Nurofen is a popular non-hormonal anti-inflammatory drug. Has a wide spectrum of action . Effective for pain of various localizations (headache, dental, muscle, menstrual, joint). For inflammatory processes, it is used for both internal and external use.
Like any medical product, Nurofen requires proper storage. Otherwise, the medicine loses its properties, becomes useless and even dangerous.
In what forms does it occur?
Regardless of the release form, all Nurofen preparations have one active ingredient - ibuprofen. They differ in concentration and method of application.
- Strawberry or orange flavored syrup . Available in bottles with a capacity of 100, 150, 200 ml or in sachets in a single dosage of 5 ml. For convenience, the kit includes a dosing syringe or measuring spoon. The drug does not contain glucose or dyes.
- Rectal suppositories, 10 pieces per package . Allowed for children from 3 months. They contain only two components - ibuprofen 60 mg and Witepsol - a fat that helps the candle keep its shape. The candles melt easily at body temperature and begin to act after 15 minutes.
- Tablets for children over 6 years old , weighing more than 20 kg and adults, at a dosage of 200 mg.
- Effervescent tablets for the preparation of liquid medicine . In addition to ibuprofen in the amount of 200 mg per 1 tablet, they contain sucrose and citric acid. They act faster and more effectively than tablet forms.
- Nurofen forte 400 mg tablets are used more often as a powerful pain reliever.
- Nurofen Express capsules contain the active component in liquid form, which facilitates its absorption.
- Nurofen plus is a tablet containing 200 mg of ibuprofen and 10 mg of codeine. Used as an anti-inflammatory, antipyretic and antitussive medicine.
- Nurofen Express Lady is prescribed to women for severe menstrual pain.
- 5% gel for external use helps with joint and muscle pain, and neuralgia.
Nurofen det supp rect 60 mg pack cont cell/pack card x10
Registration Certificate Holder:
RECKITT BENCKISER HEALTHCARE INTERNATIONAL, Ltd (UK)
Manufactured by: FAMAR AVE (Greece)
Contacts for inquiries: RECKITT BENKISER HEALTHCARE Ltd. (UK) ATX code: M01AE01 (Ibuprofen) Active substance: ibuprofen Rec.INN registered by WHO
Dosage form
NUROFEN® FOR CHILDREN
Suppositories rect. (for children) 60 mg: 10 pcs.reg. No.: LSR-006017/08 dated 07/30/08 - Indefinitely Re-registration date: 01/22/15
Release form, packaging and composition of Nurofen® For Children
Rectal suppositories (for children) are white or almost white, torpedo-shaped, smooth, an air rod or funnel-shaped depression is allowed on the cut.
1 sup.
ibuprofen 60 mg
Excipients: solid fat 1 (vitepsol H15) - 258 mg, solid fat 2 (vitepsol W45) - 258 mg.
5 pieces. - aluminum blisters (2) - cardboard packs.
Clinical-pharmacological group: NSAIDs Pharmaco-therapeutic group: NSAIDs
pharmachologic effect
NSAIDs. It has analgesic, antipyretic and anti-inflammatory effects.
The mechanism of action of ibuprofen, a derivative of propionic acid, is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks COX-1 and COX-2, as a result of which it inhibits the synthesis of prostaglandins. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect is most pronounced for inflammatory pain. The effect of the drug lasts up to 8 hours.
Pharmacokinetics
Suction and distribution
Absorption is high. Ibuprofen is absorbed from the rectal lumen and quickly enters the systemic circulation.
Binding to blood plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma.
In limited studies, ibuprofen has been found in breast milk at very low concentrations.
Metabolism and excretion
After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Metabolized in the liver. It is excreted by the kidneys (unchanged - no more than 1%) and, to a lesser extent, with bile.
Indications for Nurofen® for Children
For children from 3 months to 2 years of age as an antipyretic for infectious and inflammatory diseases and conditions accompanied by an increase in body temperature, including:
acute respiratory diseases, influenza, childhood infections, other infectious and inflammatory diseases and post-vaccination reactions.
As an analgesic for pain of mild or moderate intensity, incl. at:
toothache, headache, migraine, neuralgia, earache, sore throat, sprain pain, muscle pain, rheumatic pain, joint pain and other types of pain.
The drug is recommended for use when taking oral medications is impossible, or in the presence of vomiting.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
ICD-10 codes
Dosage regimen
Nurofen® for children suppositories are specially designed for children. The drug is administered rectally.
For fever and pain, the dose of the drug depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg/kg of the child’s body weight with intervals between doses of the drug of 6-8 hours.
Children aged 3-9 months (body weight 6-8 kg) are prescribed 1 supp. (60 mg) up to 3 times/day, but not more than 180 mg/day.
Children aged 9 months to 2 years (body weight 8-12 kg) are prescribed 1 supp. (60 mg) up to 4 times/day, no more than 240 mg/day.
The duration of treatment is no more than 3 days. Do not exceed the indicated dose.
If, when using the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), symptoms persist or worsen, you should stop treatment and consult a doctor.
For post-immunization fever, children under 1 year of age are prescribed 1 supp. (60 mg), if necessary, after 6 hours you can introduce another 1 supp. (60 mg). Do not use more than 2 supp. (120 mg) for 24 hours.
Side effect
The risk of side effects can be minimized if the drug is used for a short time, at the minimum effective dose required to eliminate symptoms.
Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day. When treating chronic conditions and with long-term use, other adverse reactions may occur.
The incidence of adverse reactions was assessed based on the following criteria: very often (≥1/10), often (from ≥1/100 to <.1/10), infrequently (from ≥1/1000 to <.1/100), rare (from ≥1/10,000 to <.1/1000), very rare (<.1/10,000), frequency unknown (no data available to estimate frequency).
From the hematopoietic system: very rarely - hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.
From the immune system: infrequently - hypersensitivity reactions (nonspecific allergic reactions and anaphylactic reactions), reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura , Quincke's edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia, very rarely - severe hypersensitivity reactions, incl. swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).
From the gastrointestinal tract: infrequently - abdominal pain, nausea, dyspepsia, rarely - diarrhea, flatulence, constipation, vomiting, very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, ulcerative stomatitis, gastritis, frequency unknown - exacerbation of ulcerative colitis and Crohn's disease.
From the hepatobiliary system: very rarely - liver dysfunction, hepatitis.
From the urinary system: very rarely - acute renal failure, especially with long-term use, in combination with an increase in the level of urea in the blood plasma and the appearance of edema, papillary necrosis.
From the nervous system: infrequently - headache, very rarely - aseptic meningitis (in patients with autoimmune diseases).
From the cardiovascular system: frequency unknown - heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.
From the respiratory system: frequency unknown - bronchial asthma, bronchospasm, shortness of breath.
Other: very rarely - swelling, incl. peripheral.
Laboratory values: hematocrit or hemoglobin may decrease, bleeding time may increase, plasma glucose concentration may decrease, creatinine clearance may decrease, plasma creatinine concentration may increase, hepatic transaminase activity may increase.
If side effects occur, the patient should stop taking the drug and consult a doctor.
Contraindications for use
a history of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, rhinosinusitis, recurrent polyposis of the nose or paranasal sinuses, Quincke's edema, urticaria) in response to the use of acetylsalicylic acid or other NSAIDs, a history of bleeding or perforation of a gastrointestinal ulcer provoked by the use of NSAIDs, erosive -ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding), severe liver failure or active liver disease, severe renal failure (CC <.30 ml/min), progressive kidney disease, confirmed hyperkalemia, decompensated heart failure, period after coronary artery bypass grafting, bleeding disorders (including hemophilia, prolongation bleeding time, tendency to bleed, hemorrhagic diathesis), third trimester of pregnancy, child's body weight up to 6 kg, proctitis, intracranial hemorrhage, hypersensitivity to ibuprofen or any of the components included in the drug.
Caution should be exercised when prescribing the drug while taking other NSAIDs, a history of a single episode of gastric ulcer or gastrointestinal ulcer bleeding, gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis, bronchial asthma or allergic diseases in the acute stage or a history ( bronchospasm may develop), severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis, renal failure, incl. with dehydration (creatinine clearance 30-60 ml/min), fluid retention and edema, liver failure, arterial hypertension and/or heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, diseases of peripheral arteries, blood diseases of unknown etiology (leukopenia, anemia ), while taking other medications that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel), in the first and second trimesters of pregnancy, during breastfeeding, in elderly patients.
Use during pregnancy and breastfeeding
The use of the drug is contraindicated in the third trimester of pregnancy. If possible, the use of ibuprofen should be avoided in the first and second trimesters of pregnancy.
There is evidence that ibuprofen can pass into breast milk in small quantities without any adverse effects on the health of the nursing infant.
Use for liver dysfunction
The use of the drug is contraindicated in severe liver failure or active liver disease.
The drug should be prescribed with caution in case of liver failure.
Use for renal impairment
The use of the drug is contraindicated in severe renal failure (creatinine clearance <.30 ml/min) and progressive kidney disease.
The drug should be prescribed with caution in case of renal failure, incl. with dehydration (creatinine clearance 30-60 ml/min), fluid retention and edema, liver failure.
Use in children The use of the drug in children weighing up to 6 kg is contraindicated.
Use in elderly patients The drug should be prescribed to elderly patients with caution.
special instructions
It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.
When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
Impact on the ability to drive vehicles and operate machinery
Patients who experience dizziness, drowsiness, lethargy, or blurred vision when taking ibuprofen should avoid driving or operating machinery.
Overdose
In children, overdose symptoms may occur after taking the drug at a dose exceeding 200 mg/kg of the child’s body weight.
Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible.
Treatment: symptomatic, with mandatory maintenance of airway patency, monitoring of ECG and vital signs until the patient’s condition is normalized. Frequent or prolonged seizures should be treated with IV diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.
Drug interactions
The simultaneous use of ibuprofen with the drugs listed below should be avoided.
Acetylsalicylic acid: with the exception of acetylsalicylic acid in low doses (no more than 75 mg/day) prescribed by a doctor, since combined use may increase the risk of side effects. With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving acetylsalicylic acid in small doses as an antiplatelet agent is possible after starting ibuprofen).
Other NSAIDs, incl. selective COX-2 inhibitors: simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects.
The drug should be used with caution simultaneously with the following medications.
Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.
Antihypertensive drugs (ACE inhibitors and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.
Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs.
Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.
Cyclosporine: increased risk of nephrotoxicity when NSAIDs are administered concomitantly with cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.
Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase.
Zidovudine: Concomitant use of NSAIDs and zidovudine may result in increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ibuprofen.
Quinolone antibiotics: In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may be increased.
Storage conditions for Nurofen® For Children
The drug should be stored out of reach of children, in a dry place at a temperature not exceeding 25°C.
Shelf life of Nurofen® For Children Shelf life - 2 years.
Terms of sale The drug is approved for use as an over-the-counter product.
Storage rules
For each package, the manufacturer determines the expiration date, which is marked on the edge or bottom of the box. Over time, the chemicals in the drug break down . The longer the drug is stored, the deeper the process, and after the expiration date the drug becomes inactive.
In addition to storage duration, temperature, humidity and exposure to light are also important. Special instructions for individual dosage forms.
Syrup
It has a pleasant and attractive taste for children, so it is stored out of the reach of children. Since the bottle is made of dark glass, it is not afraid of small doses of ultraviolet radiation. It does not require low temperatures, but heating above 22 degrees is not advisable.
The optimal storage location is a dark shelf in a closet away from heating appliances. The medicine in untouched packaging retains its properties for 3 years ; after opening, the syrup is used for no longer than 2 months.
Suppositories
You can place it in a cold place, but this is not a requirement. Melting of candles occurs at a temperature of 36 degrees and above, but heating to 25 degrees leads to deformation of the shape. If the packaging is preserved, the drug is valid for 2 years from the date of manufacture. Candles from damaged packaging should not be used.
Effervescent tablets
They lose their properties when exposed to moisture. They are stored in a tightly closed container out of the reach of children, and the temperature should not exceed 25 degrees. Shelf life 3 years .
Hard-coated tablets
The most stable form of storage. They retain their qualities for 3 years , provided that the temperature is maintained (up to 25 degrees), and there is no direct exposure to sunlight and water.
Capsules
The capsule is a hard gelatin shell that is resistant to dampness and exposure to high temperatures. This dosage form should not be stored in the bathroom or kitchen in high humidity. The optimal place is the side shelf of the refrigerator. There the drug can be kept for up to 3 years . An opened bottle does not affect the quality of the medicine, since each dose is enclosed in an individual capsule.
Gel for external use
Good for 3 years if temperature recommendations are observed (from 15 to 25 degrees). Since the gel is packaged in an opaque tube, it is not afraid of exposure to ultraviolet radiation. It can be kept on an open shelf away from children. An opened tube should be used for no longer than six months.
