Bostacet Boston medicine treats medium to severe pain (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Paracetamol, tramadol
Ingredient Boston

Ingredient

Thành phần cho 1 viên

Composition information	Content
Paracetamol	325mg
Tramadol	37.5mg

Uses

Indications

Bostacet analgesic are indicated in the following cases:

Treatment of medium to severe pain.

Paracetamol (acetaminophen) is a synthetic analgesic, derivative of p-aminophenol. The mechanism of antipyretic and analgesic effects like salicylic acid and its derivative but paracetamol does not have anti -inflammatory and anti -plateletic binding effects like salicylic acid.

paracetamol works to reduce body temperature in a fever, but does not reduce body temperature in normal people. The drug acts on the hypothalamus causing cooling, increasing heat due to vasodilation and increasing peripheral blood flow.

When evaluating on animals in the laboratory, the combination of paracetamol and tramadol shows that they have a force impact.

pharmacokinetic

absorption

The average bioavailability of tramadol hydrochloride is about 70%. The peak concentration in plasma is about 2 and 3 hours after drinking. Absorb paracetamol after oral oral occurs quickly, almost completely and in the small intestine. Paracetamol's peak in plasma concentration is achieved within 1 hour after drinking with tramadol.

Take medicine with food without any change in the peak concentration in plasma or the level of absorption of tramadol or paracetamol, so it can be taken without depending on the meal.

Distribution

Tramadol's distribution volume after intravenous injection of 100mg on men and women corresponding to 2.6 and 2.9L/kg respectively. About 20% tramadol binds to plasma proteins. Paracetamol is widely distributed, most of the body's tissue eliminates fat tissue. The distribution volume is about 0.9L/kg. A small percentage (about 20%) Paracetamol binds to protein.

Metabolism

About 30% of the drug is eliminated in the urine in the form of unchanged, while about 60% of the drug is eliminated in the form of metabolites. The metabolites mainly remove methyl groups at N-and O- or combined with glucuronide or sulfate in the liver.

tramadol is metabolized in many ways, including CYP2D6. Paracetamol is metabolized mainly in the most dynamic mechanism and in three separate ways: combined with glucuronide, combined with sulfate and oxidation through Cytochrome P450 enzyme.

Elimination

tramadol and its metabolites excreted mainly through the kidneys. Racemic tramadol and M1's emissions are about 6 and 7 hours, respectively. Racemic tramadol waste time increased by 6 hours to 7 hours when used to increase the dose of Bostacet. The sale time of paracetamol is about 2 to 3 hours, paracetamol is eliminated from the body mainly by combining with glucuronide and sulfate depending on the dose. Under 9% Paracetamol is eliminated in the form of unchanged urine.

Before taking Bostacet Boston medicine treats medium to severe pain (2 blisters x 10 tablets)

How to use

Bostacet analgesic oral analgesic. The drug is not affected by food.

Dosage

Adults and children over 16 years old

The maximum dose is 1 to 2 tablets every 4 to 6 hours and no more than 8 tablets of the day.

Children under 16 years old

Safety and effectiveness of drugs have not been studied in children.

Elderly (over 65 years old)

There is no difference in safety or pharmacokinetic properties between users over 65 years old and younger users.

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? While Naloxone resolves a number (not all) symptoms due to tramadol overdose, the risk of convulsions also increases when used with Naloxone.

Dialysis does not expect to help overdose because it eliminates less than 7% of the medication in 4 hours of filtration. When treating overdose, first of all must ensure breathable. Mechanical vomiting can be caused or using ipeca syrup if the patient is in critical condition (depending on the reflexes of the pharynx and the throat), taking active carbon (1g/kg) after the stomach cleanser.

The first dose should take an additional mild removal dose. If the dose is repeated, alternating with mild bleach. Hypotension is usually due to a decrease in blood volume and should be adequate. Handling vascular shrinkage factors and other supportive measures also need to be implemented. The internal intubation should be placed before performing gastrointestinal therapy with an unconscious patient, and when necessary, respiratory aids.

For patients who are adults and children, any case has taken an unknown amount of paracetamol or when doubted or uncertain about the time to use the drug should determine the concentration of paracetamol in plasma and processed by n-acetylcysteine. If it is impossible to quantify and the amount of paracetamol has been taken exceeding 7.5-10g for adults and adults, 150 mg/kg for children, first should take N-acetylcysteine and continue other handling measures.

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 Bostacet, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nausea, dizziness, dizziness, drowsiness.

Uncommon, 1/1000

weakness, fatigue, emotion.

Abdominal pain, constipation, diarrhea, indigestion, flatulence, dry mouth, vomiting.

Anorexia, anxiety, confusion, stimulation, insomnia, restlessness.

Itching, rash, increased sweating.

Rare, 1/10000

Chest pain, chills, fainting, cessation syndrome.

Loss of balance, convulsions, muscle tension, migraine, muscle contraction, abnormal, bewildered, dizzy.

Difficult to swallow, black feces due to digestive discharge, tongue edema.

Rhythmic, chest drumming, fast pulse, increased or decreased blood pressure.

Anemia.

Difficulty breathing.

albuminuria, urination disorders, little urine, urinary retention.

Cases of reporting when using tramadol include: vertical hypertension, allergic reactions (including anaphylactic reaction, urticaria, Stevens - Johnson syndrome), cognitive dysfunction, want to kill suicide and hepatitis. The abnormalities reported in the laboratory are increased creatinine. Serotonin syndrome (symptoms may be fever, irritation, tremor, anxiety) occurs when using tramadol along with substances that affect serotonin such as selective inhibitors to reconcile serotonin and capillary inhibitors. The monitoring monitoring of tramadol after circulation on the market shows that it rarely changes the effects of warfarin, including increasing blood clotting time.

Doctors need to warn the patient about signs of serious skin reactions such as Steven - Johnson syndrome (SJS), toxic skin necrosis syndrome (Ten) or Lyell syndrome, acute pustules syndrome (AGEP).

Instructions on how to handle ADR

When experiencing side effects of Bostacet, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Bostacet drug contraindicated in the following cases:

Hypersensitivity to tramadol, paracetamol or any ingredients of the drug or with opioids.

In case of acute poisoning caused by alcohol, sleeping pills, narcotic substances, central analgesics, opioid drugs and mental drugs.

Children under 6 years old.

People who are taking Mao inhibitors or newly used (stopping the drug less than 15 days).

Severe respiratory failure.

Severe liver failure.

breastfeeding women

Untreated epilepsy by treatment.

Opioid addiction.

Caution when using

In long -term treatment, if stopping the drug suddenly can cause cessation syndrome with manifestations such as panic, sweating, insomnia, nausea, tremor, diarrhea, hairy. Some cases cause hallucinations, paranoia. Therefore, in treatment, it is recommended to use the lowest doses of tramadol, not to use the drug regularly, long and not suddenly stop but must gradually reduce the dose.

The risk of convulsions when used simultaneously with SSRIs (Serotonin selective reabsorption inhibitors), TCA (3 -round antidepressant compounds), opioids, maoi, sedatives or drugs that reduce seizures, or in patients with seizures, patients with a history of convulsions, or at risk of convulsions.

The risk of respiratory failure in patients with the risk of respiratory failure, high doses of tramadol with anesthetic, anesthetic, alcohol.

Be cautious when using central neurological inhibitors such as alcohol, opioid, anesthetic, anesthetic, sleeping pills and sedatives.

Patients with increased intracranial pressure or head injury.

Patients with opium addiction because it can cause relapse.

Patients with chronic alcoholism and risk of liver toxicity.

Naloxone use in tramadol overdose may cause seizures.

For patients with creatinine clearance under 30ml/minute, it is recommended to use no more than 2 tablets every 12 hours.

Patients with severe liver failure.

People with a history of anaphylaxis with codeine or other opioids when using tramadol are at risk of anaphylactic shock.

Do not use drugs for people with an opioid dependence, because if used tramadol will depend on drugs again.

Be cautious when using tramadol because the drug has the potential for addictive morphine. Patients crave drugs, search for drugs, and increase the dose due to drugs. Avoid prolonged and special drugs for people with a history of opioid addiction.

The ability to drive and operate machinery

tramadol reduces alertness, so do not use drugs when driving a train, operating machinery and working on high.

Pregnancy

tramadol passes through the placenta. There is no complete and reliable research on pregnant women. Safe use for pregnant women has not been confirmed.

Breastfeeding period

should not be used for breastfeeding women because of its safety for children and infants who have not been studied.

Drug interaction

used with Mao inhibitors and Serotonin's reabsorption inhibitors: may increase the risk of side effects, including seizures and serotonin syndrome.

Used with carbamazepine: significantly increases the metabolism of tramadol, reducing the pain effect of tramadol.

Used with quinidine: tramadol is converted into M1 (metabolites that work) with CYP2D6. Drinking quinidine along with tramadol will increase the content of tramadol. Clinical results of this interaction are unknown.

Used with substances belonging to the warfarin group: periodic assessment of foreign blood clotting time due to Inr (International Normalized Ratio - Normal Normal Number) increases in some patients.

Use with CYP2D6 inhibitors: Take Bostacet along with CYP2D6 inhibitors such as fluoxetine, paroxetine and amitriptyline, which can limit tramadol metabolism.

Storage

Where dry, less than 30 ° C, avoid light.

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