Notus Antitussive 10Mg 24 Pills Honey-Lemon Flavor

Notus Antitussive (10 Mg 24 Honey Pills - Lemon)

ACTION AND MECHANISM

- Antitussive Dextromethorphan is a derivative of 3-methoxy-levorphanol, a codeine analog opioid alkaloid, which acts at the level of the cough center, depressing it. Although its exact mechanism of action is unknown, opiates could act by inhibiting the production of tachykinins, the main neurotransmitters of C fibers, which constitute such a control center.

It has an antitussive effect similar to codeine, but lacks narcotic or depressant effects of the respiratory center.

PHARMACKINETICS

Orally:

- Absorption: rapid absorption, with cmax of 5.2-5.8 ng / ml and tmax of 2 h after a dose of 60 mg. Its effects appear in 15-30 min and last for 6 h. Its bioavailability is reduced due to an intense hepatic first pass effect.

Effect of food: do not affect the pharmacokinetics of dextromethorphan.

- Distribution: your Vd is 7.3 l.

- Metabolism: extensive and rapid in the liver by CYP2D6 and CYP3A4, resulting in several demethylated metabolites. The majority is dextrorphan, partially active, and to a lesser extent 3-methoxy and 3-hydroxy-morphinan, both inactive.

Enzyme inducing / inhibiting capacity: no data available.

- Excretion: in urine (20-86% in 48 h), in the form of free or conjugated metabolites. Minimum amounts in feces (<1%). Its t1 / 2 is 1.4-3.9 h (dextromethorphan) and 3.4-5.6 h (dextrorphan).

Pharmacokinetics in special situations:

- Genetic polymorphism: dextromethorphan is a substrate of CYP2D6, cytochrome P450 isoenzyme from which populations with non-functional alleles have been described, which act as slow metabolizers (up to 6% of population). These patients could see dextromethorphan elimination reduced, with cmax and AUC up to 16 and 150 times higher respectively and prolonged t1 / 2 up to 45 h.

- Other situations: there are no specific data in children, the elderly or patients with renal or hepatic impairment. However, an increase in t1 / 2 is expected in patients with hepatic impairment.

INDICATIONS

- Symptomatic treatment of unpoductive [TOS DRY], such as irritative cough or nervous cough.

POSOLOGY

- Adults: 10-20 mg / 4-6. Maximum dose 120 mg / 24 h.

- Children and adolescents <18 years:

* Adolescents from 12 years: same as adults.

* Children <12 years: not adapted to this age.

- Elderly: no dose adjustment required.

Duration of treatment: it is recommended to use it for the minimum possible time to control the symptoms. If symptoms continue or worsen after 7 days, or if they are accompanied by high fever, skin rashes or persistent headache, consult a doctor and / or pharmacist.

Missed dose: administer the next dose at the usual time. Do not double the next dose.

POSOLOGY IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made. Use with caution.

POSOLOGY IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made. Use with caution.

RULES FOR THE CORRECT ADMINISTRATION

Administration with food: can be taken with or without food. Avoid grapefruit juice or bitter oranges.

- Sucking pills: let the tablet dissolve in the mouth, without chewing or swallowing. Once dissolved, drink a glass of water.

CONTRAINDICATIONS

- Hypersensitivity to dextromethorphan, [OPIOID ALLERGY] or any other component of the medication.

- Severe respiratory diseases such as [ASTHMA], [PRODUCTIVE TOS], [CHRONIC OBSTRUCTIVE PULMONARY DISEASE], [PNEUMONIA], [RESPIRATORY INSUFFICIENCY] or [RESPIRATORY DEPRESSION].

- Children <2 years (see Children).

- Treatment with MAOI, SSRI, bupropion, linezolid, procarbazine or selegiline in the previous 2 weeks (see Interactions; enzyme inhibitors).

- Lactation (see Lactation).

PRECAUTIONS

- Cough. It should not be used in case of chronic cough or in cough due to smoking, as it can impair expectoration and increase the resistance of the respiratory tract.

- Atopic processes. It could worsen the symptoms of diseases such as [ATOPIC DERMATITIS] or [MASTOCITOSIS] due to the increase in histamine release.

- [DRUG OFFICE]. Dextromethorphan can potentially lead to dependency phenomena (cases of abuse have been reported in adolescents, which occasionally produced fatal poisonings), although to a much lesser extent than other opioids such as morphine. It is recommended to take precautions and monitor the patient, especially people with a history of drug dependence, in case of symptoms of abuse, such as mood swings, changes in the person's habits or appearance, abuse of large quantities of products for coughing or disappearance of medicines from the home medicine cabinet.

- Neurological diseases. To assess the benefit / risk ratio in patients with neurological disorders associated with a decrease in the cough reflex, such as [ICTUS], [DEMENTIA] or [PARKINSON'S DISEASE].

- Slow metabolizers. Dextromethorphan is a substrate of CYP2D6. About 10% of the general population is a slow metabolizer of this isoenzyme, with a risk of dextromethorphan accumulation and toxicity. Lower doses of dextromethorphan may be required.

- Limitations in clinical experience. Its efficacy and safety have not been evaluated in patients with [RENAL INSUFFICIENCY] or [HEPATIC INSUFFICIENCY]. Use with caution, especially in severe patients.

PRECAUTIONS RELATING TO EXCIPIENTS

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

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

- 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 sucrose. Its use in oral fluids and pharmaceutical forms that remain in contact with the mouth for some time can harm the teeth.

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

PATIENT ADVICE

- Drink plenty of water during treatment.

- Do not take dextromethorphan if you have been treated with antidepressants in the previous 14 days. Consult your doctor and / or pharmacist.

- Warn your doctor and / or pharmacist if you have symptoms such as persistent cough for more than 7 days despite treatment, or if it is accompanied by severe headache, fever or rash.

SPECIAL WARNINGS

- Monitor the appearance of possible symptoms of dextromethorphan abuse, such as changes in mood, modification of the person's habits or appearance or abuse of large amounts of cough products.

- Risk of serious interactions when associating antidepressants such as MAOI or SSRI, as well as drugs with MAOI activity such as linezolid.

INTERACTIONS

- Expectorants and mucolytics. Inhibition of the cough reflex could lead to pulmonary obstruction in case of increased volume or fluidity of bronchial secretions.

- Hypnotics. Risk of potentiating the sedative effect when associated with alcohol or drugs such as barbiturates, benzodiazepines, antihistamines H1, other opioid analgesics or antipsychotics.

- Enzymatic inhibitors. Dextromethorphan is a CYP2D6 substrate, so its effects and toxicity may be increased by associating drugs such as abiraterone, antiarrhythmics (amiodarone, flecainide), bupropion, coxibes, imatinib or terbinafine. Reduce the dose of dextromethorphan if association is necessary.

Avoid consumption of grapefruit juice or bitter oranges, which can inhibit CYP2D6 and 3A4.

The association of dextromethorphan with certain CYP2D6 inhibitors such as MAOI, drugs with IMAO activity (eg linezolid, procarbazine) or SSRI (eg paroxetine) has been linked to the occurrence of severe serotonergic syndrome. The association is contraindicated, these medications must be at least 14 days apart.

Associate with caution other serotonergic drugs such as tricyclic antidepressants.

- Memantine. Dextromethorphan may potentiate the toxicity of memantine. Avoid the association.

PREGNANCY

Animal safety : dextromethorphan is not teratogenic in animals.

Safety in humans : adequate and well-controlled studies in humans are not available. According to data collected in retrospective studies with women who used dextromethorphan during the initial stages of pregnancy (weeks 4-14), the use of this opioid was not related to an increased risk of congenital malformations, abortion or low birth weight. However, its use could lead to respiratory depression in the newborn. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Fertility effects : no side effects have been observed in animals. No specific studies have been conducted in humans.

LACTATION

Animal safety: no data available.

Safety in humans: it is unknown if it is excreted with milk, and the consequences it could have for the infant. Given the risks of respiratory depression in infants, its use is contraindicated.

CHILDREN

Dextromethorphan could be used in children from 2 years of age, with the corresponding dose adjustments depending on age. It is recommended to select those presentations especially indicated in children between 2-12 years (see Dosage).

Children can be especially sensitive to the adverse effects of opiates.

Its use in <2 years is contraindicated. Serious adverse reactions, some fatal, have been described when using OTC flu medications in these children.

ELDERLY

Although no specific dosage recommendations have been made, it is advised to use with caution. It may be necessary to decrease the dose by administration or increase the interval between doses.

EFFECTS ON DRIVING

Dextromethorphan does not appear to have significant central depressant effects, unlike other opiates. However, dizziness is common.

ADVERSE REACTIONS

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

- Immune system disorders: frequency unknown [HYPERSENSITIVITY REACTIONS] including [ANAFILAXIA], [ANGIOEDEMA], [URTICARIA], [PRURITO], rash and [ERITEMA].

- Psychiatric disorders: very rare [ALUCINATIONS], [OPPOSE DEPENDENCE].

- Nervous system disorders: frequent [MAREO]; very rare [SOMNOLENCE]; unknown frequency [CEFALEA], [CONFUSION].

- Gastrointestinal disorders: frequent [NAUSEAS], [VOMITOS], and intestinal discomfort; unknown frequency [CONDEMNATION].

- Skin and subcutaneous tissue disorders: frequency unknown [MEDICINAL ERUPTION].

- General disorders and administration site conditions: frequent [FATIGUE].

OVERDOSE

Symptoms: Adverse reactions are usually especially important in children and adolescents or in case of abuse. Among the symptoms described are nausea, vomiting and gastrointestinal disorders, dizziness, fatigue, drowsiness, hallucinations, restlessness and excitability. In more severe cases, symptoms such as decreased concentration and consciousness may occur, including coma, dysphoria and euphoria, psychotic disorders such as disorientation and delusions, to confused or paranoid states, increased muscle tone, ataxia, dysarthria, nystagmus, and visual disturbances. , as well as respiratory depression, changes in blood pressure and tachycardia.

Finally there is a risk of serotonergic syndrome.

Measures to take:

- Antidote: in case of severe poisoning, the administration of naloxone (0.01 mg / kg in children) could be considered.

- General disposal measures: gastric lavage with aspiration, followed by the administration of active carbon.

- Monitoring: respiratory and cardiovascular functionality.

- Treatment: keep the airways open, establishing assisted breathing if necessary. Symptomatic treatment.

Notus Antitussive Leaflet 10Mg Honey-Lemon Flavoring