Product Name: Principen
Common Brand Names: Omnipen-N; Polycillin-N; Totacillin
Pharmaceutical Category: Antibiotics / Anti-Infectives
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There is an additional general information about this medication active ingredient ampicillin:
Principen is an antibiotic of semisynthetic broad-spectrum penicillin group. This medication has a bactericidal effect by suppressing the synthesis of bacterial cell walls. Principen is active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp., Enterococcus spp., Listeria monocytogenes; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae.
Ampicillin destroyed by penicillinase. This drug is acid-resistant.
After oral administration Principen is well absorbed from the gastrointestinal tract. This medicine is distributed in most organs and tissues; crosses the placental barrier, poorly penetrates the BBB. When inflammation of the meninges, BBB permeability increases dramatically. 30% of ampicillin is metabolized in the liver. This medication is excreted in the urine and bile.
Why is Principen prescribed?
Infectious-inflammatory diseases caused by organisms susceptible to ampicillin: including ear infections, throat, nose, odontogenic infections, bronchopulmonary infections, acute and chronic urinary tract infections, gastrointestinal infections (including salmonella, cholecystitis), gynecological infections, meningitis, endocarditis, septicemia, sepsis, rheumatic fever, erysipelas, scarlet fever, infections of skin and soft tissues.
Dosage and administration
The dosing regimen of Principen is set individually depending on the severity, localization of infection and sensitivity of the pathogen.
For adults for oral administration a single dose of this medication is 250-500 mg, the multiplicity of the reception is 4 times / day. The dose for children weighing up to 20 kg is 12.5-25 mg / kg every 6 hours.
For IV and IM using the single dose for adults is 250-500 mg every 4-6 hours; for children the single dose is 25-50 mg / kg.
The duration of treatment depends on the localization of infection and features of the disease.
The maximum oral daily dose for adults is 4 g, for IM and IV administration - 14 g.
Principen side effects, adverse reactions
Allergic reactions: urticaria, erythema, angioedema, rhinitis, conjunctivitis, rarely - fever, joint pain, eosinophilia, extremely rare - anaphylactic shock.
Digestive system: nausea, vomiting.
The effects caused by chemotherapeutic action: oral candidiasis, vaginal candidiasis, intestinal dysbiosis, colitis caused by Clostridium difficile.
Infectious mononucleosis, lymphatic leukemia, increased sensitivity to ampicillin and other penicillins, abnormal liver function.
Using during pregnancy and breastfeeding
Perhaps the use of Principen during pregnancy if it may be needed. Ampicillin is excreted in breast milk in low concentrations. If necessary to use ampicillin in the lactation period it should be solved the issue of termination of breastfeeding.
Category effects on the fetus by FDA - B.
In the course of treatment with ampicillin there is need the regular control of renal function, liver and peripheral blood picture. Patients with impaired renal function requires correction dosing regimen in accordance with the values of CCr.
When used in high doses in patients with renal insufficiency it may be toxic effects on the CNS.
For using of Principen in patients with bacteremia (sepsis) it can be bacteriolysis reaction (Jarisch-Herxheimer reaction).
Principen drug interactions
Simultaneous administration of Principen with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) there is manifested synergism; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism.
Ampicillin enhances the effect of indirect anticoagulants by inhibiting the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.
Principen decreases the effect of drugs in the process of metabolism which produce PABA.
Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of ampicillin which may be accompanied by an increase in its concentration in blood plasma.
Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of Principen. Ascorbic acid increases the absorption of ampicillin.
Ampicillin decreases the effectiveness of oral contraceptives.
Principen in case of emergency / overdose
Symptoms: the toxic effect on the central nervous system (especially in patients with renal insufficiency), nausea, vomiting, diarrhea, impaired water and electrolyte balance (as a consequence of vomiting and diarrhea).
Treatment: gastric lavage, activated charcoal, saline laxatives, a maintain of water and electrolyte balance, symptomatic therapy. This drug is derived by means of hemodialysis.