Ospen – indications, contraindications, composition, side effects

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Ospen is a prescription penicillin antibiotic intended for oral use. The drug is used in the case of bacterial infections, especially infections involving the respiratory tract, throat, nose, ears, skin and soft tissues. Ospen 1000 and Ospen 1500 are two variants of this antibiotic in the form of film-coated tablets. When to use Ospen and what side effects may occur?

Ospen – what is this drug?

Ospen is an antibiotic with a strong antibacterial effect. This medicine contains phenoxymethylpenicillin, a penicillin used to treat, inter alia, infections with streptococci A, C, G, H, L, M, part of staphylococci and anaerobic bacteria, pneumonia and some strains of enterococci. It works by inhibiting cell wall synthesis, which results in a bactericidal effect on reproducing microorganisms.

Ospen – indications

The use of Ospen is recommended for infections estimated to be mild to moderate in severityif the pathogen responsible for their development is sensitive to penicillin. The indications for the use of the antibiotic are:

  1. prevention of rheumatic fever;
  2. the treatment of skin and soft tissue infections including abscess, phlegmon, erysipelas, erysipelas, and purulent dermatitis such as furunculosis or impetigo;
  3. leczenie throat, nose and ear infectionsincluding pharyngitis or pharyngitis and tonsillitis, acute otitis media, sinusitis, Vincent’s angina, scarlet fever, and nasopharyngitis;
  4. leczenie respiratory tract infections – bacterial lung or bronchial infections, bronchopneumonia.

important

If a patient is diagnosed with an acute phase of infection (e.g. sepsis, pericarditis or endocarditis, osteomyelitis), your doctor may recommend parenteral penicillin administration.

Ospen – contraindications

Ospen should not be used if the patient is allergic to penicillin or any of the other ingredients. Another contraindication is an allergy to cephalosporins which have caused swelling (in the neck, face or body), rash or difficulty breathing when used in the past. Ospen is also not suitable for people with gastrointestinal problems accompanied by persistent diarrhea and vomiting.

Ospen – warnings

The use of the antibiotic Ospen should take place on the recommendation of a doctor, and also after prior discussion of issues such as:

  1. the patient is allergic to drugs, especially from the group of penicillins and cephalosporins;
  2. previous or ongoing bronchial asthma or severe allergic reactions;
  3. renal dysfunction – it may be necessary to monitor renal function and adjust the dosage of the antibiotic accordingly;
  4. infectious mononucleosis in a patient – promotes the appearance of a rash on the skin;
  5. severe diarrhea after using antibacterial drugs in the past;
  6. complaints such as diarrhea, nausea or vomiting, as well as diagnosed disorders related to excessive intestinal motility or achalasia of the esophagus;
  7. treatment of relapses of rheumatic fever with Ospen – if the patient is to undergo surgery, the dosage of the preparation should be changed accordingly;
  8. scheduled vaccination for typhoid fever.

Attention

If severe and persistent diarrhea occurs during or after treatment with Ospen, do not use medications that inhibit intestinal peristalsis. In such a situation, patients are advised to consult a physician.

Before starting treatment with Ospen, inform your doctor about any medications you are taking, in particular antibacterial, anticoagulant, anti-rheumatic drugs, fever and inflammatory drugs, and about taking methotrexate, sulfinpyrazone or probenecid.

Ospen 1000 and 1500 – composition

The active substance in Ospen is antibiotic in the form of fenoksymetylopenicyliny potasowej. Depending on the product selected, one tablet may contain 1 million units (654 g) or 1,5 million units (981 mg) of the active substance.

Ospen contains excipients – talc, povidone, maltodextrin, magnesium stearate and macrogol 6000. Additionally, the tablet coating includes titanium dioxide, hypromellose, titanium dioxide, talc, sodium saccharin and peppermint oil.

Ospen – method of administration

The antibiotic Ospen should be taken 1 hour before a meal in the doses prescribed by your doctor. The specialist also determines the duration of use of the preparation. The dosage of the drug depends on the patient’s age and the ailments being treated:

  1. in adults, pregnant women, the elderly or obese – 1 tablet of Ospen 1500 three times a day (a total of 4,5 million units a day), every 8 hours;
  2. in adults weighing less than 60 kg, as well as children and adolescents weighing more than 40 kg – 1 tablet of Ospen 1000 three times a day (a total of 3 million units a day), every 8 hours;
  3. in children older than 6 years – between 1 and 1,5 million units per day, according to the doctor’s guidelines;
  4. in the prevention of rheumatic fever – 1 million units daily in adults; for children, the Ospen suspension is used.

important

The duration of treatment with Ospen is determined by the doctor. General recommendations are to use the preparation for 3 days after symptoms disappear. In the case of streptococcal infections, antibiotics are usually taken for a minimum of 10 days.

Ospen – overdose

Follow the dosage of Ospen prescribed by your doctor. In case of overdose, gastrointestinal symptoms (e.g. diarrhea, vomiting, abdominal pain), disturbance of the fluid and electrolyte balance, rarely convulsions may occur. Symptoms other than those mentioned may be associated with an allergic reaction.

Ospen – side effects

Taking the antibiotic Ospen can cause side effects in some people. Swelling of the lips, face, throat or other parts of the body, problems with breathing or swallowing, hives are particularly dangerous and require immediate medical or hospital admission.

Other side effects of Ospen include common nausea, diarrhea, abdominal pain, allergic skin reactions, hives and inflammation of the mouth. Neuropathies, paraesthesia, convulsions, nephropathies and sensory disturbances are uncommon. Rare and very rare symptoms include severe allergic reactions, angioedema, anaphylaxis, exfoliative dermatitis, black hairy tongue or changes in blood tests (e.g. leukopenia, neutropenia, agranulocytosis).

Detailed information about possible side effects of Ospen is included in the product leaflet.

Ospen 750 – an antibiotic in the form of an oral suspension

In addition to the tablets Ospen 1000 and Ospen 1500 is also available Ospen 750 oral suspension containing 750 thousand. units in 5 ml of liquid. The composition of the suspension and the method of its dosing are different.

W the composition of the preparation Ospen 750 enter:

  1. active substance – phenoxymethylpenicillin benzathine lecithinated in the amount of 750 thousand. units per 5 ml of solution;
  2. the following substances – water, sorbitol, simethicone, sodium saccharin, citric acid monohydrate, propyl parahydroxybenzoate, methyl parahydroxybenzoate, yellow iron oxide, sodium carmellose, magnesium aluminum silicate, sodium citrate dihydrate and Tutti Frutti flavor.

The dosage of Ospen 750 is determined by the doctor, taking into account the age and weight of the child in the case of children.

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Active substance

Phenoxymethylpenicillin* (Phenoxymethylpenicillin*)

ATX

J01CE02 Phenoxymethylpenicillin

Pharmacological group

Penicillins

Nosological classification (ICD-10)

List of ICD-10 codes

Composition and form of release

1 tablet contains phenoxymethylpenicillin (as potassium salt) 250 mg; in a cardboard box 50 blisters of 20 pcs.

1 coated tablet – 500,000, 1,000,000 and 1,500,000 IU; in a box of 100 blisters of 10 pcs. or 2 blisters of 6 pcs. (respectively).

5 ml (1 scoop) granules for oral suspension – benzathine phenoxymethylpenicillin 400,000 IU / 5 ml (corresponding to 250 mg phenoxymethylpenicillin); in bottles with a capacity of 60 ml, complete with a measuring spoon, in a box 1 set.

5 ml syrup – benzathine phenoxymethylpenicillin 400,000 or 750,000 IU; in bottles with a capacity of 60 ml, complete with a measuring spoon, in a box 1 set.

Pharmachologic effect

Pharmacological action – antibacterial .

Suppresses the biosynthesis of the bacterial cell wall.

Suppresses the biosynthesis of the bacterial cell wall.

Pharmacodynamics

Active against streptococci of groups A, C, G, H, L, M, Streptococcus pneumoniae, staphylococci that do not produce penicillinase, Neisseriae, Erysipelothrix rhusiopathiae, Listeriae, Corynebacterium, Bacillus anthracis, actinomycetes, streptobacilli, Pasteurella multocida, Spirillum minus, spirochetes ( Leptospira, Treponema, Borrelia, etc.), anaerobes (Peptococci, Peptostreptococci, Fusobacteria, Clostridia). Among enterococci (group D streptococci), sensitivity is noted only among some strains.

Pharmacokinetics

Well absorbed, not inactivated by gastric juice. Cmax , providing a therapeutic effect, is achieved after 30-60 minutes, T 1/2 –  30-45 minutes. 55% binds to plasma proteins. Easily penetrates into tissues (kidneys, lungs, skin, mucous membranes, muscles, etc.). It is excreted by the kidneys in unchanged form, a small part of the active ingredient is excreted in the bile. Passes through the placental barrier and penetrates into breast milk.

Indications

Infections of the respiratory tract (bronchitis, pneumonia), ENT organs (scarlet fever, tonsillitis, Vincent’s tonsillitis, pharyngitis, tonsillopharyngitis, purulent pharyngitis, acute otitis media, sinusitis), skin (erysipelas, pyoderma, including contagious impetigo, furunculosis, abscess, phlegmon, chronic migratory erythema and other clinical signs of Lyme disease, infected wounds and burns); prevention of streptococcal infections and their complications (rheumatic attack, polyarthritis, endocarditis, glomerulonephritis, etc.), bacterial endocarditis in patients with congenital or acquired rheumatic heart disease before and after minor surgical interventions, pneumococcal infections in children with sickle cell anemia.

Contraindications

Hypersensitivity to beta-lactam antibiotics or to the excipients that make up the drug, gastrointestinal diseases , accompanied by persistent diarrhea and vomiting.

Use during pregnancy and lactation

Perhaps if the expected effect of therapy outweighs the potential risk to the fetus or newborn.

Dosage and administration

Inside, 30 minutes before meals, adults 500 mg (for mild to moderate infections), 750 mg (for severe) 3-4 times a day for 7-10 days. Children from 1 to 6 years old – 250 mg 3 times a day, 6-12 years old – 500 mg 3 times a day.

Ospen 750 syrup: children 1-6 years old (10-22 kg) – 1/2 scoop 3 times a day, 6-12 years old (22-38 kg) – 1 scoop 3 times a day, adolescents and adults – 2 measuring spoons 3 times a day; if necessary, increase the dose. The daily dose for adults and children over 12 years old is 3-4.5 million IU, for children from 1 to 12 years old – 50,000-100,000 IU / kg (in 2-3 doses). The minimum pediatric dose is 25,000 IU/kg, the maximum adult dose is 6 million IU.

Treatment is continued for 3 days after the symptoms disappear, to prevent complications in patients with streptococcal infections, the duration of the course is at least 10 days.

Side effects

On the part of the digestive tract: nausea, diarrhea, vomiting, feeling of stomach fullness, stomatitis, glossitis, pseudomembranous colitis.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): hemolytic anemia, leuko-, thrombocytopenia, agranulocytosis, eosinophilia, positive direct Coombs test.

Allergic reactions: urticaria, angioedema, erythema multiforme, exfoliative dermatitis, anaphylactic shock, collapse and other anaphylactoid reactions.

Other: fever, joint pain.

Interaction

When combined with allopurinol, phenylbutazone, NSAIDs , calcium secretion decreases and the concentration of phenoxymethylpenicillin increases. Increases the effectiveness of anticoagulants by suppressing the intestinal microflora and lowering the prothrombin index, weakens the effect of oral contraceptives taken. Incompatible with bacteriostatic antibiotics. With the simultaneous administration of ethinylestradiol and drugs, during the metabolism of which PABA is formed , there is a risk of breakthrough bleeding. Simultaneous use of allopurinol increases the risk of developing allergic reactions. Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid – increases.

Precautionary measures

With the development of allergic reactions in patients, the drug should be discontinued. In case of suspected staphylococcal infections, bacteriological studies are recommended. Before carrying out planned surgical interventions (tonsillectomy, tooth extraction, etc.), in the postoperative period in patients receiving penicillin for the purpose of antirheumatic prophylaxis, it is necessary to double the dose. During therapy, it is recommended to monitor the composition of the blood, liver and / or kidney function. With long-term treatment, the potential for the growth of resistant strains of microorganisms, fungi and pseudomembranous colitis should be borne in mind (the drug should be discontinued and, based on the results of bacteriological examination, appropriate treatment should be prescribed; antiperistaltic drugs are contraindicated). In patients with known hypersensitivity to cephalosporins, a possible cross-allergy should be borne in mind. In severe pneumonia, empyema, sepsis, pericarditis, meningitis, arthritis and osteomyelitis, in the acute stage, a transition to parenteral administration of the drug is necessary. In combination with other antibiotics with a proven synergistic effect, the dose of a more toxic drug may be reduced. In patients with anuria, the dose should be reduced or the interval between doses of the drug should be increased. Caution should be given to patients with allergic diathesis, bronchial asthma. In combination with other antibiotics with a proven synergistic effect, the dose of a more toxic drug may be reduced. In patients with anuria, the dose should be reduced or the interval between doses of the drug should be increased. Caution should be given to patients with allergic diathesis, bronchial asthma. In combination with other antibiotics with a proven synergistic effect, the dose of a more toxic drug may be reduced. In patients with anuria, the dose should be reduced or the interval between doses of the drug should be increased. Caution should be given to patients with allergic diathesis, bronchial asthma.

Special instructions

Patients with diabetes should take into account that synthetic saccharin is used in the manufacture of Ospen 750 syrup. During therapy, a false positive reaction is possible with a non-enzymatic determination of sugar in the urine and analysis for urobilinogen, as well as false positive results for the quantitative determination of amino acids in the urine by the ninhydrin method.

Storage conditions

granules for suspension for oral administration 400,000 IU/5 ml vial; coated tablets 1500000 IU blister, 1000000 IU blister; tablets 250 mg blister – In a dry, dark place, at a temperature below 25 ° C. syrup 400,000 IU / 5 ml bottle – In a dry, dark place, at a temperature below 15 ° C.
Keep out of the reach of children.

Best before date

granules for the preparation of a suspension for oral administration 400,000 IU / 5 ml vial – 3 years. coated tablets 1500000 IU blister, 1000000 IU blister – 4 years. tablets 250 mg blister – 5 years. syrup 400,000 IU / 5 ml bottle – 2 years.
Do not use after the expiry date stated on the packaging.

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.

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