Bronchogrip 10 Powder Envelopes For Oral Solution

Bronchogrip (10 Powder Sachets For Oral Solution)

Action and Mechanism - How does Bronchogrip act on?

- Combination of a [ANALGESIC] [ANTIPYRETIC], a [HISTAMINERGIC ANTAGONIST (H-1)] and a [NASO/PHARYNGEAL DECONGESTIONANT]. Paracetamol exerts analgesic and antipyretic effects, probably due to the inhibition of prostaglandin synthesis at a central level. For its part, phenylephrine is an alpha-1 adrenergic agonist, which causes vasoconstriction, reducing nasal congestion. Finally, chlorphenamine antagonizes H1 and cholinergic receptors, eliminating catarrhal symptoms such as sneezing, whining or rhinorrhea.

Indications Bronchogrip Envelopes

Bronchogrip sachets are indicated for the symptomatic relief of the common cold and flu that cause fever, mild or moderate pain and nasal congestion.

Bronchogrip Envelopes Dosage

Adults, the elderly and children from 15 years of age: 1 sachet/6 hours, if necessary. Maximum dose: 4 sachets/day.

- Children and adolescents under 15 years of age: Do not administer, except under medical supervision.

If symptoms persist for more than 3 days, evaluate the clinical situation.

Dosage in renal failure

Do not administer in severe renal failure.

Dosage in liver failure

Do not administer in severe liver failure.

Rules for correct administration

Dissolve the contents of one sachet in half a glass of hot water (not boiling). Let it cool and drink when it reaches a temperature at which it can be drunk.

Advice to the patient

- It is advisable to drink plenty of water during treatment, avoiding alcoholic beverages as much as possible.

- It is recommended not to exceed the recommended daily doses and avoid treatments longer than ten days without a doctor's prescription.

- If symptoms continue or worsen after five days, it is recommended to consult a doctor.

- The doctor or pharmacist must be notified of any illness the patient suffers or any medication the patient is taking.

- It can cause drowsiness, so it is recommended to be careful when driving, and not combine it with drugs or other sedative substances such as alcohol.

Contraindications

- Hypersensitivity to any component of the medication, including cases of [ALLERGY TO PARACETAMOL].

- [HEPATOPATHY], such as severe liver failure or [HEPATITIS]. Paracetamol can cause hepatotoxicity.

- Severe kidney failure.

- [POPHYRIA]. H1 antihistamines are not considered safe in these patients.

- Severe heart disease or uncontrolled diabetes mellitus. There is a risk of serious decompensation.

- [ARTERIAL HYPERTENSION].

- [HYPERTHYROIDISM]

- [TAchyCARDIA]

- Patients on treatment with MAOI antidepressants in the 14 days before starting therapy with phenylephrine (See Interactions).

Precautions

- [RENAL INSUFFICIENCY]. Accumulation of the active ingredients could occur. In these patients, the appearance of adverse renal reactions to paracetamol is more common.

- Patients with [DIABETES], [GLAUCOMA], [CORONARY INSUFFICIENCY], [ISCHEMIC CARDIOPATHY], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [HYPERTHYROIDISM], [PHEOCHROMOCYTOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION ], [MYASTHENIA GRAVE], stenosing [PEPTICA ULCER] or [INTESTINAL OBSTRUCTION]. Both phenylephrine and chlorphenamine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.

- [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE LUNG DISEASE]. Chlorphenamine could worsen these processes due to its anticholinergic effects. Bronchospastic reactions have been described when paracetamol is administered to asthmatic patients with [ALLERGY TO SALICYLATE], so special caution is recommended in these patients.

- [EPILEPSY]. Some H1 antihistamines have been associated with the occurrence of seizures.

- [BLOOD DYSCRASIAS]. Paracetamol could sometimes lead to [ANEMIA], [LEUCOPENIA] or [THROMBOCYTOPENIA]. It is recommended to take extreme precautions, avoiding prolonged treatments, and perform periodic hematological counts in these cases.

- [LIVER FAILURE], Hepatotoxicity. The metabolism of paracetamol could give rise to hepatotoxic substances. It is recommended to avoid its use in patients with previous liver damage (See Contraindications), as well as to take extreme precautions in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity phenomena. It is advisable to avoid prolonged treatments and not exceed doses of 2 g/24 hours in these patients. Likewise, it is recommended to monitor transaminase levels, suspending treatment if a significant increase occurs.

Precautions regarding excipients

- This medicine contains sodium salts, which should be taken into account in patients on low-sodium diets.

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

- This medicine contains aspartame as an excipient. Aspartame contains a source of phenylalanine that can be harmful if you suffer from [PHENYLKETONURIA] (FCN), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it correctly. 10 mg of aspartame equivalent to 5.61 mg of phenylalanine.

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

Special warnings

- In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, controlling coagulation parameters.

- It is recommended to perform hematological counts in patients treated with high doses or for prolonged periods of time.

- It is advisable to control transaminase levels in patients with prolonged treatments or at risk of hepatotoxicity.

- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.

Interactions

- Ethyl alcohol. Ethyl alcohol may enhance the sedative effects of this medication. Additionally, ingesting alcoholic beverages along 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 (anti-migraine ergotamines, oxytocin). Simultaneous use is not recommended because increased vasoconstrictive effects may occur. Antihypertensive alpha blockers or those for benign prostatic hyperplasia, by not blocking beta receptors, may cause an increased risk of hypotension and tachycardia.

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

- Oral anticoagulants. In very rare cases, usually with high doses, the anticoagulant effects could be enhanced by paracetamol's inhibition of hepatic synthesis of coagulation factors. It is recommended to administer the minimum dose, with the lowest possible treatment duration, and control the INR.

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

- 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 enhance the pressor effects of phenylephrine.

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

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

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

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

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

- Diuretics that can cause hypokalemia (furosemide). Hypokalemia may be enhanced and arterial sensitivity to vasopressors such as phenylephrine may be decreased.

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

- Thyroid hormones. There could be a potentiation of the effects of both drugs, with the risk of high blood pressure and coronary insufficiency.

- MAOI. MAOIs could potentiate the effects of phenylephrine by inhibiting the metabolism of norepinephrine, increasing the risk of hypertensive crises and other cardiac events. It is recommended to avoid the administration of this medication 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, decreasing its effects and increasing the risk of hepatotoxicity.

- Lamotrigine. Paracetamol could reduce the serum concentrations of lamotrigine, leading to a decreased therapeutic effect.

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

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

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

- Ion exchange resins (cholestyramine). Decrease in the absorption of paracetamol, with possible inhibition of its effect, due to paracetamol binding in the intestine.

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

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

- Sympathomimetics. There may be an increase in 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 both drugs.

Pregnancy

Some active ingredients of this specialty are capable of crossing the placental barrier. The safety and effectiveness of this medication in pregnant women has not been evaluated, so it is recommended to avoid its administration, unless there are no safer therapeutic alternatives, and as long as the benefits outweigh the possible risks.

Lactation

Some of the active ingredients of this medication are excreted with milk, so it is recommended to discontinue breastfeeding or avoid the use of this medication in pregnant women.

Advanced age

Elderly patients may be more susceptible to the adverse effects of this medication, so it is recommended to use it with caution, and discontinue its administration if the adverse reactions are not tolerable.

No specific problems have been described in elderly patients that require dosage readjustment.

Effects on driving

This medication may substantially affect your ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them.

Adverse reactions

The adverse reactions described are:

- Digestive. Anticholinergic phenomena such as [DRY MOUTH] and [CONSTIPATION] may appear. More rare is the appearance of [ANOREXIA].

- Hepatic. Occasionally [HEPATOPATHY] could occur with or without [JAUNDERY].

- Cardiovascular. [ARTERIAL HYPERTENSION], [TAchyCARDIA].

- Neurological/psychological. Sometimes [Drowsiness], mental [CONFUSION] and [EUPHORIA] may appear. The appearance of phenomena of [EXCITABILITY], with [NERVIOSISM] and [INSOMNIA] is very rare, being especially frequent in children and the elderly.

- Genitourinary. [URINARY RETENTION].

- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [DERMATITIS], [EXANTEMATIC ERUPTIONS], [PHOTOSENSITIVITY REACTIONS] and [HYPERHYDROSIS].

- Ophthalmological. [MYDRIASIS], [BLURRY VISION], [EYE HYPERTENSION].

- Sanguine. [ANEMIA], [HEMOLYTIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOCYTOPENIA].

- Metabolic. Rarely [HYPOGLYCEMIA].

Overdose

Symptoms: Overdose with 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, with 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, diaphoresis, 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, the patient's death 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, you should immediately go to a medical center, 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 the stomach contents will initially proceed, preferably within four hours following 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, for 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 initially administered slowly intravenously over 15 minutes, either directly or diluted in 200 ml of 5% dextrose.

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

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

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

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

Administration of 20% N-acetylcysteine ​​may be stopped when paracetamol blood levels are less than 200 mcg/ml.

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

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

Buy Bronchogrip 10 Powder Envelopes for Oral Solution

Bronchogrip 10 Sachets Powder for Oral Solution  can be purchased without a prescription. As it is a medicine, the price of Enandol is set by the CIPM.

Bronchogrip Leaflet 10 Powder Sachets For Oral Solution