RAMI SANDOZ ® COMPOSITUM (RAMI SANDOZ COMPOSITUM)
Sandoz C09B A05
STRUCTURE AND PACKAGING:
tab. of 2.5 mg + 12.5 mg the blister, No. 30
| Ramipril | 2.5 mg |
| Hydrochlorothiazide | 12.5 mg |
No. UA/4259/01/01 from 12.04.2011 to 12.04.2016
tab. of 5 mg + 25 mg the blister, No. 30
| Ramipril | 5 mg |
| Hydrochlorothiazide | 25 mg |
No. UA/4259/01/02 from 12.04.2011 to 12.04.2016
PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics. Ramipril who is a part of medicament oppresses activity of APF, kininaza of II, causing vasodilatation and decrease in the ABP.
At persons with AG ramiprit lowers the arterial blood pressure as in a prone position, and standing, not raising a warm rhythm. At most of patients the antihypertensive effect begins in 1–2 h after medicament use, reaches a maximum in 3–6 h and lasts for 24 h. The maximum decrease in the ABP usually is registered after 3–4 weeks of continuous treatment.
Hydrochlorothiazide causes moderate diuretic effect, increasing removal from an organism of water, ions of sodium, chlorine and potassium. Reduces the maintenance of ions of sodium in a vascular wall, reducing its sensitivity to vasopressor influences and enhancing thereby antihypertensive effect of a ramipril.
Combination of a ramipril with a hydrochlorothiazide is characterized by stronger hypotensive effect, than each of its components separately; at the same time the potassium loss caused by effect of diuretics decreases.
Pharmacokinetics. Ramipril is quickly absorbed after oral administration. Meal essentially does not influence medicament absorption. Its active metabolite ramiprilat is about 6 times more active than a ramipril. The C max ramiprilat in blood plasma is reached in 2–4 h after oral administration of a ramipril. Linking with proteins of blood plasma for the ramiprilat makes about 56%.
T ½ — 13–17 h against the background of regular reception; about 40% are removed with a stake and 60% — with urine.
Bioavailability of a hydrochlorothiazide after oral administration is about 70%. Time of achievement of the C max in blood plasma — 1.5-3 h. Linking with blood proteins — 40–70%. Removal from blood plasma — two-phase; T ½ in an initial phase — 2 h, in a final phase — about 10 h. In general 50–75% of the dose accepted orally are excreted with urine in not changed look.
General use of a ramipril and hydrochlorothiazide does not affect bioavailability of separate components.
INDICATION:
treatment of essential hypertensia at patients to whom combination therapy is shown (ramiprit also a hydrochlorothiazide).
USE:
mode of dosing is set individually depending on a condition of the patient, weight of AG and presence of other contributing factors of risk. Treatment should be begun with low doses of medicament with gradual increase in a dose. Drug is used orally irrespective of meal. The appointed daily dose should be accepted in the morning together with enough liquid (approximately 1 / 2 a glass).
Recommended medicament dose — 2.5 mg of a ramipril and 12.5 mg of a hydrochlorothiazide of 1 times a day.
As necessary a tablet Rami Sandoz compositum of 5 mg / 25 mg can be divided into two parts. On a tablet of 2.5 mg / 12.5 to mg of risk it is put only for a break for the purpose of swallowing simplification, but not for division into two equal doses.
Maximum daily dose — 10 mg of a ramipril and 50 mg of a hydrochlorothiazide (corresponds to 4 tablets on 2.5 mg / 12.5 to mg or 2 tablets on 5 mg / 25 mg).
If the next intake of medicine is missed, it should be accepted as soon as possible. However, if the fact of the admission of a dose is elicited at the moment close by the time of reception of the following dose, then it is not necessary to accept the passed dose, and to observe schemes of regular dosing. It is not necessary to double a dose.
Patients with a renal failure
Maximum daily dose for patients with disturbance of renal function (clearance of creatinine of 30-60 ml/min.) makes 5 mg of a ramipril and 25 mg of a hydrochlorothiazide. Patients with an abnormal liver function
to Patients with a moderate abnormal liver function the treatment is possible br only under control of the doctor and with the maximum daily dose of a ramipril of 2.5 mg and a hydrochlorothiazide of 12.5 mg.
Patients of advanced age
Initial dose has to be low. Further dose adjustment has to be gradual, considering high probability of undesirable effects.
CONTRAINDICATION:
hypersensitivity to a ramipril, other APF inhibitors or to any of medicament components. Because the hydrochlorothiazide is a part of drug, medicament is contraindicated to patients with an anury or hypersensitivity to tiazida and other derivatives of sulfonamide. A Quincke's disease in the anamnesis (hereditary, idiopathic or connected with use of APF inhibitors); hemodynamically unstable state; dialysis or haemo filtration with use of negatively charged membranes of high capacity (for example polyacrylonitrile membranes); primary hyper aldosteronism; a renal artery stenosis (bilateral or unilateral at patients with one kidney); a heavy renal failure (the clearance of creatinine <30 ml/min. is at patients who are not on dialysis), an anury; clinically significant electrolytic imbalance (hypercalcemia, hyponatremia, hypopotassemia); heavy abnormal liver function and/or cholestasia, hepatic encephalopathy. Period of pregnancy or feeding by a breast. Children's age.
SIDE EFFECTS:
frequency of side reactions is defined by: very often (≥1/10), it is frequent (≥1/100, <1/10), sometimes (≥1/1000, <1/100), is rare (≥1/10,000, <1/1000), is very rare (<1/10,000), it is unknown (cannot be defined).
from a cardiovascular system: it is frequent — stenocardia, feeling of the strengthened heartbeat, arterial hypotension, postural hypotension, tachycardia, disturbance of orthostatic regulation, an asthenia, cardiac arrhythmias, a syncope, an ischemic stroke of a brain and peripheral hypostases, hyperaemia; very seldom — a myocardial infarction, hemorrhage in a brain, thrombolytic complications, a vascular stenosis, hypoperfusion, Reynaud's syndrome, a vasculitis.
from a krovoobrazovaniye: it is frequent — reduction of quantity of leukocytes, erythrocytes, decrease in hemoglobin, a hematocrit, thrombocytopenia, hemolytic anemia; very seldom — oppression of marrow, a neutropenia, including an agranulocytosis, a pancytopenia, an eosinophilia.
from central nervous system: it is very frequent — a headache, dizziness; often — vertigo, paresthesia, a tremor, balance disturbance, loss of taste; sometimes — drowsiness; very seldom — brain ischemia, including an ischemic stroke and passing ischemic disturbances, a parosmiya.
from an organ of sight: it is frequent — a disorder of vision, including indistinct sight, conjunctivitis, blepharitis; very seldom — a xanthopsia (the image in yellow color), tranzitorny shortsightedness, decrease in a slezootdeleniye owing to increase in sensitivity to a hydrochlorothiazide.
from an organ of hearing: it is frequent — noise or a ring in ears; very seldom — decrease in hearing.
from a respiratory system: it is very frequent — unproductive dry cough, bronchitis; often — sinusitis, short wind, congestion of a nose; very seldom — a bronchospasm, including asthmatic attacks, rhinitis, pharyngitis, alveolar pneumonia, allergic interstitial pneumonia, not cardiogenic fluid lungs owing to increase in sensitivity to a hydrochlorothiazide, a Quincke's disease with obstruction of airways.
from a GIT: it is frequent — digestive disturbances, abdominal pain, dyspepsia, gastritis, a gastroenteritis, nausea, a constipation; seldom — nausea, aphthous stomatitis, a glossitis, diarrhea, an abdominal pain, dryness of language; very seldom — pancreatitis, a Quincke's disease of a small intestine, a vasculitis, dryness in a mouth, feeling of thirst, inflammatory reactions in an oral cavity and a GIT, disturbance of perception of a smell and taste, a sialadenitis owing to increase in sensitivity to a hydrochlorothiazide.
from a gepatobiliarny system: it is frequent — cholestatic or cytolytic hepatitis, increase in concentration of hepatic enzymes and/or bilirubin; the calculous cholecystitis caused by a hydrochlorothiazide; very seldom — an acute liver failure, cholestatic jaundice, gepatonekroz.
from an urinary system: it is frequent — depression of function of kidneys, increase in a diuresis, dehydration, increase in level of urea and creatinine in blood serum; very seldom — an acute renal failure, strengthening of the existing proteinuria, a nephrotic syndrome, interstitial nephrite owing to increase in sensitivity to a hydrochlorothiazide.
from integuments: it is frequent — the strengthened sweating, rash, an itching; sometimes — a Quincke's disease, makulopapulezny rash, a small tortoiseshell; very seldom — a toxic epidermal necrolysis, Stephens's syndrome — Johnson, a multiformny erythema, a vasculitis, aggravation of a course of psoriasis, exfoliative dermatitis, reaction of photosensitivity, onikholizis, a psoriazoformny or pemfigoidny dieback or an enantema, an alopecia, a volchanochnopodobny syndrome owing to increase in sensitivity to a hydrochlorothiazide.
from a skeletal and muscular system: it is frequent — myalgia; very seldom — an arthralgia, arthritis, muscular spasms; muscle weakness, spasms owing to increase in sensitivity to a hydrochlorothiazide.
Metabolic disturbances: it is very frequent — decrease in tolerance to glucose (at patients with diabetes it can lead to disturbance of metabolic balance), increase in level of glucose in blood serum, increase in level of uric acid in blood serum, exacerbation of gout, increase in concentration of XC and/or TG in blood serum owing to hypersensitivity to a hydrochlorothiazide; often — anorexia, a loss of appetite; decrease in level of potassium in blood serum; seldom — increase in level of potassium in blood serum, a hyperchloremia; very seldom — decrease in level of sodium in blood serum; a glucosuria, a metabolic alkalosis, a hypochloraemia, a hypomagnesiemia, a hypercalcemia, increase in activity of serumal amylase, strengthening of removal of liquid owing to hypersensitivity to a hydrochlorothiazide.
Organism in general: it is very frequent — an asthenia, fatigue, weakness; often — a stethalgia, fervescence.
from the immune system: it is very rare — anaphylactic or anaphylactoid reactions, increase in quantity of antinuclear antibodies.
from a reproductive system: it is frequent — temporary disturbance of an erection; very seldom — decrease a libido, impotence, a gynecomastia.
Mental disorders: it is frequent — a depression, apathy, uneasiness, nervousness, sleep disorders; very seldom — confusion of consciousness, a condition of excitement, depression of mood, concern, disturbance of concentration of attention.
SPECIAL INSTRUCTIONS:
patients with risk of developing arterial hypotension.
At treatment of patients at whom the activity renin-angiotensin-aldosteronovoy of a system is significantly increased should show extra care. For such patients the risk of sharp and considerable decrease in the ABP and deterioration in renal function as a result of APF inhibition, especially is possible if APF inhibitor or the accompanying diuretic is appointed for the first time or at the first increase in a dose.
In an initiation of treatment or at increase in a dose should carry out by medicament careful control of the ABP, for example, at such states as:
- heavy AG;
- noncompensated chronic heart failure;
- stenosis of the aortal or mitral valve, hypertrophic cardiomyopathy;
- a unilateral renal artery stenosis with the second functioning kidney;
- loss of liquid or salt or a possibility of its development (including patients who receive diuretics);
- cirrhosis and/or ascites;
- when performing big surgical interventions or during anesthesia medicines which cause arterial hypotension.
At development of arterial hypotension of the patient needs to be put backwards, and if necessary — to carry out in to infusion 0.9% by chloride sodium solution. Tranzitorny arterial hypotension at reception Rami SANDOZ compositum is not a contraindication for medicament treatment, therapy can be continued after restoration of volume of liquid and normalization of the ABP. It is recommended to br to korrigirovat dehydration, a hypovolemia or a lack of salt before an initiation of treatment (for patients with heart failure such corrective actions should be weighed carefully concerning risk of an overload).
Surgical intervention
Before surgical intervention or anesthesia by the patient should inform the doctor on intake of APF inhibitors. A day before operation it is recommended to stop use of APF inhibitors.
to Patients with the menacing heart failure or ischemic disturbance of cerebral circulation in heavy arterial hypotension
Primary hyper aldosteronism
Drug is not appointed for treatment of primary hyper aldosteronism. If therapy by the combined medicament is necessary for such patients, it is necessary to control carefully potassium level in blood plasma.
Elderly person
At elderly people the reaction to APF inhibitors can be more expressed. At the beginning of their treatment it is recommended to estimate renal function.
Patients with liver diseases
At patients with disturbance of hepatic function or with the progressing disease of a liver should apply tiazida with care as changes of water and electrolytic balance can provoke hepatic encephalopathy.
Control of function of kidneys
Function of kidneys should be estimated to and during treatment, to korrigirovat a dose, especially in the first weeks of therapy. In the presence of damage of kidneys the special control is necessary. There is a risk of deterioration in function of kidneys, more at patients with stagnant heart failure or after renal transplantation.
Deterioration in function of kidneys
At patients with diseases of kidneys of a tiazida can provoke uraemia. The hydrochlorothiazide can contribute to the development of an azotemia or strengthen it. The cumulative effect of medicament is possible for patients with disturbance of renal function. If deterioration in function of kidneys progresses, it is necessary to stop use of diuretics.
kidneys, Sore after transplantation
Experience of use of a ramipril for patients after renal transplantation is absent therefore patients of this category are not recommended to appoint drug.
Hemodialysis
At patients who are on dialysis with use of membranes of high capacity and apply at the same time APF inhibitor, anaphylactoid reactions in certain cases developed. Therefore for such patients the use of dialysis membranes of other type or antihypertensive of other group is recommended. Disturbance of water and electrolytic balance
When performing therapy by diuretics is regularly recommended to carry out by br determination of level of electrolytes in blood serum. Tiazida, including a hydrochlorothiazide, can serve as the reason of an imbalance of liquid or electrolytes (hypopotassemia, a hyponatremia and a gipokhloremichesky alkalosis).
Risk of a hypopotassemia can increase at patients with the raised diuresis, with the insufficient use of electrolytes and liquids, at the patients receiving at the same time therapy by corticosteroids or adrenocorticotropic hormone (AKTG).
Thiazide diuretics can reduce removal of calcium with urine and cause temporary small increase in level of calcium in blood serum in the absence of the known disturbances of metabolism of calcium. The expressed hypercalcemia can testify to the latent hyperparathyreosis. Before analyzing function of an epithelial body, it is necessary to cancel tiazida.
Tiazida increase magnesium removal that can lead to a hypomagnesiemia.
Quincke's disease
At patients who received APF inhibitors, including ramiprit, it was reported about a possibility of a Quincke's disease. In this case administration of medicament should be stopped and to immediately appoint emergency treatment. Patients should be under control of the doctor for 12–24 h before total disappearance of symptoms.
At patients who accepted APF inhibitors, cases of a Quincke's disease of intestines noted. These patients complained of a stomach ache (with or without nausea/vomiting); in certain cases there was also a Quincke's disease of the person. Symptoms of a Quincke's disease of intestines disappeared after APF inhibitor phase-out.
Anaphylactic reactions during desensitization
Probability and weight of anaphylactic and anaphylactoid reactions to poison of insects and other allergens increase at intake of APF inhibitors. Before desensitization it is necessary to consider the possibility of the temporary termination of administration of drug.
It was reported about neutropenia/agranulocytosis cases and also about a possibility of oppression of function of marrow. Recommend to control quantity of white blood cells for identification of a possible leukopenia. It is more often to carry out monitoring at an initial stage of treatment and at patients with impaired renal function, the accompanying collagenic disease (system lupus erythematosus or a scleroderma) or if patients take other medicaments which can cause changes of a picture of blood.
Ethnic differences
APF Inhibitors cause a Quincke's disease in patients of negroid race more often, than in the Caucasian. The same as at use of other APF inhibitors, ramiprit it can be less effective for decrease in the ABP level at patients of negroid race.
Drug contains a hydrochlorothiazide that can yield positive take in the anti-doping test that it is important to consider to athletes. Metabolic and endocrine effects
Tiazida are capable to change br tolerance to glucose. Correction of doses of anti-diabetic drugs, including insulin can be necessary. At therapy by thiazide diuretics the demonstration of latent diabetes is possible, levels XC and TG can increase. Therapy by thiazide diuretics can cause a hyperuricemia and exacerbation of gout in some patients.
At use of APF inhibitors it was reported about cases of unproductive persistent cough which passes after the therapy termination. The possibility of the cough caused by APF inhibitors should be considered at implementation of differential diagnosis of cough. Others
Are possible br reactions of hypersensitivity, irrespective of existence in the anamnesis of an allergy or OH. It was reported about a possibility of aggravation of a system lupus erythematosus at patients who were treated by a hydrochlorothiazide.
Use during pregnancy and feeding by a breast. do not apply. In case of pregnancy confirmation immediately to cancel drug. During medicament treatment it is necessary to stop feeding by a breast.
Children. do not apply.
Ability to influence speed of response at control of vehicles or work with other mechanisms. Drug can reduce attention and/or speed of response at patients, especially in an initiation of treatment that can affect ability to run vehicles and to work with other mechanisms.
INTERACTION:
such combinations are contraindicated to .
Methods of extracorporal therapy as a result of which there is a contact of blood with negatively charged surfaces, such as dialysis or haemo filtration using certain membranes to high intensity of a stream (for example membranes from polyacrylonitrile) and aferez LDL using dextran sulfate owing to the increased risk of heavy anaphylactoid reactions. If such treatment is necessary, it is necessary to consider a question of use of other type of dialysis membranes or other class of antihypertensive medicines.
Caution at use
potassium Salts, heparin, kaliysberegayushchy diuretics and other medicines which increase potassium level in blood plasma (including antagonists of angiotensin ІІ, Trimethoprimum, takrolimus, cyclosporine, lovastatin): there can be a hyperpotassemia therefore careful monitoring of level of potassium in blood plasma is necessary.
Antihypertensive medicaments (for example diuretics) and other medicines reducing the ABP level (for example nitrates, tricyclic antidepressants, anesthetics, ethanol, Baclofenum, alfuzozin, docsazozin, Prazozinum, tamsulozin, terazozin): it is possible to expect strengthening of hypotensive effect. It is regularly recommended to br to control serumal concentration of sodium at patients to whom simultaneous therapy is appointed diuretics.
Angiotonic sympathomimetics and other medicaments (for example Isoproterenolum, Dobutaminum, a dopamine, epinephrine) which can reduce antihypertensive effect of a ramipril: control of the ABP is recommended.
Allopyrinolum, immunosuppressants, corticosteroids, procaineamide, cytostatics and other substances which can change quantity of blood cells: increased probability of hematologic reactions.
Salt of lithium: APF inhibitors reduce lithium excretion therefore the probability of lithium toxicity can increase. Control of level of lithium is recommended.
Anti-diabetic drugs, including insulin: hypoglycemic reactions are possible. Control of level of glucose in blood plasma is recommended.
NPVP and acetylsalicylic acid: should expect decrease in antihypertensive effect of a ramipril. Besides, the combined use of APF and NPVP inhibitors can be followed by the increased risk of deterioration in function of kidneys and increase in level of potassium in blood.
Oral anticoagulants: reduction of expressiveness of effect of anticoagulants owing to the accompanying use of a hydrochlorothiazide.
Corticosteroids, AKTG, Amphotericinum B, karbenoksolon, light laxative medicines (at their prolonged use) and other potassiumuretic means: risk of emergence of a hypopotassemia increases.
foxglove Drugs, medicines extending a Q-T-interval and antiarrhytmic drugs: their toxicity can increase or their antiarrhytmic effect can decrease at disturbance of electrolytic balance (for example a hypopotassemia, a hypomagnesiemia).
Methyldopum: hemolysis is possible.
Colestyraminum or other ion-exchange medicaments operating in a small intestine: decrease in absorption of a hydrochlorothiazide. Sulphonamide diuretics it is necessary to take a minimum for 1 h before intake of these medicaments or in 4–6 h later.
Muscle relaxants (like a curare): lengthening of effect is possible.
Salt of calcium and the medicaments increasing its concentration in blood plasma: increase in concentration of calcium in blood plasma owing to the accompanying use of a hydrochlorothiazide.
Sotalol: hypopotassemia caused by tiazida can increase risk of developing of arrhythmia.
Karbamazepin: risk of emergence of a hyponatremia at the accompanying use of a hydrochlorothiazide.
Contrast agents containing iodine: in dehydration caused by diuretics the increased risk of an acute renal failure, especially with high doses of the contrast agents containing iodine exists.
Penitsillin: hydrochlorothiazide reduces penicillin excretion.
Hinin: hydrochlorothiazide reduces quinine excretion.
Sodium chloride: antihypertensive effect of a combination of a ramipril and hydrochlorothiazide reduces.
Treatment by high doses of salicylates (> 3 g/days): hydrochlorothiazide can exponentiate their toxic influence on central nervous system.
OVERDOSE:
symptoms: an excessive peripheral vazodilatation (with the profound arterial hypotension, shock), bradycardia, disturbance of electrolytic balance, a renal failure, cardiac arrhythmias, disturbance of consciousness up to a coma, cerebral spasms, paresis, paralytic Ilheus. At predisposed patients (for example a prostate hyperplasia), the overdose by a hydrochlorothiazide can promote an ischuria.
Treatment: symptomatic and maintenance therapy: primary detoxication (gastric lavage, use of sorbents) and means for restoration of hemodynamic stability, including appointment α 1 - adrenergic agonists or angiotensin ІІ (Angiotensinamidum). Ramiprilat, an active metabolite of a ramipril, is badly brought from the general blood-groove by a hemodialysis.
Removal from an organism of thiazide diuretics by means of dialysis insignificant.
STORAGE CONDITIONS:
at a temperature up to 30 °C.
Description of goods is certified by the Lek producer .
Editorial group Date of creation: 04.01.2023 Date of updating: 05.04.2023
Urusov Hannah Mikhayl_vna Author 
Turumkulov of a _rin Mikhayl_vna Reviewer Pay attention!
Description of the medicament Rami Sandoz tab. compositum 5mg/25mg No. 30 on this page — the simplified author's version of website apteka911 created on the basis of the instruction(s) for use. Before acquisition or use of medicament you have to consult with the doctor and study the original instruction of the producer (it is applied to each packing of drug).
Information on medicament is provided toonly with the fact-finding purpose and should not be used as the management to self-treatment. Only the doctor can make the decision on prescribing of medicament and also define doses and ways of its use.
Frequently asked questions
How much is Rami Sandoz table compositum. 5mg/25mg No. 30?
Prices on Rami Sandoz tab. compositum 5mg/25mg begin No. 30 from 46.23 UAH - whether a plate / 10 piecesCan be given this medicine to children?
It is impossible. It is necessary to consult with your attending physician more in details.What storage conditions at tablets Rami (Lek)?
It agrees with the instruction storage temperature Rami (Lek) makes from 5 °C to 25 °C. To store out of children's reach.What analogs at Rami No. 10 tablets?
Full analogs Rami Sandoz tab. compositum 5mg/25mg No. 30 are:
- Ampril HD of the tab. 5mg/25mg No. 30
- Ramizes Côme of the tab. 5mg/25mg No. 30
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Characteristics Active ingredients Hydrochlorthiazidum, Ramipril Amount of active ingredient 5 mg + 25 mg Applicant Sandoz Code of automatic telephone exchange C09BA05 Ramipril and diuretics Interaction with food It doesn't matter Light sensitivity Not sensitive Market status The branded generic Origin Chemical Prescription status According to the prescription Primary packing blister Producer S.A. LEK. Quantity in packing 30 tablets (3 blisters on 10 pieces) Release form tablets for internal use Route of administration Oral Sign Import Storage temperature from 5 °C to 25 °C Trade name Rami
Rami Sandoz tab. compositum 5mg/25mg No. 30
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