Cetyl Lupine - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline - 83.25 mg or 166.5 mg, sodium lauryl sulfate 4.5 mg or 9 mg, croscarmellose sodium 40 mg or 80 mg, vegetable hydrogenated oil 9 mg or 18 mg, silicon dioxide colloid 1.5 mg or 3 mg.

Sheath: hypromellose (Methocel E15 LVP) 2 mg or 4 mg, hypromellose (Methocel E5 LVP) 6 mg or 12 mg, macrogol 4000 0.65 mg or 1.30 mg, propylene glycol 1.35 mg or 2.70 mg, titanium dioxide 3 mg or 6 mg, talc 1 mg or 2 mg.

Description:

White or almost white, biconvex, film-coated tablets in capsule form, with the inscription "LUPIN" on one side and risk on the other side.

Pharmacotherapeutic group:Antibiotic-cephalosporin.

ATX: & nbsp

J.01.D.C.02 Cefuroxime

Pharmacodynamics:

Cefuroxime axetil is a precursor of cefuroxime, which belongs to the second generation of cephalosporin antibiotics. Cefuroxime is active against a wide range of pathogens, including strains producing β-lactamases. The bactericidal effect of cefuroxime is associated with the suppression of bacterial cell synthesis by binding to the main target proteins. Cefuroxime is usually active in vitro against the following microorganisms:

Gram-negative aerobics:

Haemophilus influenzae (including ampicillin-resistant strains); Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Esherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp, Proteus rettgeri and Neisseria gonorrhoeae (including penicillinase-producing and non-penicillinase-producing strains).

Gram-positive aerobes (except strains resistant to methicillin): Staphylococcus aureus; Streptococcus pneumoniae; Streptococcus pyogenes (and other β-hemolytic streptococci); Streptococcus group B (Streptococcus agalactiac).

Anaerobes:

Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp.

Other microorganisms:

Borrelia burgdorferi

The following microorganisms are insensitive or insensitive to cefuroxime:

Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epiderniidis, Enterococcus (Streptococcus) faecalis, Morganella morganii, Proteus vulgaris, Entcrobacter spp., Serratia spp., Bacteroides fragilis.

Pharmacokinetics:

After oral administration cefuroxime Acetyl is slowly absorbed from the gastrointestinal tract and rapidly hydrolyzes in the mucosa of the small intestine with the release of cefuroxime.Maximum serum concentrations (2-3 mg / L for a dose of 125 mg and 4-6 mg / L for a dose of 250 mg) are observed approximately 2-3 hours after taking the drug. Optimum absorption under condition of taking the drug right after eating. Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Concentrations of cefuroxime exceeding the minimum inhibitory concentrations for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the blood-brain barrier. The drug passes through the placenta and penetrates into breast milk.

Communication with plasma proteins is 33% -50%. Cefuroxime not metabolized, secreted by glomerular filtration and tubular secretion - in adults 50% of the dose - after 12 hours. The half-life period is 1-1.5 hours. If the kidneys T1 / 2 is impaired, it lengthens. Serum cefuroxime levels decrease with dialysis.

Indications:Infection-inflammatory diseases caused by microorganisms sensitive to cefuroxime:

- Infections of the upper respiratory tract, ENT organs (otitis media, sinusitis, tonsillitis and pharyngitis).

- Infections of the lower respiratory tract (pneumonia, acute bronchitis and exacerbation of chronic bronchitis).

- Urinary tract infections (pyelonephritis, cystitis, asymptomatic bacteriuria, urethritis).

- Infections of the skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipelitis).

- Gonorrhea, acute uncomplicated gonorrheal urethritis and cervicitis.

- Borreliosis Lyme (in the early stages and prevention of late stages in adults and children over 12 years old).

Contraindications:Hypersensitivity to cephalosporin antibiotics, penicillins and carbapenems; Children under 3 years old (for this dosage form).

Carefully:With caution should be used for kidney failure, diseases of the gastrointestinal tract (including in the history and with nonspecific ulcerative colitis), pregnancy, lactation, weakened and emaciated patients.

Pregnancy and lactation:

The use of the drug in pregnancy is possible only in those cases when the intended use for the mother exceeds the potential risk to the fetus.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside. For optimal absorption cefuroxime Aksetil should be taken after meals. Adults:

Most infections	250 mg twice daily
Urinary tract infections	125 mg twice daily
Light and moderate infections of the lower respiratory tract, for example, bronchitis	250 mg twice daily
Heavier infections of the lower respiratory tract or if there is a suspicion of pneumonia	500 mg twice a day
Pyelonephritis	250 mg twice daily
Uncomplicated gonorrhea	Single dose 1 g
Lyme borreliosis in adults and children over 12 years of age	500 mg twice a day for 20 days.

Children:

Most infections	125 mg twice a day, up to a maximum of 250 mg per day
Otitis media or more serious infections	250 mg (1 tablet of 250 mg) twice a day to a maximum of 500 mg per day

The standard course of therapy is 5 to 10 days.

Side effects:

Allergic reactions: chills, rash, itching, urticaria, rarely - multiforme exudative erythema (including Stevens-Johnson syndrome), whey, bronchospasm, anaphylactic shock.

From the digestive system: diarrhea, nausea, vomiting, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, rarely - pseudomembranous enterocolitis.

From the central nervous system: convulsions, headache. From the urinary system: a violation of the kidneys, dysuria.

From the genitourinary system: itching in the perineum, vaginitis.

From the sense organs: hearing loss.

From the hematopoiesis: thrombocyte singing, leukopenia, eosinophilia, hemolytic anemia.

Laboratory indicators: increased activity of "hepatic" enzymes, alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia, false-positive Coombs test.

Overdose:

Symptoms: increased excitability of the brain with the development of seizures. Treatment: gastric lavage, the appointment of antiepileptic drugs, control and maintenance of vital body functions, hemodialysis and peritoneal dialysis.

Interaction:Drugs that reduce the acidity of gastric juice can cause a decrease in the bioavailability of the drug and prevent increased absorption associated with food intake. With simultaneous administration with aminoglycosides, diuretics, the risk of nephrotoxic effects increases.

Simultaneous reception with "loop" diuretics slows tubular secretion, reduces renal clearance,increases the concentration in the plasma and increases the half-life of cefuroxime.

Special instructions:

Patients who had a history of allergic reactions to penicillins, may have a hypersensitivity to cephalosporin antibiotics.

In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses.

Treatment continues for 48-72 hours after the disappearance of symptoms, in case of infection caused by Streptococcus pyogenes, treatment course - at least 7-10 days.

During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.

In patients receiving cefuroxime, when determining the concentration of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.

When switching from parenteral to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered. If 72 hours after taking cefuroxime inside, there is no improvement, it is necessary to continue parenteral administration. As with other antibiotics, prolonged administration of cefuroxime may lead to an excessive growth of resistant organisms, which may require discontinuation of treatment.Pseudomembranous colitis was observed with a wide range of antibiotics, so it should be borne in mind the possibility of its occurrence in patients with severe diarrhea that occurred during or after a course of antibiotic treatment.

When appointing patients with Lyme borreliosis, it is possible to develop a bacteriolysis reaction (Jarish-Gerxheimer reaction) (rarely).

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving, and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.

Form release / dosage:

Film coated tablets, 250 mg and 500 mg.

Packaging:

4 tablets in a strip of aluminum foil, laminated with polyethylene. For 1 or 10 strips in a cardboard box together with instructions for use.

10 tablets in a strip of aluminum foil, laminated with polyethylene. 1 strip in a cardboard box together with instructions for use.

10 tablets in a blister of aluminum foil with a film of polymers. 1 blister in a cardboard box along with instructions for use.

Packing for hospitals. 100 tablets in polyethylene bags, followed by a high density polyethylene container, together with instructions for use.

Storage conditions:In dry, the dark place at a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001905/10

Date of registration:12.03.2010

The owner of the registration certificate:Lupine Co., Ltd.Lupine Co., Ltd. India

Manufacturer: & nbsp

LUPIN, Ltd. India

Representation: & nbspLUPIN LIMITEDLUPIN LIMITED

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Cetil Lupine (Cetil Lupine)