Anticatarral Edigen 20 Sachets Powder for Oral Solution

Anticatarral Edigen (20 Sachets Powder For Oral Solution)

Paracetamol, Phenylephrine hydrochloride, Chlorphenamine maleate

ACTION AND MECHANISM

- Flu.

* Paracetamol: analgesic and antipyretic, probably due to the inhibition of cyclooxygenase at the central level, especially COX-2, decreasing the synthesis of prostaglandins.

* Chlorphenamine: H1 antihistamine and anticholinergic. Reduces catarrhal symptoms such as sneezing, lacrimation or rhinorrhea.

* Phenylephrine: alpha-1 adrenergic agonist. Produces vasoconstriction, reducing nasal congestion.

INDICATIONS

- Symptomatic treatment of [COMMON COLD] or [FLU] that present with mild or moderate pain, fever, congestion and runny nose in adults and adolescents from 12 years of age.

POSOLOGY

- Adults and adolescents> 12 years: 1 envelope / 6-8 h. Maximum dose 4 sachets / 24 h.

- Children <12 years: not recommended because the content of paracetamol is not adjusted to this age.

- Elderly: no specific dosage recommendations have been made. Use with caution.

Duration of treatment: consult your doctor and / or pharmacist if symptoms continue for more than 3 days (fever) or 5 days (pain and other symptoms), or if new symptoms appear. Stop treatment when symptoms disappear.

Missed dose: administer the forgotten dose as soon as possible, unless there is a short time before the next one. Administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY INSUFFICIENCY

Adjust the dose of paracetamol based on the degree of CrCl:

- Mild renal insufficiency (CrCl 50-90 ml / min): does not require dose adjustment.

- Moderate to severe renal failure (CrCl 10-50 ml / min): 500 mg / 6 h.

- End-stage renal failure (CrCl <10 ml / min): 500 mg / 8 h.

DOSAGE IN LIVER INSUFFICIENCY

- Mild to moderate hepatic impairment (Child-Pugh classes A and B): maximum dose 4 sachets / 24 h, with a minimum interval between doses of 8 h.

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

RULES FOR CORRECT ADMINISTRATION

- Envelopes: dissolve the contents of the envelope in half a glass of liquid, preferably water.

Administration with food: can be taken with or without food.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug, including [ALLERGY TO PARACETAMOL]. There may be cross hypersensitivity reactions between different antihistamines.

- Pathologies that could be aggravated by this drug, such as [ARTERIAL HYPERTENSION], [FEOCROMOCITOMA], [HYPERTHROIDISM], [ISCHEMIC CARDIOPATIA], [TACHYCARDIA], [GLAUCOMA] or [DIABETES].

- Severe renal impairment (CrCl <30 ml / min) or severe hepatic impairment (Child-Pugh class C).

- [PORFIRIA]. H1 antihistamines have been associated with the appearance of porphyric outbreaks and are therefore not considered safe in these patients.

- Patients being treated with an MAOI in the previous 14 days (see Interactions; antidepressants).

- Treatment with beta-blockers or other sympathomimetics.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. In general, its use is not recommended in patients with renal insufficiency, since a dosage adjustment is required that would not be possible with this medicine (see Dosage in renal insufficiency for more information).

- [HEPATOTOXICITY]. Paracetamol has been associated with hepatotoxicity phenomena when used at high doses (> 4 g / 24 h) or for prolonged periods of time.

Evaluate its use in case of [HEPATIC INSUFFICIENCY], [HEPATITIS] or [HEPATIC CIRRHOSIS], as well as in patients with other risks of liver damage, such as [CHRONIC ALCOHOLISM], [HYPOVOLEMIA], [DEHYDRATION] or [MALNUTRITION] with levels low glutathione, or treated with other hepatotoxic drugs.

Paracetamol doses should not exceed 3 g / 24 h as a general rule.

Avoid the administration of other medications that contain paracetamol, as well as the consumption of alcoholic beverages during treatment.

- [ALLERGY TO SALICILATES]. Patients allergic to acetylsalicylic acid do not usually present with cross-hypersensitivity reactions with paracetamol, but cases of mild bronchospasm have been reported, therefore caution is advised in the case of [ASMA].

- Patients with pathologies that could be aggravated by anticholinergic or sympathomimetic effects, such as [CONSTIPATION], [INTESTINAL OBSTRUCTION], [HIATE HERNIA], [GASTROESOPHAGIC REFLUX DISEASE], [PEPTIC ULCER], stenosing, [COLITIS ULCEROSA] HEART FAILURE], [ATHEROSCLEROSIS], [PERIPHERAL ARTERIOPATHY], [ANEURYSM], [PROSTATIC HYPERPLASIA] or other causes of [URINARY RETENTION].

- Skin tests for hypersensitivity to allergenic extracts. Due to their antihistamine effects, they could give false negatives in diagnostic tests using these extracts. It is recommended to suspend the administration at least 72 hours before performing the test.

- Situations that could raise the body temperature. Anticholinergic drugs could interfere with the body's thermoregulatory capacity, which is why they could favor the appearance of heat stroke in patients exposed to extreme heat, especially the elderly, who perform intense physical exercise with inappropriate clothing or hours, or under drug treatment such as diuretics or others that favor [DEHYDRATION].

PRECAUTIONS RELATING TO EXCIPIENTS

- 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 orange yellow S as an excipient. May cause allergic-type reactions including [ASTHMA], especially in patients with [SALICYLATE ALLERGY].

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

ADVICE TO THE PATIENT

- Avoid drinking alcohol during treatment.

- Do not exceed the recommended doses. Administration of other drugs with paracetamol could lead to very serious poisoning.

- Consult a doctor and / or pharmacist in case the pain continues after 5 days of treatment, the fever lasts for more than 3 days, or the symptoms worsen or new ones appear.

- Avoid driving or doing activities that require your attention until you verify that the treatment does not adversely affect you.

- Advise your doctor and / or pharmacist if you are going to undergo allergy diagnostic tests.

- Tell your doctor and / or pharmacist if you have any of these symptoms:

* Dry mouth, visual disturbances, constipation or inability to urinate.

SPECIAL WARNINGS

- In case the patient experiences difficulty urinating or urine retention, it is recommended to suspend the treatment.

- Patients who are going to undergo allergy tests with the use of allergenic extracts must suspend treatment at least 72 hours before, to avoid false negatives.

INTERACTIONS

- Ethyl alcohol. Ethyl alcohol might enhance the sedative effects of this drug. In addition, the intake of alcoholic beverages together with paracetamol could cause liver damage. It is recommended to avoid alcohol intake during treatment. In chronic alcoholics, no more than 2 g / 24 hours of paracetamol should be administered.

- Alpha blockers (antimigraine ergotamines, oxytocin). Its simultaneous use is not recommended because it may produce an increase in vasoconstrictor effects. Alpha blockers for antihypertensives or for benign prostatic hyperplasia, by not blocking beta receptors can cause an increased risk of hypotension and tachycardia.

- Inhaled anesthetics (halothane). They can increase the risk of arrhythmias.

- Oral anticoagulants. On very rare occasions, normally with high doses, the anticoagulant effects could be potentiated by inhibition of the hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with a duration of treatment as low as possible, and to control the INR.

- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine could potentiate anticholinergic effects, so it is recommended to avoid the association.

- Oral contraceptives. They could increase the plasma clearance of paracetamol, reducing its effects.

- Tricyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, maprotiline). Its simultaneous use can potentiate the pressor effects of phenylephrine.

- Antihypertensives (beta blockers, diuretics, guanethidine, methyldopa). Phenylephrine could antagonize the antihypertensive effects, and even lead to hypertensive crisis, so it is recommended to monitor blood pressure. Propranolol could inhibit the metabolism of paracetamol, leading to toxic effects.

- Atropine. It blocks the reflex bradycardia caused by phenylephrine and increases the pressor response to phenylephrine.

- Active carbon. It can produce an adsorption of paracetamol, reducing its absorption and pharmacological effects.

- Chloramphenicol. The toxicity of chloramphenicol could be enhanced, probably by inhibiting its metabolism.

- Digital. The risk of phenylephrine-associated cardiac arrhythmias could be increased.

- Diuretics that can cause hypokalaemia (furosemide). Hypokalemia may be potentiated and arterial sensitivity to vasopressors such as phenylephrine may decrease.

- Nerve stimulants (amphetamines, cocaine, xanthines). Nerve stimulation could be enhanced, leading to intense excitability.

- Thyroid hormones. A potentiation of the effects of both drugs could occur, with a risk of arterial hypertension and coronary insufficiency.

- MAOI. MAOIs could potentiate the effects of phenylephrine by inhibiting norepinephrine metabolism, increasing the risk of hypertensive crisis and other cardiac events. It is recommended to avoid the administration of this medicine in patients treated with MAOIs in the previous 14 days.

- Enzyme inducers. Medications such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone, could induce the metabolism of paracetamol, reducing its effects and increasing the risk of hepatotoxicity.

- Lamotrigine. Paracetamol could reduce the serum concentrations of lamotrigine, reducing the therapeutic effect.

- Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a decrease in the dose of the adrenergic agonist might be necessary.

- Metoclopramide and domperidone. They increase the absorption of paracetamol in the small intestine, due to the effect of these drugs on gastric emptying.

- Probenecid. Increases the plasma half-life of paracetamol, by decreasing the degradation and urinary excretion of its metabolites.

- Ion exchange resins (cholestyramine). Decreased absorption of paracetamol, with possible inhibition of its effect, by fixation of paracetamol in the intestine.

- Nitrates. Phenylephrine could antagonize the antianginal effects of nitrates, so it is recommended to avoid the association.

- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The sedative effects could be enhanced.

- Sympathomimetics. It can produce a potentiation of side effects, both of nervous and cardiovascular origin.

- Zidovudine. Although a possible potentiation of zidovudine toxicity (neutropenia, hepatotoxicity) has been described in isolated patients, there does not appear to be any kinetic interaction between the two drugs.

PREGNANCY

Safety in animals : phenylephrine was associated with increased fetal mortality and premature delivery in rabbits, as well as decreased blood flow to the uterus in sheep.

Studies with paracetamol in animals have not shown cases of malformations or foetotoxic effects.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on Fertility : No specific studies have been performed in humans.

LACTATION

Excretion in milk:

- Paracetamol: small amounts (similar to maternal CP).

- Chlorphenamine: unknown. Other antihistamines do.

- Phenylephrine: limited excretion and reduced oral bioavailability.

The consequences for the infant are unknown. It is recommended to avoid its administration during lactation.

KIDS

It can be used in adolescents from 12 years of age at the same doses as in adults.

Its use in children <12 years of age is not recommended because the doses of paracetamol are not adjusted to this age.

SENIORS

No specific problems have been described in the elderly that require a dosage adjustment.

However, these patients could be more sensitive to the side effects of this drug, so it is advisable to use it with caution, paying special attention to the appearance of anticholinergic effects.

EFFECTS ON DRIVING

It can produce significant sedation due to the presence of chlorphenamine. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

"RAM OF PARACETAMOL"

- Hepatic: rare [INCREASE IN TRANSAMINASES], [INCREASE IN ALKALINE PHOSPHATASE], [HYPERBILIRUBINEMIA]; very rare [HEPATOTOXICITY], with [JAUNDICE].

- Cardiovascular: rare [HYPOTENSION].

- Neurological / psychological: [DIZZINESS], [DISORIENTATION], [EXCITABILITY].

- Genitourinary: very rare kidney disorders such as cloudy urine and kidney disorders; frequency unknown [INCREASE IN SERIAL CREATININE], increase in ammonia levels, [INCREASE IN UREIC NITROGEN].

- Allergic: very rare [HYPERSENSITIVITY REACTIONS], with symptoms ranging from [SKIN ERUPTIONS] and [URTICARIA] to [ANAPHYLAXIA].

- Hematological: very rare [THROMBOCYTOPENIA], [AGRANULOCYTOSIS], [LEUCOPENIA], [NEUTROPENIA], [HEMOLITIC ANEMIA], [METAHEMOGLOBINEMIA]. Prothrombin time could be increased, although it does not seem significant.

- Metabolic: very rare [HYPOGLYCAEMIA]; frequency unknown [INCREASE IN LACTATE DEHYDROGENASE].

- General: rare [GENERAL DISASTER].

"CHLORPHENAMINE RAM"

- Digestive: frequency unknown [NAUSEA], [VOMITING], [DIARRHEA], [CONSTIPATION], [ABDOMINAL PAIN], [DRY MOUTH].

- Hepatic: frequency unknown [HEPATITIS], [CHOLESTASIS].

- Cardiovascular: unknown frequency [PALPITATIONS], [HYPOTENSION], [ARTERIAL HYPERTENSION].

- Neurological / psychological: frequency unknown [SOMNOLENCE], [DIZZINESS], [DISTONIA] facial, [ATAXIA], [TREMOR], [PARESTHESIA], [DYSGEUSIA], [PAROSMIA].

In children and the elderly, paradoxical reactions of excitability may appear, with [AGITATION], [INSOMNIA], [NERVIOSISM], [DELUSION], [SEIZURES].

- Respiratory: frequency unknown [NASAL DRYNESS] or throat, [SORE THROAT], thickening of mucus, [THORACIC TIGHTENING], [WHEELING].

- Genitourinary: unknown frequency [URINARY RETENTION] or difficulties when urinating, [SEXUAL IMPOTENCE], advance of menstruation.

- Dermatological: frequency unknown [HYPERHIDROSIS].

- Allergic: frequency unknown [HYPERSENSITIVITY REACTIONS], with symptoms such as [COUGH], [DYSPHAGIA], [TACHYCARDIA], [URTICARIA], [EDEMA] facial or [ANGIOEDEMA], [DYSNEA], [FATIGUE]. Also [PHOTOSENSITIVITY REACTIONS].

- Osteomuscular: frequency unknown [MYASTENIA].

- Ophthalmological: frequency unknown [BLURRED VISION], [DIPLOPIA].

- Otic: frequency unknown [TINNITUS], [LABYRINTHTITIS].

- Hematological: frequency unknown [AGRANULOCYTOSIS], [LEUCOPENIA], [APLASIC ANEMIA], [THROMBOCYTOPENIA], [BLEEDING].

- Metabolic: frequency unknown [ANOREXIA].

- General: unknown frequency [FATIGUE], [EDEMA].

"RAM OF PHENYLEPHRINE"

- Digestive: frequency unknown [VOMITING], [HYPERSALIVATION].

- Cardiovascular: frequency unknown [ARTERIAL HYPERTENSION], [HYPOTENSION], [RUBORIZATION], [BRADYCARDIA], [TACHYCARDIA], [ANGINA PEAK], [PALPITATIONS], [HEART ARREST].

- Neurological / psychological: frequency unknown [HEADACHE], [BRAIN HEMORRHAGE], [VERTIGO], [DIZZINESS], dullness.

- Respiratory: frequency unknown [DYSNEA], [PULMONARY EDEMA].

- Genitourinary: frequency unknown [VACILATING MICTION], [URINARY RETENTION].

- Dermatological: frequency unknown [HYPERHYDROSIS], [PARESTHESIA].

- Metabolic: frequency unknown [HYPERGLYCAEMIA], [HYPOGLYCAEMIA].

- General: frequency unknown cold sensation on the skin.

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- Because it contains orange yellow (E-110), it may cause [HYPERSENSITIVITY REACTIONS].

OVERDOSE

Symptoms: Overdose from paracetamol products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately, and may even take up to three days to appear. These symptoms include confusion, excitability, restlessness, nervousness and irritability, dizziness, nausea and vomiting, loss of appetite, and liver damage. Hepatotoxicity usually manifests within 48-72 hours with nausea, vomiting, anorexia, malaise, sweating, jaundice, abdominal pain, diarrhea, and liver failure.

In children, states of drowsiness and alterations in the way of walking also appear.

In the most severe cases, death of the patient may occur due to liver necrosis or acute renal failure.

The minimum toxic dose of paracetamol is 6 g in adults and 100 mg / kg in children. Doses greater than 20-25 g of paracetamol are potentially fatal.

In addition to the symptoms of paracetamol overdose, symptoms of chlorphenamine overdose (deep sedation, anticholinergic symptoms) and phenylephrine (excitability, seizures, tachycardia, high blood pressure) may appear.

Treatment: In case of overdose, go to a medical center immediately, since paracetamol poisoning can be fatal, even if no symptoms appear. In children, early identification of paracetamol overdose is especially important, due to the severity of the condition, as well as the existence of a possible treatment.

In any case, gastric lavage and aspiration of stomach contents will be initially carried out, preferably within four hours of ingestion. The administration of activated charcoal can reduce the amount absorbed.

There is a specific antidote in case of paracetamol poisoning, N-acetylcysteine. It is recommended to administer a dose of 300 mg / kg of N-acetylcysteine, equivalent to 1.5 ml / kg of 20% aqueous solution, with a pH of 6.5, intravenously, over a period of 20 hours and 15 minutes, according to the following scheme:

- Adults. A shock dose of 150 mg / kg (0.75 ml / kg of 20% solution) will be administered initially by slow intravenous route, over 15 minutes, either directly or diluted in 200 ml of 5% dextrose.

Then a maintenance dose with 50 mg / kg (0.25 ml / kg of 20% solution) in 500 ml of 5% dextrose in slow intravenous infusion over 4 hours will be established.

Finally, 100 mg / kg (0.50 ml / kg of 20% solution) in 1000 ml of 5% dextrose will be administered in slow intravenous infusion over 20 hours.

- Kids. The same amounts per unit of weight will be administered as in the adult, but the volumes of dextrose should be adjusted based on the age and weight of the child in order to avoid vascular congestion.

The efficacy of the antidote is maximum if it is administered within 8 hours of ingestion. The effectiveness decreases progressively thereafter and is ineffective after 15 hours.

The administration of 20% N-acetylcysteine ​​can be interrupted when paracetamol levels in the blood are below 200 mcg / ml.

In addition to the administration of the antidote, a symptomatic treatment will be established, keeping the patient under clinical surveillance.

In the event of hepatotoxicity, it is advisable to perform a liver function study and repeat the study at 24-hour intervals.

Edigen Anticatarrhal Leaflet 20 Sachets Powder For Oral Solution