Oral
DOSAGE AND ADMINISTRATION
Health 2000 Cotrimoxazole DS tablet 960 mg should be taken with fluid, preferably after a meal. Adequate fluids should be taken when on Health 2000 Cotrimoxazole DS tablet 960mg. The patient should notify the physician of skin rash, sore throat, fever or unusual bruising or bleeding.
Adults
and children (above 12 years)
Mild infections
One Health 2000 Cotrimoxazole DS tablet 960mg twice daily.
Severe
infections
One Health 2000 Cotrimoxazole DS tablet 960mg thrice daily.
In impaired
renal function
Dosage adjustment is required.
------------------------------------------------------------------------
Creatinine Recommended
clearance (ml/min) dosage
------------------------------------------------------------------------
> 30 Usual dosage
15 - 30 Half the usual
dosage
<
15 Use of Health 2000 Cotrimoxazole DS tablet 960mg not recommended
-------------------------------------------------------------------------
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
RESPIRATORY
TRACT INFECTIONS
Acute and chronic bronchitis (treatment and prophylaxis), bronchiectasis,
lung abscess, lobar and bronchopneumonia, Pneumocystis carinii pneumonitis,
sinusitis, otitis media.
GENITOURINARY
TRACT INFECTIONS
Pyelonephritis, acute and chronic cystitis, urethritis, prostatitis, male
and female gonorrhoea.
GASTROINTESTINAL
INFECTIONS
Salmonella typhi and S. paratyphi infections including the chronic carrier
state, bacillary dysentery and cholera. (As an adjuvant to fluid and electrolyte
replacement.)
SKIN
AND SOFT TISSUE INFECTIONS
Pyoderma, furuncles, abscesses and wound infections.
(iii) DESCRIPTION OF DOSAGE FORM
Health 2000 Cotrimoxazole DS tablet 960mg, a combination of trimethoprim and sulphamethoxazole (cotrimoxazole) exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of bacterial folic acid. The synergy thus produced, accounts for the high degree of bactericidal activity.
(iv) CONTRAINDICATIONS
Marked liver parenchymal damage, blood dyscrasias, severe renal insufficiency and glucose 6-phosphate dehydrogenase deficiency, known hypersensitivity to sulphonamides and/or trimethoprim. Treatment must be discontinued on the appearance of a skin rash, or if any element of the blood count is reduced.
Warnings and Precautions
DRUG
INTERACTIONS
Cyclosporin: A decrease in the therapeutic effect
of cyclosporin and an increased risk of nephrotoxicity may occur on coadministration
of cotrimoxazole.
Methotrexate: The bone marrow depressant effects
of methotrexates may be potentiated by sulphamethoxazole .
Phenytoin: Hepatic clearance of phenytoin may be decreased and half life increased.
Diuretics: An increased incidence of thrombocytopenia with purpura has been observed in elderly patients concurrently receiving certain diuretics, primarily thiazides.
Hypoglycaemics: Care should be taken when giving Health 2000 Cotrimoxazole DS tablet 960mg to patients receiving strongly serum proteinbound drugs such as oral hypoglycaemic agents or coumarin anticoagulants as the action of these drugs may be increased. Health 2000 Cotrimoxazole DS tablet 960mg may prolong the prothrombin time in patients receiving the anticoagulant, warfarin. This interaction should be borne in mind when Health 2000 Cotrimoxazole DS tablet 960mg is given to patients already on anticoagulant therapy. In such cases, the coagulation time should be redetermined.
PREGNANCY
Health 2000 Cotrimoxazole DS tablet 960mg is not recommended
for use in pregnant women.
NURSING
MOTHERS
Health 2000 Cotrimoxazole DS tablet 960mg is not recommended
for use by nursing mothers, because both drugs are secreted in breast milk.
PAEDIATRIC
USE
Not recommended for premature babies and full term infants during the first
six weeks of life.
IN
THE ELDERLY
There is an increased risk of severe adverse reactions in the elderly and
in patients with bronchial asthma.
IN
IMPAIRED RENAL FUNCTION
See Dosage and Administration.
IN
IMPAIRED HEPATIC FUNCTION
The drug should be given with caution in these patients.
DURATION
OF THERAPY
The indiscriminate use of Health 2000 Cotrimoxazole DS tablet 960mg
for common conditions can lead to serious blood disorders.
Longterm therapy particularly in elderly patients for prolonged periods (exceeding three months), requires regular monthly blood counts since it has been suggested that the elderly are more susceptible to blood dyscrasias.
OTHERS
Adequate fluid intake should be ensured to maintain an adequate urinary output
in order to prevent crystalluria and stone formation.
(v) SIDE EFFECTS
The most common side effects are gastro-intestinal disturbances and allergic skin reactions. Hypersensitivity reactions have occasionally been reported.
Overdosage
Symptoms and signs of overdosage may include nausea, vomiting, mental and
visual disturbances, pyrexia, petechiae, purpura, jaundice, anorexia, colic,
bone marrow depression and abdominal pain. Blood dyscrasias are potential
late manifestations. Haematuria, crystalluria and anuria may occur in severe
cases.
Treatment is symptomatic and may include gastric lavage and forced diuresis. Alkalinisation of the urine may aid the elimination of the sulphamethoxazole component but may decrease the elimination of the trimethoprim component.
Hypersensitivity reactions may require treatment with steroids. Calcium folinate, 3 to 6 mg intramuscularly for five to seven days, may be given to counteract the effects of trimethoprim on haemopoiesis
(vi) TOXIC EFFECTS
Mutagenicity, Carcinogenicity and Teratogenicity
Considerable experience of safety is observed in first trimester. Cotrimoxazole is Kernicterus to fetus. There are no known human data on long-term potential for carinogenicity, mutagenicity, or impairment of fertility. A few cases of accelerated growth of lung carcinoma have been reported in man, but a causal relationship with the drug has not been established. No evidence of carcinogenicity was found in male mice of the same strain, mice of a different strain, or rats under similar experimental conditions