Negram
(Nalidixic Acid)
• brand of Nalidixic Acid Tablets/Caplets/Suspension Chemotherapy of urinary and intestinal infections Active against gram-negative pathogens
ACTION:
Nalidixic acid has high antibacterial activity against infections caused by gram negative organisms. At very low concentrations it is active against E. coli, various types of Proteus, Aerobacter, Klebsiella, shigella and Salmonella. Pseudomonas strains are generally resistant to the drug. Negram is bactericidal and is effective over the entire urinary pH range. Conventional chromosomal resistance to Negram taken in tu\\ dosage has been reported, however, bacterial resistance to Negram has not been shown to be transferable via R-factor.
INDICATIONS:
Acute and chronic urinary infections produced by susceptible gram-negative species, cystitis, pyelonephritis, postpartum pyelitis, urethritis and trigones
Intestinal infections, caused by organism susceptible to nalidixic acid.
In chronic and resistant infections, initial therapy should be followed after several weeks by a second course of treatment.
Urinary stasis, which can aggravate and prolong urinary infections, should be corrected (surgically, if necessary).
Appropriate culture arid sensitivity tests should be performed to determine the causative organism and its susceptibility to Nalidixic acid.
CONTRAINDICATIONS:
Negram is contraindicated in patients with known hypersensitivity to nalidixic acid and in patients with a history of convulsive disorders.
WARNINGS:
CNS effects including brief convulsions, increased intracranial pressure, and toxic psychosis have been reported rarely. These have occurred in infants and children or in geriatric patients, usually from overdosage or in patients with predisposing factor, if these reactions occur, negram should be discontinued and appropriate measures should be instituted (See Adverse Reactions and Overdosage).
Usage in Pre pubertal Patients:
Recent toxicological studies have shown that naraixic acia an related drugs can produce erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of most species tested. No such joint lesions have been reported in man to date. Nevertheless, until the significance of this finding is clarified, care should be exercised when prescribing this product for Pre-pubertal patients.
Usage in Pregnancy:
Safe use of Negram during the first-trimester of pregnancy has not been establisted. However, the drug has been used during the last two trimesters without producing apparent ill effects in mother or child.
Keep out of reach of children.
PRECAUTIONS:
Blood counts, renal and liver function tests should be performed periodically if treatment is continued for more than two weeks. Negram should be used with caution in patients with liver disease, severely impaired kidney function, epilepsy, or severe cerebral arteriosclerosis.
Patients should be cautioned to avoid,
undue exposure to direct sunlight while receiving Negram. Therapy should be discontinued it photosensitivity occurs.
Bacteria resistant to negram may emerge rapidly. Therefore, cultures and bacterial sensitivity tests should be repeated if the clinical response is unsatisfactory or if a relapse occurs.
Cross resistance between Negram and other quinolone derivatives has been observed, but not with known antibiotics.
Nalidixic acid may enhance the effects
of oral anticoagulants, warfarin or bishydroxycoumarine by displacing significant amounts from serum albumin binding sites.
When Benedict's or Fehling's solutions or cltnitest Reagent Tablets are used to test the urine of patients taking Negram a false-positive reaction
for glucose may be obtained, due to the liberation of glucuronic acid from the metabolites excreted. However, a colorimetric test for glucose based on an enzyme reactions (e.g., with Clinistix-Reagent Strips or Tes-Tape) do not give a false-positive reaction to the liberated glucuronic acid.
Incorrect values may be obtained for urinary 17-keto and ketogenic steroids in patients receiving Negram because of an interactions between the drug and the m-dinitrobenzene used in the usual assay method. In such cases, the Porter-Siber test for 17-hydroxycorticoids may be used.
ADVERSE REACTIONS:
Reactions reported after oral administration of Negram include CNS effects: drowsiness, weakness, headache, dizziness and vertigo. Reversible subjective visual disturbances without objective findings have occurred infrequently (generally with each dose during the first few days of treatment).
These reactions include
overbrightness of lights, change in color perception, difficulty in focusing, decrease in visual acuity, and double vision. They usually disappeared promptly when dosage was reduced or therapy was discontinued. Toxic psychosis or brief convulsions have been reported rarely, usually following excessive doses.
In general, the convulsions have occurred in patients with predisposing factors such as epilepsy or cerebral arteriosclerosis. In infants and cnildren receiving therapeutic doses of Negram increased intracranial pressure with bulging anterior fontanel, papilledema, and headache has. occasionally been observed. A few cases-of 6th cranial nerve palsy have been reported.
Although the mechanisms of these reactions are unknown, the signs and symptoms usually disappeared rapidly with no sequelae when treatment was discontinued.
Gastrointestinal:
abdominal pain, nausea, vomiting, and diarrhoea. Allergic: rash, pruritus, urticaria, angioedema. eosinophilia, joint stiffness and rarely anaphylactoid reaction. Photosensitivity reactions, primarily involving exposed skin surfaces, have disappeared after therapy was discontinued, other: rarely.
(Nalidixic Acid)
• brand of Nalidixic Acid Tablets/Caplets/Suspension Chemotherapy of urinary and intestinal infections Active against gram-negative pathogens
ACTION:
Nalidixic acid has high antibacterial activity against infections caused by gram negative organisms. At very low concentrations it is active against E. coli, various types of Proteus, Aerobacter, Klebsiella, shigella and Salmonella. Pseudomonas strains are generally resistant to the drug. Negram is bactericidal and is effective over the entire urinary pH range. Conventional chromosomal resistance to Negram taken in tu\\ dosage has been reported, however, bacterial resistance to Negram has not been shown to be transferable via R-factor.
INDICATIONS:
Acute and chronic urinary infections produced by susceptible gram-negative species, cystitis, pyelonephritis, postpartum pyelitis, urethritis and trigones
Intestinal infections, caused by organism susceptible to nalidixic acid.
In chronic and resistant infections, initial therapy should be followed after several weeks by a second course of treatment.
Urinary stasis, which can aggravate and prolong urinary infections, should be corrected (surgically, if necessary).
Appropriate culture arid sensitivity tests should be performed to determine the causative organism and its susceptibility to Nalidixic acid.
CONTRAINDICATIONS:
Negram is contraindicated in patients with known hypersensitivity to nalidixic acid and in patients with a history of convulsive disorders.
WARNINGS:
CNS effects including brief convulsions, increased intracranial pressure, and toxic psychosis have been reported rarely. These have occurred in infants and children or in geriatric patients, usually from overdosage or in patients with predisposing factor, if these reactions occur, negram should be discontinued and appropriate measures should be instituted (See Adverse Reactions and Overdosage).
Usage in Pre pubertal Patients:
Recent toxicological studies have shown that naraixic acia an related drugs can produce erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of most species tested. No such joint lesions have been reported in man to date. Nevertheless, until the significance of this finding is clarified, care should be exercised when prescribing this product for Pre-pubertal patients.
Usage in Pregnancy:
Safe use of Negram during the first-trimester of pregnancy has not been establisted. However, the drug has been used during the last two trimesters without producing apparent ill effects in mother or child.
Keep out of reach of children.
PRECAUTIONS:
Blood counts, renal and liver function tests should be performed periodically if treatment is continued for more than two weeks. Negram should be used with caution in patients with liver disease, severely impaired kidney function, epilepsy, or severe cerebral arteriosclerosis.
Patients should be cautioned to avoid,
undue exposure to direct sunlight while receiving Negram. Therapy should be discontinued it photosensitivity occurs.
Bacteria resistant to negram may emerge rapidly. Therefore, cultures and bacterial sensitivity tests should be repeated if the clinical response is unsatisfactory or if a relapse occurs.
Cross resistance between Negram and other quinolone derivatives has been observed, but not with known antibiotics.
Nalidixic acid may enhance the effects
of oral anticoagulants, warfarin or bishydroxycoumarine by displacing significant amounts from serum albumin binding sites.
When Benedict's or Fehling's solutions or cltnitest Reagent Tablets are used to test the urine of patients taking Negram a false-positive reaction
for glucose may be obtained, due to the liberation of glucuronic acid from the metabolites excreted. However, a colorimetric test for glucose based on an enzyme reactions (e.g., with Clinistix-Reagent Strips or Tes-Tape) do not give a false-positive reaction to the liberated glucuronic acid.
Incorrect values may be obtained for urinary 17-keto and ketogenic steroids in patients receiving Negram because of an interactions between the drug and the m-dinitrobenzene used in the usual assay method. In such cases, the Porter-Siber test for 17-hydroxycorticoids may be used.
ADVERSE REACTIONS:
Reactions reported after oral administration of Negram include CNS effects: drowsiness, weakness, headache, dizziness and vertigo. Reversible subjective visual disturbances without objective findings have occurred infrequently (generally with each dose during the first few days of treatment).
These reactions include
overbrightness of lights, change in color perception, difficulty in focusing, decrease in visual acuity, and double vision. They usually disappeared promptly when dosage was reduced or therapy was discontinued. Toxic psychosis or brief convulsions have been reported rarely, usually following excessive doses.
In general, the convulsions have occurred in patients with predisposing factors such as epilepsy or cerebral arteriosclerosis. In infants and cnildren receiving therapeutic doses of Negram increased intracranial pressure with bulging anterior fontanel, papilledema, and headache has. occasionally been observed. A few cases-of 6th cranial nerve palsy have been reported.
Although the mechanisms of these reactions are unknown, the signs and symptoms usually disappeared rapidly with no sequelae when treatment was discontinued.
Gastrointestinal:
abdominal pain, nausea, vomiting, and diarrhoea. Allergic: rash, pruritus, urticaria, angioedema. eosinophilia, joint stiffness and rarely anaphylactoid reaction. Photosensitivity reactions, primarily involving exposed skin surfaces, have disappeared after therapy was discontinued, other: rarely.
0 comments