Maxicold Lor Tabs Double Action, tablets 8.75mg+1 mg 20 pcs

Pharmacological action Pharmacodynamics

Flurbiprofen is a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has significant analgesic, anti-inflammatory and antipyretic effect due to inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity towards COX-1, resulting in reduced production of prostaglandins – mediators of pain, inflammation and hyperthermic response.

The drug has a local anesthetic and anti-inflammatory effect on the mucous membrane of the mouth and throat: it reduces swelling, difficulty in swallowing, pain and irritation in the throat.

Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds with antimicrobial, antifungal and virulicidal action.

The combined use of flurbiprofen and cetylpyridinium chloride allows to achieve greater effectiveness, in comparison with cetylpyridinium chloride, for sore throat caused by infections of the upper respiratory tract. The more pronounced effect of the combination is manifested in the form of a more rapid reduction in the manifestations of tonsillopharyngitis, as well as a faster and more pronounced reduction in the intensity of sore throat, within 1 hour and 2 hours after application of the drug.

Pharmacokinetics Flurbiprofen

The degree of absorption is high, flurbiprofen is quickly and almost completely absorbed, distributed throughout the body and is largely bound to plasma proteins. Flurbiprofen is detected in blood after 5 min, maximum flurbiprofen concentration in blood plasma (Cmax) is reached after 40-45 min after resorption.

Flurbiprofen can be absorbed in the oral cavity by passive diffusion. Absorption rate depends on the dosage form; Cmax of flurbiprofen is reached faster with resorption than with oral administration of the equivalent dose of flurbiprofen.

The half-life (T½) is 3-6 hours. Flurbiprofen is excreted with breast milk in insignificant amounts (< 0.05 µg/ml). It is metabolized in the liver by hydroxylation. It is excreted by kidneys and, to a lesser extent, with bile. About 20-25% of the oral dose of flurbiprofen is excreted unchanged.

Cetylpyridinium chloride

It has local action and is practically not absorbed through the oral mucosa.

Indications

As a symptomatic agent for the relief of sore throat in infectious and inflammatory diseases of the mouth and throat.

Active ingredient

Flurbiprofen, Cetylpyridinium chloride

Composition

One tablet

Active ingredients: flurbiprofen – 8.75 mg, cetylpyridinium chloride monohydrate – 1.05 mg (in terms of cetylpyridinium chloride – 1.00 mg).

Auxiliary substances: povidone – 20.80 mg, levomenthol – 3.00 mg, pectin – 5.80 mg, eucalyptus ball leaf oil – 1.00 mg, citric acid monohydrate – 8.30 mg, mint flavoring* – 13,80 mg, sucralose – 5.00 mg, lactose monohydrate – 153.80 mg, polysorbate-80 – 3.00 mg, sorbitol – 760.70 mg, colloidal silicon dioxide – 5.00 mg, magnesium stearate – 10.00 mg.

* In the flavoring: flavoring ingredients, gum arabic (E414) – 71.5%, maltodextrin – 3.7%, lactose – 3.6%.

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How to take, the dosage

Adults – 1 tablet every 3-6 hours. The tablets should be slowly swallowed until they are completely dissolved.

The tablets should not be taken immediately before or during meals.

The maximum daily dose is 5 tablets.

The duration of use is no more than 3 days.

If it is necessary to continue taking the drug for more than 3 days (if pain syndrome persists), it is necessary to consult a physician.

Please only use the drug according to the indication, route of administration, and dosage listed in the instructions.

Interaction

Flurbiprofen Simultaneous use with the following drugs should be avoided:

• Acetylsalicylic acid: except for low doses of acetylsalicylic acid (75 mg or less daily) prescribed by a physician, as co-administration may increase the risk of side effects.
• Other NSAIDs, including ibuprofen and selective cyclooxygenase-2 inhibitors: Concomitant use of two or more drugs from the NSAID group should be avoided due to possible increased risk of side effects.

Cautiously should be used concomitantly with the following drugs and medicines:

• Anticoagulants: NSAIDs may increase the effect of anticoagulants, particularly warfarin.
• Antiaggregants and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
• Hypotensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of these groups and may increase nephrotoxicity due to cyclooxygenase inhibition, especially in patients with impaired renal function (adequate fluid replacement in these patients must be provided).
• Cyclosporine: increased risk of nephrotoxicity with NSAIDs.
• Glucocorticosteroids: increased risk of GI ulcers and gastrointestinal bleeding.
• Lithium preparations: There is data on the possibility of increased plasma lithium concentrations with NSAIDs.
• Methotrexate: There is data on the possibility of increased plasma methotrexate concentrations with NSAIDs. NSAIDs should be taken 24 hours before or after methotrexate.
• Mifepristone: NSAIDs should not be started less than 8-12 days after mifepristone administration because NSAIDs may decrease the effectiveness of mifepristone.
• Quinolone antibiotics: Congestion may increase if combined with NSAIDs.
• Tacrolimus: Concomitant use with NSAIDs may increase the risk of nephrotoxicity.
• Peroral hypoglycemic drugs: changes in blood glucose levels are possible (increased frequency of blood glucose monitoring is recommended).
• Phenytoin: serum levels of phenytoin may be increased (monitoring serum levels of phenytoin and, if necessary, adjusting the dose is recommended).
• Kaliesaving diuretics: co-administration with flurbiprofen may lead to hyperkalemia.
• Probenecid and sulfinpyrazone: may delay excretion of flurbiprofen.
• Tolbutamide and antacids: to date, studies have shown no interaction between flurbiprofen and tolbutamide or antacids.

Cetylpyridinium chloride

Do not use with milk because this decreases the antimicrobial activity of cetylpyridinium chloride.

If you are using the above or other medicines (including over-the-counter medications), talk to your doctor before taking MAXICOLD® ENT TABS DOUBLE ACTION.

Special Instructions

It is recommended that the drug be taken in the shortest possible course and at the lowest effective dose necessary to relieve symptoms.

In case of symptoms of gastropathy, close monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), fecal occult blood test.

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

Ethanol intake is not recommended during treatment.

Patients with renal or hepatic impairment, as well as elderly patients and patients taking diuretics should consult a physician before using the drug, since there is a risk of impairment of renal function. In short-term use of the drug the risk is insignificant.

Patients with arterial hypertension, including a history of and/or chronic heart failure, should consult a physician before using the drug, since the drug may cause fluid retention, increased blood pressure, and edema.

Information for women planning pregnancy: The drug suppresses cyclooxygenase and prostaglandin synthesis and may affect ovulation, impairing female reproductive function (reversible after discontinuation of treatment).

In case of irritation in the oral cavity, skin rash, mucosal lesions and other manifestations of allergic reaction, the drug should be stopped and a physician should be consulted.

If there is no benefit after 3 days of therapy or if existing symptoms worsen or new symptoms develop, including signs of bacterial infection, promptly see a physician to revise therapy.

If the drug must be used concomitantly with antipyretics, NSAIDs should be avoided because of the increased risk of side effects, and drugs in other pharmacological groups (e.g., paracetamol) should be chosen.

Maxicold® ENT TABS DOUBLE ACTION should not be used in the presence of open wounds in the mouth because cetylpyridinium chloride slows wound healing.

Cetylpyridinium chloride is not an antimicrobial (antibacterial) agent – it is an antiseptic and does not develop resistance.

Effects on driving or operating machinery

In case of dizziness, drowsiness, lethargy or visual disturbances while taking the drug, avoid driving or operating machinery.

Contraindications

• High sensitivity to the drug components;
• .History of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, Quincke’s edema, urticaria, recurrent nasal or paranasal sinus polyposis) in response to use of acetylsalicylic acid or other NSAIDs;

erosive ulcerative diseases of the gastrointestinal (GI) tract (including gastric and duodenal ulcer, Crohn’s disease, ulcerative colitis) or ulcer bleeding in the acute phase or in the history (two or more confirmed episodes of ulcer disease or ulcer bleeding);

• Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;
• severe hepatic insufficiency or active liver disease;
• severe renal insufficiency (creatinine clearance (CK) 30 ml/min);
• decompensated heart failure;
• period after coronary artery bypass grafting;
• pregnancy (III trimester);
• confirmed hyperkalemia;
• deficiency of glucose-6-phosphate dehydrogenase;
• children under 18 years of age (due to lack of experience with medical use in children).

If you have one or more of the above diseases and conditions, you should talk to your doctor before taking this medicine.

With caution

If you are taking other NSAIDs at the same time; have a history of a single episode of peptic ulcer disease or GI ulcer bleeding; A history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), gastritis, enteritis, colitis, Helicobacter pylori infection, bronchial asthma, or allergic diseases (bronchospasm may develop); systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome), because of increased risk of aseptic meningitis (with short-term use of flurbiprofen the risk is low); renal failure, including dehydration (CK less than 30-60 ml/min), nephrotic syndrome; hepatic insufficiency; cirrhosis with portal hypertension; hyperbilirubinemia; arterial hypertension and/or heart failure, edema; concomitant use of drugs that may increase the risk of ulceration or bleeding, in particular oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); In I and II trimesters of pregnancy; in elderly patients; in case of alcohol use.

If you have one or more of the conditions listed above, you should talk to your doctor before starting this medication.

Side effects

The risk of side effects can be minimized by taking a short course of the drug at the lowest effective dose necessary to control symptoms.

The incidence of adverse drug reactions is determined according to the WHO classification: Very common (≥1/10), common (≥1/100 to < 1/10), infrequent (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10000), frequency unknown (cannot be determined from available data).

Blood and lymphatic system disorders

Frequency unknown: hematopoiesis disorders (anemia, thrombocytopenia).

Immune system disorders

Rarely: anaphylactic reactions.

Mental disorders

Infrequent: insomnia.

Nervous system disorders

Often: dizziness, headache, paresthesia.

Infrequent: drowsiness.

Cardiac disorders

Infrequent unknown: heart failure, edema.

Vascular disorders

Area unknown: increased blood pressure.

Respiratory system, chest and mediastinal organs

Often: feeling of irritation in the throat.

Infrequent: aggravation of asthma and bronchospasm, shortness of breath, wheezing, blisters in the mouth and pharynx, pharyngeal hypoesthesia (decreased sensitivity in the mouth and throat).

Gastrointestinal tract disorders

Often: diarrhea, oral ulceration, nausea, oral pain, oral paresthesia, pain in the mouth and pharynx, oral discomfort (feeling of heat, burning or tingling in the mouth).

Infrequent: bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning sensation in the mouth), dysgeusia (change in taste perception), oral dysesthesia, vomiting.

Hepatic and biliary tract disorders

Frequency unknown: hepatitis.

Skin and subcutaneous tissue disorders

Infrequent: skin rash, itching.

Very rare: hypersensitivity reactions, including irritation and skin rash.

Prevalence unknown: severe skin reactions, such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome).

Other

Infrequent: fever, pain.

If any of the side effects listed in the instructions worsen or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Given the amount of active ingredient contained in a single lozenge, the possibility of overdose is minimal.

Flurbiprofen

Symptoms: nausea, vomiting, epigastric pain or, less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In severe cases there are manifestations of the central nervous system: drowsiness, rarely – agitation, convulsions, disorientation, coma. In severe cases of poisoning metabolic acidosis and increased prothrombin time, acute renal failure, liver tissue damage, decreased blood pressure, respiratory depression and acidosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible.

Treatment

Symptomatic, with mandatory provision of airway patency, ECG monitoring and basic vital signs until the patient’s condition normalizes. Oral administration of activated charcoal or gastric lavage within 1 hour of taking a potentially toxic dose of flurbiprofen is recommended. Frequent or prolonged seizures should be controlled with intravenous diazepam or lorazepam. If bronchial asthma worsens, the use of bronchodilators is recommended. There is no specific antidote to flurbiprofen.

Cetylpyridinium chloride Symptoms

Signs and symptoms of intoxication may develop as a result of ingestion of significant amounts of cetylpyridinium chloride, include: nausea, vomiting, shortness of breath, cyanosis, asphyxia with possible subsequent development of respiratory muscle paralysis, central nervous system (CNS) depression, hypotension, and coma. Lethal dose in humans is about 1-3 grams.

Treatment

In the absence of a specific antidote to cetylpyridinium chloride, treatment of acute cetylpyridinium chloride overdose is symptomatic.

In case of symptoms of overdose, discontinue the drug and seek medical attention immediately.

Pregnancy use

Pregnancy

The use of the drug is contraindicated in the III trimester of pregnancy. The drug should be avoided in the I-II trimester of pregnancy, if necessary the use of the drug should be consulted with the doctor.

Breast-feeding period

Application of the drug during breast-feeding is contraindicated. If it is necessary to use the drug during breastfeeding, breastfeeding should be stopped.

Consult your doctor before using the drug if you are pregnant or think you may be pregnant, or if you are planning to become pregnant.