Full Prescribing Info
Azithromycin monohydrate.
Azithromycin monohydrate is active against active bacteria. It passes into the bloodstream from the digestive tract and is carried to the diseased tissue, where it starts acting against the bacteria. Because azithromycin monohydrate remains at the site of infection for longer than other antibiotics, the healing action continues for several days after taking the medicine.
Azyth is suitable for treating the following conditions which are caused by organisms sensitive to azithromycin monohydrate: Infections of the upper and lower respiratory tract eg, ear, nose and throat, bronchitis and pneumonia; skin and soft tissues; genitals due to Chlamydia trachomatis.
Dosage/Direction for Use
Infections of the Genitals Caused by Chlamydia trachomatis: Adults: 1000 mg in 1 single oral administration.
Other Infections: Adults, Children and Infants >45 kg in Weight: 1500 mg in a 3-day or 5-day regimen.
3-Day Regimen: 500 mg/day for 3 days.
5-Day Regimen: 500 mg as a single dose on the 1st day followed by 250 mg once daily on Days 2-5.
Azyth tablet can be taken at any time, irrespective of mealtimes. Azyth tablet should be swallowed whole with sufficient fluid and not chewed.
If possible, doses should be taken at the same time of day. If a dose is missed take the intended dose as soon as remembered, then continue treatment as normal.
No information is yet available. In any case, stomach-pumping and other measures may be required.
Azyth is not advised in the case of serious liver disease. If side effects occur eg, severe and persistent diarrhea the doctor must be informed immediately.
Use in pregnancy & lactation: Do not use if pregnant or breastfeeding.
Special Precautions
Impaired liver function, kidney disease or serious gastrointestinal problems with vomiting and diarrhea; serious allergies or asthma.
Use In Pregnancy & Lactation
Do not use if pregnant or breastfeeding.
Side Effects
Azithromycin monohydrate is generally very well tolerated. The following are almost all observed side effects, even those which are extremely rare. Side effects do not occur in every patient: Hypersensitivity Reactions: Skin and mucous membrane reactions are rare eg, redness with or without itching, sensitivity to light (especially sunlight and UV rays), pains in the joints, swelling and nettle rash. As with other antibiotics, hypersensitivity symptoms can be severe ie, causing allergy, in some cases even fatal reactions (shortness of breath, vomiting, dizziness and hypotension). In some cases the symptoms reappear and require long-term monitoring or treatment.
Gastrointestinal Tract: Problems may occasionally occur in the form of loss of appetite, impaired digestion, loose stools, upper abdominal complains (pain, cramps), nausea, vomiting, diarrhea (in rare cases involving considerable loss of fluid), constipation and flatulence. Rare cases of pseudomembranous colitis and tongue discoloration have been reported.
Liver and Bile Ducts: Cases of impaired liver function including hepatitis, jaundice, hepatic necrosis and hepatic failure have been reported.
Kidneys: Inflammation of the kidneys and acute renal failure have been reported.
Blood Picture: In rare cases, there were changes in the blood picture.
Cardiovascular System: Palpitations, chest pains and irregular heart beat (as with other macrolides) have been reported.
Skin: Skin reactions rarely occur, sometimes involving the mucous membranes (erythema multiforme and Stevens-Johnson syndrome) and tissue necrosis.
Others: Fungal infections and vaginitis rarely occur. Dizziness, vertigo, cramps, headaches, drowsiness and weakness, hyperactivity, agitation, anxiety, nervousness and impaired sensation have been observed. As with other macrolide antibiotics, treatment with azithromycin monohydrate in a few cases resulted in impaired hearing (reduced acuity, deafness, tinnitus). Many of these reports were associated with long-term use of high doses in clinical studies. There have been rare reports of altered sense of taste.
Drug Interactions
Adverse reaction could occur if ergot alkaloids (eg, ergotamine) are used at the same time as Azyth.
Warfarin, cyclosporin, digoxin, theophylline and terfenadine must only be taken according to the physician's instructions. If antacid is used, an interval of 2-3 hrs between taking the 2 medicines.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
FC tab 500 mg x 3's. Powd for susp 200 mg/5 mL x 20 mL x 1's.
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