Daktarin Oral Janssen Gel Treatment of candidiasis (10g)

Dosage form Tube x 10g
Specifications Miconazole

Ingredient

Thành phần cho 10g

Composition information	Content
Miconazole	200mg

Uses

indicated

daktarin oral gel is indicated in the following cases:

Treatment of candidiasis infections in the oral cavity and gastrointestinal tract.

Miconazole has antifungal activity for regular skin fungi and yeasts as well as antibacterial activity for some bacteria and GR (+) bacteria. The activity of the drug is based on the inhibition of Ergosterol biosynthesis in the fungus and changes the lipid composition of the membrane structure, leading to fungal cell necrosis.

Pharmacokinetics

absorption

Miconazole is absorbed the whole body after swallowing the gel. Using the gel mouth of 60 mg miconazole will achieve the peak concentration in plasma 31 - 49 mg/ml, about 2 hours after swallowing.

Distribution

Miconazole is absorbed and cohesive with plasma proteins (88.2%), mainly albumin of serum and red blood cells (10.6%).

Metabolism

The absorption miconazole is almost completely metabolized.

Elimination

less than 1% of the dose is eliminated in a constant form in the urine. The last half -life is 20-25 hours in most patients. The sale time of miconazole in patients with renal failure is constant. Miconazole's plasma plasma concentrations decrease in a moderate level (about 50%) during dialysis. About 50% of oral dose can be eliminated in partial fertilizer for metabolism and a constant part.

Before taking Daktarin Oral Janssen Gel Treatment of candidiasis (10g)

How to use

daktarin oral gel use mouth after meals.

A spoon of medicine is equivalent to 124 mg miconazole every 5 ml of gel.

For young children: Each dose should be divided into smaller parts and use a clean finger to get into the lesion. Do not put the drug in the back of the throat because it is likely to cause suffocation. Do not swallow gel immediately but keep in the mouth as long as possible.

For children 2 years and older and adults: take medicine after meals, keep the gel in the mouth as long as possible.

Dosage

Candida fungus - Most

Children 4 - 24 months old: 1.25 ml of gel (equivalent to ¼ spoon)/ time x 4 times/ day.

Adults and children 2 years and older: 2.5 ml of gel (equivalent to ½ spoon of measuring)/time x 4 times/day.

Continue to treat at least a week after the stagnation disappears.

In case of cantida fungus, every night should remove dentures and scrub with gel.

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?

Symptomatic treatment and support, no specific antidote.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 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

Common, ADR> 1/100

Digestive: dry mouth, nausea, discomfort in the mouth, vomiting.

Status at the place of use: The taste of abnormal product.

Uncommon, 1/1000

Neurological: taste disorders.

Unknown frequency

Immune: Anaphylaxis, hypersensitivity.

Respiratory: asphyxiation.

Digestive: diarrhea, stomatitis, tongue changes.

Skin and subcutaneous tissue: Evaluation, poisoned epidermal necrosis, Stevens-Johnson syndrome, urticaria, rash, acute pustules rash, acute eulogy.

Instructions on how to handle ADR

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

Warnings

Contraindicated

Hypersensitivity to miconazole, other Imidazole derivatives or any excipients of the drug.

Children under 4 months of age or children that swallow reflexes have not developed completely.

Patients with liver dysfunction.

Combined with drugs metabolized by CYP3A4 including: The drug extends the QT (Astemizol, Cisaprid, Dofetilid, Mizolastin, Pimozid, Quinidin, Serindol and Terfenadin), Ergot alkaloi, HMG-CAA Reductase inhibitors (Simvastatin, Lovastatin ...), triazolam and triazolam ...) oral Midazolam.

Be cautious when using

If you plan to simultaneously use Daktarin and a anticoagulant drug, anticoagulant effects should be continued to monitor and adjust the dose carefully.

Serious hypersensitivity reactions include anaphylactic and angioedema, which have been reported during treatment with Daktarin and other micronazol cell forms. Treatment should be stopped if the reaction is suggested as hypersensitivity or irritation.

Main miconazol and phenytoin levels should be monitored if these two drugs are used simultaneously. In patients who are taking several hypoglycemic oral medications such as sulfonylurea, an increase in the treatment effect leads to hypoglycemia that may occur during simultaneous treatment with miconazol and need to consider appropriate treatment measures.

Choking in children and young children, especially in children and children (≥ 4 years): Be careful to make sure the gel does not clog the throat. Therefore, gel should not be used in the back of the throat. Each dose should be divided into smaller parts to mouth with a clean finger, monitor patients because of suffocation may occur.

Also due to the risk of suffocation, not applying gel to the nipple of the mother who is giving her children to provide medicine for children's emulsion. It is important to consider the change in the function of swallowing in children, especially when using miconazole gel for children from 4 to 6 months of age. The lower limit of the age should be increased to 5-6 months of age for early children, or children show slow nerve development.

The drug contains a small amount of ethanol (alcohol), less than 100mg per dose.

Serious skin-skin reactions (eg poisoned epidermal necrosis and Stevens-Johnson syndrome) have been reported in patients using Daktarin Oral Gel. The patient should be notified of signs of serious skin reactions, and should stop using Daktarin Oral Gel when the first signs of the rash.

The ability to drive and operate machinery

daktarin oral gel does not affect the ability to drive and operate machinery.

Pregnancy

Avoid using Daktarin Oral Gel on pregnant women.

The period of breastfeeding

It is unknown whether miconazole will be excreted through breast milk. Should be cautious when using Daktarin Oral Gel on breastfeeding women.

Model interaction

miconazole can inhibit the metabolism of the drug metabolized by CYP3A4 and CYP2C9, which has increased and/or prolonged the effects of those drugs.

Contraindicated Daktarin Oral Gel with drugs metabolized by CYP3A4 include: drugs that extend the QT (Astemizol, Cisaprid, Dofetilid, Mizolastin, Pimozid, Quinidin, Servindol and Terfenadine), Ergot Alkaloi, HMG-COA Reductase inhibitors (Simvastatin, Simvastin, Simvastin (Simvastin, Simvastin (Simvastin, Simvastin (Simvastin (Simvastin, Simvastin Lovastatin ...), Triazolam and Midazolam oral.

Be cautious when using the following drugs with Daktarin Oral Gel because it can be increased or prolonged the treatment effect and/or adverse effects. If necessary, dose reduction and surveillance of plasma concentrations:

Metabolized drugs by CYP2C9, oral anticoagulants such as warfarin, oral hypoglycemic drugs such as sulfonylurea, phenytoin.

Other drugs are metabolized by CYP3A4: HIV protease inhibitors such as saquinavir; Anti -cancer drugs such as Vinca alkaloid, Busulfan and Docetaxel; Immune inhibitors (cyclosporin, tacrolimus, syrolimus); Carbamazepin, Cilostazol, Disopyramid, Bospiron, Alfentanll, Sildenafil, Alprazolam, Brotizolam, Midazolam IV, Rifabutin, Methylprednisolon, Trimetrexat, Ebastin and Reboxetin.

Storage

Store at temperatures below 250C.

Janssen Pharmaceutical Company was founded in 1953 and headquartered in Beerse, Belgium. After nearly 70 years of establishment, Janssen has researched and put into the market many essential drugs. Some outstanding products of the company include Imodium, Haldol, Ergamisol, Daktarin, Vermox, Risperdal, SirtoRo, ...

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