Ampisid - Instructions For The Use Of An Antibiotic, Price, Analogues, Reviews

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

Ampisides

Ampisid: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ampisid

ATX code: J01CR04

Active ingredient: ampicillin (ampicillin) + sulbactam (sulbactam)

Manufacturer: Mustafa Nevzat Ilach Sanai A. Sh. (Mustafa Nevzat Ilac Sanayii, AS) (Turkey)

Description and photo updated: 2018-26-11

Ampisid is a broad-spectrum antibiotic of the penicillin group in combination with a beta-lactamase inhibitor.

Release form and composition

Dosage forms of Ampisid:

• film-coated tablets: in the form of capsules, white with a yellow tinge or white, scored on both sides; at the break - a homogeneous, almost white or white mass (10 pcs. in orange glass bottles together with a cylindrical container with silica gel, in a cardboard box 1 bottle; for hospitals - in a cardboard box 200 bottles);
• powder for suspension for oral administration: almost white or white; ready-made suspension - homogeneous, almost white or white (in yellow glass bottles with a volume of 40 or 70 ml, sealed with an aluminum lid, in a cardboard box 1 bottle complete with a measuring spoon; for hospitals - in a cardboard box 100 bottles);
• powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration (powder for preparing a solution for i / m administration): almost white or white powder [by (250 mg + 125 mg), (500 mg + 250 mg) or (1000 mg + 500 mg) in colorless glass vials complete with a solvent ampoule of 1 / 1.8 / 3.5 ml, respectively; in a cardboard box 1 set; for hospitals - 100 bottles in a cardboard box];
• powder for preparation of solution for injections: white [at (1000 mg + 500 mg) or (500 mg + 250 mg) in vials complete with a solvent ampoule of 1.8 or 3.5 ml, respectively; in a cardboard box 1 set].

1 tablet contains:

• active substance: sultamicillin tosylate, in terms of sultamicillin - 375 mg;
• additional components: magnesium stearate, sodium carboxymethyl starch, microcrystalline cellulose;
• film shell: titanium dioxide, hypromellose, macrogol 400.

5 ml of a suspension made from powder contains:

• active ingredient sultamicillin - 250 mg;
• additional components: xanthan gum, acetic acid anhydride, sucrose, sodium dihydrogen phosphate, sodium carmellose, hyprolose, guarana flavor.

1 bottle of powder for preparation of a solution for parenteral administration contains the following active substances: ampicillin (in the form of sodium salt) - 250/500/1000 mg and sulbactam (in the form of sodium salt) - 125/250/500 mg, respectively.

Solvent (colorless transparent liquid): complete with powder for preparation of solution for intramuscular and intravenous administration - water for injection; complete with powder for preparation of solution for injections and for intramuscular administration - lidocaine hydrochloride solution 0.5%.

Pharmacological properties

Pharmacodynamics

Ampisid is a combined antibacterial agent.

Ampicillin (the antibacterial component of the drug) belongs to the group of semisynthetic penicillins and exhibits a bactericidal effect against sensitive microorganisms during the phase of active reproduction, by suppressing the biosynthesis of mucopeptide of the bacterial cell wall.

Sulbactam does not show clinically significant antibacterial activity (with the exception of Acinetobacter and Neisseriaceae) and is an irreversible inhibitor of a large number of beta-lactamases produced by microorganisms resistant to beta-lactam antibiotics. Sulbactam is also characterized by a connection with some penicillin-binding proteins. For this reason, individual strains are more susceptible to a combination of active ingredients than to a single beta-lactam antibiotic.

A significant number of gram-positive and gram-negative microorganisms are sensitive to Ampisid, including: Staphylococcus epidermidis and Staphylococcus aureus (including penicillin-resistant and some methicillin-resistant strains); Streptococcus faecalis and Streptococcus pneumoniae and other streptococci, Haemophilus parainfluenzae and Haemophilus influenzae (strains producing and not producing beta-lactamases), Klebsiella spp., Escherichia coli, Branhamella catarrhalis, Proteus spp. (indole positive and indole negative), Enterobacter spp. and Citrobacter spp., Morganella morganii, Neisseria gonorrhoeae and Neisseria meningitidis; anaerobes, including Peptococcus spp., Bacteroides fragilis, Peptostreptococcus spp. and species close to it.

Pharmacokinetics

When taken orally, Ampisid is well absorbed and does not undergo destruction in the acidic environment of the stomach. The drug is distributed in most fluids and tissues of the body, poorly passes through the blood-brain barrier, but against the background of inflammation of the meninges, the passage is much improved. After intravenous and intramuscular injections, high concentrations of sulbactam and ampicillin are noted in the blood; for both active ingredients, the half-life is approximately one hour.

The drug is excreted mostly by the kidneys (70-80%), while a very high content of unchanged antibiotic is found in the urine, and the drug is also excreted in the bile and penetrates into breast milk. Since sulbactam undergoes almost no biotransformation, it is excreted mainly unchanged, only 25% is excreted in the form of a metabolite.

With repeated injections, Ampisid does not accumulate, which allows it to be used for a long time in high doses.

Indications for use

According to the instructions, Ampisid is recommended for use for the treatment of infectious and inflammatory lesions excited by microorganisms sensitive to it:

• infections of the genitourinary system: pyelonephritis, endometritis, cystitis, urethritis; additionally for parenteral administration - prostatitis, pyelitis;
• infections of the upper and lower respiratory tract, and ENT organs: tonsillitis, sinusitis, epiglottitis, otitis media, bacterial pneumonia; additionally for parenteral administration - chronic bronchitis, lung abscess, pleural empyema;
• biliary tract infections: cholangitis, cholecystitis;
• infections of the skin and soft tissues: impetigo, erysipelas, secondarily infected dermatitis;
• infections of bones and joints;
• gonococcal infections.

In the form of injection solutions, Ampisid is also indicated for the following diseases: scarlet fever, dysentery, salmonella, salmonellosis, peritonitis, sepsis, meningitis, septic endocarditis.

In order to prevent complications, the antibiotic Ampisid is used in the postoperative period during surgical interventions on the organs of the abdominal cavity and small pelvis.

Contraindications

• lymphocytic leukemia;
• infectious mononucleosis (since the disease is of viral origin);
• severe violations of the liver and / or kidneys;
• age up to 3 years (with the appointment of tablets);
• hypersensitivity to any of the constituents of Ampisid and beta-lactam antibiotics.

Instructions for the use of Ampisid: method and dosage

Tablets and powder for oral suspension

The tablets and the prepared suspension are taken orally.

For children weighing more than 30 kg and adults, Ampisid is prescribed in a daily dose of 375-750 mg. Children with a body weight of less than 30 kg are recommended to take 25-50 mg of sultamicillin per day (taking into account the severity of the infection) per 1 kg of body weight. The daily dose should be divided into two doses. The course can vary from 5 to 14 days.

In the treatment of uncomplicated gonorrhea, Ampisid is prescribed once in a dose of 2250 mg (6 tablets), preferably in combination with probenecid in a dose of 1000 mg.

It is advisable for children to take the drug in the form of a suspension.

To prepare a suspension, immediately before the first dose, the powder should be diluted with boiled water at room temperature, gradually adding it to the mark on the bottle. In this case, the contents of the bottle must be constantly shaken. The suspension is recommended to be taken 5 minutes after the powder is dissolved in water to ensure its complete dissolution. The vial with the drug should be shaken before each dose. For an accurate dosage of the product, use the measuring spoon supplied with the preparation, which must be thoroughly rinsed with water after each use.

Powder for preparation of solution for parenteral administration

Ampisid solution prepared from a powder is injected intravenously (jet / drip) or intramuscularly.

Further, the total doses of ampicillin and sulbactam are recommended (in a 2: 1 ratio). The daily dose of an antibacterial agent can vary from 1500 mg (1000 mg ampicillin + 500 mg sulbactam) to 12,000 mg (8000 mg ampicillin + 4000 mg sulbactam). The dose is administered in several doses, depending on the severity of the infection, every 6, 8 or 12 hours. Intravenous injections are carried out for 5-7 days, if further therapy is necessary, they switch to intramuscular administration of the drug.

The course of treatment is usually 5-14 days, but in severe cases it can be increased, or an additional appointment of ampicillin is possible. Treatment should be continued for another 48 hours after the normalization of body temperature and removal of symptoms of the disease.

To prevent the development of surgical infections, Ampisid is administered at 1500–3000 mg during induction of anesthesia, then, within 24 hours after the operation, repeated injections of the antibiotic are allowed every 6–8 hours at the same dose.

In uncomplicated gonorrhea, Ampisid is administered as a single dose of 1500 mg. In order to increase the duration of the presence of the active components in the plasma, 1000 mg of probenecid should be taken orally simultaneously.

For children in the treatment of most infections, the drug is prescribed per day at 150 mg / kg (ampicillin 100 mg / kg + sulbactam 50 mg / kg), the dose is divided into 3-4 injections. For newborns (especially premature babies), Ampisid is usually prescribed at a dose of 75 mg / kg per day, divided into 2 administrations with an interval of 12 hours.

Intravenous drip solution is recommended to be infused at a rate of 60–80 drops per minute. A single dose of Ampisid must be dissolved in 100-200 ml of isotonic sodium chloride solution (0.9%) or 5-10% glucose solution.

Intravenous jet solution must be injected slowly over 3-5 minutes, the recommended single dose should be dissolved in 10-20 ml of isotonic sodium chloride solution.

For intramuscular administration, the powder is diluted in 2-4 ml of isotonic sodium chloride solution or 0.5% lidocaine solution.

Side effects

• digestive system: decreased appetite, nausea, diarrhea, vomiting, pseudomembranous enterocolitis, liver functional disorders (increased activity of hepatic transaminases, cholestatic jaundice);
• nervous system: malaise, drowsiness, headache; extremely rare - convulsions;
• allergic reactions: skin hyperemia, urticaria, conjunctivitis, rhinitis, arthralgia, fever, angioedema; rarely - itching, rash, eosinophilia, serum sickness, bronchospasm, anaphylactic shock; extremely rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, polymorphic erythema;
• hematopoietic system: lymphopenia, neutropenia, leukopenia, anemia, hemolytic anemia, eosinophilia, thrombocytopenia (these disorders are transient, after the abolition of Ampisid, the blood picture returns to normal);
• laboratory parameters: increased urea levels, azotemia, hypercreatininemia, hyperbilirubinemia;
• local reactions: pain at the injection site, especially with intramuscular injection, rarely - hyperemia or phlebitis at the injection site;
• others: extremely rarely - interstitial nephritis; with prolonged therapy - superinfection due to antibiotic-resistant microorganisms (candidiasis).

Overdose

Data on the toxic effects of ampicillin and sulbactam are limited. The disorders arising from an overdose of Ampisid are significantly different from its side reactions. A high level of beta-lactam antibiotics in the cerebrospinal fluid can provoke the development of undesirable effects from the central nervous system, including seizures.

Both active components of the drug are removed from the body using hemodialysis, as a result of which, in case of an overdose of Ampisid, in order to accelerate its elimination (especially in patients with functional disorders of the kidneys), hemodialysis is performed. Also, gastric lavage is prescribed in case of an overdose of oral forms of the drug and further symptomatic treatment.

special instructions

During the period of therapy with penicillins, very severe, and in some cases fatal, allergic (anaphylactic) reactions were recorded. If an allergic reaction occurs during the course, it is necessary to urgently stop using Ampisid and carry out appropriate treatment. With the development of this side effect, oxygen, adrenaline, glucocorticosteroid (GCS) hormones IV can be prescribed, and measures are taken to ensure airway patency (including intubation).

When patients with sepsis receive the drug, a bacteriolysis reaction may occur (Yarish-Herxheimer reaction).

During the use of Ampisid, as well as with any other antibiotic therapy, timely detection of signs of possible overgrowth of microorganisms resistant to the agent, including fungi, is of great importance. With the development of superinfection, the use of the drug should be discontinued and / or adequate concomitant therapy should be prescribed.

Against the background of long-term treatment, it is recommended to periodically monitor the indicators of the function of internal organs, including the liver, kidneys, and the hematopoietic system. This control is extremely important for newborns (primarily premature babies) and young children.

It was noted that with the appointment of ampicillin to pregnant women, a transient decrease in plasma levels in the blood of total bound estriol, estriol glucuronide, as well as bound estrone and estradiol was observed.

With Ampisid therapy, non-enzymatic methods for determining the level of glucose in urine using the Felling, Benedict or KliniTest reagents can show a false positive result.

Patients on a low sodium diet should remember that 1500 mg of Ampisid for parenteral administration contains approximately 115 mg (5 mmol) of sodium.

Application during pregnancy and lactation

There are no data showing the effectiveness and safety of using an antibacterial agent during pregnancy and breastfeeding. If it is necessary to use Ampisid during pregnancy, it is necessary to scrupulously evaluate the expected benefits of treatment for the mother and the possible threat to the health of the fetus.

If the antibiotic Ampisid is prescribed to be taken during lactation, you must stop breastfeeding.

Pediatric use

Children under 3 years old are contraindicated to take Ampisid in tablet form.

With impaired renal function

In the presence of renal failure with creatinine clearance below 30 ml / min, it is recommended to increase the intervals between the injections of Ampisid in accordance with the usual practice of using ampicillin.

For patients with severe functional impairment of the kidneys, the appointment of Ampisid is contraindicated.

For violations of liver function

In the presence of severe liver dysfunction, antibacterial therapy is contraindicated.

Drug interactions

• allopurinol: the threat of skin reactions is aggravated;
• anticoagulants: the effect of these drugs is enhanced, since penicillins are capable of disrupting platelet aggregation and altering hemocoagulation parameters;
• laxatives, glucosamine, antacids, aminoglycosides (when taken orally), food: slow down and reduce the absorption of Ampisid;
• medicines showing a bacteriostatic effect (sulfa drugs, tetracyclines, erythromycin, chloramphenicol): their antagonistic effect is noted;
• ascorbic acid: absorption of the drug is enhanced;
• bactericidal antibiotics (including cephalosporins, aminoglycosides, rifampicin, vancomycin, cycloserine): synergistic action is noted;
• nonsteroidal anti-inflammatory drugs, phenylbutazone, allopurinol, diuretics, probenecid and other substances that reduce tubular secretion: the plasma concentration of ampicillin and sulbactam increases, which leads to their longer persistence in the blood, an increase in the half-life and an increased risk of toxicity;
• oral contraceptives containing estrogen (including ethinyl estradiol): the effectiveness of these drugs decreases, the threat of breakthrough bleeding increases (it is recommended to use additional methods of contraception);
• methotrexate: clearance decreases and the risk of toxicity of this drug is aggravated (due to the influence of penicillins); this combination requires careful monitoring;
• drugs, during the metabolism of which para-aminobenzoic acid is formed: their effect is weakened;
• aminoglycosides (with intramuscular injection): there was a significant mutual inactivation when mixing ampicillin and aminoglycosides (in in vitro studies); with the joint appointment of Ampisid and these funds, it is required to inject them into different parts of the body with a period between injections of at least 60 minutes;
• blood products or protein hydrolysates: Ampisid should not be mixed with these drugs, since they are pharmaceutically incompatible.

Analogs

Analogs of Ampisid are: Sultasin, Libakcil, Sulbacin, Ampicillin + Sulbactam, Unazin, Amoxicillin + Sulbactam, etc.

Terms and conditions of storage

Keep out of the reach of children. Store in a place protected from light and moisture, at a temperature not exceeding 25 ° C. The finished suspension is stored for no more than 14 days at a temperature of 2–8 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ampisis

According to reviews, Ampisid is an effective drug used for the treatment of various infectious diseases, excited by microorganisms sensitive to its action. With the correct selection of the treatment regimen, some patients noted an improvement in their condition already several days after the start of the course.

However, there are also reviews that indicate the weakly expressed therapeutic effect of the antibiotic and the appearance of negative side reactions during its use. There are especially many complaints about a violation of the intestinal microflora, which entails the development of diarrhea, abdominal pain, candidiasis. In such cases, many patients are advised to take prebiotics at the same time. Sometimes they point to the rather high cost of Ampisis.

The price of Ampisid in pharmacies

The reliable price for Ampisid is not known, since the drug is currently not available for sale.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

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