Ospen® 1500: composition and pharmaceutical form
One film-coated tablet contains 500,000 IU, 1,000,000 IU or 1,500,000 IU of phenoxymethylpenicillin as the potassium salt. The range also includes a suspension: one 5 ml measuring spoon contains 400,000 IU or 750,000 IU of lecithinated benzathine phenoxymethylpenicillin — this form is intended primarily for children.
Doses here are counted in international units rather than milligrams, and that is worth keeping in mind when reading the prescription. The tablet is swallowed whole with a glass of water an hour before a meal, and the daily dose is best divided into 2-3 intakes.
How Ospen® 1500 works
Phenoxymethylpenicillin is an oral penicillin with pronounced antibacterial activity. It acts bactericidally on susceptible multiplying microorganisms by inhibiting cell wall synthesis. Its spectrum matches that of benzylpenicillin and covers streptococci of groups A, C, G, H, L and M, Streptococcus pneumoniae, non-penicillinase-producing staphylococci and neisseriae, as well as Erysipelothrix rhusiopathiae, listeria, corynebacteria, Bacillus anthracis, actinomycetes, streptobacilli, Pasteurella multocida, Spirillum minus, spirochaetes and other spiral organisms — leptospira, treponema, borrelia — and many susceptible anaerobes, for example peptococci, peptostreptococci, clostridia and fusobacteria.
One practically important property: phenoxymethylpenicillin is not destroyed by gastric juice. It is absorbed rapidly, peak plasma and tissue concentrations are reached 30-60 minutes after intake, the plasma half-life is 60-80 minutes, and about 55% of the dose binds to plasma proteins. The substance passes readily into the kidneys, lungs, liver and skin.
Indications
The medicine is used in mild and moderate infections caused by penicillin-susceptible microorganisms. These are ear, nose and throat infections, including streptococcal ones: scarlet fever, pharyngitis, tonsillopharyngitis, purulent inflammation of the nasal and pharyngeal mucosa, sinusitis, acute otitis media, Vincent's angina. Next come respiratory tract infections: bacterial bronchitis, bacterial pneumonia and bronchopneumonia as a continuation of treatment with parenteral preparations. The third group is skin and soft tissue infections: erysipelas, erysipeloid, purulent skin lesions such as impetigo and furunculosis, abscesses and phlegmon. A separate indication is the prophylaxis of rheumatic fever.
It also matters in which conditions the oral form is unsuitable: in severe pneumonia, pleural empyema, sepsis, pericarditis, endocarditis, meningitis, arthritis and osteomyelitis in the acute phase, penicillin is given parenterally.
Method of use and dosage
Daily doses in children are 50,000-100,000 IU per kilogram of body weight, and going below 25,000 IU per kilogram per day is not allowed. Children over 6 years of age are usually prescribed 1-1.5 million IU per day. Adults and adolescents are generally given 3-4.5 million IU per day: adolescents and children weighing more than 40 kg and adults weighing less than 60 kg receive 3 million IU per day, that is 1 million IU three times a day every 8 hours; adults, including patients with obesity, elderly people and pregnant women, receive 4.5 million IU per day, that is 1.5 million IU every 8 hours. If necessary the daily dose is increased: adults tolerate up to 6 million IU per day well.
Treatment duration is a separate topic, and two rules apply here. First: intake continues for another 3 days after symptoms disappear. Second: in streptococcal infections the course must last at least 10 days — this is needed to prevent complications. For the prophylaxis of rheumatic fever adults receive no less than 1 million IU per day, while children are given the suspension.
| Patient group | Daily dose |
|---|---|
| Children | 50,000-100,000 IU/kg, not below 25,000 IU/kg |
| Children over 6 years | 1-1.5 million IU |
| Body weight above 40 kg in adolescents and adults up to 60 kg | 3 million IU, 1 million IU every 8 hours |
| Adults, including elderly people and pregnant women | 4.5 million IU, 1.5 million IU every 8 hours |
| If necessary | up to 6 million IU per day is well tolerated |
| Duration | another 3 days after symptoms disappear; at least 10 days in streptococcal infection |
Contraindications
The first contraindication is established hypersensitivity to penicillin, sorbitol or preservatives, that is an allergy to the «para group». In patients hypersensitive to cephalosporins the possibility of cross-allergy must be taken into account.
The second contraindication is not obvious and relates not to allergy but to absorption: oral penicillin is not prescribed in gastrointestinal disorders causing persistent diarrhoea or vomiting, because the medicine simply will not be absorbed. Particular caution is needed in patients with food allergy or bronchial asthma.
Special warnings and precautions
The key point is allergy. Before starting treatment it is important to find out whether the patient has had reactions to penicillins, cephalosporins or other allergens; with food allergy and bronchial asthma the risk is higher. Severe allergic reactions require immediate help, and if they appear the medicine is discontinued.
The second point is the correct duration. A course that is too short in a streptococcal infection does not prevent complications, so the minimum 10 days are observed even if the throat stopped hurting on the third day. As with any antibiotic therapy, overgrowth of non-susceptible microorganisms including fungi is possible, and if severe or prolonged diarrhoea appears one should remember pseudomembranous colitis and see a doctor.
Drug interactions
Bacteriostatic antibiotics — tetracyclines, chloramphenicol, macrolides and sulfonamides — may weaken the bactericidal action of penicillin, so such combinations are not prescribed without strong reasons. Probenecid, on the contrary, slows the renal elimination of penicillin and raises its blood concentration.
Separately, the effect on absorption is worth remembering. The medicine is taken an hour before a meal precisely because food reduces its uptake, while persistent vomiting or diarrhoea makes the oral form ineffective. When several medicines are taken at once it is worth asking the doctor whether they interfere with each other in terms of timing.
| Group | What happens |
|---|---|
| Bacteriostatic antibiotics | possible weakening of the bactericidal action of penicillin |
| Probenecid | slower elimination of penicillin and a rise in its concentration |
| Food | reduces absorption, hence intake an hour before a meal |
| Persistent vomiting and diarrhoea | the oral form is not absorbed, another approach is needed |
Pregnancy and breastfeeding
Penicillins are among the antibiotics with the widest experience of use in pregnancy, and the product information mentions pregnant women explicitly in the dosing scheme: like other adults, they receive 4.5 million IU per day. Even so, the decision on treatment is made by the doctor, who weighs the need for an antibiotic.
Phenoxymethylpenicillin passes into breast milk in small amounts. This usually does not prevent breastfeeding, but the child may have changes in stool or a rash, which should be reported to the doctor. As in other cases, self-treatment with an antibiotic during these periods is unacceptable.
Adverse effects
The most common are digestive tract reactions — nausea, vomiting, diarrhoea — and allergic manifestations: rash, urticaria, itching. Severe reactions, including anaphylactic ones, are rare but require immediate help.
| Group | Manifestations |
|---|---|
| Digestive tract | nausea, vomiting, diarrhoea, abdominal pain, inflammation of the oral mucosa and tongue |
| Allergic reactions | rash, urticaria, itching, oedema, rarely anaphylactic reactions |
| Blood | eosinophilia, rarely changes in leucocyte and platelet counts |
| Infections | overgrowth of non-susceptible bacteria and fungi, pseudomembranous colitis |
Overdose
Overdose of phenoxymethylpenicillin usually shows itself as intensified gastrointestinal symptoms: nausea, vomiting and diarrhoea. Penicillins have a wide therapeutic range, so serious consequences after a single excess dose are unlikely.
There is no specific antidote; treatment is symptomatic with fluid replacement in case of vomiting and diarrhoea. If a very large amount of the medicine has been taken, especially by a child, medical help should be sought rather than waiting for the symptoms to pass on their own.
How to get a prescription for Ospen® 1500 online
Ospen® 1500 is a prescription-only medicine, and the electronic prescription is issued by a doctor after assessing the patient's condition. On the e-zdrowie.com service you fill in a questionnaire: patient details, age and body weight, the nature and duration of symptoms, results of any tests performed, including a rapid test or culture if streptococcal tonsillitis is suspected, allergy to penicillins and cephalosporins, concomitant diseases and all medicines being taken.
The doctor reviews the questionnaire and makes a decision; if data are missing they ask follow-up questions or suggest an in-person consultation — prescribing an antibiotic without confirming the bacterial nature of the infection is undesirable. After it is issued, a four-digit code arrives by SMS and email, and with it and the PESEL number the medicine will be dispensed in any Polish pharmacy. And the main rule of the course: in a streptococcal infection it is carried through to the end — at least 10 days — even if you feel well sooner.
