Ibuprofen-Akrihin - instructions for use, dose, side effects, contraindications

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Non-selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), which inhibits the synthesis of prostaglandins. Besides, ibuprofen reversibly inhibits platelet aggregation.

Has analgesic, antipyretic and anti-inflammatory effect.

Analgesic effect is most pronounced for inflammatory pains.

The drug lasts up to 8 hours.

Pharmacokinetics:

Absorption is high, binding to plasma proteins is 90%. Ibuprofen absorbed from the lumen of the rectum, quickly reaching the systemic blood flow. The half-life (T_1/2) - 2 hours. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it greater concentrations than in the blood plasma.After absorption about 60% of pharmacologically inactive Rform is slowly transformed into an active S-form. It is metabolized in the liver. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

In limited studies ibuprofen was found in breast milk in very low concentrations.

Indications:

Suppositories rectal Ibuprofen-Akrihin is used in children from 3 months of life to 2 years.

The drug is used for:

- symptomatic treatment as an antipyretic agent when:

acute respiratory infections;
influenza;
children's infections;
other infectious-inflammatory diseases and post-vaccination reactions, accompanied by an increase in body temperature.

- symptomatic analgesic for pain syndrome of mild or moderate intensity, including:

toothache;
headache, migraine;
neuralgia;
pain in the ears;
sore throat;
pain with sprains;
muscle pain;
Rheumatic pain, joint pain and other types of pain.

The drug is recommended for use if oral medication (for oral administration) is not possible or if there is vomiting.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Hypersensitivity to ibuprofen or any of the components that make up the drug.

- The presence in the history of the hypersensitivity reaction (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.

- Bleeding or perforation of the gastrointestinal tract ulcer (GI) in history, triggered by the use of NSAIDs.

- Erosive and ulcerative diseases of the digestive tract (including stomach and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcer bleeding in the active phase or in the anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding).

- Severe hepatic insufficiency or liver disease in the active phase.

- Severe renal insufficiency (creatinine clearance <30 ml / min), progressive kidney disease, confirmed hyperkalemia.

- Decompensated heart failure, the period after aortocoronary bypass surgery.

- Violations of blood clotting (including hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diathesis).

- Pregnancy (III trimester).

- The child's body weight is up to 6 kg.

- Proctitis.

- Intracranial hemorrhage.

Carefully:

In the presence of conditions specified in this section, before using the drug should consult a doctor.

Simultaneous reception of other NSAIDs, the presence in the history of a single episode of stomach ulcer or ulcer bleeding GIT, gastritis, enteritis, colitis, the presence of infection Helicobacter pylori, ulcerative colitis; A bronchial asthma or allergic diseases in a stage of an exacerbation or in the anamnesis - development of a bronchospasm is possible; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; renal failure, including, with dehydration (creatinine clearance 30-60 ml / min), fluid retention and swelling, hepatic insufficiency,arterial hypertension and / or heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial diseases, unclear etiology (leukopenia, anemia); simultaneous administration of other drugs that may increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine , paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), the period of breastfeeding, the elderly.

Pregnancy and lactation:

Contraindicated use of the drug in the III trimester of pregnancy. If possible, the use of ibuprofen in I-II trimesters of pregnancy.

There is evidence that ibuprofen in small quantities can penetrate into breast milk without any negative consequences for the health of the infant.

Dosing and Administration:

Ibuprofen-Akrihin - suppositories, specially developed for children.

For rectal administration. Only for short-term use.

Read the instructions carefully before using the product.

Fever (fever) and pain

Dosage for children depends on the age and body weight of the child.

The maximum daily dose should not exceed 30 mg / kg of the body weight of the child with intervals between doses of the drug 6-8 hours.

Age (weight)	Single dose	Daily dose
3-9 months (6.0 kg-8.0 kg)	1 suppository (60 mg)	up to 3 times within 24 hours, not more than 180 mg per day
9 months - 2 years (8.0 kg-12.0 kg)	1 suppository (60 mg)	up to 4 times within 24 hours, not more than 240 mg per day

Duration of treatment is no more than 3 days. Do not exceed the indicated dose.

If symptoms persist or worsen during 24 hours (for children aged 3-5 months) or for 3 days (in children 6 months and older), stop treatment and consult a doctor.

Postimmunization fever

1 suppository for children under 1 year; if necessary, another 1 suppository in 6 hours. Do not use more than 2 suppositories (120 mg) for 24 hours.

Side effects:

The risk of side effects can be minimized if you take the drug with a short course, at the lowest effective dose needed to eliminate the symptoms.

Side effects are predominantly dose-dependent.

The following adverse reactions were noted with a short-term intake of ibuprofen in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and with prolonged use, other side reactions may occur.

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely > 1/10 000, <1/1000), very rarely (<1/10 000, including individual messages); frequency is unknown - there is no data on frequency estimation.

Violations of the blood and lymphatic system: very rarely - hemopoiesis 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 bruising, bleeding, and bruising of unknown etiology.

Immune system disorders: infrequently - hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its aggravation, bronchospasm, dyspnea, 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, including swelling of the face, tongue and larynx, dyspnea, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

Disorders from the gastrointestinal tract: infrequently - pain in the abdomen, nausea, dyspepsia; rarely - diarrhea, flatulence, constipation, vomiting; very rarely - peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis; frequency unknown - exacerbation of ulcerative colitis and Crohn's disease.

Disorders from the urinary system and liver: very rarely - acute renal failure, especially,with prolonged use, in combination with an increase in the level of urea in the blood plasma and the appearance of edema, papillary necrosis, impaired liver function, hepatitis.

Disturbances from the nervous system: infrequently - a headache; very rarely - aseptic meningitis (in patients with autoimmune diseases).

Disorders from the cardiovascular system: frequency unknown - heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (eg, myocardial infarction, stroke), increased blood pressure.

Disturbances from the respiratory system and mediastinal organs: the frequency is unknown - bronchial asthma, bronchospasm, dyspnea.

Other: very rarely - edema, including peripheral.

Laboratory indicators: hematocrit or hemoglobin (may decrease); bleeding time (may increase); the concentration of glucose in the blood plasma (may decrease); clearance of creatinine (may decrease); plasma concentration of creatinine (may increase); activity of "liver" transaminases (may increase).

If side effects occur, stop taking the medication and consult a doctor.

Overdose:

In children, the symptoms of overdose may occur after taking a dose of the drug, exceeding 200 mg / kg of the child's body weight.

Symptoms: nausea, vomiting, pain in the epigastric region or, more rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely - excitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, damage to liver tissue, lowering blood pressure, respiratory depression and cyanosis may develop. Patients with bronchial asthma may exacerbate this disease.

Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic indicators of vital activity, up to the normalization of the patient's condition. Frequent or prolonged seizures should be stopped with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.

Interaction:

It should be avoided simultaneous use of ibuprofen with the following medicines:

Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by the doctor, since joint application may increase the risk of side effects. With simultaneous application ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agent after the onset of ibuprofen administration).

Other NSAIDs, including selective inhibitors of COX-2: should avoid the simultaneous use of two or more drugs from the group of NSAIDs because of the possible increase in the risk of side effects.

Use with caution simultaneously with the following medicines:

Anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs.

Hypotensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of these drugs. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs.

Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Antiaggregants and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides: the simultaneous administration of NSAIDs and cardiac glycosides may lead to worsening of heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in blood plasma.

Lithium preparations: there are data on the probability of an increase in the concentration of lithium in the blood plasma against the background of NSAIDs.

Methotrexate: there are data on the probability of an increase in the concentration of methotrexate in the blood plasma against the background of NSAIDs.

Cyclosporine: increased risk of nephrotoxicity with the simultaneous administration of NSAIDs and cyclosporine.

Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, because NSAIDs may reduce the effectiveness of mifepristone.

Tacrolimus: with the simultaneous appointment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Zidovudine: simultaneous use of NSAIDs and zidovudine may lead to an increase in hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

Antibiotics of the quinolone series: in patients receiving co-treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible.

Special instructions:

It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms.

Use of ibuprofen in high doses (greater than 2400 mg / day) may increase the risk of acute coronary or stroke.

In patients with hypertension, heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, and risk factors for disorders of the cardiovascular system should be particularly careful and consult with your doctor before you start taking the drug.

During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Effect on the ability to drive transp. cf. and fur:

Patients who report dizziness, drowsiness, blockage, or visual impairment when taking ibuprofen should avoid driving motor vehicles or controlling mechanisms.

Form release / dosage:Suppositories rectal [for children], 60 mg.

Packaging:

For 5 suppositories in a PVC / PE film blister.

For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003708

Date of registration:28.06.2016

Expiration Date:28.06.2021

The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland

Manufacturer: & nbsp

Apipol-Pharma, Open Company Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp19.10.2017

Illustrated instructions

Instructions

Ibuprofen-Akrihin (Ibuprofen-Akrichin)