Lizifen 8.75 Mg 16 Lozenges

Lizifen (8.75 Mg 16 Lozenges)

ACTION AND MECHANISM

Non-steroidal anti-inflammatory drug (NSAID) belonging to the group of arylpropionics, which works by preventing the synthesis of prostaglandins, by means of the competitive and reversible inhibition of cyclooxygenase activity, an enzyme that converts arachidonic acid to prostaglandins.

INDICATIONS

- Short-term symptomatic relief of [THROAT PAIN].

POSOLOGY

"Dosage tablets to suck"

- Adults and adolescents from 12 years: 1 pill / 3-6 h, up to a maximum of 5 pills / 24 h.

- Children <12 years: not recommended or contraindicated.

- Elderly: clinical experience is very limited, and does not allow establishing specific dosage recommendations.

Treatment duration: maximum 3 days.

POSOLOGY IN KIDNEY FAILURE

- Mild to moderate renal insufficiency (ClCr 30-90 ml / min): no dosage adjustment is required.

- Severe renal failure (CrCr <30 ml / min): contraindicated.

POSOLOGY IN LIVER FAILURE

- Mild to moderate hepatic impairment (Child-Pugh classes A and B): no dosage adjustment is required.

- Severe hepatic impairment (Child-Pugh class C): contraindicated.

RULES FOR THE CORRECT ADMINISTRATION

- Tablets and lozenges to suck: slowly suck in the mouth. To avoid local irritation, it should be kept moving while dissolving.

CONTRAINDICATIONS

- Known hypersensitivity to flurbiprofen or [NSAID ALLERGY].

- Patients with a history of hypersensitivity to acetylsalicylic acid or other NSAIDs, which include patients who have experienced asthma attacks, acute rhinitis, urticaria or angioneurotic edema after using acetylsalicylic acid or other NSAIDs.

- [DIGESTIVE HEMORRHAGE], [ULCERA PEPTICA] active.

- Severe renal failure (CrCr <30 ml / min).

- Severe liver failure (Child-Pugh class C).

- [HEART FAILURE] severe.

- Third trimester of pregnancy.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Contraindicated use in severe kidney failure. NSAIDs could lead to decreased renal blood flow with reversible acute renal failure due to inhibition of vasodilator prostaglandin synthesis, and cases of nephrotic syndrome and acute interstitial nephritis have even been described with prolonged treatment. The patients with the highest risk of kidney failure are those with previous kidney failure, the elderly or situations that could reduce renal flow, such as [HYPOVOLEMIA], [DEHYDRATION], low-sodium diets, [HEART FAILURE], liver failure, [HEPATIC CIRROSIS] or diuretic, ACEI or AIIRA treatment. In high-risk patients, during prolonged treatments, it is recommended to determine renal functionality (serum creatinine, CLcr) before starting treatment, and periodically. In case of impaired renal function, a dose reduction may be necessary.

- [LIVER FAILURE]. Use in severe insufficiency is contraindicated.

- Gastrointestinal toxicity. NSAID treatment has led to gastroduodenal ulcers as well as life-threatening bleeding and perforation. There is an increased risk of ulcer with high dose treatments or for long periods of time, with a history of peptic ulcer, especially if they have already had gastrointestinal bleeding or perforation due to NSAIDs, as well as in [TOBACCO], [CHRONIC ALCOHOLISM] or elderly patients or weakened. However, short-term treatment is also not without risks.

As a general rule to reduce gastric damage, it is advisable to administer any NSAID with food. In addition, in risk groups, it is advisable to start treatment with the lowest possible dose, and always associate an anti-ulcer drug (anti h3 or PPI) whenever possible.

High-risk patients should be closely monitored, as well as those who are under treatment with drugs that may promote or aggravate gastrointestinal bleeding, such as oral anticoagulants, antiplatelet agents, corticosteroids or SSRIs. If a peptic ulcer or gastrointestinal bleeding appears, treatment will be discontinued. Furthermore, it should be used with caution in people with [INFLAMMATORY BOWEL DISEASE], where NSAIDs may precipitate a crisis.

- Cardiovascular diseases. NSAIDs could lead to fluid retention and edema, which could increase blood pressure and worsen the symptoms of patients with cardiovascular diseases. It is recommended to individually evaluate the benefit / risk ratio in patients with [Hypertension], [HEART FAILURE], [ISCHEMIC CARDIOPATIA], [CEREBRAL ISCHEMIA], [ICTUS] or [PERIPHERAL ARTERIOPATIA], as well as in patients with cardiovascular risk factors , such as [DYSLIPEMIA], [DIABETES] or [TOBACCO]. NSAIDs should always be used at the lowest effective dose and for the shortest period of time.

- Liver effects. Patients with [HEPATIC INSUFFICIENCY] may have their plasma levels increased. Furthermore, due to its high binding to plasma proteins, its free plasma levels could be increased, as has been verified in the case of [HEPATIC CIRROSIS].

On the other hand, the use of NSAIDs has been occasionally related to the appearance of liver symptoms, such as increased transaminases, [ICTERICIA] and [HEPATITIS], which could be serious and even fatal. Due to the risk of toxicity, it is recommended that patients with liver disease use this medicine at the minimum effective dose, and periodically check the liver functionality (transaminases, bilirubin) to detect any indication of liver damage. Its use is contraindicated in severe liver failure (Child-Pugh class C) as there are no data on its safety.

- Skin reactions. The use of NSAIDs has caused very rare, but life-threatening serious adverse reactions, such as exfoliative dermatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome. These adverse reactions are usually early onset, in the first month of treatment. If symptoms of hypersensitivity, mucosal lesions or skin erythema are observed, treatment will be suspended.

- [HYPERSENSITIVITY REACTIONS]. The administration of any NSAID has been linked to the appearance of allergic reactions. Cases of cross hypersensitivity have been reported between different NSAIDs, as well as between NSAIDs and salicylates, so patients with a history of [NSAID ALLERGY] different from this active ingredient or [ALLERGY TO SALICILATES] should use this active ingredient with extreme caution. .

It is recommended to avoid its use in those patients in which a salicylate or an NSAID have previously given rise to serious allergic reactions, including [ASTHMA], [NASAL POLYPS], [ANGIOEDEMA] or [RHINITIS], because there is an increased risk of life-threatening anaphylaxis.

- [ASTHMA]. Asthmatic patients are more likely to experience bronchospasm in the case of administration of an NSAID. Furthermore, they could be more susceptible to anaphylactic symptoms after administration of an NSAID.

- [ALTERATIONS OF COAGULATION]. NSAIDs show antiplatelet activity, although less than that of acetylsalicylic acid.

- [ASEPTIC MENINGITIS]. Rare cases of aseptic meningitis have been reported in patients with NSAIDs, with fever and coma, probably due to a hypersensitivity reaction, although no cross allergy has been found between NSAIDs. This meningitis seems to be more frequent in patients with [COLLAGENOSIS] such as [LUPUS ERITEMATOSO SISTEMICO], although it has also been reported in some patients who did not suffer from these pathologies. In patients treated with NSAIDs who develop symptoms of meningitis, the possibility of aseptic meningitis should be considered.

- Ophthalmic charts. NSAIDs have been linked to the appearance of eye reactions, such as blurred vision, vision loss, impaired color vision, scotoma, or retinal abnormalities.

- [FEMALE INFERTILITY]: Like other NSAIDs, it can decrease female fertility and its use is not recommended in women who want to become pregnant. In women with difficulties conceiving or being studied for infertility, withdrawal of NSAIDs should be considered.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains glucose. Patients with glucose or galactose malabsorption should not take this medicine.

- This medicine contains sucrose. Patients with hereditary [FRUCTOSE INTOLERANCE], glucose or galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

- This medicine contains sucrose. The administration of amounts greater than 5 g daily should be taken into account in patients with [DIABETES].

- This medicine contains glucose. Its use in oral liquids and pharmaceutical forms that remain in contact with the mouth for a time can harm the teeth.

- This medicine contains sucrose. Its use in oral liquids and pharmaceutical forms that remain in contact with the mouth for a time can harm the teeth.

INTERACTIONS

- NSAIDs, including antiplatelet doses of acetylsalicylic acid. Increases the risk of peptic ulcer and gastric bleeding.

-Aliskiren. Possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with compromised renal function (dehydrated or elderly), deterioration of renal function (possible acute renal failure, usually reversible) may be precipitated. Caution, especially in the elderly, monitoring the antihypertensive effect and kidney function.

- SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram). There is an increased risk of bleeding in general, and gastrointestinal in particular, especially in the elderly and patients with a history of digestive bleeding.

- Diuretics. Fflurbiprofen may oppose diuretic and antihypertensive effects. It is recommended to periodically assess blood pressure.

- Glitazones (pioglitazone, rosiglitazone). Theoretical risk of potentiation of edema that both glitazones and NSAIDs can cause. Caution and monitor for possible signs of fluid retention and heart failure (swollen ankles, dyspnea).

- Antiplatelet agents, including pentoxifylline: there is an increased risk of bleeding in general, and gastrointestinal in particular. Administer with caution.

- Potassium supplements: possible increase in potassium levels, with risk of hyperkalemia.

PREGNANCY

Category B of the FDA, in the 3rd quarter category D of the FDA. There are no adequate and well-controlled studies in humans. Occasional use, except shortly before delivery, does not appear to produce fetal adverse effects. However, with chronic use during the 3rd trimester, they could theoretically cause premature closure of the ductus arteriosus of the fetus, by inhibition of prostaglandin synthesis. They can also produce an antiplatelet effect, which could complicate or prolong maternal bleeding and predispose the newborn. Before delivery, they can reduce and even cancel uterine contractility, delaying labor and prolonging pregnancy. The use of these drugs, especially during the third trimester, is only accepted in the absence of safer therapeutic alternatives.

LACTATION

Concentrations of flurbiprofen in milk have been detected below 0.7% of maternal serum. It is highly unlikely that the amount excreted will have a negative impact on the infant. However, caution is recommended for use in nursing mothers.

CHILDREN

This medicine is indicated in adults and children from 12 years of age.

ELDERLY

The elderly are at increased risk of serious consequences of adverse reactions. If the administration of an NSAID is considered necessary, the minimum effective dose should be administered for the minimum time necessary. The patient should be regularly monitored for gastrointestinal bleeding during treatment.

ADVERSE REACTIONS

The following side effects are related to short-term use of flurbiprofen at over-the-counter doses.

- Blood: (<0.1%): [ANEMIA]. (<0.01%): hematopoietic alterations, ([ANEMIA HEMOLITICA], [ANEMIA APLASICA], [NEUTROPENIA], [TROMBOCITOPENIA], [AGRANULOCITOSIS]). The first signs are: fever, sore throat, superficial cold sores, flu-like symptoms, severe tiredness, unexplained bruising and bleeding.

- Nervous system: (<1%): [HEADACHE] and [MAREO]. (0.1-0.01%): [INSOMNIA]

- Respiratory: (0.1-0.01%): [DISNEA]. Exacerbation of [ASTHMA] and [BRONCHIAL SPASM].

- Gastrointestinal: (> 10%): Oral discomfort (burning or itching sensation in the mouth). (1-10%): [ABDOMINAL PAIN], [DIARRHEA], [MOUTH DRYNESS], [MOUTH ULCERA], [NAUSEA] and oral paresthesia. (<1%): [DYSPEPSIA], [FLATULENCE] and vomiting. (0.1-0.01%): [GASTRIC PERFORATION] and [GASTRIC ULCERA] or [DUODENAL ULCERA].

- Renal and urinary: (<0.1%): [INTERSTITIAL NEPHRITIS], [NEPHROTIC SYNDROME] and renal failure.

OVERDOSE

- Symptoms : symptoms due to overdose are unknown, similar drugs have produced gastrointestinal disorders (vomiting, anorexia, abdominal pain), neurological disorders (drowsiness, vertigo, disorientation, headache).

- Measures to be taken : Gastric aspiration and lavage, administration of adsorbent carbon, alkalinization of urine, monitoring and maintenance of vital signs, symptomatic treatment of gastrointestinal irritation, hypotension, respiratory depression and seizures, with monitoring of kidney and liver functions and stool detection of possible gastrointestinal bleeding.

Leaflet Lizifen 8.75 Mg 16 Lozenges