Novomycine 1.5 M.u Mekophar tablets for sore throat, acute sinusitis (2 blisters x 8 tablets)

Dosage form Box of 2 blisters x 8 tablets
Specifications Spiramycin

Ingredient

Composition informationContent
Spiramycin1500000iu

Uses

Indication

Novomycine 1.5 M.IU is indicated for treatment of infections caused by sensitive bacteria strains:

  • Sore throat due to Streptococcus beta-Hemolysis, used to replace beta-lactam (especially in case of not using this therapy). chronic. In the case of not typical pneumonia, macrolid antibiotics are indicated regardless of the severity and atopic level. Beta-lactam.
  • Pharmacological

    Spiramycin is a macrolid antibiotic, which works on bacteria that are dividing cells. The mechanism of action of the drug is the effect on the subuniters of 50S of bacterial ribosom and prevent protein synthetic bacteria. In serum concentrations, the drug has the main effect of bacteria, but when it reaches high concentrations, the drug can kill bacteria slowly for sensitive bacteria.

    antibacterial spectrum:

  • Aerobic positive: Bacillus Cereus, Corynebacterium diphtheriae, Enterococci, Rhodococcus spp. Streptococcus Pyogenes.
  • Aerobic Gram: Bordetella Pertussis, Branhamella CatVrhalis, Campylobacter, Legionella, Moraxella.

    Anaerobic bacteria: Actinomyces, bacteroides, eubacterium, mobiluncus, peptostreptococcus, porphyromonas, Prevotella, propionibacterium acnes.

  • Other: Borrelia Burgdorferi, Chlamydia, Coxiella, Leptospira, Mycoplasma Pneumoniae, Treponema Pallidum.
  • resistance:

  • Aerobic: Corynebacterium jeikeium, Nocardia Asteroides.
  • Aerobic grams: Acinetobacter, Enterobacteriaceae, Haemophilus, Pseudomonas. anaerobic: fusobacterium.

    Other: Mycoplasma hominis.

    Spiramycin has in vitro and in vivo activity on Toxoplasma gondii.

    Pharmacokinetics

    absorption

    The absorption of Spiramycin is fast but not completely, and is not changed when used with food.

    Distribution

    After taking a dose of 6 M.IU, the peak concentration in serum reaches 3.3 PG/ml. Selling time in plasma is about 8 hours. The drug does not pass through the bloody barrier, but in the breast milk. The ratio of binding with low plasma proteins (about 10%). Good distribution in salivary glands and tissues (lungs: 20-60 PG/g, amidan: 20-80 PG/G, sinus infection: 75-110 PG/G, bone: 5-100 PG/G).

    After 10 days of stopping the drug, about 5-7 PG/g is active in the spleen, liver and kidney. Macrolid antibiotics are distributed and accumulated in macrophages (neutral polymorphic leukocytes, single white blood cells, peritoneal, lungs). High concentration in humans. These properties explain the effects of macrolid on intracellular bacteria.

    Metabolism

    Spiramycin converts through the liver into active metabolites.

    Elimination

    Semi -cancellation time is from 5–8 hours. Mainly excreted in bile: concentration 15-40 times higher than serum concentration and about 10% through urine.

    Before taking Novomycine 1.5 M.u Mekophar tablets for sore throat, acute sinusitis (2 blisters x 8 tablets)

    How to use

    Take oral use. Take medicine with a glass of water.

    Dosage

    Adults: Take 4-6 tablets/day, 2-3 times a day. Sore throat treatment time is 10 days.

    Preventive meningitis caused by meningocococcus: Adults take 2 tablets/12 hours, for 5 days.

    Patients with renal failure: No dose adjustment.

    The drug has the form of making film tablets that are not suitable for young children.

    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?

    Overdose:

  • The poisoning dose of Spiramycin is not known.
  • Signs that can occur when high doses: nausea, vomiting, diarrhea.

  • Cases of prolonged QT recovery when stopping treatment has been reported in infants treated with high doses of Spiramycin and after intravenous spiramycin intravenous injection in the risk of about QT.
  • How to handle:

  • In case of spiramycin overdose, it is advisable to make electrocardiograms to measure the QT interval, especially when there are other risks (reduced potassium, congenital QTC interval, combined with drugs that extend the amount of QT and/or cause torsion).
  • No specific antidote.
  • Symptomatic treatment.

  • Actively monitor for timely treatment.
  • 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

    Common
  • Digestive: Nausea, vomiting, diarrhea , indigestion.
  • nerve: Bh face, headache .
  • Less

  • Body: fatigue, nosebleeds , sweating, chest pressing.
  • temporary, disturbing, staggering, pain, muscle and joint, burning sensation. digestive: acute colitis.

  • Skin: Ban Da, Ban Ban, Rural.
  • Rare

  • Systemic body: Anaphylaxis, superinfection due to long -term use of spiramycin oral medicine.
  • heart: extend the range of qt.

    Very rare

  • Digestive: fake colitis.
  • DA: Phu Quincke, Anaphylaxis , Syndrome of acne pustules.

    Liver: Unusual liver test. blood: Anemia hemolysis.

    Unknown frequency: liver (cholestatic hepatitis, rarely necrotic).

    Instructions on how to handle ADR:

    Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

    Warnings

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

    Contraindicated

    people with a history of hypersensitivity to Spiramycin, or with other macrolid antibiotics, or any ingredients of the drug.

    Be cautious when using

    When starting to treat, if the body rash appears related to acne, suspect is an acute overseas pustules syndrome, stop using drugs and contraindications to spiramycin in all sugars and related substances.

    The active metabolites are not eliminated through the kidneys, so there is no need to adjust the dose in patients with renal impairment.

    Hemolysis is reported (although very rare) in patients with glucose-6-phosphate-dehydrogenase enzyme deficiency, do not recommend using spiramycin in these objects.

    Use cautiously when using Spiramycin for people with liver dysfunction because the drug can be toxic to the liver.

    Be cautious for people with heart disease, arrhythmia (including people who tend to extend QT).

    The ability to drive and operate machinery

    dizziness can occur after medication. If the patient has this symptom, do not drive a train, operate machinery and do other overhead jobs.

    Pregnancy

    There are no evidence of teratogenic or fetal poisoning, because there is no study of using spiramycin in pregnant women. Spiramycin may be considered for pregnant women when necessary.

    The period of breastfeeding

    Spiramycin is excreted through breast milk with high concentrations. Gastrointestinal disorders have been reported in newborns. Should stop breastfeeding while being treated with this drug.

    Drug interaction

    Levodopa: In coordination with Carbidopa, Carbidopa absorption inhibitors and reduce Levodopa concentration in plasma. Clinically monitor and adjust the dose of levodopa.

    Oral anticoagulant drugs: There have been many reports to increase oral anticoagulant activity in patients with antibiotics.

    Oral contraceptive medicine: Using Spiramycin simultaneously with birth control pills will cause loss of conception effect.

    Spiramycin is small or does not affect the cytochrom P450 enzyme system in the liver; So compared to erythromycin, Spiramycin has less interaction with drugs metabolized by this enzyme.

    Storage

    Store in a dry place, avoid light, temperature not exceeding 300C.

    Other drugs

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