Primpex Tablet And Syrup Composition, Dose, Side Effect, Use

Primpex is an antibiotic. It is composed of two antibiotics. They work synergistically. Primpex is made by SKG-Pharma Limited, Lagos, Nigeria.

primpex

Composition Of Primpex Tablet And Syrup

The active ingredients in Primpex are:

Trimethoprim-5-(3, 4, 5- Trimembenzy) Pyrimidine-2, 4-diamine Sulfamethoxazole (4-Amino N-(5-methylisoxazol-3y1) benzenesulfonamide

Presentations

Primpex Tablets: each white, round, biconvex uncoated tablet is scored and embossed SKG D3A on one side and plain on the other side and contains 80mg Trimethoprim B.P and 400mg sulphamethoxazole B.P.

Primpex DS caplets: Each white, uncoated caplet is embossed G3A SKG on one side and scored on the other side and contains 160mg Trimethoprim B.P. and 800mg sulfamethoxazole B.P.

Suspensions: Each 5ml of flavored suspension contains 40 mg Trimethoprim B.P and 200mg sulphamethoxazole B.P.

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Properties

Primpex's antibacterial effect covers a wide range of gram-positive and gram-negative organisms such as staphylococci, pneumococci, Haemophilus, streptococci, neisseria, E.coli, proteus mirabilis, proteus vulgaris, Bordetella, Salmonella, Klebsiella-Aerobacter, Shigella, Vibrio cholerae, Brucella, Pseudomonas, Pneumocystis Carinii, Serratio, Marcescen, Yersinia and Nocardia.

Indications And Use Of Primpex Tablet And Syrup

Primpex is indicated for the treatment of sensitive bacterial infections of the:

Respiratory Tract: Acute and chronic bronchitis, Pneumonia, Pneumocysfis carinii pneumonitis, bronchiectasis, otitis media, sinusitis, Pharyngitis.

Urinary Tract: Acute and chronic cystitis, Pyelonephritis, Urethritis, Prostatitis Acute upper and lower urinary tract infections. Long-term prophylaxis of recurrent or suppression of chronic infections following sterilization of the urine.

Genital Tract: Oro-pharyngeal and ano-rectal gonorrhea infection, gonococcal urethritis, salpingitis, chancroid, lymphogranuloma venereum and granuloma inguinale veneraum.

Gastrointestinal Tract: Typhoid and Paratyphoid fever, typhoid carrier State and bacillary dysentery, cholera, (as an adjunct to fluid and electrolyte placement). Shigellosis, gastroenteritis due to enteric-pathogens and biliary tract infections.

Skin and Soft Tissues: Pyoderma furuncles, abscessed and infected Wounds.

Other Bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemia due to sensitive organisms, Nocardiosis, mycetoma. (except when caused by the true fungi).

Protozoal Infections: Malarial due to P. Falciparum

Prophylaxis of infections in immuno-compromised patients.

Mode Of Action

The two components of primpex interfere with the bacterial synthesis of tetrahydrofolic acid, an essential stage in the production of thymidine, Purines and subsequently nucleic acids.

Dosage And Administration Of Primpex Tablet And Syrup

Primpex should be taken with some food or drink to minimize the possibility of gastro-intestinal disturbances.

Primpex Tablet

Adults and Children over 12 years: 2 tablets every 12 hours

Children 6-12 years: 1 tablet every 12 hours

Primpex Ds Caplet

Adults and children over 12 years: 1 tablet every 12 hours

Children 6-12 years: ½ tablet every 12 hours

Primpex Suspension

Children 6-12 years 10ml every twelve hours

Children 6 months-5 years 5ml every 12 hours

Children 6 weeks-5 months 2.5ml every 12 hours

Children below 6 weeks not recommended

The above dosage regimen corresponds approximately to an average dose of 6mg Trimethoprim and 30mg sulfamethoxazole per kilogram body weight per 24hrs. For severe infections the dosage shown may be increased by 50%.

Treatment should be continued until the patient has been symptom free for two days, the majority will require treatment for at least 5 days.

Special Dosage Recommendations:

Unless otherwise specified standard dosage applies

Chronic Prostatitis: It may be advisable to use a higher than standard dosage initially. The course of treatment should last for three months to reduce the risk of relapse.

Pneumocystis carinii pneumonitis: Treatment 20 mg trimethoprim and 100mg sulfamethoxazole per kilogram body weight per day in two or more divided doses for two weeks.

Prevention: Standard dosage for the duration of the period at risk.

Gonorrhea: Dosage restricted to adults only

Uncomplicated cases: 4 tablets (2 DS tablets) every 12 hours for two days or 5 tablets (2 and ½ DS tablets) followed by a further dose of 5 tablets (2 and ½ DS tablets) eight hours later.

If poor patient compliance is expected a single dose of 8 tablets (2 and ½ DS tablets) taken under supervision may be employed.

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Oro-pharyngeal gonococcal infection: 2 tablets (1 DS tablets) three times daily for seven days or 9 tablets (4½ DS tablets) daily for five days.

Chancroid: Standard dosage should be continued for 10-15 days.

Granuloma inguinale: Standard dosage should be continued for up to 2 weeks.

Acute Brucellosis: A higher than standard dosage should be used initially and treatment continued for a period of at least four weeks and may be repeated.

Malaria due to P. Falciparum: Four tablets (2 DS tablets) twice daily for two days may be given as an alternative regimen for adults. Children would require a reduced dose.

Typhoid and paratyphoid carriage: Standard dosage treatment should be continued for at least 13 months.

Long-Term Prophylaxis Of Recurrent Or Suppression Of Chronic Infection Following Sterilization Of The Urine.

Adults and children over 12 years: 1 tablet every night

Children aged 12 years and under: A single nightly dose of 2 mg Trimethoprim and 10 mg sulfamethoxazole per kg body weight. Treatment may be continued for 3-12 months or more as appropriate.

Side-effects Of Primpex

At the recommended dosage, Primpex is usually well tolerated. Of the reported adverse effects most are mild and comprise nausea with or without vomiting and drug rashes. As with a great variety of drugs, Primpex, in isolated cases, has been associated with the Stevens-Johnson and Lyell's syndromes.

Hematological changes have been reported, the majority being mild, asymptomatic and reversible on withdrawal of the drug. The changes mainly took the form of leukopenia, neutropenia and thrombocytopenia. Very rarely, agranulocytosis, Megaloblastic anemia and purpura occurred.

Precautions And Warnings

In patients with impaired renal function, the dosage of primpex should be reduced or the interval between doses prolonged in order to prevent accumulation in the blood.

Determination of plasma drug concentrations is recommended in such patients. Especially in the elderly, there is a possibility of hematological changes indicative of folic acid deficiency; these are reversible by folinic acid and therapy. Regular blood courts are advisable when primpex is given for prolonged periods. An adequate urinary output should be maintained at all times during therapy and treatment should be discontinued immediately a skin rash appears or blood disorders develop. An adequate fluid intake should be maintained to reduce the risk of crystalluria.

Contra-indications

Primpex should not be administered to patients with a history of hypersensitivity to sulfonamides or Trimethoprim. It is contraindicated in patients with marked liver Parenchymal damage, severe renal insufficiency when repeated determinations of the Plasma concentration cannot be made.

except in rare cases. Primpex should not be given to patients with serious hematological disorders. The combination has occasionally been administered to patients receiving cytotoxic agents for the treatment of leukemias, without evidence of any adverse effect of the bone marrow or peripheral blood. It is contraindicated in patients with megaloblastic anemia due to folate deficiency.

For safety reasons, Primpex is contraindicated during pregnancy. If pregnancy cannot be excluded, possible risks should be balanced against the expected therapeutic effect.

Primpex should not be given to premature and newborn infants during the first few weeks of life.

Pregnancy And Lactation

The safety of Primpex in human pregnancy has not been established. Despite the excretion of Trimethoprim and sulfamethoxazole into breast milk, the administration of primpex to lactating women represents a negligible risk to the sucking infant.

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Drug-interactions

Co-trimoxazole prolongs the half-life of phenytoin. Concurrent use of rifampicin and co-trimoxazole results in shortening the plasma half-life of Trimethoprim after a period of about one week. Reversible detention in renal function has been observed in patients treated with cotrimoxazole and cyclosporine following renal transplantation.

Co-trimoxazole has been shown to potentiate the anticoagulant activity of warfarin via stereo-selective inhibition of its metabolism. In elderly patients concurrently receiving diuretics, mainly thiazides, there appears to be an increased risk of thrombocytopenia with or without purpura.

Occasional reports suggest that patients receiving pyrimethamine in Malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if Primpex is prescribed concurrently.