Ramazid N, tablets 5 mg+12, 5 mg 30 pcs

Hypertension (high blood pressure), OedemaArterial hypertension (patients who are indicated for combination therapy).

Active ingredient

How to take, the dosage

Interaction

Contraindicated combinations
– Extracorporeal treatments leading to blood contact with negatively charged surfaces, such as hemodialysis or hemofiltration with certain high-strength membranes (polyacrylonitrile membranes) and low-density lipoprotein apheresis with dextrin sulfate.
Risk of severe anaphylactoid reactions (see section “Contraindications”, “Special indications”).
– Simultaneous use of Ramazid N (12.5/5 mg) and drugs containing aliskiren
Simultaneous use of Ramazid N (12.5/5 mg) and drugs containing aliskiren in patients with diabetes or moderate to severe renal impairment and creatinine clearance less than 60 ml/min is contraindicated and not recommended in other patients (see “Contraindications. Section “Contraindications”, “With caution” “Special indications”).
– Concomitant use of Ramazid N (12.5/5 mg) and angiotensin II receptor antagonists
Concomitant use of Ramazid N (12.5/5 mg) and angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see sect. See Contraindications, Caution, and Particular Indications).

Unrecommended combinations
– With potassium salts, potassium-saving diuretics (e.g., spironolactone, epleron [spironolactone derivative], amiloride, triamterene), other drugs that can increase serum potassium levels (including angiotensin II receptor antagonists, tacrolimus, cyclosporine, trimethoprim, sulfamethoxazole, a component of co-trimoxazole [a combined antibacterial agent containing trimethoprim and sulfamethoxazole]).
Increase in serum potassium is possible, sometimes significantly pronounced (with concomitant use careful monitoring of serum potassium is required).

Combinations in which caution should be exercised
– With hypotensive drugs and other drugs with antihypertensive effect (nitrites, tricyclic antidepressants)
Potentiation of antihypertensive effect is possible.
With agents for general anesthesia, barbiturates, ethanol
Orthostatic hypotension may develop. Ramipril may potentiate the vasodilator effect of ethanol.
– With diuretics
An excessive decrease in BP at the beginning of treatment is possible (regarding concomitant use with diuretics, see section “Contraindications”, “With caution” “Special notes”).
– With vasopressor sympathomimetics (epinephrine (adrenaline), isoproterenol, dobutamine, dopamine)
Decrease of antihypertensive effect of Ramazid N (12.5/5 mg). It is recommended to monitor BP carefully. In addition, the vasopressor effect of sympathomimetics may be weakened by hydrochlorothiazide.
– With allopurinol, immunosuppressive drugs, corticosteroids (glucocorticoids and mineralcorticoids), procainamide, cytostatics and other drugs that may alter the peripheral blood
The possibility of blood disorders increases (see section “Side effects”, “Precautions”).
– With lithium salts
Reduction of lithium excretion is possible, leading to increased serum concentrations of lithium and increasing its toxicity. Therefore, serum concentrations of lithium should be monitored regularly.
– With hypoglycemic agents (e.g., insulin, hypoglycemic agents for oral administration (sulfonylurea derivatives).
ACE inhibitors may decrease insulin resistance. In some cases, in patients receiving hypoglycemic agents, such decrease in insulin resistance may lead to the development of hypoglycemia. This effect may develop after several days or months of treatment. Hydrochlorothiazide may weaken the effect of hypoglycemic agents. Therefore, at the initial stage of concomitant use of hypoglycemic agents and Ramazide N (12.5/ 5 mg), especially careful monitoring of blood glucose concentration is required.
– With vildagliptin, other glyptins and estramustine
Increased incidence of angioedema.
– With mTOR inhibitors (mammalian Target of Rapamycin in mammalian cells), such as temsirolimus

Combinations to consider
– With nonsteroidal anti-inflammatory drugs (indomethacin, acetylsalicylic acid (over 3 g/day).
The action of the drug Ramazid N (12.5/5 mg) may be impaired, the risk of renal dysfunction and the increase of serum potassium ions may increase.
Strict monitoring of serum creatinine and potassium concentrations is recommended.
– With heparin
Possible increase in serum potassium.
– With corticosteroids (glucocorticoids and mineralcorticoids), carbenoxolone, preparations containing licorice root, laxatives (when taken for a long time) and other potassium-regulating agents
There is an increased risk of hypokalemia.
– With cardiac glycosides, drugs that may prolong the QT interval, antiarrhythmic agents
Potential development of hypokalemia or hypomagnesemia (due to the content of hydrochlorothiazide in the drug) that may lead to potentiation of proarrhythmogenic effect of these drugs or to decrease the antiarrhythmic effect of antiarrhythmic agents.
– With methyldopa
Hemolysis is possible
– With calcium salts and drugs that increase the calcium content in the blood plasma
With hydrochlorothiazide simultaneous use may increase the calcium content in the blood serum.
– With vitamin D
In concomitant use with hydrochlorothiazide increased serum calcium content is possible (due to delayed renal excretion of calcium), requires careful monitoring of serum calcium.
– With carbamazepine
Risk of hyponatremia due to the potentiating effect of hydrochlorothiazide.
– With iodine-containing contrast agents
In the case of dehydration caused by diuretics, including hydrochlorothiazide, there is an increased risk of acute renal dysfunction, especially when administering high doses of contrast agent.
– With penicillin
Hydrochlorothiazide is excreted by the distal renal tubules and therefore reduces the excretion of penicillin.
– With quinidine
Hydrochlorothiazide reduces the excretion of quinidine.
– With orally administered ion exchange resins such as colestipol and colestirami
Absorption of hydrochlorothiazide is reduced.
– With non-depolarizing myorelaxants
Possible enhancement and prolongation of the myorelaxant effect.
– With table salt.
If there is a large quantity of table salt in food, the antihypertensive effect of Ramazid H (12.5/5 mg) may decrease.
– With desensitization therapy
The likelihood and severity of anaphylactic reactions to insect venom is increased with ACE inhibition. It is assumed that similar reactions are possible to other allergens.
– With warfarin, acenocoumarol
When used concomitantly with ramipril, no effect on the anticoagulant effect of these drugs was observed.

Influence on the results of laboratory tests
– Assessment of parathyroid function
Hydrochlorothiazide stimulates renal calcium reabsorption and may cause hypercalcemia. This should be considered when assessing the function of parathyroid glands (see section “Special Precautions”).

Special Instructions

Contraindications

Side effects

Overdose

Symptoms
In overdose there may be a persistent increase in urine output, excessive peripheral vasodilation (with a marked decrease in BP, development of shock), bradycardia, electrolyte-water balance disorders, renal failure, cardiac rhythm disorders, depression of consciousness, up to coma development; cerebral seizures, paresis and paralytic ileus.

In patients with impaired urine outflow (e.g., prostatic hyperplasia), profuse diuresis may provoke acute urinary retention with bladder overdistension.

Treatment
If possible within the first 30 minutes, gastric lavage should be performed, adsorbents, sodium sulfate should be given. In case of a persistent decrease of blood pressure the administration of alpha1-adrenergic receptor agonists (norepinephrine, dopamine) is indicated in addition to the therapy aimed at replenishment of circulating blood volume and electrolytes. If bradycardia is refractory to drug treatment, a temporary artificial pacemaker may be required. In case of overdose serum concentrations of creatinine and serum electrolyte content should be monitored.

There is no experience regarding the effectiveness of forced diuresis, changes in urine pH, hemofiltration or hemodialysis to accelerate excretion of ramipril and ramiprilat. Hydrochlorothiazide can be excreted by hemodialysis. If hemodialysis or hemofiltration is still intended, the risk of anaphylactoid reactions should be taken into account when using high-flow membranes and do not use them (see section “Contraindications”, “Special notes”, “Interaction with other medicinal products”).

Pregnancy use

Similarities