Negram (Tablets) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

J01MB02 (Nalidixic acid)

Active Substance

Nalidixic acid (Rec.INN registered by WHO)

Dosage Form

Negram

Tablets 500 mg: 56 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, slightly biconvex, brownish-pink in color, with a score on one side.

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, dye (E172), corn starch, gelatin, potassium sorbate, gelatinized starch, magnesium stearate.

8 pcs. – blisters (7) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the quinoline group

Pharmacotherapeutic Group

Antimicrobial agent, quinolone

Pharmacological Action

An antimicrobial agent of the quinolone group. It has a bactericidal or bacteriostatic effect depending on the sensitivity of the pathogen and the concentration. Strains of microorganisms resistant to antibiotics and sulfonamides are sensitive to nalidixic acid.

Nalidixic acid is active against gram-negative bacteria: Escherichia coli, Enterobacter spp., Salmonella spp., Shigella spp., Proteus spp., Klebsiella spp.

Pseudomonas aeruginosa, gram-positive and anaerobic bacteria are usually resistant to nalidixic acid.

Pharmacokinetics

After oral administration, it is highly absorbed from the gastrointestinal tract. The bioavailability is 96%, plasma protein binding is 93%. C_max in blood plasma is reached after 1-2 hours, in urine – after 3-6 hours (250-300 µg/ml). The content in kidney tissue is higher than in blood. It penetrates the blood-brain barrier and the placental barrier, and is excreted in breast milk. T_1/2 is 1.1-2.5 hours (in case of impaired renal function – up to 21 hours). It is partially metabolized in the liver, forming an active metabolite – hydroxynalidixic acid. It is excreted by the kidneys (2-3% as nalidixic acid, 13% as an active metabolite, 80% as an inactive metabolite).

Indications

Infectious and inflammatory diseases, mainly of the gastrointestinal tract and genitourinary system (including pyelonephritis, cystitis, urethritis, prostatitis; gastrointestinal infections, cholecystitis), caused by susceptible microorganisms.

Prevention of infectious complications during surgical interventions on the kidneys, ureters, and bladder.

ICD codes

Dosage Regimen

Administer orally with a full glass of water.

For adults, the standard initial dose is 1 g (two 500 mg tablets) taken four times daily.

Continue this regimen for a minimum of 7 days.

For longer-term therapy, after the initial treatment period, the dose may be reduced to 500 mg (one tablet) four times daily.

For children, calculate the total daily dose at 60 mg per kg of body weight.

Divide this total daily dose into three or four equal administrations.

Do not administer to children under 2 years of age.

In patients with impaired renal function, adjust the dosage or avoid use due to potential accumulation; the half-life is significantly prolonged.

Complete the full prescribed course of therapy, even if symptoms improve.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, epigastric pain are possible; rarely – gastrointestinal bleeding, cholestasis.

From the central and peripheral nervous system: rarely – drowsiness, headache, visual disturbances; in some cases with prolonged use – convulsions.

From the musculoskeletal system: myalgia.

Allergic reactions: skin rash, itching, angioedema.

From the hematopoietic system: in some cases with prolonged use, thrombocytopenia, leukopenia, hemolytic anemia are possible.

Dermatological reactions: photosensitization.

Contraindications

Severe impairment of liver and kidney function, epilepsy, severe cerebral atherosclerosis, children under 2 years of age, hypersensitivity to nalidixic acid, pregnancy, glucose-6-phosphate dehydrogenase deficiency.

Use in Pregnancy and Lactation

Nalidixic acid is contraindicated for use during pregnancy. During lactation, it should be used with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the breastfed infant.

Use in Hepatic Impairment

Contraindicated in severe liver function impairment.

Use in Renal Impairment

Contraindicated in severe renal function impairment.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

During the use of nalidixic acid, a false-positive urine reaction when determining glucose is possible.

Drug Interactions

Should not be prescribed simultaneously with indirect anticoagulants.

Nalidixic acid may have a depressant effect on the central nervous system, especially in case of simultaneous use with ethanol or drugs that depress the central nervous system.

Incompatible with nitrofurans.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.