Stamlo M - Instructions For Use, Indications, Doses

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Stamlo M

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Terms and conditions of storage

Stamlo M is a drug with antianginal and antihypertensive action.

Release form and composition

Stamlo M is produced in the form of tablets: almost white or white; 5 mg each - round, with beveled edges, flat, embossed on one side "R 177", on the other - dividing line; 10 mg - oval, biconvex, embossed R on one side, “178” on the other (14 pcs. in blisters, 2 blisters in a cardboard box).

Composition of 1 tablet:

• active substance: amlodipine - 5 or 10 mg (amlodipine maleate - 6.42 or 12.84 mg);
• auxiliary components (5 mg / 10 mg, respectively): microcrystalline cellulose - 148.33 / 296.66 mg; sodium starch glycolate - 2.25 / 4.5 mg; anhydrous colloidal silicon dioxide - 0.75 / 1.5 mg; magnesium stearate - 2.25 / 4.5 mg.

Indications for use

• arterial hypertension (monotherapy / in combination with other antihypertensive drugs);
• angiospastic angina (Prinzmetal's angina);
• exertional angina.

Contraindications

Absolute:

• cardiogenic shock;
• severe arterial hypotension (systolic pressure less than 90 mm Hg);
• unstable angina (except for Prinzmetal's angina);
• collapse;
• pregnancy and the period of breastfeeding;
• age up to 18 years (the safety profile for this group of patients has not been studied);
• hypersensitivity to drug components and dihydropyridines.

Relative (the appointment of Stamlo M requires caution in the presence of the following diseases / conditions):

• moderate / mild arterial hypotension;
• acute myocardial infarction (and within 30 days after it);
• liver dysfunction;
• chronic heart failure in the stage of decompensation;
• diabetes;
• lipid metabolism disorders;
• sick sinus syndrome (tachycardia, severe bradycardia);
• hypertrophic obstructive cardiomyopathy;
• aortic / mitral stenosis;
• elderly age.

Method of administration and dosage

Stamlo M is taken orally.

Recommended daily dose (in 1 dose):

• angina pectoris, arterial hypertension: initial dose, maintenance dose for arterial hypertension - 5 mg, maximum - 10 mg;
• exertional angina, angiospastic angina: 5-10 mg.

Do not adjust the dose for the combined use of Stamlo M with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates and nitroglycerin (sublingually).

For elderly patients, patients of short stature, as well as with reduced body weight and functional disorders of the liver, Stamlo M is prescribed at a dose of 2.5 mg (as an antihypertensive agent; initial dose) or 5 mg (as an antianginal agent).

Correction of the dosage regimen for renal failure should not be carried out.

Side effects

• digestive system: vomiting, nausea, epigastric pain; rarely - pancreatitis, increased levels of hepatic transaminases and jaundice (caused by cholestasis), dry mouth, gingival hyperplasia, flatulence, diarrhea or constipation; very rarely - increased appetite, gastritis;
• central nervous system: mood changes, drowsiness, fatigue, headache, dizziness, convulsions; rarely - unusual dreams, loss of consciousness, nervousness, depression, hypesthesia, asthenia, paresthesia, vertigo, tremors, insomnia, malaise; very rarely - ataxia, agitation, apathy, amnesia;
• cardiovascular system: flushing of the face, shortness of breath, palpitations, marked lowering of blood pressure, vasculitis, fainting, edema (swelling of the feet / ankles); rarely - chest pain, rhythm disturbances (ventricular tachycardia, bradycardia, atrial flutter), orthostatic hypotension; very rarely - extrasystole, aggravation / development of heart failure, migraine;
• genitourinary system: rarely - painful urge to urinate, pollakiuria, sexual dysfunction (including decreased potency), nocturia; very rarely - polyuria, dysuria;
• musculoskeletal system: rarely - arthralgia, back pain, arthrosis, myalgia (with a long course); very rarely - myasthenia gravis;
• respiratory system: rarely - dyspnea; very rarely - rhinitis, cough;
• hematopoietic system: rarely - thrombocytopenia, leukopenia;
• sense organs: rarely - visual disturbances, diplopia, eye pain, conjunctivitis, ringing in the ears; very rarely - disturbances in taste, parosmia, accommodation disturbances, xerophthalmia;
• allergic and dermatological reactions: pruritus, rash (including maculopapular / erythematous rash, urticaria), angioedema; very rarely - purpura, discoloration of the skin, alopecia, xeroderma, dermatitis;
• others: rarely - thirst, hyperglycemia, gynecomastia, weight change, increased sweating, nosebleeds; very rarely - cold clammy sweat.

special instructions

In most cases, Stamlo M can be used as monotherapy. In case of insufficient efficacy, it can be taken in combination with drugs such as angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, thiazide diuretics, alpha- or beta-blockers.

As monotherapy or in combination with other antianginal drugs, Stamlo M is prescribed to patients refractory to the use of nitrates / beta-blockers in adequate doses.

During therapy, control of body weight and sodium intake is required, as well as adherence to an appropriate diet.

In order to prevent pain, hyperplasia and bleeding of the gums, it is necessary to maintain dental hygiene and regularly visit the dentist.

In elderly patients, when the dose is increased, careful monitoring of the condition is necessary.

Before canceling Stamlo M, it is recommended to reduce the dose gradually.

In some patients, mainly at the beginning of therapy, it is possible to develop such disorders as drowsiness and dizziness, which must be taken into account when driving and working with mechanisms.

Drug interactions

With the combined use of Stamlo M with some drugs / substances, the following effects may develop:

• beta-blockers, thiazide / "loop" diuretics, nitrates, verapamil, angiotensin-converting enzyme inhibitors: increased antianginal and hypotensive effects;
• quinidine, procainamide and other drugs that cause lengthening of the QT interval: increased negative inotropic effect, increased likelihood of significant lengthening of the QT interval;
• inhibitors of microsomal oxidation: an increase in the plasma concentration of amlodipine, an increase in the likelihood of adverse reactions;
• non-steroidal anti-inflammatory drugs, especially indomethacin, alpha-adrenostimulants, estrogens, sympathomimetics: weakening the hypotensive effect;
• inducers of liver microsomal enzymes: reducing the likelihood of adverse reactions;
• calcium preparations: decrease in the effectiveness of Stamlo M;
• blockers of slow calcium channels, amiodarone, quinidine, antipsychotics, alpha ₁ -adrenergic blockers: increased antihypertensive action;
• lithium preparations: an increase in the manifestation of their neurotoxicity in the form of tinnitus, nausea, diarrhea, vomiting, tremor, ataxia.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

Shelf life is 2 years.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!