Pronunciation:

nal-i-DIX-ik AS-id

Brand Names:

• Neggram

Dosage Forms:

• Tablet
• Suspension

Classifications:

Therapeutic—

Antibiotic

Chemical—

Non-Fluorinated Quinolone

Uses of This Medicine:

Nalidixic acid is used to treat infections of the urinary tract. It may be used for other problems as determined by your doctor.

Nalidixic acid is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine should not be used in infants up to 3 months of age since nalidixic acid has been shown to cause bone development problems in young animals.

Caution is recommended in using nalidixic acid in children up to 18 years of age because nalidixic acid has been shown to cause bone development problems in young animals. However, your doctor my choose to use this medicine if other medicines cannot be used.

Older adults—

This medicine has been studied in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ajmaline
• Disopyramide
• Pirmenol
• Prajmaline
• Procainamide
• Quinidine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsive disorders, history of (seizures, epilepsy) or
• Hardening of the arteries in the brain (severe)—Patients with these medical problems may have an increased chance of serious side effects affecting the nervous system

• Diarrhea—May be a sign of colon problems and taking nalidixic acid could make this problem worse. Your doctor will want to check you before you begin taking this medicine.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Patients with G6PD deficiency may have an increased chance of side effects affecting the blood

• Heart rhythm problems—Nalidixic acid should be used with caution in patients with these conditions.

• Kidney disease (severe) or
• Liver disease—Patients with liver disease or severe kidney disease may have an increase in side effects

• QTc prolongation (rare heart rhythm problem)—Nalidixic acid may cause this condition to become worse, especially with higher doses of this medicine.

• Sensitivity of the skin to sunlight—Patients taking nalidixic acid may have an increased risk of severe reactions to sunlight. Patients with this condition should not take nalidixic acid.

Proper Use of This Medicine:

Do not give this medicine to infants or children unless otherwise directed by your doctor. It has been shown to cause bone problems in young animals and may cause these problems in children.

Nalidixic acid is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals). However, if this medicine causes nausea or upset stomach, it may be taken with food. Several additional glasses of water should be taken every day, unless you are otherwise directed by your doctor.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  • Adults and children 12 years of age and older: 1 gram (g) every six hours (four times a day) for one to two weeks to start; then, 500 milligrams (mg) every six hours.
  • Children 3 months to 12 years of age: The dose is based on body weight and must be determined by the doctor.
  • Infants up to 3 months of age: This medicine should not be used in infants up to 3 months of age since nalidixic acid has been shown to cause bone problems in young animals.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be taking this medicine for more than 2 weeks, your doctor should check your progress at regular visits.

If your symptoms do not improve within 2 days, or if they become worse, check with your doctor.

If you are taking aluminum-, calcium-, or magnesium-containing antacids, didanosine (e.g., Videx), iron supplements, zinc-containing multivitamins, or sucralfate, do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or 2 hours after taking nalidixic acid.

This medicine may cause blurred vision or other vision problems. It may also cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

This medicine may increase the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using this medicine. If you have questions about this, check with your doctor.

Nalidixic acid may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

This medicine may rarely cause inflammation or even tearing of a tendon (the cord that attaches muscles to bones). If you get sudden pain in a tendon after exercise (for example, in your ankle, back of the knee or leg, shoulder, elbow, or wrist), stop taking nalidixic acid and check with your doctor. Rest and do not exercise until the doctor has made sure that you have not injured or torn the tendon.

This medicine can cause a muscle disease called peripheral neuropathy. If you begin having pain, burning, tingling, numbness, and/or weakness, tell your doctor right away.

If you have a severe reaction from the sun, check with your doctor.

For patients with diabetes:

• This medicine may cause false test results with some urine glucose (sugar) tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Skin rash

Less common

Blurred or decreased vision

change in color vision

confusion

double vision

halos around lights

lightheadedness

overbright appearance of lights

restlessness

tremor

Rare

Abdominal or stomach cramps or pain (severe)

blistering, peeling, or loosening of skin and mucous membranes

bulging of fontanel (soft spot) on top of head of an infant

burning or tingling skin sensation

changes in facial skin color

chills

convulsions (seizures)

dark or amber urine

diarrhea, watery and severe, which may also be bloody

fever

general feeling of discomfort or illness

hallucinations (seeing, hearing, or feeling things that are not there)

headache (severe)

hives

hoarseness

increased frequency of breathing

itching

joint pain, stiffness, or swelling

mood or other mental changes

nausea or vomiting

pale skin

pale stools

red skin lesions, often with a purple center

shortness of breath

sore throat

sudden trouble in swallowing or breathing

swelling of face, mouth, hands, or feet

unusual bleeding or bruising

unusual tiredness or weakness

visual changes

yellow eyes or skin

Incidence not known

(occurred during clinical practice)

Black, tarry stools

bone pain

burning, numbness, tingling, or painful sensations

chest pain

cough

difficulty swallowing

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

lower back or side pain

painful or difficult urination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of skin

sores, ulcers, or white spots on lips or in mouth

swollen glands

tightness in chest

unsteadiness or awkwardness

weakness in arms, hands, legs, or feet

welts

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

dizziness

feeling of constant movement of self or surroundings

drowsiness

headache

stomach pain

weakness

Less common

Increased sensitivity of skin to sunlight

Incidence not known

(occurred during clinical practice)

Muscle pain or stiffness

difficulty in moving

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.