Efferalgan 500 mg 24 cap View larger

Efferalgan 500 mg 24 capsulas

Symptomatic treatment of pain and / or fever mild to moderate in states like, flu, headache, toothache, menstrual pain or muscle aches.

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Active principle
Paracetamol: 500 mg. indications: symptomatic relief of mild to moderate occasional pain, such as headaches and toothaches. febrile states.

Indications
- [PAIN]: symptomatic treatment of mild to moderate pain intensity.
- [FEVER]

Action and mechanism
non-opioid painkiller and antipyretic, derived from p-aminophenol. peripherally blocks pain impulses through reversible inhibition of cyclooxygenase, an enzyme involved in the synthesis of prostaglandins. Antipyretic action is due to inhibition of prostaglandins level located thermoregulatory center in the hypothalamus. It has demonstrated weak anti-inflammatory properties in some non-rheumatic disorders. In other circumstances is not expected antiinflammatory action. A dose equal, antipyretic analgesic paracetamol and power is similar to aspirin.

Pharmacokinetics
orally, rectally :.
- Absorption: Its bioavailability is 75-85%. It is widely and rapidly absorbed (Tmax: 10-60 min), reaching a plasma concentration of 2.1 mcg / ml (single oral dose of 500 mg). The time to maximum effect is 1 to 3 h, and the duration of action is 3 to 4 hours (conventional forms).
- Distribution: Is distributed widely and evenly by most body tissues. The degree of plasma protein binding is 10% -25%.
- Elimination: It is metabolized in the liver by the microsomal P-450, being eliminated mainly with urine, conjugated with glucuronic acid, and to a lesser extent with sulfuric acid, less than 5% is excreted unchanged. A small amount of paracetamol is deacetylated p-aminophenol, metabolite apparently responsible for paracetamol methemoglobinemia. Its half-life is 1.5-3 h. (Increases in overdose and in patients with liver failure). High doses can saturate the usual mechanisms of hepatic metabolism, which makes alternative metabolic pathways leading to hepatotoxic metabolites, glutathione depletion are used.

Posology
Oral:
- Adults: 325-650 mg / 4-6 h or 1g / 6-8 hours, up to 4 g / day.
- Children: Under 3 months: 10 mg / kg per dose, which may be repeated every 4-6 hours to a maximum of 4 doses / day. 3 months to 1 year: 60-120 mg; 1 to 5 years: 120-250 mg; 6-12 years: 250-500 mg. These doses may be repeated every 4-6 h if necessary, up to 4 divided doses / day.
It can be set dosing schedule of 10 mg / kg body weight, by taking, with a minimum of 4 hours or 15 mg / kg, by taking every 6 hours.
Rectal:
- Adults: 600-650 mg / 4-6 h, up to 4 g / day.
- Children: Children 1 to 3 years: 150 mg to be repeated 4 or 5 times a day without exceeding a total of 5 doses in 24 hours. Children 4 to 8 years: 300 mg. This dose may be repeated 4 or 5 times a day without exceeding a total of 5 doses in 24 hours.
- Note: As painful or febrile symptoms disappear, medication should be discontinued. Except prescription, it is not advisable to administer for more than 5 consecutive days without medical advice.
- Renal failure: In case of severe renal impairment (creatinine clearance - Standards for the correct administration: flashtabs: children under 6 years, orodispersible tablets dissolve in a bucket of water or milk (not fruit juice, by the risk of bitter taste) before being customarily administered in adults or children over 6 years orodispersible tablets dissolve in the mouth, they quickly melt in your mouth..

Contraindications
- [ALLERGY Paracetamol].
- [Liver disease] (with or without liver failure), [HEP] viral: increased risk of hepatotoxicity.

Precautions
- [CHRONIC ALCOHOLISM]: Chronic alcohol consumption (more than 3-4 drinks / day) may potentiate the liver toxicity of paracetamol. Chronic alcoholics should avoid prolonged treatment or excessive doses of acetaminophen (should not be given more than 2 g / day). It has been observed increased incidence of hepatotoxicity and gastrointestinal bleeding in patients treated with fixed doses of acetaminophen plus aspirin.
- [ANEMIA] due to the possible occurrence of blood disorders such as thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, etc., caution is recommended in patients with anemia, avoiding prolonged treatment. In these patients there is a risk that is not manifest cyanosis despite high concentrations of methemoglobin.
Also they avoid prolonged treatment in patients with heart or lung disorders.
- [Deficiency anemia glucose 6-phosphate dehydrogenase] have observed cases of hemolysis.
- [RENAL] grave with creatinine clearance below 10 ml / min, the interval between two doses should be at least 8 h. In patients with severe or moderate renal impairment there may be accumulation of conjugated derivatives of paracetamol. prolonged treatment with high doses increase the risk of renal toxicity.
- [ALLERGY SALICYLATES]: paracetamol as an analgesic and antipyretic is a very valid alternative in patients allergic to salicylate. However, bronchospastic reactions have been observed in some asthmatic patients hypersensitive to aspirin or other AINE's. Although the incidence of cross-reaction is low (less than 5%), clinical monitoring is advised in patients allergic to salicylates treated with paracetamol.
- If the pain persists for more than 10 days (5 days for children) or fever for more than 3 days or gets worse or other symptoms appear, you should re-evaluate clinical situation.

Warnings / Tips
ADVICE TO THE PATIENT:
- High doses or prolonged treatment without clinical control, can cause liver disorders, especially in patients who regularly consume alcoholic beverages.
- Do not use this medicine more than 10 days without medical supervision. High doses or prolonged treatment should be taken under doctor supervision.
- Do not exceed the recommended (maximum 4 g / day; 2 g / day in alcoholics) daily dose.
- Do not use paracetamol with anti-inflammatories (AINE'S) without medical consent.
- Caffeine increases the analgesic effect of paracetamol.
- The fenacetina (metabolite of paracetamol) may darken urine.
SPECIAL CONSIDERATIONS:
- During prolonged treatment it is recommended periodic monitoring of liver function and complete blood count.
- Although not significantly reduce inflammation, they have had very positive effects on processes arthritic knee, probably because of its analgesic effect.
- Effervescent granules Some continental a considerable amount of sodium salts.
- Food delays absorption of paracetamol.

Interactions
Paracetamol is metabolized in the liver, leading to hepatotoxic metabolites, which may interact with medicines that use their same metabolic pathways. Thus, clinical data at this level interactions with the following medicines:
- Oral anticoagulants (acenocoumarol, warfarin): possible potentiation of the anticoagulant effect, possible inhibition of hepatic synthesis of coagulation factors. Given their apparent lack clinical relevance, it is considered therapeutic alternative to salicylates, when there anticoagulant therapy. However, the dose and duration of treatment should be as low as possible, with periodic monitoring of INR.
- Ethyl alcohol: potentiation of the toxicity of paracetamol, for possible induction of hepatic production of paracetamol-derived hepatotoxic products.
- Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone): decreased bioavailability of paracetamol and potentiation of overdose hepatotoxicity due to induction of hepatic metabolism.
- Chloramphenicol: potentiation of toxicity of chloramphenicol, their possible inhibition by hepatic metabolism.
- Estrogens decrease plasma levels of paracetamol, possibly inhibiting its effect, possible induction of metabolism.
- Isoniazid: decreased clearance of paracetamol, with possible potentiation of its action and / or toxicity, by inhibiting its hepatic metabolism.
- Lamotrigine: decrease under curve (20%) and half-life (15%) of lamotrigine area, with possible inhibition of its effect, its possible induction of liver metabolism.
- Propranolol: increased plasma levels of paracetamol, for possible inhibition of their hepatic metabolism.
- Rifampicin increased clearance of paracetamol for possible induction of the hepatic metabolism.
In addition, clinical data on interactions with other mechanisms:
- Anticholinergics (glycopyrrolate, propantheline): decreased absorption of paracetamol, with possible inhibition of its effect, by decreasing gastric emptying rate.
- Ion exchange resins (cholestyramine): decreased absorption of paracetamol, with possible inhibition of its effect by binding of paracetamol in intestine.
Acetaminophen may alter the values ​​of the following analytical determinations:
- Blood: increase (biological) transaminases (ALT and AST), alkaline phosphatase, ammonia, bilirubin, creatinine, lactate dehydrogenase (LDH) and urea; increase (analytical interference) glucose; reduction (analytical interference) glucose.
- Urine: increase (analytical interference) of metadrenalina and uric acid.
- Tests of pancreatic function by bentiromide: paracetamol increases the apparent amount of PABA recovered. It is advised to stop taking acetaminophen at least three days prior to administration of bentiromide.
- Determination of 5-hydroxyindoleacetic acid (5-HIAA) in urine for qualitative tests using nitrosonaphtol as a reagent, acetaminophen can produce false negative results. Quantitative tests are not altered.

Pregnancy
Category B FDA. No reproduction studies have been performed with the intravenous form of paracetamol in animals. However, studies with the oral route did not show malformations or fetotoxic effects. Paracetamol crosses the placenta. Clinical experience in intravenous administration of paracetamol is limited. With regard to the oral route, there is no evidence of a link between paracetamol use and birth defects. In one study, three cases of congenital hip dislocation may be associated with paracetamol, however, confirmation is required. Also, there has been a case of severe anemia in a mother and fatal kidney disease in the neonate probably due to the use of continuous daily oral doses of the medicine. The use of short term therapeutic oral doses is generally accepted in all stages of pregnancy. Orally, it has been used as an antipyretic just before birth in women with high fever chorioamnionitis, showing a significant improvement in the fetal state and newborn, after normalization of maternal temperature. Intravenous paracetamol should only be used after careful assessment of the benefit-risk. In this case, the recommended dosage and duration must be strictly observed.

Lactation
Paracetamol is excreted in breast milk in low concentrations. Maximum concentrations were observed 10-15 mcg / ml at 1-2 h with single oral dose of 650 mg. paracetamol has not been detected or its metabolites in urine after oral infant maternal administration. No adverse effects have been reported in the newborn after oral maternal administration, except an isolated case of an infant with reversible maculopapular rash on the upper body and face. The American Academy of Pediatrics considers the use paracetamol compatible with breastfeeding.

Children
No registered specifically pediatric problems in this age group, however, there has been liver toxicity and death in isolated cases of children receiving multiple doses of paracetamol excessive. Accepted use in children. It is recommended based on the weight doses, using the measuring system provided with the given dose pharmaceutical formulation in each case, not to exceed the recommended daily dose. You should also report not used in conjunction with other products containing paracetamol because of the potential risk of overdose.

Elderly
Geriatric have seen an increase in the elimination half-life of paracetamol, so it is recommended adult dose reduction of 25%. So far it has not been established whether the risk of hepatotoxicity is increased in these patients. Overall, it is considered the painkiller of choice den mild to moderate pain.

Adverse reactions
Adverse effects of paracetamol are generally infrequent but moderately important in some cases. The most characteristic side effects are:
- Blood: Exceptionally, blood disorders, such as [thrombocytopenia], [leukopenia], [pancytopenia], [NEUTROPENIA], [agranulocytosis] and [haemolytic anemia] (in patients with G6PD deficiency).
- Gastrointestinal: [HEPATOTOXICITY] (associated with overdoses).
- Dermatologic: [Eruptions exantemáticas], [URTICARIA], [DERMATITIS ALLERGIC], [FEVER].
- Endocrine / Metabolic: Exceptionally, [Hypoglycemia], especially children.
- Hepatobiliary: rarely, [Jaundice], [INCREASED transaminase values].
- Genitourinary: [Pyuria] esteril (cloudy urine), renal adverse effects (high dose).
- Cardiovascular: rarely, [HYPOTENSION].

Overdose
- Symptoms of overdose include: dizziness, vomiting, loss of appetite, jaundice and abdominal pain. If swallowed an overdose should quickly go immediately to a medical center even if no symptoms, since these, too severe,
usually they manifest on the third day after ingestion.
Overdosing is evaluated in four phases, starting at the time of ingestion of overdose: Phase | (12-24 h): nausea, vomiting, sweating, anorexia; Phase II (24-48 h): clinical improvement begin to rise in AST, ATL, bilirubin and prothrombin; Phase III (72-96 h): peak hepatotoxicity may occur 20,000 for AST values; Phase IV (7-8 days): recovery.
paracetamol overdose, ingestion of a single dose of more than 6 g in adults and 100 mg / kg in children are considered. 20-25 g higher doses are potentially fatal. Symptoms of liver toxicity include nausea, vomiting, anorexia, malaise, sweating, abdominal pain and diarrhea. Hepatotoxicity not manifested until after 48-72 h after ingestion. Patients in treatment with barbiturates or chronic alcoholics may be susceptible to the toxicity of an overdose of paracetamol.
- Treatment: in all cases will proceed to aspiration and gastric lavage, preferably within 4 h after ingestion.
Specific Antidote: N-acetylcysteine ​​300 mg / kg (equivalent to 1.5 ml / kg of 20% aqueous solution) intravenously for 20 h 15 min according to the following scheme.
I) Adults: Loading dose: 150 mg / kg iv slow or diluted in 200 ml of glucose 5% for 15 minutes. Maintenance: initially 50 mg / kg in 500 ml of 5% glucose in slow infusion for 4 h; subsequently, 100 mg / kg in 1000 ml of 5% glucose iv infusion for 16 h.
II) Children: The period in which treatment offers the best guarantee of effectiveness is within 8 hours following ingestion of the overdose. The effectiveness decreases progressively trascurridas 8 hours, being ineffective after 15 h of intoxication. The volume of the solution of 5% glucose infusion should ajsutarse age and weight of the child.
The administration of N-acetylcysteine ​​solution of 20% prodrá be interrupted when plasma concentrations of paracetamol are less than 200 mcg / ml.

Laboratory
Bristol Myers Squibb

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