorders

Myopia, blurred vision, visual impairment

Not known

Cardiac disorders

Arrhythmia

Very rare

Torsades de pointes (potentially fatal)

Not known

Vascular disorders

Orthostatic hypotension

Uncommon

Hypotension

Very rare

Gastrointestinal disorders

Vomiting

Uncommon

Nausea, constipation, dryness of the mouth

Rare

Pancreatitis

Very rare

Hepatobiliary disorders

Abnormal hepatic function

Very rare

Possibility of onset of hepatic encephalopathy in patients with impaired liver function , hepatitis

Not known

Skin and subcutaneous tissue disorders

Hypersensitivity reactions, mainly dermatological, may be observed in patients predisposed to allergic and asthmatic manifestations:

Maculopapular rash

Common

Purpura

Uncommon

Erythema multiforme

Rare

Angioneurotic oedema, urticaria, toxic epidermal necrolysis, Steven Johnson syndrome

Very rare

Photosensitivity , possible exacerbation of acute disseminated lupus erythematosus

Not known

Musculoskeletal and connective tissue disorders

Muscular cramps

Rare

Renal and urinary disorders

Renal failure

Very rare

Renal insufficiency

Not known

Reproductive system and breast disorders

Impotence

Not known

Investigations

Electrocardiogram QT prolonged , elevated liver enzyme levels, increased blood uric acid , hyperglycaemia

Not known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Symptoms

Actapam has been found free of toxicity at up to 40 mg, i.e. 16 times the therapeutic dose. Signs of acute poisoning take the form above all of water/ electrolyte disturbances; (hyponatraemia, hypokalaemia). Clinically, possibility of nausea, vomiting, hypotension, cramps, vertigo, drowsiness, confusion, polyuria or oliguria possibly to the point of anuria (by hypovolaemia).

Management

Initial measures involve the rapid elimination of the ingested substance(s) by gastric wash-out and/or administration of activated charcoal, followed by restoration of water/electrolyte balance to normal in a specialised centre.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Sulfonamides, plain, ATC code: C03BA11

Actapam is a non-thiazide sulfonamide with an indole ring, belonging to the diuretic family which has certain structural similarities to furosemide as well as the thiazides and has actions and uses similar to those of chlorothiazide.

Diuresis is initiated within about 1 to 2 hours and has been reported to last for up to 36 hours. Its inhibitory action on carbonic anhydrase is only weak. At the dose of 2.5 mg per day Actapam exerts a prolonged antihypertensive activity in hypertensive human subjects.

Dose-effect studies have demonstrated that, at the dose of 2.5 mg per day, the antihypertensive effect is maximal and the diuretic effect is sub-clinical.

Mechanism of action

At this antihypertensive dose of 2.5 mg per day, Actapam reduces vascular hyperreactivity to noradrenaline in hypertensive patients and decreases total peripheral resistance and arteriolar resistance.

The implication of an extrarenal mechanism of action in the antihypertensive effect is demonstrated by maintenance of its antihypertensive efficacy in functionally anephric hypertensive patients.

The vascular mechanism of action of Actapam involves:

- a reduction in the contractility of vascular smooth muscle due to a modification of transmembrane ion exchanges, essentially calcium;

- vasodilatation due to stimulation of the synthesis of prostaglandin PGE2 and the vasodilator and platelet antiaggregant prostacyclin PGI2;

- potentiation of the vasodilator action of bradykinin.

It has also been demonstrated that in the short-, medium- and long-term, in hypertensive patients, Actapam:

- reduces left ventricular hypertrophy;

- does not appear to alter lipid metabolism: triglycerides, LDL-cholesterol and HDL-cholesterol;

- does not appear to alter glucose metabolism, even in diabetic hypertensive patients.

Normalisation of blood pressure and a significant reduction in microalbuminuria have been observed after prolonged administration of Actapam in diabetic hypertensive subjects.

Lastly, the co-prescription of Actapam with other antihypertensives (beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors) results in an improved control of hypertension with an increased percentage of responders compared to that observed with single-agent therapy.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Absorption

Actapam is rapidly and completely absorbed from the gastrointestinal tract and peak plasma concentrations are seen 1-2 hours after oral dosing.

Distribution

Actapam is concentrated in the erythrocytes and is 79% bound to plasma protein and to erythrocytes. It is taken up by the vascular wall in smooth vascular muscle according to its high lipid solubility.

Biotransformation and elimination

70% of a single oral dose is eliminated by the kidneys and 23% by the gastrointestinal tract. Actapam is metabolised to a marked degree with 7% of the unchanged product found in the urine during the 48 hours following administration. Elimination half-life (β phase) of Actapam is approximately 15 - 18 hours.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Sulfonamides, plain, ATC code: C03BA11

Preclinical safety data

The information provided in Preclinical safety data of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Actapam has been tested negative concerning mutagenic and carcinogenic properties.

The highest doses administered orally to different animal species (40 to 8000 times the therapeutic dose) have shown an exacerbation of the diuretic properties of Actapam. The major symptoms of poisoning during acute toxicity studies with Actapam administered intravenously or intraperitoneally were related to the pharmacological action of Actapam, i.e. bradypnoea and peripheral vasodilation.

Reproductive toxicity studies have not shown embryotoxicity and teratogenicity.

Fertility was not impaired either in male or in female rats.

Incompatibilities

The information provided in Incompatibilities of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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None stated.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Actapam is based on data of another medicine with exactly the same composition as the Actapam of the medicine (Indapamid). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Actapam directly from the package or from the pharmacist at the pharmacy.
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Not applicable