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Antibiotics

Cotrimstada/Cotrimstada forte

 

Pack size:

Box of 10 blisters x 10 tablets.

 

Composition:

Each Cotrimstada tablet contains sulfamethoxazole 400 mg and trimethoprim 80 mg.

Each Cotrimstada forte tablet contains sulfamethoxazole 800 mg and trimethoprim 160 mg.

 

Shelf-life:

60 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.


 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Cotrimstada is administered orally with some food or drink to minimize the possibility of GI disturbances. 
  • Dosage of cotrimoxazole is expressed in terms of the trimethoprim content of the fixed combination containing 5 mg of sulfamethoxazole to 1 mg of trimethoprim.
     
  • Acute otitis media
    In children 2 months of age or older, the usual oral dosage of cotrimoxazole is 8 mg/kg of trimethoprim (as cotrimoxazole) daily in 2 divided doses every 12 hours.
    The usual duration of treatment is 10 days.
  • Chronic or recurrent urinary tract infections (UTIs) or prostatitis
    Adults: 160 mg trimethoprim (as cotrimoxazole) every 12 hours for 10 - 14 days for chronic or recurrent UTIs or for 3 - 6 months in men with prostatitis. For the prophylaxis of chronic or recurrent UTIs, cotrimoxazole doses of 40 - 80 mg of trimethoprim (as cotrimoxazole) have been administered daily or 3 times weekly for 3 - 6 months.
    In children 2 months of age or older: Usual oral dosage is 8 mg/kg daily of trimethoprim (as cotrimoxazole), administered in 2 divided doses every 12 hours.
  • Respiratory tract infections
    Adults: The usual oral dosage is 160 mg of trimethoprim (as cotrimoxazole) administered every 1 2 hours for 1 4 days.
  • Gastrointestinal infections
    Shigella Infections (S.flexneri or S. sonnei):
    Adults: The usual oral dosage is 160 mg of trimethoprim (as cotrimoxazole) administered every 1 2 hours.
    Children: The usual oral dosage is 8 mg/kg daily of trimethoprim (as cotrimoxazole) administered in 2 divided doses every 12 hours for 5 days.
  • Brucellosis
    Pediatric patients: A dosage of oral trimethoprim (as cotrimoxazole) of 10 mg/kg daily (maximum 480 mg/daily) in 2 divided doses for 4 - 6 weeks.
  • Cholera
    Adults: The usual oral dosage of 160 mg trimethoprim (as cotrimoxazole) twice daily for 3 days.
    Children: The usual oral dosage of 4 - 5 mg/kg trimethoprim (as cotrimoxazole) twice daily for 3 days, in conjunction with fluid and electrolyte replacement.
  • Plague
    For anti-infective prophylaxis of patients with close exposure to pneumonic plague.
    Adults: 320 - 640 mg trimethoprim (as cotrimoxazole) daily in 2 equally divided doses every 12 hours for 7 days.
    Children at least 2 months of age: 8 mg trimethoprim (as cotrimoxazole)/kg daily in 2 equally divided doses for 7 days.
  • Pneumocystis jiroveci(Pneumocystis carinii) pneumonia
    Adults and children older than 2 months: A usual oral dosage of trimethoprim (as cotrimoxazole) is 15 - 20 mg/kg daily, given in 3 or 4 equally divided doses. The usual duration for treatment is 14 - 21 days.
    For both primary and secondary prevention of PCP in HIV-infected adults and adolescents, an oral trimethoprim (as cotrimoxazole) dosage of 160 mg once daily; alternatively an oral trimethoprim (as cotrimoxazole) dosage of80 mg once daily is recommended.
    For both primary and secondary prevention of PCP in children, including HIV-infected children, an intermittent regimen of trimethoprim 150 mg/m2 (as cotrimoxazole) daily in 2 divided doses or 3 consecutive days each week is recommended.
  • Toxoplasmosis
    For primary prophylaxis against toxoplasmosis in adults and adolescents, an oral trimethoprim (as cotrimoxazole) dosage of 160 mg once daily; alternatively an oral trimethoprim (as cotrimoxazole) dosage of 80 mg once daily is recommended.
    For primary prophylaxis against toxoplasmosis in HIV-infected children, an oral trimethoprim 150 mg/m2 (as cotrimoxazole) daily in 2 divided doses.
  • For patients with renal impairment
    When renal function is impaired, a reduced dosage should be employed as in the following table:

     

Or as prescribed by physicians.

 

  • Patients with known hypersensitivityto sulfamethoxazoleor trimethoprimor any components ofthe drug.
  • Patients with marked hepatic damage.
  • Patients with severe renal impairment when renal function status cannot be monitored or creatinine clearances less than 15 ml/minute.
  • Patients with documented megaloblastic anemia to folate deficiency.
  • Pregnancy and lactation.
  • Infants younger than 2 months of age.

     

Common:

  • Nausea, vomiting, anorexia and diarrhea.

Hypersensitivityreactions:

  • Common: Fever, reactions involving the skin may include rashes, pruritus, photosensitivity reactions, exfoliative dermatitis and erythema.
  • Severe: Potentially fatal, skin reactions including toxic epidermal necrolysis and the StevensJohnson syndrome.
  • Other: Dermatitis, systemic lupus erythematosus, particularly exacerbation ofpre-existing disease.

Nephrotoxic reactions:

  • Interstitial nephritis and tubular necrosis, lumbar pain, haematuria, oliguria, anuria may also occur.

Blood disorders:

  • Agranulocytosis, aplastic anaemia, thrombocytopenia, leucopenia, hypoprothrombinaemia and eosinophilia.

Disturbances ofliver enzyme values and cholestatic jaundice.

Rarely:

  • Cyanosis due to methaemoglobinaemia, acute haemolytic anaemia.

     

  • Pharyngitis caused by S. Pyogenes: Cotrimoxazole should not be used.
  • Cotrimoxazole should be used with caution in patients with impaired renal function, possible folate deficiency (e.g., geriatric individuals, chronic alcoholics, patients receiving anticonvulsants, malnourished patients, those with malabsorption syndrome), with severe allergy or bronchial asthma, or with glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency.
  • Patients receiving cotrimoxazole should be cautioned to maintain adequate fluid intake to prevent crystalluria and stone formation.
  • Regular blood counts and urinalyses and renal-function tests should be carried out in patients receiving prolonged treatment with cotrimoxazole.
  • Elderly patients may be more susceptible to adverse effects.
  • Pregnancy: Cotrimoxazole crosses the placenta and may interfere with folic acid metabolism; the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Because sulfonamides may cause kernicterus in neonates, use of cotrimoxazole in pregnant women is contraindicated.
  • Lactation: Cotrimoxazole is distributed into milk. Because sulfonamides may cause kernicterus in infants younger than 2 months of age, a decision should be made whether to discontinue nursing or cotrimoxazole or to use an alternative drug, taking into account the importance ofcotrimoxazole to the woman.
  • Effects on ability o drive and use machines: As cotrimoxazole can cause dizziness, drowsiness, tinnitus, insomnia and hallucinations, patients should make sure  they are not affected before driving or operating machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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