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

Active ingredient

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.

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

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.

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

Contraindications

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).

Frequency unknown: hematopoiesis disorders (anemia, thrombocytopenia).

Rarely: anaphylactic reactions.

Infrequent: insomnia.

Often: dizziness, headache, paresthesia.

Infrequent: drowsiness.

Infrequent unknown: heart failure, edema.

Area unknown: increased blood pressure.

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).

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.

Frequency unknown: hepatitis.

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).

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.

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.

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.

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.

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

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.

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.