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1. Drug name
Time-night
2. Drug formula ingredients
Each tablet contains: Paracetamol 500mg; Dextromethorphan hydrobromide 15mg
3. Dosage form
Film-coated tablets.
4. Route of administration
Oral route
5. Indications
- Treats cough, sore throat, headache, fever and mild aches or pains due to throat irritation or the common cold.
6. Administration, dosage
Dosage
Adults and children 12 years and older: 1-2 tablets/time x 2-3 times/day.
Administration
Use orally. Drink with cooled boiled water.
7. Contraindications
Hypersensitivity to any ingredient of the drug.
Liver or kidney failure.
Have or are at risk of developing respiratory failure (for example in people with chronic obstructive airway disease or pneumonia, or during an asthma attack or exacerbation of asthma).
Patients are taking or have taken monoamine oxidase inhibitors (MAOIs) in the past two weeks.
Dextromethorphan, like other centrally acting antitussives, should not be used in individuals with or at risk of respiratory depression.
This product is contraindicated in patients taking serotonin reuptake inhibitors (SSRIs, see section 4.5).
Not for use in children under 12 years of age.
8. Special warnings and precautions for use
Caution should be exercised if paracetamol is used concomitantly with flucloxacillin due to an increased risk of high anion gap metabolic acidosis (HAGMA), especially in patients with severe renal impairment, sepsis, malnutrition and deficient sources. other glutathione (e.g. chronic alcoholism), as well as those using maximum daily doses of Paracetamol. Close monitoring is recommended, including measurement of urinary 5-oxoproline concentrations.
Use with caution in the elderly, who are more likely to experience anticholinergic side effects including confusion and paradoxical irritability. Avoid use in elderly patients with confusion.
Children are more likely to experience paradoxical irritability when taking sedating antihistamines.
Medical advice should be sought if symptoms persist or are accompanied by high fever, skin rash or persistent headache.
There have been no specific studies of this product in patients with kidney or liver dysfunction. Because dextromethorphan is extensively metabolized in the liver, caution should be exercised in the presence of liver failure. Underlying liver disease increases the risk of liver damage associated with Paracetamol.
This product should not be taken with any other cough and cold medication.
Use of dextromethorphan with alcohol or other CNS depressants may potentiate CNS effects and cause toxicity at relatively smaller doses.
Caution should be exercised when using this product in children with allergies due to histamine release.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The risk of overdose is higher in people with non-cirrhotic alcoholic liver disease.
Do not exceed the prescribed dose. Always use the measuring cup provided with the box.
Patients should be advised not to use products containing paracetamol or other decongestant containing products concomitantly.
If symptoms persist consult your doctor.
Keep all medications out of sight and reach of children.
Warning: May cause drowsiness. If affected, do not drive or operate machinery.
Avoid drinking alcohol.
Drug dependence, tolerance, and abuse potential
In all patients, prolonged use of this product may lead to physical dependence (addiction), even at therapeutic doses. Risk is increased in people with a history or history of substance abuse (including alcohol abuse) or mental health disorders (e.g., major depression).
Smoking withdrawal syndrome
Withdrawal syndrome is characterized by some or all of the following: restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain, dilated pupils, and palpitations. Other symptoms that may also develop include irritability, agitation, anxiety, hyperactivity, tremor, weakness, insomnia, anorexia, abdominal pain, nausea, vomiting, diarrhea, hypertension, increased respiratory rate or heart rate.
Cases of dextromethorphan abuse and dependence have been reported. Particular caution is required in adolescents and young adults and in patients with a history of drug or psychoactive substance abuse.
Dextromethorphan is metabolized by cytochrome P450 2D6 in the liver. The activity of this enzyme is genetically determined. Approximately 10% of the general population are poor metabolizers of CYP2D6. Poor metabolizers and patients taking concomitant CYP2D6 inhibitors may experience excessive and/or prolonged effects of dextromethorphan. Therefore, caution is advised in patients who are slow CYP2D6 metabolizers or who are taking CYP2D6 inhibitors (see also section 4.5).'
Serotonin syndrome
Serotonin secreting effects, including the development of potentially life-threatening serotonin syndrome, have been reported with dextromethorphan when administered concomitantly with drugs that affect serotonin, such as selective serotonin reuptake inhibitors. (SSRI), drugs that impair serotonin metabolism (including monoamine oxidase inhibitors). (MAOIs)) and CYP2D6 inhibitors.
Serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, treatment with this medicine should be discontinued.
Special label warnings
Do not use with any other products containing Paracetamol.
Medical advice should be sought immediately in case of overdose, even in the absence of signs of overdose.
9. Fertility, pregnancy and lactation
Pregnancy
This product should not be used during pregnancy without medical advice. Epidemiological studies in pregnant women have shown no adverse effects due to the use of Paracetamol at recommended doses, but patients should follow their doctor's advice regarding the use of the drug. A large amount of data in pregnant women indicates no malformative effects or fetal/neonatal toxicity. Epidemiological studies of neurodevelopment in children exposed to paracetamol in utero have shown inconclusive results. If clinically necessary, Paracetamol can be used during pregnancy but should be used at the lowest effective dose for the shortest time and with the lowest possible frequency.
There are no relevant data available for products containing dextromethorphan. Should only be used when deemed necessary by your doctor.
Breastfeeding
This product should not be used while breastfeeding without medical advice.
Paracetamol is excreted in breast milk but in clinically insignificant amounts. Available published data do not contraindicate breastfeeding.
It is not known whether dextromethorphan or its metabolites are excreted in human milk.
As with all medicines, a physician should be consulted before using the product during pregnancy and lactation, and should only be used when considered necessary by the physician.
10. Effects on ability to drive and use machines
The drug may impair cognition and may affect the ability to drive and operate machinery. Be cautious when using medicine.
11. Drug interactions and incompatibilities
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Wine |
Concomitant use of alcohol with dextromethorphan may potentiate the CNS depressant effects of these drugs. Paracetamol's liver toxicity can be increased by drinking too much alcohol. Concomitant use with drugs containing propylene glycol or ethanol may lead to ethanol accumulation and adverse effects, especially in young children with low metabolism or immaturity. |
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Cholestyramine |
Cholestyramine can reduce the absorption rate of Paracetamol. |
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Central nervous system depressants such as antipsychotics, sleeping pills, or anxiolytics |
Dextromethorphan may potentiate the CNS-depressant effects of other CNS depressants or alcohol, antihistamines, or psychotropic drugs. |
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Metoclopramide and domperidone |
The rate of absorption of Paracetamol may be increased when taking metoclopramide or domperidone. |
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Monoamine-oxidase inhibitors (MAOIs) |
Serious reactions, including serotonin syndrome (see below), may occur when this product is taken concurrently with or within two weeks of taking an MAOI. MAOIs may prolong and enhance the anticholinergic effects of antihistamines. Dextromethorphan should be avoided in patients receiving monoamine oxidase inhibitors because serious reactions have been reported. |
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reuptake inhibitors (SSRIs), tricylic antidepressants, or MAOIs |
Dextromethorphan should not be used concurrently in patients receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs because of the risk of serotonin syndrome (e.g., high fever, hypotension). paralysis, severe excitation or coma, mental status, hypertension, restlessness, diaphoresis, trembling and shaking) Antihistamines have additive antimuscarinic effects with other antimuscarinic agents including tricyclic antidepressants. |
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Warfarin and other coumarins |
The anticoagulant effect of warfarin and other coumarins may be enhanced by long-term, regular daily use of Paracetamol with an increased risk of bleeding; Regular dosages have no significant effect. |
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CYP2D6 inhibitor |
Dextromethorphan is metabolized by CYP2D6 and has extensive first-pass metabolism. Concomitant use of strong CYP2D6 enzyme inhibitors may increase dextromethorphan concentrations in the body to levels several times higher than normal. This increases the patient's risk of experiencing dextromethorphan toxicity (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Strong CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine, and terbinafine. When used concurrently with quinidine, dextromethorphan plasma concentrations increased up to 20 times, increasing the drug's central nervous system side effects. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of a CYP2D6 inhibitor and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced. |
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Flucloxacillin |
Caution is advised when using acetaminophen concomitantly with flucloxacillin as concurrent use may lead to high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). |
12. Undesirable effects
During the process of taking medication, it is inevitable that you may encounter some unwanted effects, possibly due to the medication, or possibly due to the infusion technique of the medical staff.
Some unwanted effects that may be encountered when using the drug include:
Hypersensitivity reactions: Skin allergy (itching, rash).
Anaphylaxis.
Fever, chills, hot flashes, malaise.
Vomiting, nausea.
Pain, inflammation at the injection site, necrosis at the injection site.
13. Overdose and treatment
Paracetamol
Liver damage can occur in adults taking 10g or more of Paracetamol. Taking 5g or more of Paracetamol can lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a) Under long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other liver enzyme inducers.
or
b) Regularly use ethanol in excess of recommended levels.
or
c) There is a possibility of glutathione deficiency such as eating disorders, cystic fibrosis, HIV infection, starvation, and weakness.
Symptoms and signs:
Symptoms of Paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, loss of appetite and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis is strongly suggested by lumbago, hematuria, and proteinuria, which may develop even in the absence of severe liver injury. Cardiac arrhythmias and pancreatitis have been reported. Liver damage can occur in adults taking 10g or more of Paracetamol. It is thought that excess amounts of toxic metabolites (which are normally adequately detoxified by glutathione when taking normal doses of paracetamol); becomes irreversibly attached to liver tissue.
To solve:
Immediate treatment is necessary in the management of Paracetamol overdose. Despite the lack of significant initial symptoms, the patient should be transported to an emergency hospital for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or risk of organ damage. Administration should be in accordance with established treatment guidelines, see BNF overdose.
Treatment with activated charcoal should be considered if overdose occurs within 1 hour. Plasma acetaminophen concentrations should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine can be administered up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is achieved up to 8 hours after ingestion. The effectiveness of the antidote drops sharply after this time. If necessary, the patient should receive intravenous N-acetylcysteine, in accordance with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote, out-of-hospital settings. The management of patients who present with severe liver dysfunction after 24 hours of ingestion should be discussed with the NPIS or liver unit.
Dextromethorphan
Overdose effects are increased when alcohol and psychotropic drugs are used concurrently.
Symptoms and signs:
Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolonged), ataxia, toxic psychosis with visual hallucinations, increased irritability.
In case of severe overdose, the following symptoms may be observed: coma, respiratory failure, convulsions.
Other observed overdose symptoms may include gastrointestinal upset, dizziness, restlessness, nervousness, and irritability.
To solve:
- Activated charcoal may be administered to asymptomatic patients who have ingested an overdose of dextromethorphan within the previous hour.
- For patients who have taken dextromethorphan and are sedated or comatose, naloxone at usual doses may be considered to treat opioid overdose.
- Benzodiazepines can be used to treat convulsions, benzodiazepines and external cooling measures can be used for hyperthermia due to serotonin syndrome.
- Other general symptomatic and supportive measures including airway clearance and monitoring of vital signs should be used until stable.
- Observe for at least four hours after administration, or eight hours if an extended-release preparation has been used.
14. Pharmacodynamic properties
Paracetamol: other analgesic and antipyretic, anilide. |
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Pharmacological group: |
Anilides, analgesics and antipyretics |
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ATC code: |
N02B E01 |
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15. Pharmacokinetic properties
Paracetamol is easily absorbed through the upper digestive tract. It is metabolized mainly in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver following oral administration. Genetically controlled O-demethylation (CYD2D6) is a major determinant of dextromethorphan pharmacokinetics in human volunteers.
There appear to be distinct phenotypes for this oxidation leading to highly variable pharmacokinetics between subjects. Unmetabolized dextromethorphan, along with three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugation products in urine.
Dextrorphan, which also has antitussive effects, is the main metabolite. In some individuals, metabolism is slower and unchanged dextromethorphan predominates in the blood and urine.
16. Packaging specifications
Box of 6 tubes x 3 ml with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage conditions: Cool and dry place, protected from light, temperature not exceeding 30 o C.
Expiry date: 36 monthsfrom the date of manufacture.
Quality standards of drugs: IN HOUSE
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
