Cefixime. suspension. 100 mg.

What is cefixime Actavis is and what it is used
This medicine is an antibiotic from the group of beta-lactams, a third generation cephalosporin - a group similar to penicillins.
Cefixime Actavis be given to children over 6 months of age for the treatment of infections caused by organisms susceptible to cefixime:
acute infections of the upper and lower respiratory tract, including. pharyngitis, tonsillitis, acute bronchitis, acute & chronic bronchitis, pneumonia (for continuation of therapy after initial treatment with parenteral antibiotic); acute and chronic sinusitis;
acute otitis media;
urinary tract infections: cystitis, tsistouretrit, uncomplicated pyelonephritis;
uncomplicated gonorrhea (cervical / urethral).

2 What you should know before using cefixime Actavis
Do not take cefixime Actavis
if you are allergic to cefixime or any of the other ingredients of this medicine listed in section 6 or antibiotic of cephalosporin.
Warnings and Precautions
Tell your doctor if you have a hypersensitivity to penicillins and / or cephalosporins. In such cases, attention is necessary in the first administration. In every manifestation of allergy during treatment immediately discontinue and
tell your doctor.
If you are allergic to other beta-lactam antibiotics is possible to allergic to cefixime.
Occurrence of diarrhea during treatment with cefixime Actavis and even several weeks after discontinuation of it can be a symptom of pseudomembranous colitis (life-threatening). If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking cefixime Actavis. Do not take medicines that stop or slow down bowel and contact your doctor.
Cephalosporins prolong prothrombin time, which is why it need not be monitored during treatment.
If you have kidney failure, tell your doctor, who may adjust the daily dose.
In children under 6 months of age use of cefixime is not recommended.

Other drugs and cefixime Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
Tell your doctor if you are taking probenecid (for gout), carbamazepine (anticonvulsant), antibiotics, aminoglycoside (gentamicin, amikacin).
If you are a urinalysis to determine acetone or sugar, as well as conducting antiglobulin test (Coombs test) necessarily tell your doctor and laboratory. Use of cefixime may lead to false positive results.

Cefixime Actavis with food, beverages and alcohol
Cefixime Actavis can be taken without regard to food and drink.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Not recommended for use cefixime Actavis during pregnancy and lactation. Application of the product during pregnancy and lactation can only be done in a rigorous assessment by the doctor and under close supervision only in case of extreme necessity.

Driving and using machines
Actavis cefixime not affect your ability to drive or operate machinery.

Cefixime Actavis contains sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3 How to take cefixime Actavis
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The slurry is intended for oral administration, regardless of mealtime.
The recommended dose is:
Children from 6 months to 12 years:
The usual dose is 8 mg / kg daily as a single dose or in two divided doses of 4 mg / kg every 12 hours.

Children over 12 years old (or weighing more than 50 kg) receive adult dosage:
The usual adult dose is 400 mg daily as a single dose or in two divided doses of 200 mg every 12 hours.
Safety and efficacy in children under 6 months of age have not been established.

Suggested dosages based on body weight:
Weight (Kg) Daily Dose (mg) daily dose (ml)
6.25 50 2.5
12.5 100 5
18.75 150 7.5
25 200 10
31.25 250 12.5
37.50 300 15
The duration of treatment is usually 7-14 days, depending on the severity of the infection. Streptococcal infections are to be treated for a minimum of 10 days.

Patients with renal insufficiency:
If the value of creatinine clearance greater than 20 ml / min, there is no need to change dosage. At creatinine clearance below 20 ml / min and in patients on hemodialysis, cefixime single dose should not exceed 4 mg / kg.

Patients with hepatic impairment:
It is not necessary to adjust the dosage.

Preparation of suspension
Add water to the powder to the line. Swirl gently to dissolve the drug and to obtain an oral suspension. Wait a few minutes. If the level of the suspension is less than indicated by line add water again.
After dissolution, the suspension can be stored for 14 days at a temperature below 25 ° C. The bottle should be tightly closed.
Shake the suspension vial before use.

If you take more than the amount of cefixime Actavis
If you take more than you should, contact your doctor or pharmacist. Treatment takes place in a health facility.

If you forget to take cefixime Actavis
In case of failure of the intake, the next dose should be taken as soon as possible. If it is almost time for your next dose, the missed dose should be skipped and the treatment should continue the established pattern. Do not take a double dose to make up for a missed dose.

Do not stop taking your medicine without consulting a doctor. Do not stop taking cefixime Actavis, just because you feel better as the infection may deem to reappear.

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

Adverse reactions are ranked by frequency.
Uncommon (between 1 and 10 in every 1000 patients may receive them): headache or dizziness, diarrhea, pain in the abdomen, loss of appetite, abdominal distention with flatulence, nausea, vomiting.

Rare (between 1 and 10 in every 10,000 patients may receive them): hypersensitivity reactions - skin rashes, urticaria, fever and itching, transient increase in liver enzymes and alkaline phosphatase, itching in the genital area, vaginal irritation , fungal infections.

Rare (less than 1 in 10,000 patients may obtain them): temporary reduction in the number of blood platelets, which increases the risk of bleeding or bruising, reduction in the number of white blood cells, which increases the possibility of occurrence of infections, reduced number of eosinophils in the blood (a type of blood cell), prolonged prothrombin time (bleeding) psevdomembanozen colitis (life-threatening condition occurring with severe and persistent diarrhea, straining, blood and mucus in the stool), transient increase in blood urea and / or creatinine levels (indicators of kidney function), erythema multiforme (skin bubbles) syndrome Steven Johnson (a serious illness accompanied by blistering of the skin, mouth, eyes and genitals ) and serum sickness-like reactions (with fever, chills, swollen lymph nodes).

5 How to store cefixime Actavis
Keep out of reach of children.
Do not use cefixime Actavis after the expiry date stated on the bottle.
Do not store above 25 ° C. Do not refrigerate or freeze. Keep the bottle tightly closed.
The duration of storage of the suspension after the first opening of the bottle is 14 days at temperatures below 25 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Package Contents and more information
What does cefixime Actavis
The active substance is 100 mg of cefixime as cefixime trihydrate in 5 ml of suspension.
The other ingredients are sucrose, xanthan gum, sodium benzoate (E211), silica colloidal anhydrous, strawberry flavor.

Cefixime Actavis looks like and contents of the pack
Cefixime Actavis is a characteristic strawberry flavor. After reconstitution with water to give a creamy yellow to nearly viscous slurry.
Amber glass bottle 125 ml, with markings on the bottle of 50 ml or 100 ml, closed with a white child resistant cap. Dispensing a plastic pipette, 5 ml (1 to 25 kg).