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Rancotrim

Ranbaxy Nigeria Limited
24, Abimbola street, Abimbola House, Isolo, Lagos.
Tel: 234-1-7932744, 7913002
Fax: 234 1 7913003, 4526371

Brand Name

Rancotrim

Manufacturer

Ranbaxy Nig. Ltd, Isolo, Lagos; Ranbaxy LABS Ltd, Dewas, India.

Therapeutic Class

Antibacterial, Sulfonamides and trimethoprim

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-0695): Sulphamethoxazole 400 mg, Trimethoprim 80 mg.

 

Pack: Bottle of 1000’s & Blister pack of 10’s.

 

 

Tablet Forte (NRN: 04-0695): Sulphamethoxazole 800 mg, Trimethoprim 160 mg.

 

Pack: Bottle of 500’s & Blister pack of 10’s.

 

 

Suspension (NRN: 04-0481): Sulphamethoxazole 200 mg, Trimethoprim 40 mg per 5 mL.

 

Pack: Bottle of 50 mL, 1000 mL & 2500 mL.

Pharmacology

Description

The active ingredient of Rancotrim are Trimethoprim is 5-(3,4,5-trimethoxylbenzyl)-pyrimidine-2,4-diamine and Sulphamethoxazole is N1-(5-methylisoxazol-3-yl) Sulphanilamide. Rancotrim is a dual action chemotherapeutic agent with bactericidal properties.

The antibacterial effect of Rancotrim covers a wide range of gram positive and gram negative organisms such as Streptococci, Staphylococci, Pneumococci, Haemophilus influenzae, Neisseria, E. coli, Proteus mirabilis, Proteus vulgaris, Bordetella, Salmonella, Klebsiella aerobacter, Shigella, Vibrio cholerae, Brucella, Pseudomonas, Pseudomallei, Pseudomonas capacia, Pneumocystis carinii, Serratia marcescens, Yersinia and Norcardia.

Indications

Respiratory tract infections: Acute and chronic bronchitis, pneumonia, pneumonitis, pharyngitis, tonsillitis ( in infections due to group A- b-haemolytic streptococci the rate of eradication is not fully satisfactory), sinusitis, otitis media.

Urinary tract infections: Acute and chronic cystitis, pyelonephritis, urethritis, prostatitis. Susceptible genital infections in both sexes, including gonococcal urethritis.

GIT infections: Including typhoid and paratyphoid fever, typhoid carrier state and paratyphoid fever, typhoid carrier state and bacillary dysentery, cholera (as an adjunct to fluid and electrolyte replacement).

Skin and soft tissue infections: Pyoderma, furuncles, abscesses and infected wounds.

Other bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemia due to sensitive organisms, Norcardiosis, mycetoma (except when caused by the true fungi). South American blastomycosis.

Contra-indications

Patients with marked liver parenchymal damage; Severe renal deficiency when repeated determination of the plasma concentration cannot be made. Except in rare circumstances Rancotrim should not be given to patients with serious haematological disorders.

The combination has occasionally been administered to patients receiving cytotoxic agents for the treatment of leukaemia, without evidence of any adverse effect on the bone marrow or peripheral blood.

History of hypersensitivity to sulphonamides or trimethoprim;

Pregnancy:

If pregnancy cannot be excluded possible risks should be balanced against the expected therapeutic effect.

Premature and newborn infants during the first six weeks of life.

Precautions/Warnings

In patients with impaired renal function the dosage should be reduced or the interval between doses prolonged in order to prevent cumulation in the blood. Determination of plasma drug concentrations is recommended in such patients.

Dosage recommendations for patients with impaired renal function are available on request.

Regular blood counts are advisable whenever Rancotrim is given for prolonged periods. Especially in the elderly, there is a possibility of haematological changes indicative of folic acid deficiency: these are reversible by folic acid therapy.

An adequate urinary output should be maintained at all times. Treatment must be discontinued immediately if a skin rash appears.

Interactions

Rancotrim may enhance the effect of concurrently administered oral anticoagulants (e.g. Warfarin and phenytoin). It may also affect the dose of hypoglycaemic drugs required.

Occasional reports suggest that patients receiving pyrimethamine as malarial prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anaemia if Rancotrim is prescribed concurrently.

Adverse Effects

Nausea, (with or without vomiting) and drug rashes. As with a great variety of other drugs. Rancotrim has in isolated cases been associated with the Stevens-Johnson and Lyell’s Syndromes. Haematological changes have been reported, the majority being mild, asymptomatic and reversible on withdrawal of the drug.

The changes mainly took the form of leucopenia, neutropenia and thrombo-cytopenia. Very rarely, agranulocytosis, megaloblastic anaemia purpura occurred. Although trimethoprim and sulphamethoxazole are excreted in breast milk, administration of Rancotrim to nursing mother represents a negligible risk to the infant.

Dosage & Administration

 For adults and children over 12 years of age:

Dosage Tablets
Forte Tablets
 morning   evening   morning   evening 

 Standard dosage

2 2 1 1

 Minimum dosage and dosage for long term therapy (longer than 14 days)

1 1 ½ ½
 High dosage (for particularly severe  cases) 3 3 1½ 1½

 Dose for uncomplicated gonorrhoea(limited to 1 Day )

5 5 2½ 2½

For children, according to age:            

Measurement of Paediatric Syrup
   Morning   evening
 6 weeks to 5 months  ½  ½
 6 months to 5 years  1  1
 6 years to 12 years  2  2

The above dosage schedule for children corresponds approximately to an average doses of 6 mg trimethoprim plus 30 mg sulpha-methoxazole per kg body weight per day.

For severe infections the dosage shown for children may be increased by 5% in acute infections. Rancotrim should be given at least five days or until the patient has been symptom free for two days.

Storage/Handling Recommendations

            

Review Date

2016-07-01 09:54:21