Di-Angesic 30 Codeine Analgiain Average level (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Paracetamol, codeine
Ingredient Pharmaceutical Joint Stock Company TV.Pharm

Ingredient

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Composition informationContent
Paracetamol500mg
Codeine30mg

Uses

indications

DI - Angesic 30 is indicated in the following cases:

Analgesic analgesic average level for adults and children over 12 years in cases of headache, toothache, joint pain, muscle pain, injury or postoperative pain, dysmenorrhea.

Pharmacokology

paracetamol (acetaminophen or N - acetyl - P - Aminophenol)

is the active metabolite of phenacetin, which has an effective analgesic - antipyretic effect that can replace aspirin; However, unlike aspirin, paracetamol is not effective in treating inflammation. With the equal dose calculated by grams, paracetamol has an analgesic and antipyretic effect similar to Aspirin.

paracetamol reduces the body temperature in fever, but rarely reduces the body temperature in normal people. The drug affects the hypothalamus causing cooling, increasing heat due to vasodilation and increased peripheral blood flow.

paracetamol, with treatment dose, less impact on the cardiovascular and respiratory system, does not change acid -base balance, does not cause irritation, ulcers or stomach bleeding as when using salicylate. The effect of paracetamol on cyclooxygenase activity is not fully known. With a dose of 1 g/day, paracetamol is a weak cyclooxygenase inhibitor. The inhibitory effect of paracetamol on cyolooxygenase - 1 weak. Paracetamol is often chosen as an analgesic and antipyretic, especially in the elderly and in people with contraindicated use of salicylate or other NSAIDs, such as people with asthma, a history of peptic ulcer and children.

Paracetamol does not work on platelets or bleeding time.

With the dose of treatment, paracetamol metabolizes mainly through the Sulfate and Glucuronid complex reaction. A small amount usually turns into a toxic metabolite, N - acetyl - P - Benzoquinonimin (Napqi). Napqi is detoxified by glutathion and eliminated into urine and/or bile. When metabolic is not connected to glutathion, it will be toxic to liver cells and cause necrosis.

Paracetamol is often safe when used for treatment, because the amount of Napqi is formed relatively low and glutathion formed in liver cells that are sufficiently associated with NAPQI. However, when overdose or sometimes with common doses used in some sensitive people (such as malnutrition, or drug interaction, alcoholism, genetics), NAPQI concentration can accumulate toxic to the liver.

codeine

Codeine is a derivative of methylmorphin, methyl group replaces the location of hydrogen in the hydroxyl group linked to aromatic nucleus in the morphine molecule, so Codeine has the same pharmacological effect as morphine, which is to reduce pain and reduce cough. Compared to Morphin, Codeine is well absorbed in the form of oral, less constipation and less bile spasms. At the treatment dose, less respiratory inhibitor (60% lower than morphine) and less addictive than morphine and much less pain relief than morphine.

Codeine and its salt have analgesic effect in the case of mild pain and medium analgesic effect of Codein may be due to the conversion of about 10% of the dose used into morphine. When used for pain relief, Codeine should give the lowest dose to reduce the dependence on the drug and often combine with nonsteroidal painkillers such as aspirin, ibuprofen, paracetamol to increase pain relief due to combination effect (pain relief mechanism of different drugs).

Codeine and its salt work to reduce the cough directly due to the effect of the cough in the brain, Codein dries the respiratory discharge and increases the bronchodilation. Codeine is not enough to reduce the cough. Codeine is a cough reduction in the case of dry cough, which causes insomnia.

Codeine causes a decrease in intestinal dynamic, so it is a very good drug in the treatment of diarrhea caused by neuropathy, diabetes. Do not be indicated when supporter and diarrhea due to infection.

pharmacokinetics

paracetamol

absorption

Quick and almost entirely through the digestive tract. Foods can cause long -lasting release pellets to be slowly absorbed in paracetamol. Carbohydrate -rich foods reduce the absorption rate of paracetamol. The peak concentration of plasma is within 30 to 60 minutes after drinking with the dose of treatment.

Distribution

Paracetamol is distributed quickly and evenly in most body tissues. About 25% Paracetamol in the blood combined with plasma protein.

Elimination

The half -life of paracetamol plasma is 1.25 - 3 hours, which can last for toxic doses or in patients with liver damage.

After the treatment dose, 90 to 100%of urine can be found on the first day, mainly after the liver combination with glucuronic acid (about 60%), sulfuric acid (about 35%) or Oystein (about 3%); Small amounts of hydroxyl metabolites are found - chemical and reducing acetyl. Young children are less likely to be more in line with the drug than adults.

paracetamol is n - hydroxylation by cytochrom P450 to create N - Acetyl - Benzoquinonimin, an intermediate reaction. This metabolic substance normally reacts with sulfhydryl groups in glutathion and is dimidated. However, if taking high doses of high dosesParacetamol, this metabolite is formed in sufficient amount to exhaust the glutathion of the liver; In that situation, NAPQ is not connected with glutathion toxic to liver cells, leading to inflammation and can lead to liver necrosis.

codeine

Codeine and its salt are well absorbed through the gastrointestinal tract. After drinking, the concentration of Codeine peak in the blood is achieved after 1 hour.

Codeine is metabolized in the liver by reducing methyl (at O - and N - methyl position in the molecule) to form morphine, norcodeine and other metabolites such as Normorphin and Hydrocodon. The transformation into indirect morphine is influenced by Cytochrom P450 ISOENZYM CYP2D6 and this effect is very different due to the effects of the genetic structure.

Codeine and its metabolic products are excreted mainly through the kidneys and into the urine in the form of an associated with glucuronic acid. Half lifetime elimination is 3-4 hours after drinking. Codeine can be placed in the placenta and distributed into breast milk.

Before taking Di-Angesic 30 Codeine Analgiain Average level (2 blisters x 10 tablets)

How to use

Take oral use.

Dosage

as directed by the doctor or the following dose:

Adults and children over 12 years: 1-2 tablets each time, every 6 hours. Do not use more than 8 tablets/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms of overdose

paracetamol:

  • Paracetamol poisoning can be used by a single dosage, or due to a large dose of paracetamol (for example, 7.5 - 10 g per day, for 1-2 days), or for long -term medication. Gades dependent on the dose are the most serious toxic effect due to overdose and may cause death.
  • Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after taking the poison of the drug. A small amount of sulfhemoglobin can also be produced. Children tend to create methemoglobin easier than adults after taking paracetamol. Next can be inhibiting the central nervous system; Stunned, lower body temperature; tired, fast breathing, shallow; Vascular fast, weak, irregular, low blood pressure, and circulatory failure. Shock may occur if a lot of vasodilation. The suffocating convulsions may occur. Often coma occurs before death suddenly or after a few days of coma. Aminotransferase plasma increases (sometimes very high) and the concentration of bilirubin in plasma can also increase; In addition, when the liver lesions spread, prothrombin time will last. It is possible that 10% of patients with untreated poisoning have serious liver damage; Among them 10% to 20% died of liver failure. The liver biopsy detects the central necrosis of the lobe except the area around the door vein. In cases of non -death, liver lesions recover after weeks or months.

    • codeine:

  • Respiratory failure (reducing breathing, respiratory cheyne - stokes, purple blue). Drinking leads to dysmenorrhea or coma, soft muscle, cold and moist skin, sometimes slow vessels and lowering blood pressure.

    • Overdose treatment

    paracetamol:

  • Early diagnosis is important in the treatment of paracetamol overdose. There are methods to quickly determine the concentration of drugs in plasma. However, do not delay treatment while waiting for the test results if the history is suggested to overdose. When severe poisoning, it is important to treat extreme support. Gastric lavage is needed in any case, preferably within 4 hours after drinking. N - Acetylcystein works when taken or intravenously. It must be for the antidote immediately if less than 36 hours after taking paracetamol. When drinking dilute N - acetylcystein solution with water or drinks without alcohol to achieve a 5% solution and must be taken within 1 hour after mixing. Oral N - Acetylcystein at the first dose should be 140 mg/kg, then give 17 more doses, each dose of 70 mg/kg each 4 hours apart. N - Acetylcysteine ​​can also be used by intravenous line: The initial dose is 150 mg/kg, mixed in 200 ml of 5%glucose, intravenous injection for 15 minutes. Then intravenously dose of 50 mg/kg in 500 ml of 5% glucose for 4 hours; The next is 100 mg/kg in 1 liter of solution for the next 16 hours. Without 5% glucose solution, 0.9% sodium chloride solution may be used.
  • The unwanted effect of N - Acetylcystein includes skin rash (including urticaria, no need to stop the drug), nausea, vomiting, diarrhea, and anaphylactic reaction. If you can use activated carbon before using methionin, you must remove activated carbon from the stomach first. In addition, there are activated carbon and/or salt bleaching, they have the ability to reduce the absorption of paracetamol.

    • codeine:

  • must recover respiration by providing control and respiratory support. Naloxon indications are immediately intravenous in severe cases.

    • What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using DI - Angesic 30, you may experience unwanted effects (ADR).

    paracetamol

    Serious skin reactions such as Stevens - Johnson syndrome, Lyell syndrome, poisonous epidermal necrotic, acne pustules of the body are dangerous, but it is likely to cause death. If you see the appearance or other skin manifestations, you must stop taking the drug and examining a physician.

    Skin rash and other allergic reactions occur. Usually the erythema or urticaria but sometimes worse and may be accompanied by fever due to drugs and mucosal lesions. If you see the fever of water around the natural cavities, you should think of Stevens - Johnson syndrome, stop immediately.

    Patients with susceptibility to rare salicylate sensitive to paracetamol and related drugs. In a few individual cases, paracetamol has caused neutropenia, thrombocytopenia reduces all bloody hematopleus.

    Uncommon, 1/1000

  • DA: Ban.
    • stomach - intestines: nausea, vomiting. Hematology: Dehydration (neutropenia, all bloody hemorrhage, leukopenia), anemia. kidney: kidney disease, kidney toxicity when abusing for a long time.

    Rare, ADR

  • Skin: Stevens - Johnson syndrome, poisoned epidermal necrosis, lyell syndrome, acute all -body pustules.

    • Other: Hypersensitivity reaction.

    codeine

    Common, ADR> 1/100

  • Neurological: headache, dizziness, thirst and a strange feeling.
    • digestive: nausea, vomiting, constipation.

    Urinary: Urinary retention, little urine. Cardiovascular: fast circuit, slow circuit, nervousness, weakness, lower blood pressure.

    Uncommon, 1/1000

  • Allergic reactions: itching, urticaria.
    • Neurology: Respiratory failure, calm, refreshing, restlessness.
  • digestive: stomach pain, bile spasms.

    • Rare, ADR

  • Allergic: Anaphylaxis reaction.
    • nerve: hallucinations, disorientation, visual disorders, convulsions. cardiovascular: circulatory failure.

    Other: blush, sweat, fatigue.

  • Drug addiction: Use Codein for a long time with high doses (from 240 - 540 mg/day) can be addictive. The common manifestations of drug shortages are restlessness, tremor, muscle convulsions, sweating, runny nose. May be dependent on psychological, physical and familiar drugs.

    • Instructions on how to handle ADR

    Paracetamol: If the ADR occurs seriously, Paracetamol must be stopped. Regarding treatment, please read the section: "Overdose and handle".

    Codeine: ADR is rarely occurring when taking the normal dose of oral treatment. Nausea, vomiting, constipation when using the dose repeated many times. Avoid high doses, or prolonged. If necessary, laxatives can be used.

    Notify the doctor with unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    DI - Angesic 30 Contraindicated in the following cases:

  • Sensitive to any ingredients of the drug.
    • Acute respiratory failure.

    Hepatic failure, severe kidney failure.

  • The risk of intestinal paralysis, abdominal distention, acute diarrhea such as ulcerative colitis or colitis due to antibiotics.

    • Diseases accompanied by increased intracranial pressure or traumatic brain injury (because of a diagnosis based on pupil response).

  • Patient in a coma.

    • All ages when the patient is very fast metabolism.

    Pain relief for all children (under 18 years of age) to perform tonsils, scraping V.A to treat sleep apnea.

    Not used for children with breathing problems, including neuromuscular diseases, heart or severe respiratory diseases, respiratory infections, multiple trauma or wide surgery.

  • Mothers breastfeeding because the drug can go to breast milk.
  • Children under 12 years old.

    • Caution when using

    paracetamol

    Serious, fatal skin reactions include Stevens - Johnson syndrome, poisoned epidermal necrosis (ten), all -body pustules syndrome (AGEP: Acute Generalized Exanthematous), Lyell syndrome but rare with paracetamol, often does not depend on the effect of other drugs.

    Although other painkillers and antipyretic (such as NSAID) can cause similar reactions, cross -sensitive with paracetamol does not occur. Patients must stop the drug and see a physician as soon as they see the rash or other skin manifestations or sensitive reactions during treatment. Patients with a history of such reactions should not be used in preparations containing paracetamol.

    Sometimes there are skin reactions including rash, itchy inlaid and urticaria, other hypersensitivity reactions including larynx edema, angioedema and anaphylactic reactions that may rarely occur. Platelets, leukopenia and all bloody hematuria have occurred with the use of P - Aminophenol derivatives, especially when used for large doses. Neutral leukopenia and thrombocytopenic hemorrhage occur when using paracetamol. Rarely loss of grain leukemia for patients using paracetamol.

    Be cautious when used for patients with liver failure, kidney failure, alcoholic, chronic malnutrition or dehydration.

    Must use paracetamol carefully in patients with anemia before, because purple blue may not manifest clearly, although high concentrations at a dangerous level of methemoglobin in the blood.

    Drinking plenty of alcohol can cause toxicity to the liver of paracetamol, should avoid or limit drinking alcohol.

    Coordinate with paracetamol -containing preparations that can cause poisoning or paracetamol overdose.

    codeine

    Be careful when using codeine for people with asthma, or emphysema because Codeine can promote respiratory failure due to increased secretion of secretions in the bronchi and losing cough reflexes.

    Oily and addicted drugs may occur when taking the drug for a long time. Codeine should only be used in the lowest doses effectively and in the shortest time.

    Codeine must be used with caution in people who are weak or in a new person who has a chest or abdominal surgery because of a cough reflex that can lead to phlegm after surgery.

    Be cautious when using drugs for patients with high risk such as elderly people, acute abdominal pain, hypothyroidism, Addison disease, benign prostatic hypertrophy, urethral stenosis.

    Due to the risk of respiratory failure, only the medications containing Codeine to relieve acute pain at an average level for children over 12 years old when other painkillers such as paracetamol and ibuprofen are ineffective.

    The ability to drive and operate machinery

    Caution when used for train drivers, operating machinery because the drug causes drowsiness, dizziness.

    Pregnancy

    Not used for pregnant people.

    The period of breastfeeding

    Codeine must be used to be cautious for mothers who are raising their children with their mother when the mother is known or suspected to be a group of people with extremely fast codeine transformation into morphine due to the effect of cytochrom P450 is0enzym 0Yp2d6 because they can be fatal to breastfeed due to morphine poisoning. Only use when really necessary.

    Drug interaction

    paracetamol

    High doses and extension of paracetamol may slightly increase the anticoagulant effect of marin and indandion derivatives.

    Pay attention to the likelihood of causing serious heat lowering in patients to simultaneously use phenthiazine and cooling therapy.

    Out of alcohol too much and long -term can increase the risk of toxicity on the liver of paracetamol.

    Anti -seizure drugs (phenyntoin, barbiturat, carbamazepin ...) cause enzyme induction in the liver microsom, which can increase the liver toxicity of paracetamol due to increased drug conversion into toxic substances to the liver.

    Lsoniazid and anti -tuberculosis drugs increase the toxicity on the liver of paracetamol.

    Colestyramin reduces paracetamol absorption.

    Probenecid can reduce paracetamol elimination and increase the half -life period in the plasma of paracetamol.

    codeine

    Pain effect of codeine increases when coordinated with aspirin and paracetamol, but decreased or lost by quinidine.

    Codeine reduces cyclosporin metabolism due to inhibition of cytochrom P450 enzyme.

    When using Codeine simultaneously with opioid analgesics, alcohol, anesthesia, calm drugs, sedatives and sleeping pills, three -ring antidepressants, oxidase monoamine inhibitors, and other central neurological inhibitors have the risk of increasing central neurological inhibitors.

    Storage

    In a dry place, not more than 300C, avoid light.

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