Apo-Doxy

Apo-Doxy

doxycycline

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Doxycycline.
Description
Each tablet contains doxycycline hyclate 100 mg.
Action
Pharmacology: Pharmacodynamics: Apo-DOXY (doxycycline) is a broad-spectrum antibiotic and is active against a wide range of Gram-negative and Gram-positive organisms. Doxycycline exerts its antimicrobial effect by inhibition of protein synthesis.
Indications/Uses
Apo-DOXY (doxycycline) is indicated for the treatment of: Pneumonia: Single and multilobe pneumonia and broncho-pneumonia due to susceptible strains of Pneumococcus, Streptococcus, Staphylococcus, H. Influenzae and Klebsiella pneumoniae.
Other Respiratory Tract Infections: Pharyngitis, tonsilitis, sinusitis, otitis media, bronchitis caused by susceptible strains of hemolytic Streptococcus, Staphylococcus, Pneumococcus and H. influenzae.
Genitourinary Tract Infections: Pyelonephritis, cystitis, urethritis, gonococcal urethritis caused by susceptible strains of the Klebsiella-Aerobacter group E. coli, Enterococcus, Staphylococcus, Streptococcus and Neisseria gonorrhoeae.
In adult patients with urethritis, cervicitis and vaginitis with a positive test for Chlamydia trachomatis and/or Ureaplasma urealyticum, clinical resolution and absence of detectable organisms have been observed at completion of therapy with doxycycline. Relapses or reinfection can occur. In these cases, limited data suggest that some patients may derive clinical benefit from the administration of doxycycline or an alternative therapy. The effect on long term morbidity has not been established.
Skin and Soft Tissue Infections: Impetigo, furunculosis, cellulitis, abscess, wound sepsis, paronychia caused by susceptible strains of Staphylococcus aureus and albus, Streptococcus, E.coli and the Klebsiella-Aerobacter group.
Gastro-intestinal Infections: Caused by susceptible strains of Shigella, Salmonella and E. coli.
Dosage/Direction for Use
The recommended oral dosage of APO-DOXY (doxycycline) in adults for the majority of susceptible infections is a single loading dose of 200 mg on the first day of treatment followed by a maintenance dosage of 100 mg once daily at the same time each day thereafter.
The recommended dosage schedule for children above 8 years weighing up to 100 pounds is a single loading dose of 2 mg/lb of bodyweight on the first day, followed by a maintenance dosage of 1 mg/lb once daily at the same time each day thereafter.
As absorption is not significantly affected by food or milk APO-DOXY should be given with or after a meal, thus minimizing the possibility of gastric upset. Antacids and iron preparations impair absorption and should not be given concomitantly to patients taking oral doxycycline.
APO-DOXY tabs should be given to patients with adequate amounts of fluids while standing or sitting upright to reduce the risk of esophageal injury.
In severe infections in adults, such as lung abscesses or osteomyelitis, and in chronic urinary tract infections, a single daily dose of 200 mg may be used throughout. For more severe infections in children, up to 2 mg/lb of bodyweight may be given.
Therapy should be continued after symptom and fever have subsided. It should be noted however, that effective antibacterial levels are usually present 24 to 36 hrs following discontinuance of APO-DOXY therapy.
When used in streptococcal infections, therapy should be continued for 10 days to prevent development of rheumatic fever or glomerulonephritis.
For treatment of acute gonococcal infections the recommended dosage is 200 mg stat. and 100 mg at bedtime, the first day, followed by 100 mg b.i.d. for 3 days.
For treatment of uncomplicated urethral endocervical, or vaginal infections in adult associate with Chlamydia trachomatis and Ureaplasma urealyticum: 100 mg, by mouth twice a day for at least 10 days.
No alteration in recommended dosage schedule need be made when treating patients with impaired renal function.
Overdosage
Gastric lavage is necessary.
Contraindications
APO-DOXY is contraindicated in individuals who have shown hypersensitivity to tetracyclines.
Warnings
As with other tetracyclines, APO-DOXY (doxycycline) may form a stable calcium complex in any bone-forming tissue, though in vitro it binds calcium less strongly than do other tetracyclines. Though not observed in clinical studies to date, it should be anticipated that the use of doxycycline, like other tetracyclines, during tooth development (last trimester of pregnancy, during lactation, neonatal period and early childhood) may cause discoloration of the teeth. Though more commonly associated with long-term use of tetracyclines, this effect has also been known to occur after short courses.
Special Precautions
In clinical studies to date doxycycline administration did not lead to increased serum levels nor to an increase in the serum half-life of doxycycline in patients with impaired renal function. APO-DOXY (doxycycline) in normal dosage may be used to treat these patients. Although no evidence of increased toxicity has been observed in such patients, the potential for increased hepatic or other toxicity should be considered until further data on the metabolic fate of doxycycline under these conditions becomes available. Liver function tests should be carried out at regular intervals on patients receiving high doses for prolonged periods of time. Concurrent administration of doxycycline and agents known to hepatotoxic should be avoided if possible.
The use of antibiotics may occasionally result in over-growth of non-susceptible organisms; thus, observation of the patient is essential. There is evidence to suggest that doxycycline may have less effect on the gut flora than other tetracyclines. Doxycycline should not be administered to pregnant and lactating women or neonates until its safety in such cases has been established beyond all reasonable doubt, unless in the judgement of the physician the potential benefit to the patient outweighs the risk to the fetus or child. Certain hypersensitive individuals may develop a photodynamic reaction to sunlight during treatment with doxycycline. If this or any other allergic reaction should occur, medication should be discontinued.
Increased intracranial pressure with bulging fontanelles has been observed in infants receiving therapeutic doses of tetracyclines. Although the mechanism of this phenomenon is unknown, the signs and symptoms have disappeared rapidly upon cessation of treatment without sequelae.
Esophageal injury consisting of esophagitis and esophageal ulceration live rarely been reported in patients receiving doxycycline orally. If this should occur, doxycycline should be discontinued until healing occurs. Administration of antacids and/or cimetidine has provided relief in the treatment of such cases. To reduce the risk of esophageal injury, patients should be advised to take APO-DOXY tabs with an adequate amount of fluid while standing or sitting upright.
Use In Pregnancy & Lactation
Though not observed in clinical studies to date, it should be anticipated that the use of doxycycline, like other tetracyclines, during tooth development (last trimester of pregnancy, during lactation, neonatal period and early childhood) may cause discoloration of the teeth.
Doxycycline should not be administered to pregnant and lactating women or neonates until its safety in such cases has been established beyond all reasonable doubt, unless in the judgement of the physician the potential benefit to the patient outweighs the risk to the fetus or child.
Adverse Reactions
As with other broad-spectrum antibiotics, gastrointestinal disturbances such as nausea, vomiting and diarrhea, as well as glossitis, stomatitis and proctitis, may occur during APO-Doxy (doxycycline) therapy, but have rarely been sufficient troublesome to warrant discontinuation of therapy. Rare instances of esophagitis and esophageal ulcerations in patients receiving the capsule form of doxycycline have been reported (see Dosage & Administration and Precautions).
As with other tetracyclines, elevation of SGOT, or SGPT values, anemia, neutropenia, eosinophilia, leukopenia or elevated BUN have been reported, the significance of which is not known.
Storage
Store in an Air-tight Container. Protect from light.
MIMS Class
ATC Classification
J01AA02 - doxycycline ; Belongs to the class of tetracyclines. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 100 mg (round, light orange, engraved APO-DOXY 100 on one side) x 100's.
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