Hympashym Oxytetracycline Hydrochloride Capsules

HYMPASHYM

OXYTETRACYCLINE CAPSULES BP 250mg

 

COMPOSITION

Each capsule contains Oxytetracycline Hydrochloride equivalent to 250 mg Oxytetracycline.

 

PHARMACOLOGICAL CLASSIFICATION

Broad and medium spectrum antibiotics.

 

PHARMACOLOGICAL ACTION

Oxytetracycline is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). In vitro activity does not necessarily imply in vivo efficacy.

It is particularly effective in vitro against the following organisms:

Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrensis, Calymmtobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.

Oxytetracycline is also effective against the following organisms in vitro:

Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyecs israelii, Bacillus anthracis, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusopathiae.

 

INDICATIONS

Infections caused by susceptible strains of pathogens:

Upper and lower respiratory tract: Sinusitis, pharyngitis, pneumonia and psittacosis

Genito-urinary tract: Non-specific urethritis, lymphogranuloma venereum, chancroid and granuloma inguinale, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphillis (in cases of penicillin allergy).

Soft tissue.

Acne Ophthalmic.

Trachoma and indusion conjunctivitis; Intestinal.

Cholera, Whipple’s disease, and tropical Sprue; Miscellaneous.

Rickettsial infections, brucellosis, tularema, actinomycosis, Lyme disease, yaws, relapsing fever.

Leptospirosis, during the early infective phase.

 

CONTRA-INDICATIONS

In patients with renal impairment

Hypersensitivity to any tetracycline.

Oxytetracycline should not be given in pregnancy, lactation and in young children.

 

WARNINGS

Use with care in patients with liver function impairment;

Do not use concomitantly with hepatotoxic medicines;

Tooth discolouration, enamel hypoplasia and retarded bone growth may occur in children under the age of 12 years. These effects may also occur in the foetus if
given to pregnant women;

Symptoms of myasthenia may be aggravated;

Photosensitivity may occur (see “Side effects and Special Precautions”);

Pseudotumor cerebri may occur.

 

DOSAGE AND DIRECTIONS FOR USE

Oxytetracyline should be taken either one hour before meals or two hours after meals.

The maximum dose for oxytetracyline should not exceed 3g daily for adults and 50 mg/kg body mass/day for children.

The usual dose for Oxytetracycline for the commonly occurring infection, depending on the severity, is 250 to 500 mg every six hours.

For acne, the adult dosage is as follows: 250 mg twice daily.

 

SIDE EFFECTS AND SPECIAL PRECAUTIONS

Oxytetracycline is not indicated for treating commonly occurring infections in children under 12 years of age.

Gastro-intestinal: Nausea, Vomiting, Diarrhea, Glossitis, Dysphagia related to oesophagitis.

Secondary fungal overgrowth (Candida Albicans): Oral candidiasis, Vulvovaginitis, Pruritus ani.

Secondary bacterial overgrowth infections may occur.

Resistant coliform organisms such as Proteus spp. may cause diarrhea.

Super-infection due to resistant staphylococci may cause fulminating enteritis.

Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses.

Blood abnormalities: Haemolytic anaemia, Eosinophilia, Neutropenis, Thrombocytopenia.

Vitamin deficiencies may occur.

Allergic (hypersensitivity) reactions: Urticaria Maculopapular & erythematous rashes, Exfoliative dermatitis, Exacerbation of systemic lupus erythematous pericarditis, Henoch-Schonlein purpura (anaphylactoid purpura), Angioneurotic oedema, Anaphylaxis.

Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur.
The use of expired oxytetracycline may lead to the Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis and aminoaciduria.

Raised intracranial pressure (pseudotumor cerebri).

 

INTERACTIONS

Absorption of oxytetracycline is diminished by milk, alkalis, aluminium hydroxide and other di-and trivalent cations such as calcium iron and magnesium if they are
given concomitantly.

Doses of anticoagulants may need to be reduced if given concomitantly with oxytetracycline.

Penicillin should not be given concomitantly with oxytetracycline as antagonism in action may occur.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See “Side effects and Special Precautions”. Treatment is symptomatic and supportive.

 

IDENTIFICATION

A hard gelatin capsule ( Size 0) with dark green cap and light green body.

 

PRESENTATION

Blister pack of 12.

 

STORAGE INSTRUCTIONS

Store in a cool dry pace (below 25oC) away from light.

KEEP OUT OF REACH OF CHILDREN

 

MANUFACTURED BY

YANGZHOU NORIER PHARMACEUITICAL CO., LTD.

YANGZHOU, JIANGSU, CHINA

 

EXPORTED BY

NOUVASANT PHARMHEALTH LTD.

NO. 217, ZHONGSHAN NORTH ROAD,

NANJING, CHINA.

WWW.NOUVASANT.COM

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