Amoxicillin Sandoz, 12 pcs., 1 g, film-coated tablets


Amoxicillin Sandoz®

Before starting amoxicillin therapy, the patient should be interviewed in detail regarding previous hypersensitivity reactions to penicillins, cephalosporins and other beta-lactams.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Serious hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions), sometimes fatal, have been reported in patients receiving penicillin therapy. The development of these reactions is more likely in persons with a history of hypersensitivity to penicillin, as well as in persons with atopy. If an allergic reaction occurs, discontinue amoxicillin therapy and institute appropriate alternative treatment.

There have been rare cases of hypersensitivity reactions such as allergic acute coronary syndrome (Kounis syndrome), in the event of which, when taken together with amoxicillin, appropriate treatment is required.

During treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver and kidneys. Increased activity of liver enzymes and changes in the number of blood cells were reported.

With long-term use, cases of superinfection and candidiasis (especially vulvovaginal candidiasis) may develop.

When taking almost all antibacterial drugs, it is possible to develop antibiotic-associated colitis up to a life-threatening condition. This should be taken into account if diarrhea occurs during antibiotic therapy or after its completion. If antibiotic-associated colitis develops, drug therapy should be stopped immediately and the attending physician should be consulted to prescribe appropriate treatment. The use of drugs that inhibit intestinal motility is contraindicated.

The occurrence of generalized erythema with fever accompanied by pustules at the beginning of therapy may be a symptom of acute generalized exanthematous pustulosis (AGEP). This adverse drug reaction requires discontinuation of treatment with amoxicillin and is a contraindication for its further use in any situation.

The use of amoxicillin should be avoided if the patient is suspected of developing infectious mononucleosis, since its use during treatment of this disease can lead to the appearance of a measles-like rash.

The Jarisch-Herxheimer reaction has been observed following the use of amoxicillin in patients with Lyme disease. Its direct cause is the bactericidal activity of amoxicillin against the bacteria that cause Lyme disease, the spirochete Borrelia burgdorferi.

Patients should be reassured that this reaction is a common and usually self-limiting consequence of antibiotic use in patients with Lyme disease.

Treatment must continue for 48-72 hours after the disappearance of clinical signs of the disease.

Convulsions may occur in patients with impaired renal function or in patients receiving high doses of the drug or with predisposing factors (for example, a history of seizures, treatment for epilepsy, or meningitis).

In case of renal failure, it is necessary to adjust the dosage regimen depending on the degree of renal failure.

In patients with reduced diuresis, crystalluria was very rarely observed, mainly during parenteral therapy. When using high doses

Amoxicillin is recommended to maintain adequate fluid intake and diuresis to reduce the possibility of crystalluria associated with the use of the drug. In patients with a catheterized bladder, catheter patency should be checked regularly.

Increased prothrombin time has been rarely reported in patients receiving amoxicillin. Patients who are indicated for simultaneous use of indirect anticoagulants should be observed by a specialist. Dose adjustment of indirect anticoagulants may be necessary. There is a possibility that increased concentrations of amoxicillin in serum and urine may influence the results of some laboratory tests. When using chemical methods, high concentrations of amoxicillin in the urine may cause false-positive test results.

To determine the presence of glucose in urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase methods. The use of amoxicillin may distort the results of the quantitative determination of estriol in pregnant women.

It is necessary to use the drug with caution in the elderly, pregnant women, and during lactation.

When using amoxicillin to treat Helicobacter pylori infections, you should take into account the information provided in the text of the instructions for medical use of other concomitantly used drugs.

Special precautions when disposing of unused drug

There is no need for special precautions when disposing of unused drug.

Amoxicillin Sandoz, 12 pcs., 1 g, film-coated tablets

Before prescribing Amoxicillin Sandoz®, you must make sure that the strains of microorganisms that cause the infectious disease are sensitive to the drug.

In case of severe infectious and inflammatory processes of the gastrointestinal tract, accompanied by prolonged diarrhea or nausea, it is not recommended to take Amoxicillin Sandoz® orally due to possible low absorption of the drug.

When treating mild diarrhea during a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided; You can use kaolin- or attapulgite-containing antidiarrheal drugs. If diarrhea is severe, consult a doctor.

If severe persistent diarrhea develops, the development of pseudomembranous colitis (caused by Clostridium difficile)

). In this case, Amoxicillin Sandoz® should be discontinued and appropriate treatment prescribed. In this case, drugs that slow down gastrointestinal motility are contraindicated.

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.

In patients who are hypersensitive to penicillins, cross-allergic reactions with other beta-lactam antibiotics are possible.

Treatment must continue for another 48–72 hours after the disappearance of clinical signs of the disease.

When using estrogen-containing oral contraceptives and amoxicillin simultaneously, other or additional methods of contraception should be used.

Amoxicillin Sandoz® is not recommended for the treatment of acute respiratory viral infectious diseases due to low effectiveness.

Particular caution is recommended for patients with allergic diathesis or bronchial asthma, or a history of gastrointestinal diseases (in particular, colitis caused by antibiotic treatment).

When taking Amoxicillin Sandoz® for a long time, nystatin, levorin or other antifungal drugs should be prescribed simultaneously.

It is not recommended to consume ethanol during treatment.

The use of Amoxicillin Sandoz® does not affect the results of the enzymatic test for glycosuria, however, false-positive results of a urine test for glucose are possible.

While taking Amoxicillin Sandoz®, it is recommended to drink plenty of fluids to prevent the formation of amoxicillin crystals in the urine.

Impact on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions

Due to the potential for side effects such as drowsiness, headache and confusion, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and psychomotor speed.

Moxonitex

Pharmacodynamics

Selective agonist of imidazoline receptors responsible for reflex control of the sympathetic nervous system (localized in the ventrolateral medulla oblongata). Slightly binds to central alpha2-adrenergic receptors, reduces systolic and diastolic blood pressure (BP) with single and long-term use.

With long-term use, it reduces left ventricular myocardial hypertrophy, eliminates signs of myocardial fibrosis, microarteriopathy, normalizes capillary blood supply to the myocardium, reduces total peripheral vascular resistance, pulmonary vascular resistance, while cardiac output and heart rate (HR) do not change significantly. During treatment, the activity of norepinephrine and epinephrine, renin, angiotensin II at rest and during exercise, atrial natriuretic peptide (with exercise) and plasma aldosterone decreases. Reduces tissue resistance to insulin by 21% compared to placebo in obese patients and insulin-resistant patients with moderate arterial hypertension, stimulates the release of growth hormone. Does not affect the metabolism of glucose and lipids.

Pharmacokinetics

Suction.

After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract (about 90%). Food intake does not affect the amount of absorption. The maximum concentration in blood plasma (Cmax) is reached 30-180 minutes after oral administration and is 1-3 ng/ml. The interval between reaching Cmax and a pronounced decrease in blood pressure at rest differs by an average of 10%, and during exercise by 7.7%. The duration of action is more than 12 hours. Bioavailability after a single oral administration is 88%, which indicates the absence of a significant effect of “primary” passage through the liver.

Distribution.

Penetrates the blood-brain barrier. Does not accumulate with prolonged use.

Volume of distribution - 1.4-3 l/kg. Connection with blood plasma proteins 7%.

Metabolism.

10-20% of moxonidine is metabolized to form 4,5-dehydromoxonidine and an aminomethanamidine derivative.

Excretion.

The half-life (T1/2) is 2-3 hours. In the first 24 hours, more than 90% is excreted by the kidneys (50-75% unchanged, 20% in the form of metabolites) and about 1% in the bile. Moxonidine is excreted in small quantities during hemodialysis.

Special patient groups

Elderly age

No significant differences in pharmacokinetics were found in young patients and elderly patients. No dose adjustment is required provided that renal function is normal.

Renal dysfunction

In patients with moderate (creatinine clearance (CR) 30-60 ml/min) and severe (CR <30 ml/min) renal impairment, steady-state plasma concentrations and final T1/2 are approximately 2 and 3 times higher, respectively, than in patients with arterial hypertension with normal renal function (creatinine clearance >90 ml/min). Therefore, the drug is contraindicated in patients with severe renal impairment, and in patients with moderate renal impairment, the drug should be used with caution, its dose should be selected individually.

Liver dysfunction

There are no reliable studies of the use of moxonidine in patients with impaired liver function. Since moxonidine is practically not metabolized in the liver, disruption of its function does not have a pronounced effect on the pharmacokinetics of the drug.

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