Neofen (ibuprofen) 100mg/5ml syrup
Nonsteroid anti-inflammation mean
Shake preparation before use during 2 minutes!
Code АТC: M01E 01
Drug form: Peroral suspension.
Pharmacotherapeutic group: Nonsteroid anti-inflammation means.
Composition: 5ml suspension contains:
Active substance: Ibuprofen – 100mg.
Aiding substances: carboxymethyl cellulose, sugar, citric acid, glycerin, methylparaben, orange
flavorings, distilled water.
Pharmacological operation: Ibuprofen is a derivation of propionic
acid, having febrifuge, analgesic and anti-inflammatory operation. Ibuprofen
mechanism of action is firstly stipulated by the suppression of prostaglandin
biosynthesis. Reduction of prostaglandin concentration in the inflammation
nidus, accompanies formation decrease of bradykinin, endogenous pyrogen and
other biologically active substances, oxygen radicals and NO. All these cause
inflammatory process activity lowering (anti-inflammation effect of Ibuprofen),
that follows perception of pain reduce (analgesic effect).
Reduction of prostaglandin
concentration and cerebrospinal fluid causes normalization of body temperature
(antipyretic effect).
Ibuprofen has double antipyretic
action - central and peripheral. As a result of central action, cyclooxygenase blocks in the central nervous system, which
causes analgesic and febrifuge effect. But, reduction of prostaglandin
concentration in the inflammation nidus stipulates anti-inflammatory operation
(peripheral action).
Pharmacokinetics: Absorption:
more than 80% of Ibuprofen is absorbed from the gastrointestinal tract after peroral intake;
maximal concentration in the blood plasma is reached in an hour. Food intake
slows absorption of Ibuprofen, but it doesn’t reduce its bioavailability.
Ibuprofen relates to blood plasma
proteins in 99%, where albumin is the main part. High quality of protein
binding restricts Ibuprofen penetration in the synovial and spinal fluid.
That’s why Ibuprofen slowly gets into the synovial fluid and preserved for a
long time by therapeutic concentration.
Metabolism: Ibuprofen mainly
transformed in the liver.
Excretion: Medicinal agent
doesn’t cumulate in the organism. 70-90% of the preparation is excreted with
urine as conjgated metabolite and
glucuronic acid.
Indication:
- Febrifuge agent at time of acute respiratory
disease, flu, post- immunization reactions and children’s infectious
diseases, accompanying body temperature increase.
- Analgesic
agent at time of various weak and moderate pain, including headache,
toothache, ear and throat pain, migraine, neuralgia, retraction and etc.
Order of intake and
dosage: The
preparation is taken after eating with great amount of water.
Recommended
single dose 5-10mg/kg. maximal daily dose makes up 30 mg/kg. on the body
weight.
The
preparation is prescribed according to the below give schedule:
Infants
from 6 to 12 months (7,7-9kg): 2,5 ml 3-4 times in a day (that corresponds 150-200
mg Ibuprofen daily);
Children
form 1 to 3 years (10-15 kg): 5 ml 3 times in a day (that corresponds 300 mg
Ibuprofen daily);
Children
form 4 to 6 years (16-20 kg): 7,5 ml 3 times in a day (that corresponds 450 mg
Ibuprofen daily);
Children
form 7 to 9 years (21-29 kg): 10 ml 3 times in a day (that corresponds 600 mg
Ibuprofen daily);
Children
form 10 to 12 years (30-40 kg): 15 ml 3 times in a day (that corresponds 900 mg
Ibuprofen daily);
Post- immunization fever: Normally is taken 2,5 ml, but in case of
necessity it is taken repeatedly after 6 hours, (not more than 5 ml during
twenty four hours).
Febrifuge effect continues for
6-8 hours.
Repeated
dose intake is possible only protecting four-hour interval.
Side effects: At time of Neofen usage, rarely, may detect
following side effects:
- nausea, vomiting, feeling of discomfort or pain in
epigastrium, diarrhea, gastrointestinal
tract erosive-ulcerous
damages;
- Allergic reactions: rash on the skin, itch,
nettle-rash, exacerbation of bronchial
asthma, bronchospasm, anaphylactic shock, exudative erythema;
- Tachycardia, hypotension, anemia, thrombocytopenia,
leukopenia;
- Disorder of kidneys function, cystitis;
- In case of detecting any side effect it is
necessary to terminate treatment and visit doctor;
Contraindication:
- Individual hypersensitivity toward preparation
components;
- When the
patient intakes aspirin or other sedatives;
- Last trimester of pregnancy;
- Stomach and duodenum ulcerous of disease;
- Children's age till 6 months;
- Hemophilia, hypocoagulation, hemorrhagic diathesis;
- Deficiency of glucose 6-phosphate dehydrogenase.
Overdose: Overdose symptoms: pains in stomach, nausea, vomiting,
headache, dizziness, coma, kidney acute insufficiency, pressure fall,
tachycardia or bradycardia.
In case of overdose it is
necessary to address to the doctor immediately.
Treatment: gastric lavage, intake
of activated
charcoal, alkaline drinks, symptomatic therapy.
Interaction with other medicinal agents: Usage together with acetylsalicylic acid or other nonsteroidal
anti-inflammatory agents, the risk of development of side effects increases
from the gastrointestinal tract.
Neofen together with
antihypertensive and diuretic agents decreases their effect.
Intake together with
anticoagulants may strengthen their action.
When using together with lithium
or methotrexate, “Neofen” may cause increase as lithium as well as methotrexate
concentration in plasma.
Production form: 100 ml in orange glass or polymeric material vial. The bottle is placed in a carton box
with polyethylene measuring glass.
Storage conditions: Store not more than 25º C, in a dry, dark place
and keep away from children
Validity: 2 years.
Issue: III group of a pharmaceutical
product (Issued without prescription).