Ramira

A medical product with an effect on the renin-angiotensin system - Ramira - is referred to as ACE inhibiting drugs with the active ingredient ramipril.

Ramira is produced by Icelandic pharmaceutical company Aktavis AT or Maltese company Aktavis Ltd. 

Indications Ramira

The drug is recommended for use:

• with an increase in blood pressure, for independent or combined treatment of high blood pressure, in conjunction with diuretics and calcium channel blockers;
• with congestion with a lack of cardiac activity, with the possibility of use with other (for example, diuretic) drugs;
• if cardiac insufficiency is insufficient, which is the result of a transferred heart attack;
• in the post-infarction state;
• with nephropathy associated with or unrelated to diabetes mellitus;
• to reduce the likelihood of an infarct, stroke, or death due to cardiovascular pathology, especially with obvious CHD, diseases of the distal vessels, diabetes mellitus;
• at the risk of developing cardiovascular diseases as a result of high blood pressure, increased amounts of cholesterol in the blood, a low amount of high-density lipoproteins.

[1], [2], [3]

Release form

Ramir is produced in tablet form, the tablets are in a blister pack. The cardboard box contains three or nine cell packs.

• 1,25 mg - 30 pcs. (3 to 10 pcs.);
• 1,25 mg - 90 pcs. (9 to 10 pcs.);
• 10 mg - 30 pcs. (3 to 10 pieces;
• 10 mg - 90 pcs. (9 to 10 pieces;
• 2.5 mg - 30 pcs. (3 to 10 pcs.);
• 2.5 mg - 90 pcs. (9 to 10 pcs.);
• 5 mg - 30 pcs. (3 to 10 pieces;
• 5 mg - 90 pcs. (9 to 10 pieces).

The active component of the drug is ramipril. One tablet may contain 1.25 mg, 2.5 mg, 5 mg or 10 mg of ramipril.

The auxiliary components are sodium hydrogen carbonate, pregelatinized starch, lactose, croscarmellose sodium, sodium stearyl fumarate. Also in the composition of tablets may be a pigmented mixture of yellow or pink.

Pharmacodynamics

The active ingredient of the drug ramipril is able to inhibit the action of ACE. The drug is able to suppress the production of angiotensin II, eliminate vasoconstriction, stimulate aldosterone production. It activates the function of renin in the blood plasma, inhibits the metabolic processes of bradykinin.

Ramira has an antihypertensive effect that does not depend on the position of the patient's body, which does not lead to a compensatory increase in heart rate. Stabilizes the pressure regardless of the content of renin in the circulatory system.

In the majority of patients, the pressure stabilizes within 1-2 hours after the use of tablets. The maximum effect can be observed after 3-6 hours: it continues throughout the day. The peak level of pressure stabilization can be achieved after 20-30 days from the beginning of treatment with the drug. Stabilizing effect is stable and can persist with prolonged course of therapy (about 2 years). A sharp cessation of treatment is not capable of provoking a sudden rise in blood pressure.

Ramipril does not have a significant effect on renal circulation, only sometimes its slight acceleration is observed. Also, the drug does not affect the glomerular filtration rate. The expressed form of a nephropathy (on a background of a diabetes, or without it or him) can be accompanied by deterioration of renal function: Ramira brakes development of the given pathological processes in kidneys. In patients with the existing danger of nephropathy of different genesis, the drug reduces the degree of albuminuria.

[4], [5], [6]

Pharmacokinetics

Ramira is easily absorbed when taken orally. Simultaneous eating does not in any way impair the absorption of the medicine.

The metabolism of the drug occurs in the liver, where active and inactive exchange products are formed. The active product of the metabolic processes of ramipril is the so-called ramiprilat, which exhibits activity six times that of the original component.

The peak content of the active metabolite in the blood can be observed after a period of time from 2 to 4 hours after the use of the tablet. The distribution volume is determined by 500 liters. The connection with the protein component of the plasma is estimated at about 56%. The half-life is 13 to 17 hours. About 40% leaves the body with fecal masses, 60% - through the urinary system.

In patients of senile age, the pharmacokinetic properties of the drug do not undergo significant changes.

With insufficient kidney function, the active component of the drug is able to accumulate in the body.

With insufficient liver function, the transformation of the active component of the drug into a final product of ramiprilate metabolism worsens. 

[7], [8], [9]

Dosing and administration

Ramir is to be taken orally, regardless of the meal time. The tablet should be swallowed without chewing or grinding, with plenty of liquid. It is allowed to divide the tablet in half.

At high blood pressure take 2.5 mg of medicine per day at one time, preferably in the morning. If an increase in dosage is required, then it is carried out gradually, for 2 or 3 weeks to 5 mg. The maximum permissible daily dosage is up to 10 mg. The prescribed amount of the drug in some cases can be divided into two doses per day.

With chronic heart failure, initially 1.25 mg of medication per day is taken. In some cases, an increase in dosage may be required, which is achieved by doubling the dose for 7-14 days. Daily intake can be divided into 2 times.

In the post-infarction state, Ramir is prescribed not earlier than three days after the infarction, provided stable hemodynamics and the absence of signs of ischemia in the patient. The optimal initial dosage is 2.5 mg twice daily. If the tablets are poorly tolerated by the patient, a reduction in the initial dose to 1.25 mg twice daily is allowed. Further, the amount of the drug is gradually increased, bringing to a stabilizing dose of 5 mg twice a day. The maximum daily amount of the drug is 10 mg.

With insufficient kidney function, Ramir dosage is adjusted at the discretion of the treating specialist.

[15], [16], [17], [18], [19], [20], [21], [22]

Use Ramira during pregnancy

Ramira is not used in the period of gestation and breastfeeding. Before appointing the drug, the doctor must make sure that the patient is not pregnant.

Throughout the course of therapy, reliable methods of contraception should be used. In case of pregnancy, the course of treatment with the drug should be stopped immediately, or the drug should be replaced with another drug permitted during pregnancy. 

Contraindications

 In what cases should the drug be avoided?

• with a tendency to allergic reactions in response to the action of the active component of the drug, or other auxiliary component;
• with an earlier allergy to ACE inhibitor drugs;
• with the narrowing of the lumen of the renal arteries (one or two);
• with complicated and severe pathologies of the kidneys (with creatinine clearance less than 30 ml per minute);
• in the recovery period after a kidney transplant;
• with the primary form of hyperaldosteronism;
• during pregnancy and during breastfeeding;
• when hemodialysis procedures are completed;
• with insufficient functionality of the liver.

 Ramira is not used to treat patients in childhood.

[10], [11], [12], [13]

Side effects Ramira

Side effect of Ramir can be reflected on various organs and systems of the body.

Cardiovascular system: lowering blood pressure, short-term loss of consciousness, cardiac failure, dizziness, chest pains, heart rhythm disturbances.

Hemostatic organs: signs of anemia, a decrease in the number of platelets, neutrophils and eosinophils in the blood, inflammatory changes in the walls of blood vessels, pancytopenia.

Gastrointestinal tract: dyspeptic phenomena, salivary gland dysfunction, emaciation, swallowing difficulties, stool disorders, inflammatory diseases of the digestive system, liver dysfunction (inflammation, cholestasis, jaundice).

Respiratory organs: attacks of dry cough, inflammatory processes in the upper respiratory tract.

Nervous system: pain in the head, asthenic condition, disorders of the vestibular apparatus, memory and sleep disorders, seizures, depressive state, trembling and numbness of the limbs, deterioration of hearing and vision.

Kidney and urinary system: renal dysfunction, the appearance of protein in the urine, dysuric disorders, peripheral puffiness.

Skin and mucous membranes: allergic rashes, redness, increased sensitivity to ultraviolet radiation.

Among other possible side effects can also be identified pain in the muscles and (or) joints, an increase in the amount of urea and creatinine in the blood, an increase in the titer of antinuclear antibodies.

[14]

Overdose

Signs of eating a large amount of Ramir are:

• excessive decrease in blood pressure;
• state of shock;
• electrolyte exchange disorders;
• impaired renal function (ARF).

Measures to assist with overdose: cleaning and washing the stomach, the use of sorbents, if necessary - intravenous infusions of saline, catecholamines, angiotensin II.

With progressive slowing of the heart rate, you can use an artificial pacemaker (pacemaker).

With the appearance of edema Quincke - an urgent injection of epinephrine (sc or IV), then - iv injection of glucocorticoid drugs, antihistamines, antagonists of H 2 -receptors.

Hemodialysis with an overdose of Ramir is ineffective, so its use is inexpedient.

[23], [24]

Interactions with other drugs

The complex reception of Ramir and other antihypertensive drugs, diuretics, opioids based on opium (narcotic analgesics), anesthetics, tricyclic antidepressants and antipsychotics can provoke an increase in the antihypertensive effect of the medication.

Joint reception with non-steroidal anti-inflammatory drugs, estrogen-containing drugs, sympathomimetics, as well as with preparations containing salt, can reduce the hypotensive effect of Ramir.

Joint reception with medications based on potassium can help increase the amount of potassium in the bloodstream.

You should not combine Ramir's and lithium-based medications, as this can provoke an increase in the toxic effect of lithium-containing drugs.

Complex treatment with diabetes mellitus (including that of insulin) can trigger an increased decrease in blood glucose levels up to hypoglycemia.

Joint reception with allopurinol, cytostatics, immunosuppressants, corticosteroid hormones increases the risk of developing leukopenia.

Ramir and its active ingredient ramipril enhances the effect of alcoholic beverages.

[25], [26], [27], [28]

Storage conditions

Ramir's remedy is recommended to be kept in a dry, dark place, in the factory packaging, in the area of inaccessibility for children. The temperature should not exceed + 25 ° C.

[29], [30], [31], [32], [33], [34]

Shelf life

 Shelf life:

• for tablets with a dosage of 2.5 mg, 5 mg and 10 mg - up to 2 years;
• for tablets with a dosage of 1.25 mg - up to one and a half years, subject to the storage conditions of the drug.

[35]