Rotacef (ceftriaxone) powder for solution for injections 1g. vial №1 + solvent 3.5 ml.

Description

Rotacef (ceftriaxone) powder for solution for injections 1g. vial №1 + solvent 3.5 ml.

Composition

active substance: ceftriaxone;

1 vial contains ceftriaxone (in the form of ceftriaxone sodium) 0.5 g or 1 g;

1 ampoule of solvent contains a solution of lidocaine hydrochloride 1% (lidocaine hydrochloride, sodium hydroxide, water for injections), or 1 ampoule of solvent contains water for injections.

Medicinal form

Powder for solution for injection.

Main physicochemical properties: crystalline powder, partially hygroscopic, almost white or yellowish in color.

• Solvent (1% solution of lidocaine hydrochloride): colorless, transparent, odorless solution.
• Solvent (water for injections): colorless transparent solution.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Other β-lactam antibiotics. Cephalosporins of the III generation. Ceftriaxone.
ATX code J01D D04.

Pharmacological properties

An antibacterial drug for systemic use, the main active ingredient is sodium ceftriaxone. It belongs to the group of beta-lactam antibiotics, being a third generation cephalosporin. It has a prolonged action, it is used exclusively parenterally (bypassing the gastrointestinal tract).

Indications

It is used to treat infections, the causative agents of which are sensitive to ceftriaxone. In particular for the treatment of infections:

• respiratory tract, including inflammation of the lungs, throat, nose, including pneumonia;
• ears (otitis media in acute form);
• organs of the abdominal cavity;
• kidney and urinary tract;
• genitals, including gonorrhea, syphilis;
• bones of soft tissues, wound infections;
• in patients with weakened immunity;
• with meningitis, sepsis, disseminated Lyme borreliosis (II and III stages).

It is used as a preoperative prophylaxis of infections during surgery.
When prescribing ceftriaxone, official guidelines for the prevention of antibiotic resistance should be followed.
Mycoplasma, mycobacteria and chlamydia are resistant to cephalosporins.
The active ingredient of the drug – ceftriaxone – is a parenteral cephalosporin antibiotic of the third generation, which has a prolonged effect.
The bactericidal activity of this drug is due to its ability to inhibit the synthesis of cell membranes, which leads to the lysis of the baterial cell and its death. Activity is manifested against the majority of gram-negative and gram-positive microorganisms.
In addition, ceftriaxone is highly resistant to most beta-lactamases.

Contraindications

It is not used for allergies to cephalosporins or the drug used to prepare the solution. If the patient is allergic to penicillins, monobactams and carbapenems, the likelihood of a cross-reaction of hypersensitivity to ceftriaxone should be considered.
They are also not used for the treatment of premature babies (up to 41 weeks), as well as for hyperbilirubinemia of newborns and premature babies.
Incompatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Contraindicated in the presence of jaundice, acidosis.
The use of this drug in combination with calcium-containing solutions is strictly contraindicated. It is also forbidden to use solutions containing calcium for 48 hours after the administration of ceftriaxone due to the high risk of precipitation of the calcium salt of ceftriaxone.

Application during pregnancy and lactation

There is no data on its safety during pregnancy, therefore, it is prescribed only in case of vital necessity, especially in the first trimester.
Ceftriaxone has the ability to cross the placenta, therefore, if necessary, breastfeeding should be suspended.

Method of administration and dosage

The drug is used parenterally, in the form of intramuscular, intravenous injections or infusions. Do not mix in the same syringe / vial with other medicines.
The average dosage for adults and children over 12 years of age is 1-2 grams of ceftriaxone. It is usually entered once a day. The maximum daily dose is 4 grams.
In severe infections or with poor sensitivity to ceftriaxone, the daily dose may be increased to 2-4 grams (in neutropenia with fever, in the case of bacterial infection, bacterial endocarditis or meningitis). The duration of treatment is from 1 day with gonorrhea to 21 days with aggravated infections (in particular, with disseminated Lyme borreliosis). The exact dosage, route of administration and duration of treatment are determined by the doctor, depending on the severity of the disease and the characteristics of the patient’s body condition.
Preparation of an injection for intramuscular administration: Dissolve 1 g of ceftriaxone in 3.5 ml of lidocaine solution (1%).
Preparation of intravenous injection: dissolve 1 gram of the drug in 10 ml of water for injection. The introduction is slow, for 4-5 minutes.
Preparation of a solution for intravenous drip infusion: Dissolve 2 grams of Rotacef in 40 ml of one of the drugs:

• 0.9% sodium chloride;
• 0.45% sodium chloride + 2.5% glucose;
• 5% glucose;
• 10% glucose;
• 6% dextran in 5% glucose solution;
• 10% hydroxyethylated starch.

When prescribed for the treatment of children, the recommended dosage is:

• newborns up to 2 weeks – at the rate of 20 to 50 mg per 1 kg of weight (administration lasts at least 60 minutes);
• children from 15 days to 12 years old – at the rate of 20 to 80 mg per 1 kg of weight.

In severe cases, 80 mg is prescribed per 1 kg of body weight. Children weighing more than 50 kg receive the dosage per adult patient.
Doses from 50 mg per 1 kg and more are administered for at least 30 minutes. The maximum dosage is 80 mg per 1 kg of patient weight. The only exception is the treatment of meningitis in children under the age of 12, when a dosage of 100 mg per 1 kg of body weight is prescribed.
Elderly patients, as well as with impaired renal and liver function, dosage adjustment is not required if their functions remain normal.

Overdose

Overdose can cause nausea, vomiting, diarrhea (diarrhea). Symptomatic treatment is prescribed.
The use of hemodialysis and peritoneal dialysis is ineffective. No antidote has been identified.

Side effects

Patients generally tolerate ceftriaxone well. However, reactions such as:

• fungal infections;
• eosinophilia, leukopenia, hemolytic anemia, thrombocytopenia, prothrombin time may increase;
• diarrhea, nausea, vomiting, stomatitis, pancreatitis, bile stasis;
• precipitates of calcium salt of ceftriaxone in the gallbladder;
• rash, itching, hives, swelling;
• oliguria, hematuria, formation of kidney stones;
• headache, fever, anaphylaxis reactions.

In rare cases, inflammation of the walls of the veins (phlebitis) was observed, so the drug is administered slowly. For anesthesia, dilution with lidocaine is recommended (only for intramuscular administration).