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Triampur compositum® (Triamterene + Hydrochlorothiazide) 50 Tablets

$12.80

4490f68dd0b8

Description

Composition Triampur Compositum Teva

One tablet contains:

  • Active ingredients: Triamterene – 25 mg, Hydrochlorothiazide – 12.5 mg
  • Excipients: lactose monohydrate, potato starch, polyvidone K 25, highly dispersed silicon dioxide, carboxymethyl starch sodium salt, magnesium stearate.

 

Indications for use

  • Arterial hypertension
  • Edema syndrome due to diseases of the heart, liver or kidneys, mainly in cases where it is necessary to avoid the loss of potassium by the body
  • Heart failure, if additional fluid excretion and reduction of potassium excretion from the body is required (in combination with cardiac glycosides)

 

List of information required before application

Contraindications

– hypersensitivity to some of the active substances or ingredients of this drug or to other sulfonamides

-hyperkalemia (high levels of potassium in the blood)

-anuria

– severe degree of renal failure (creatinine clearance < 30 ml / min);

– severe degree of liver failure (hepatic ancestor and coma)

-hypokalemia resistant to therapy

– severe hyponatremia

-simultaneous use with other potassium-sparing diuretics and other potassium-containing products (especially when administered intravenously)

– severe hypotension

– pregnancy, lactation

– children and adolescents weighing less than 50 kg

 

Necessary precautions for use

It should be used with caution:

– with gout

– patients with limited renal function with serum creatinine between the upper normal value and 1.8 mg / dl or a slight limitation of creatinine clearance (30-60 ml / min), kidney stones

– with hepatic dysfunction

– with diabetes

– Patients with suspected folic acid deficiency

– the simultaneous use of other drugs containing potassium (eg, spironolactone, amiloride) or potassium salts should be avoided due to an increased risk of hyperkalemia.

 

Interactions with other drugs

Other antihypertensive agents

Triamterene + hydrochlorothiazide may enhance the effect of other antihypertensive drugs.

Simultaneous use with other potassium-sparing diuretics, such as Amiloride and spironolactone, or preparations containing potassium, can lead to severe hyperkalemia. Simultaneous use with ACE inhibitors may increase the risk of hyperkalemia.

Non-steroidal anti-inflammatory drugs

The simultaneous use of these drugs (especially indomethacin) can weaken the diuretic and antihypertensive effect of hydrochlorothiazide and even cause acute renal failure in predisposed patients or in patients with dehydration.

Cholestyramine

The absorption of thiazide diuretics is impaired, so a decrease in the pharmacological effect can be expected.

Lithium preparations

Diuretics, including hydrochlorothiazide, should not be taken concomitantly with lithium, as the renal clearance of lithium is reduced, increasing the risk of lithium toxicity.

digitalis preparation

Hypokalemia or hypomagnesemia caused by thiazide can lead to digitalis toxic effects (arrhythmias). Serum potassium and ECG should be monitored.

Insulin and oral antidiabetic drugs

It may be necessary to adjust the dosage of insulin and oral antidiabetic agents due to changes in glucose tolerance.

Corticosteroids and laxatives

Combined use with corticosteroids or laxatives may result in excessive loss of potassium.

Chlorpropamide

Simultaneous use with chlorpropamide may lead to the risk of severe hyponatremia.

Remedies for gout

Hydrochlorothiazide may increase the frequency of hypersensitivity reactions to allopurinol, which reduces the effectiveness of drugs for the treatment of the bladder.

Curare – derivatives and ganglion blocking substances

Thiazides may enhance the response to these drugs.

Anticancer drugs (eg, cyclophosphamide, methotrexate)

The simultaneous use of these drugs with thiazides may reduce their renal excretion and increase their myelosuppressive effect.

Anticholinergics (eg atropine, biperiden)

The bioavailability of thiazide diuretics can be increased by reducing gastrointestinal motility and gastric emptying rate.

Vitamin D

Simultaneous use with hydrochlorothiazide can reduce the excretion of calcium in the urine and increase the content of calcium in the blood serum.

Cyclosporine

There is an increased risk of developing hyperuricemia and gout symptoms.

Oral anticoagulants

The effectiveness of oral anticoagulants may be reduced, so it may be necessary to adjust the dosing regimen.

The following drugs, taken simultaneously with triamterene + hydrochlorothiazide, can cause hyperkalemia: blood from a blood bank; milk with reduced salt content; potassium and potassium-containing drugs; potassium salt used as a substitute for sodium salt.

 

Special Warnings

Changes in acid-base hematological status (hyperkalemia, hyponatremia, metabolic acidosis, and other electrolyte and fluid disturbances)

It is necessary to conduct a periodic blood test for the content of electrolytes. With long-term use, it is necessary to determine the concentration of potassium before the start of treatment and 3 to 4 weeks after treatment. If the potassium balance is not disturbed, the next analysis to determine the concentration of potassium should be carried out every 4-6 months. If signs of hyperkalemia (high potassium concentration) appear, triamterene + hydrochlorothiazide should be discontinued. especially strict monitoring of serum electrolytes is required in the following patient groups: the elderly, patients receiving digitalis preparation, corticosteroids and laxatives or intravenous injections.

Thiazide diuretics can increase the amount of magnesium excreted in the urine, causing hypomagnesemia (low magnesium levels in the blood).

Thiazide diuretics can reduce calcium excretion and cause a temporary increase in blood calcium levels.

Triamterene can reduce alkaline reserves and lead to the development of metabolic acidosis.

kidney failure

Thiazide diuretics should be used with caution in patients with moderate renal impairment. The dosage is reduced in patients with renal insufficiency (creatinine clearance> 30 ml / min). They are ineffective in severe renal insufficiency – creatinine clearance <30 ml / min, as they can exacerbate existing renal dysfunction or cause azotemia. Therefore, periodic monitoring of serum urea and serum creatinine is necessary.

Liver failure

Triamterene + hydrochlorothiazide, like other thiazide diuretics, should be used with caution in patients with severe hepatic impairment or progressive liver disease, since minor changes in fluid and electrolyte balance can cause hepatic coma.

Hyperuricemia and gout

In patients treated with thiazide diuretics, serum uric acid concentrations may increase and clinical signs of gout may appear. Therefore, periodic monitoring of the level of uric acid in the blood serum is required during treatment.

Glucose tolerance

During treatment with thiazide diuretics, latent diabetes mellitus may occur or insulin requirements may increase in patients with diabetes mellitus. Therefore, it is recommended to periodically check the level of sugar in the blood.

Lipid levels

With long-term treatment, thiazide diuretics can cause a small and partially reversible increase in total cholesterol, triglycerides and LDL cholesterol.

folic acid deficiency

If folic acid deficiency is suspected (for example, in the case of cirrhosis of the liver and chronic alcohol use), regular monitoring of the complete blood count is necessary, since the medicinal substance triamterene, being a weak folic acid antagonist, can contribute to the development of megaloblastic anemia.

Systemic lupus erythematosus

The possibility of exacerbation or activation of systemic lupus erythematosus by thiazides should be considered when treating with triamterene + hydrochlorothiazide.

Non-melanoma skin cancer

An increased risk of developing non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with an increase in the total dose of hydrochlorothiazide (HCTZ) was noted in two epidemiological studies according to the Danish national cancer registration system. The photosensitizing effects of HCTZ may serve as a possible mechanism for the development of NMSC.

Patients taking HCTZ should be informed of the risk of developing NMSC and advised to regularly check the skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures include limiting sun exposure and exposure to ultraviolet rays, and in case of sun exposure, patients are advised to use reliable protection measures to reduce the risk of skin cancer. Suspicious skin lesions should be promptly investigated, including histological examination of biopsies. It may be necessary to reconsider the use of drugs containing HCTZ in patients who have previously been diagnosed with NMSC (see also the section “Adverse reactions”).

Choroidal effusion, acute myopia and secondary angle-closure glaucoma

Sulfonamide or sulfonamide derivatives can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia, and acute angle-closure glaucoma. Symptoms include an acute onset of decreased visual acuity or eye pain and usually occur within hours or weeks of starting the drug. Left untreated, acute angle-closure glaucoma can lead to permanent vision loss. Primary treatment consists of urgent discontinuation of the drug. Uncontrolled intraocular pressure may require immediate medical or surgical treatment. Risk factors for developing acute angle-closure glaucoma may include a history of allergic reactions to a sulfonamide or penicillin.

Impact on doping tests

The use of the drug Triampur compositum-Teva can lead to positive results of doping tests.

Lactose content

The preparation contains lactose. Contraindicated in patients with hereditary galactose intolerance, deficiency of the Lapp enzyme (LAPP) – lactase, malabsorption of glucose-galactose.

During pregnancy or lactation

Experience with the use of hydrochlorothiazide during pregnancy, especially during the first trimester, is limited. Hydrochlorothiazide crosses the placenta. Based on the mechanism of pharmacological action of hydrochlorothiazide, its use during the second and third trimesters of pregnancy can cause impaired feto-placental perfusion, fetal and neonatal reactions such as jaundice, electrolyte imbalance and thrombocytopenia.

Because of the risk of reduced plasma clearance and placental hypoperfusion, without affecting the course of the disease, hydrochlorothiazide should not be used in gestational edema, gestational hypertension, or preeclampsia.

In the case of hypertension in pregnant women, hydrochlorothiazide should be used strictly according to indications in the absence of alternative treatment.

Hydrochlorothiazide is excreted in breast milk in small amounts. A thiazide diuretic used in high doses for intensive diuresis may reduce lactation. The use of Triampur compositum – Teva during lactation is not recommended. If Triampur compositum – Teva is used during breastfeeding, then the lowest effective dose is prescribed.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Carrying out therapy with the use of this drug requires constant medical supervision. The ability to actively participate in traffic, drive machines or work non-stop can be impaired by individual reactions. To a greater extent, these warnings relate to the initial period of therapy, the period of increasing the dose of the drug, when switching to another drug, or in the case of taking the drug in combination with alcohol.

 

Recommendations for use

Dosing regimen

Doses of the drug are selected by the doctor individually for each patient.

For adults and adolescents weighing more than 50 kg, there are the following dosage regimens:

Arterial hypertension

The initial dose of the drug is 2 tablets in the morning and 2 tablets at noon. With the additional intake of other antihypertensive drugs or for long-term therapy, 2 tablets of Triampur compositum – Teva per day are sufficient (1 tablet in the morning and at noon).

Edema syndrome (heart, liver, kidneys)

At the beginning of treatment in the morning and at noon, 2 tablets of the drug are prescribed. Further doses are prescribed depending on the degree of dehydration. Maintenance dose – 1 tablet per day, taken every day in the morning, or 2 tablets every other day (1 tablet in the morning and at noon). If necessary, the maintenance dose can be increased to 4 tablets per day (2 tablets in the morning and at noon).

Heart failure treatment

Doses of the drug are selected depending on the data of the examination of the patient. Usually, patients are prescribed 1 tablet in the morning and at noon, if necessary, give a maximum of 4 tablets per day (2 tablets in the morning and at noon). In patients with severe cardiac decompensation, the absorption of Triampur compositum – Teva may be significantly limited.

Do not exceed the dosage of 1 tablet per day in case of deterioration of renal function (blood creatinine 1.5-1.8 mg / dl or creatinine clearance 50-30 ml / min).

Method and route of administration

Tablets are taken after meals, without chewing and with a small amount of liquid. During treatment with Triampur compositum – Teva, there is no need to limit fluid intake.

After long-term treatment Triampur compositum – Teva should not be canceled suddenly. Cancellation of the drug should be carried out with a gradual decrease.

Duration of treatment

The duration of the course of treatment is determined by the doctor.

 

Measures to be taken in case of overdose

Symptoms of intoxication In case of acute overdose, an initial drop in blood pressure may occur (in extreme cases, orthostatic collapse). Chronic overdose can lead to dangerous fluid loss and electrolyte imbalance (especially hypo- or hyperkalemia, hyponatremia).

Symptoms: Symptoms described in overdose include: excessive urination, nausea, vomiting, weakness, fatigue, confusion, fever, flushed face, neuromuscular irritability, cardiac arrhythmias, ECG changes, decreased blood pressure, convulsions leading to coma. These symptoms are caused by hyperkalemia, electrolyte imbalance, dehydration, and changes in acid-base balance.

Treatment: Appropriate measures in case of overdose: immediate gastric emptying, gastric lavage and administration of activated charcoal to reduce absorption. If hypotension occurs, therapy is used to restore the volume of lost fluid and vasopressors. It is recommended to monitor and correct the water-electrolyte balance and metabolic balance.

There is no specific antidote.

Indication of risk of withdrawal symptoms

After long-term treatment Triampur compositum – Teva should not be canceled suddenly. Cancellation of the drug should be carried out with a gradual decrease in the dose.

Recommendations for seeking advice from a healthcare professional about how to use the drug

If you have any questions on the use of the drug Triampur compositum – Teva, discuss them with your doctor.

 

Description of adverse reactions that occur with the standard use of drugs and measures to be taken in this case

The frequency of side effects is determined according to the following criteria: very often (≥ 1/10), often (≥ 1/100 to < 1/10), infrequently (≥ 1/1000 to < 1/100), rarely ( ≥ 1/10000 to < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data).

Often

– worsening pre-diabetic or diabetic condition due to increased blood glucose levels

– disturbances in the balance of fluid and electrolytes (especially hyper – or hypokalemia and hyponatremia) in case of long-term continuous use; hypomagnesemia, hypochloremia, hypercalcemia, metabolic acidosis

– in predisposed patients, depending on the total dose taken, the level of lipids in the blood may increase (an increase in the concentration of cholesterol and triglycerides, in particular VLDL and LDL-cholesterol, as well as the β-lipoprotein fraction)

Often

– ECG changes, heart palpitations, unwanted drop in blood pressure

– CNS symptoms (ataxia, lethargy), headache, nervousness

– orthostatic dysregulation with dizziness, drowsiness or collapse

– nausea, vomiting, diarrhea (these side effects can usually be avoided if the drug is taken after a meal), pain in the upper abdomen, cramping abdominal pain, adynamia of the smooth muscles of the digestive tract with constipation and partial intestinal obstruction to paralytic intestinal obstruction

– skeletal muscle hypotension, muscle tension, calf muscle cramps

– fatigue, dry mouth or thirst

Infrequently

– thrombosis and embolism as a result of hemoconcentration at high doses and / or excessive diuresis convulsions and confusion due to dehydration and hypovolemia

– minor visual disturbances, such as blurred vision and impaired color perception (yellow light vision), worsening of existing myopia or reduced tearing (especially when wearing contact lenses).

– jaundice, hemorrhagic pancreatitis, acute cholecystitis with existing cholelithiasis

– mainly at the beginning of treatment, a temporary increase in the content of nitrogen in the urine (urea, creatinine) in the blood can be observed; taking large doses of the drug and / or excessive diuresis can cause hemoconcentration due to dehydration and hypovolemia, acute renal failure; increased levels of uric acid (development of attacks of gout in particularly predisposed patients).

– allergic skin disorders such as purpura, pruritus, urticaria, skin erythema, photoallergic skin rash and drug fever

– erectile dysfunction

Rarely

– changes in the composition of the blood, such as aplastic anemia, leukopenia, thrombopenia, agranulocytosis, megaloblastic anemia with a previous deficiency of folic acid, hemolysis by the formation of antibodies to hydrochlorothiazide while used with methyldopa.

– interstitial pneumonia

– exacerbation of acute renal failure, abacterial interstitial nephritis with subsequent acute renal failure, the formation of urinary stones

– anaphylactoid reactions, necrotizing vasculitis, sudden pulmonary edema with symptoms of shock (systemic anaphylactic reactions caused by circulating immune complexes)

– non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)

– rare cases of thrombocytopenia and pancreatitis have been reported in newborns whose mothers took thiazides during pregnancy.

Very rarely

– jaundice, hemorrhagic pancreatitis with existing cholelithiasis, acute cholecystitis

– aplastic anemia, leukopenia, thrombopenia, agranulocytosis, megaloblastic anemia with a previous deficiency of folic acid in the body; hemolysis resulting from the appearance in the blood of antibodies to hydrochlorothiazide with the simultaneous use of methyldopa

– anaphylactoid reactions, necrotizing vasculitis, exacerbation of acute renal failure, aseptic interstitial nephritis with subsequent acute renal failure

– A sudden onset of pulmonary edema with symptoms of shock has been described. The reason for this is probably an allergic reaction of patients to the active substance hydrochlorothiazide.

– interstitial pneumonia

unknown

– non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)

– aplastic anemia, thrombocytopenia, leukopenia, megaloblastic anemia, agranulocytosis and eosinophilia

– anaphylactic reactions, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), rash, urticaria, pruritus, purpura, photosensitivity, vasculitis, exacerbation of pre-existing lupus, erythema multiforme

– hyperkalemia, hyperglycemia, hyperuricemia, hypokalemia, hyponatremia, hypochloremia, metabolic acidosis, etc.

islipidemia

– low libido

– paresthesia, presyncope, dizziness, weakness, fatigue, depression, headache, muscle spasms and convulsions

– xanthopsia, temporary blurred vision, reduced vision or eye pain due to high pressure (possible signs of fluid accumulation in the choroid (choroidal effusion) or acute angle-closure glaucoma)

– cardiac arrhythmia, orthostatic hypotension (which can be aggravated by alcohol, antidepressants and drugs)

– allergic pneumonitis, pulmonary edema, respiratory failure

– pancreatitis, dry mouth, inflammation of the salivary gland, loss of appetite, gastrointestinal upset, nausea, vomiting, abdominal pain, constipation or diarrhea, intrahepatic cholestatic jaundice

– acute renal failure, frequent urination, polyuria, nocturia, elevated serum urea and creatinine, abnormal urinary sediment, isolated cases of interstitial nephritis, glycosuria. An increase in the incidence of kidney stones associated with high doses of triamterene has been reported.

– an increase in urea in the blood, an increase in liver enzymes.

 

Storage conditions

Shelf life – 5 years
Do not use after the expiration date.

Store at a temperature not exceeding 25◦С.
Keep out of the reach of children!

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