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Cefotaxim 1 g. 10 vials

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What is Cefotaxime and what is it used for
Cefotaxime is an antibiotic, i.e. medicine used to treat bacterial infections of:

the lungs (pneumonia);
skin and soft tissues;
urinary tract;
genitals (including gonorrhea);
heart valves (endocarditis);
membranes covering the cerebral cortex (meningitis);
abdomen;
blood (so-called "bacteremia").
In addition, cefotaxime is used to treat Lyme disease (borreliosis, which is an infection caused mainly by tick bites, ie recurrent fever). Cefotaxime can also be used before and during surgery to prevent possible infections.

2. What you need to know before using Cefotaxime
Do not take Cefotaxime if:

you are allergic to cefotaxime or other cephalosporins;
have you ever had a severe allergic reaction [a hypersensitivity reaction to other beta-lactam antibiotics (penicillins, monobactam and carbapenems).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cefotaxime-MIP:

if you have allergic reactions. If you have had an allergic reaction to other antibiotics such as penicillin, you may also be allergic to Cefotaxime-MIP. If an allergic reaction occurs, treatment should be discontinued;
if you suffer from severe, persistent diarrhea during or after treatment with Cefotaxime. In this case, contact your doctor immediately. Do not take diarrhea without consulting your doctor;
if you have a generalized rash with blisters and flaky skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis);
if you have kidney problems;
for example, if you have a disability, abnormal movement and cramps after you have started taking this medicine;
if you are on a low-salt diet, you should consider the sodium content of this product.
If any of these apply to you, your doctor may want to change your treatment or give you specific advice.

If you are given this medicine for a longer period, your doctor should examine your blood for possible changes. In this case, the overgrowth of cefotaxime-resistant bacteria should also be monitored regularly.

Other medicines Cefotaxime
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Simultaneous intake or use of:

other antibiotics, such as penicillin or aminoglycosides;
medicines that cause more frequent urination (diuretics, eg furosemide);
probenecid (a medicine for the treatment of joint diseases (arthritis) and gout);
may enhance or weaken the action of Cefotaxime. Tell your doctor if you are currently being treated with these medicines.

Cefotaxime may reduce the effectiveness of birth control pills. Women should use additional contraceptive methods during treatment and one month after cefotaxime therapy.
As with other antibiotics, the result of the Coombs test may be positive, ie. have a false positive reaction for glucose in the urine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will prescribe you cefotaxime during pregnancy only after weighing the benefits and risks of it. Cefotaxime passes into breast milk in small amounts. Therefore, it should not be used during lactation.

Driving and using machines
Cefotaxime has no or negligible influence on the ability to drive and use machines.

Cefotaxime contains sodium
This medicine contains 48 mg (or 2.1 mmol) of sodium per 1000 mg dose and 96 mg (or 4.2 mol) of sodium per 2000 mg dose. Take this into consideration if you are on a salt-free diet.

3. How to take Cefotaxime-MIR
Application method
Cefotaxime-MIP is always administered by healthcare professionals. This medicine is first dissolved in sterile water or other suitable solvent. The solution can be given as an injection or through a catheter (infusion) into a vein, for some infections it can also be injected into the muscle.

Dosage
Adults and adolescents over 12 years
The usual dose ranges from 2 to 6 grams of cefotaxime daily. The daily dose should be divided into two single doses every 12 hours. The dose may vary depending on the severity of the infection and your condition:

Common infections caused by (or suspected of) susceptible bacteria: 1 g every 12 hours (ie total daily dose of 2 g);
Infections caused by (or suspected of) several sensitive or moderately sensitive bacteria: 1 - 2 grams every 12 hours (ie a total daily dose of 2 - 4 g);
Severe or non-localizable infections: 2-3 grams as a single dose every 6 to 8 hours (ie maximum
Other special recommendations
Gonorrhea
For the treatment of gonorrhea, a single dose of 0.5-1 g of cefotaxime is injected intramuscularly or intravenously.

Bacterial meningitis

Adults: daily dose of 9 to 12 grams of cefotaxime divided into two equal doses every 6 to 8 hours;
Children: daily dose of 150 to 200 mg per kilogram body weight divided into two equal doses every 6 to 8 hours;
Newborns: Babies 0-7 days receive 50 mg per kg body weight every 12 hours, Babies 7- 28 days receive 50 mg per kg body weight every 8 hours.
Prevention of infections (perioperative prophylaxis)
Apply 1 to 2 grams of cefotaxime before surgery to prevent possible infections. If the surgery lasts longer than 90 minutes, an additional dose can be given preventively.

Abdominal infections
A combination of cefotaxime and an antibiotic active against anaerobic bacteria is administered.

Duration of treatment
The duration of your treatment depends on the severity of the infection as well as your recovery from the disease. Generally, the medicine should be given to you at least 2 to 3 days after you have started to recover from your illness. Treatment for at least 10 days is required for infections caused by Streptococcus pyogenes.

If you take more Cefotaxime than you should
Tell your doctor or nurse if you think you have taken more Cefotaxime-MIP than you should.

If you forget to take Cefotaxime
Please contact your doctor immediately. Do not take a double dose to make up for a forgotten dose. The missed dose should only be given if the time to the next regular dose is long enough.

If you stop taking Cefotaxime
Low dosage, misuse, or discontinuation too soon may compromise treatment results or lead to more relapsing treatment. Please follow your doctor's instructions.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to look out for
Few patients who use Cefotaxime have an allergic reaction, potentially serious skin reactions or other side effects requiring additional treatment. Symptoms of such reactions include:

Severe allergic reaction. Signs include a rash and itchy rash, swelling, sometimes on the face or mouth, which causes shortness of breath;
Generalized rash with blisters and flaking of the skin. (These may be signs of Stevens-Johnson syndrome, or toxic epidermal necrolysis);
Severe, persistent diarrhea during or after treatment with this medicine (pseudomembranous colitis);
Superinfection: In rare cases, Cefotaxime mud medicines can cause yeast overgrowth in the body, which can lead to fungal infections. This side effect is more likely if you use Cefotaxime for a long time.
Very common side effects that occur in up to 1 in 10 patients treated:

Pain at the injection site after administration to the muscle.
Uncommon side effects seen in 1 to 10 in 1000 patients treated:

Spasms, fever;
Diarrhea;
Skin redness, hives (hives), itching (pruritus);
Decrease or increase in the number of some blood cells (eosinophilia, leukopenia, thrombocytopenia);
Increase in substances (enzymes) produced by the liver;
Temporary "healing crisis" with sudden fever and shaking (Jarisch-Herxheimer reactions);
Kidney problems and increased levels of creatinine in the blood;
Pain at the site of injection, swelling and redness in the vein.
Other side effects with unknown frequency:

Headache, dizziness, blurred consciousness or difficult thinking;
Uneven heart rate after rapid drug injection;
Skin rash that may develop with bladder (erythema multiformae);
Nausea, vomiting, abdominal pain;
Inflammation of the liver (hepatitis), sometimes with yellowing of the skin or whites of the eyes (jaundice);
Changes in the number of blood cells (agranulocytosis, neutropenia), red blood cells are destroyed too quickly (hemolytic anemia);
Adverse reactions may occur as a result of the use of painkillers when administering this medicine to the muscle.
5. How to store Cefotaxime
Store below 25 ° C. Keep the vial in the outer carton in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and the carton after the abbreviation used to indicate the expiry date. The expiry date refers to the last day of that month.
Method of administration:
Intravenous infusion
1 g of cefotaxime is dissolved in 40-50 ml of water for injection or other compatible liquid (eg 5% glucose or sodium chloride saline). After reconstitution, the solution should be administered as a 20 minute intravenous infusion.
Dissolve 2 g of cefotaxime in 100 ml of water for injection or other suitable liquid (eg 5% glucose or sodium chloride saline). After preparation, the solution can be administered as a 50-60 minute intravenous infusion.

Intravenous injection
For intravenous injection, 1 g of cefotaxime is dissolved in 4 ml of water for injections, 2 g of cefotaxime is dissolved in 10 ml of water for injections and is injected for 3-5 minutes.

Muscle injection
Intramuscular administration is limited to clinical emergencies (eg, gonorrhea) that need to be evaluated for benefit-risk. It is recommended that no more than 4 ml be injected unilaterally. If the daily dose exceeds 2 g of cefotaxime, or cefotaxime should be injected more than twice daily, intravenous administration is recommended.
For intramuscular administration, 1 g of cefotaxime is dissolved in 4 ml of water for injection. To prevent pain from injection, a 1% lidocaine hydrochloride solution may be used as an alternative (adult only). The solution should be administered by deep intramuscular injection. The lidocaine solution should not be administered intravenously. Information on the selected product containing lidocaine should be taken into account.
Intramuscular injection is not recommended for severe infections.

Compatibility with intravenous fluids
The following solvents are suitable for solution preparation: water for injections, 5% glucose solution, and sodium chloride saline.
As with all parenteral medicinal products, check the reconstituted solution for visible particles and discoloration prior to administration. The solution should only be used if it is clear and practically free of particulate matter.
For single use only. The remaining solution should be discarded.

Storage after reconstitution
The demonstrated chemical and physical stability of the reconstituted solution is within 3 hours at temperatures up to 25 ° C, and 6 hours at temperatures from 2 to 8 ° C. From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, the period of use and storage conditions before use are the responsibility of the user.

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