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Interdoxin

Reals Pharmaceuticals Limited
Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Email: reals@realsgroup.com
Tel: + 234-1-774-1205
Fax: +234-1-263-0919
Website: http://realsgroup.com

Brand Name

Interdoxin

Manufacturer

PT Interbat, JI. Mampang Prapatan Raya No. 81, South Jakarta 12790, Indonesia.

Therapeutic Class

Antibacterial, Tetracyclines

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-2425): Each capsule contains: Doxycycline hyclate equiv. to Doxycycline 100 mg.

Pack size: 1 blister of 10 capsules; 5 blisters of 10 capsules (in box).

Pharmacology

Interdoxin is a broad-spectrum antibiotic of the tetracycline class. It has a bacteriostatic action on sensitive micro-organism by inhibiting protein synthesis.

Indications

Interdoxin is indicated for: Rocky mountain spotted fever and the typhus group; Q fever; rickettsial pox and fick fever caused byRickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis.

Psittacosis (orniithosis) caused by Chlamydia psittaci.

Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunoflorescence.

Inclusion conjuctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.

Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing due to Borrelia recurrentis.

Interdoxin is also indicated for the treatment of infections caused by the following Gram-negative micro-organisms: Chancroid caused by Haemophillus ducreyi. Plague due to Yersinia pestis (formerly Pasteurella pestis). Tuleremia due to Francisella tulernesis (formally Pasteurella tulerensis).

Cholera caused by Vibrio cholerae (formerly Vibrio comma). Infections caused by Campylobacter fetus. Brucellosis due to Brucella sp (in conjunction with streptomycin).

Bartonellosis due to Bartonella barcilliformis. Granuloma inguinale caused by Calymmatobacerium granulomatis.

Contra-indications

The drug is contradicted in persons who have shown hypersensitivity to any of the tetracyclines. Pregnancy and lactation;

Children < 8 years).

Precautions/Warnings

Because tetracycline have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

In long therapy, periodic laboratory evolution of organic system,includng hematopoietic, renal, and hepatic studies should be performed .

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs and treatment should be discontinued at the first evidence of skin erythema.

The use of antibiotics may occasionally result in over growth of insusceptible organisms.

Constant observation of the patients essential. If a resistant organism appears, the antibiotics should be discontinued and appropriate therapy instituted.

Interactions

Absorption of tetracycline is impaired by antacids containing Aluminum, calcium magnesium, iron, and bismuth.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving doxycycline in conjuction with penicillin.

Riboflavin inhibits the antibiotic activity of tetracyclines. Acidifying agents potentiate tetracyclines.

Adverse Effects

Superinfections caused by insusceptible microrganisms.

Nausea, vomiting and diarrhoea, anorexia, glossitis, dysphagia, enterocollitis and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely.

Skin erythema (discontinue the treatment if this reaction occurs). The tetracycline are deposited in tooth enamel and bone tissues and may bring about tooth discoloration and enamel dysplasia.

Exfoliative dermatitis and photosensitivity.

Hypersensitivity reactions, like urticaria anaphylactic angioneurotic edema, anaphylactoid purpura, pericarditis, and exacerbation of systemic lupus erythematosus.

Bulging fentanels in infants and benign intra cranial hypertension in adults have been reported in individuals receiving full therapeutic dosage. These conditions disappeared rapidly when the drug was discontinued.

Hemolytic anemia thrombocytopenia, neutropenia and eosinophilia have been reported.

When given over prolonged periods, tetracyclines have been reported in produce brown black microscopic discoloration of thyroid glands, no abnormalities of thyroid function studies are known to occur.

Dosage & Administration

Adults and children above eight years of age (and > 50 kg): the usual dose is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

The maintenance dose may be administered as single dose or as 50 mg every 12 hours.

In the management of more severe infections (particularly chronic infections of the urinary tract) 100 mg every 12 hours is recommended.

For children above eight years of age (and

Administration of adequate amounts of fluid with the capsules is recommended to reduce the risk of oesophageal irritation and ulceration.

Exceeding the recommended dosage may result in an increased incidence of side effects.

Storage/Handling Recommendations

Store at room temperature, protected from light, moisture and children.

Review Date

2015-11-19 07:06:55