Azifam 250/Azifam 500/Azifam Rediuse
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Azifam 250/Azifam 500/Azifam Rediuse
Full Prescribing Info
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Distributor
Contents
Azithromycin dihydrate.
Indications / Uses
Azifam 250/Azifam 500: For the relief of symptoms of upper and lower respiratory tract infections: Pharyngitis, Tonsillitis, Acute bacterial sinusitis, Acute bacterial otitis media, Acute exacerbation of chronic bronchitis; Mild to moderately severe community acquired pneumonia. Skin and soft tissue infections & Urogenital infections.
Azifam Rediuse: Treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms.
Treatment of upper respiratory tract infections (including ear, nose and throat infections): Tonsilitis, sinusitis, otitis media and pharyngitis; lower respiratory tract infections: Community acquired pneumonias, acute bacterial exacerbations of chronic bronchitis, chronic obstructive pulmonary disease, bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae; genitourinary tract infections (including sexually transmitted diseases): Urethritis, prostatitis, cervicitis, cervico-vaginitis and salpingitis due to N. gonorrhoeae and C. trachomatis; genital ulcer disease (chancroid) in men due to Haemophilus ducreyi; skin and skin sturcture infections: Folliculitis, furuncles, carbuncles, impetigo, pyoderma, infected ulcer, infected dermatitis, cellulitis and erysipelas due to S. aureus, S. pyogenes or S. agalactiae.
Dosage / Direction for Use
Azifam 250/Azifam 500: Azithromycin should be given as a single daily dose. Duration of the treatment for the different infection/diseases is given as follows:
Children and adolescents with a body weight above 45 kg, adults and the elderly: The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg) can be administered in a period of 5 days, 500 mg on the first day and 250 mg on day 2 to 5.
In the case of uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dosage is 1000 mg as a single oral dose.
Children and adolescents with a body weight below 45 kg: Azithromycin tablets are not suitable for patients under 45 kg body weight. Other dosage forms are available for this group of patients.
Elderly patients: For elderly patients, the same doses as for adults can be applied. Since elderly patients can be patients with ongoing proarrhythmic conditions, a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes.
Patients with renal and hepatic impairment: Dose adjustment is not required.
Administration: Oral.
Azifam Rediuse: Treatment of Infections: Adults: 500-2000 mg once a day as a single-dose. Depending on the type of infection, this may be followed with doses of 250-500 mg once a day for several days.
Children and Infants ≥6 months: Dose is based on body weight and must be determined by the physician. Usual Dose: 10-30 mg/kg of body weight once a day as a single-dose. Depending on the type of infection, this may be followed with doses of 5-10 mg/kg of body weight once a day for several days.
Infants <6 months: Use and dose must be determined by the physician.
Treatment of Pharyngitis or Tonsilitis: Adults: 500 mg on Day 1 (first day) as a single-dose. Then, 250 mg on Day 2 through 5.
Children ≥2 years: Dose is based on body weight and must be determined by the physician. Usual Dose:12 mg/kg body weight once a day for 5 days.
Children <2 years: Use and dose must be determined by the physician.
Administration: Azithromycin should be administered as a single-dose or as directed by the physician. It can be taken with or without food.
Overdosage
Azifam 250/Azifam 500: Symptoms: The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea.
Treatment: In the event of overdose, general symptomatic and supportive measures are indicated as required.
Azifam Rediuse: Any medication taken in excess can have serious consequences.
Contraindications
Azifam 250/Azifam 500: Hypersensitivity to any macrolide or ketolide antibiotic, or to any excipient of the formulation.
Azifam Rediuse: Hypersensitivity to azithromycin, erythromycin, macrolide antibiotics, or to any of the excipients of Azifam Rediuse.
Warnings
Azifam Rediuse: In severe kidney or liver disease, the physician may choose to lower the dose of azithromycin normally given or opt to prescribe Azifam Rediuse at all.
Special Precautions
Azifam 250/Azifam 500: Renal and hepatic dysfunction, pseudo-membranous colitis. Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving Azithromycin therapy.
Effects on ability to drive and use machines: The possibility of undesirable effects like dizzines and convulsions should be taken into account when performing these activities.
Azifam Rediuse: Azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Before taking azithromycin, inform physician if the patient has allergy on Azifam Rediuse or to any other antibiotics (eg, erythomycin, clarithromycin, telithromycin), or if the patient have any other allergies.
Use In Pregnancy & Lactation
Azifam 250/Azifam 500: Pregnancy: Caution should be exercised during pregnancy and only be used if the benefit outweighs the risk.
Breast-feeding: Among other things, diarrhoea, fungal infection of the mucous membrane as well as sensitisation is possible in the nursed infant. It is recommended to discard the milk during treament and up until 2 days after discontinuation of treatment. Nursing may be resumed thereafter.
Adverse Reactions
Azifam 250/Azifam 500: Nausea, epigastric distress, vomiting, diarrhea, dizziness, headache and flatulence. Fever, skin rash & cholestatic jaundice.
Azifam Rediuse: The most common adverse effects are related to the gastrointestinal tract eg, nausea, flatulence, vomiting, diarrhea or abdominal pain. Rare adverse effects include abnormal liver tests, allergic reactions and nervousness.
Click to View ADR Monitoring Form
Interactions
Azifam 250/Azifam 500: Aluminium and magnesium containing antacids: Decrease peak serum levels.
Theophylline: Serum concentrations of theophylline increased.
Warfarin: Anticoagulant effects enhanced.
Digoxin & Cyclosporin: Increased in their serum concentrations.
Carbamazepine: Toxicity occurs which may require hospitalization.
Triazolam: Increases serum levels of triazolam leading to toxicity.
Ergot alkaloids: Acute ergotism manifested as peripheral ischaemia.
Food: Absorption reduced by as much as 52% (should be taken 1 hr before or 2 hrs after meal).
Azifam Rediuse: Azithromycin should not be taken at the same time as aluminum or magnesium based antacids because antacids will bind the azithromycin and prevent it from being absorbed from the intestine.
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Storage
Azifam 250/Azifam 500: Store below 30°C. Protect from light and moisture.
Azifam Rediuse: Store below 30°C. Protect from light.
Description
Azifam 250: Each Film-Coated Tablet contains Azithromycin USP (as Dihydrate) eqvt to Azithromycin Anhydrous 250 mg.
Azifam 500: Each Film-Coated Tablet contains Azithromycin USP (as Dihydrate) eqvt to Azithromycin Anhydrous 500 mg.
Azifam Rediuse: Each 5 mL of Azifam Rediuse oral suspension contains azithromycin dihydrate BP equivalent to azithromycin 100 mg and 200 mg.
Excipients/Inactive Ingredients: Azifam Rediuse: Flavoured syrupy base and sunset yellow FCF as colour.
Azithromycin oral suspension contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin prevents bacteria from growing by interfering with their protein synthesis.
Mechanism of Action
Azifam 250/Azifam 500: Pharmacotherapeutic Group: Antibacterials.
Pharmacology: Pharmacodynamics: Azithromycin is an azalide, a sub-class of the macrolide antibiotics. By binding to the 50S ribosomal sub-unit, azithromycin avoids the translocation of peptide chains from one side of the ribosome to the other. As a consequence of this, RNA-dependent protein synthesis in sensitive organisms is prevented.
Pharmacokinetics: Absorption: Bioavailability of Azithromycin after oral administration is approximately 37%. Peak plasma concentrations are attained after 2-3 hours.
Distribution: Orally administered Azithromycin is widely distributed throughout the body. Binding of Azithromycin to serum proteins is variable and varies from 52% at 0.05 mg/L to 18% at 0.5 mg/L, depending on the serum concentration.
Elimination: The terminal plasma elimination half-life from tissues is 2-4 days.
ATC Classification
J01FA10 – azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
POM
Presentation / Packing
Azifam 250: FC tab 250 mg (white to off-white coloured) x 6 x 5’s.
Azifam 500: FC tab 500 mg (white to off-white coloured, scored on one side) x 3 x10’s.
Azifam Rediuse: Oral susp 100 mg/5 mL x 15 mL x 1’s. 200 mg/5 mL x 15 mL x 1’s.
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