As per US FDA guidelines as per USPDA 1997

It is the intention to bring out the salient features. Hence relevent details as prescribed by US FDA guidelines as per USPDA 1997  are brought out clearly in the following chapters. 

Descriptons are detailed only to the Group Head and the indiviual items can be seen by visiting the Web Site

ANTIDIARHEAL-

Includes- Codeine (systemic), Glycopyrrolate (Systemic), Loperimide (oral),Morphine (systemic), Opium Tincture(systemic), Paregoric (systemic),Polycarbophil (oral), Psylium Hydrophilic Mucilloid (oral),Defonixin and Atropine (systemic), Piphenoxylate and Atropine (systemic), Bisumuth Subsalicylate (oral), Octrotide, Chlorstyramine (oral), Colestipol (oral)

Others -

Include- Furazolidone, Nalidixic acid, Diphenyl oxylate, Balsalazide, Mesalazine, nitrozoxanide, Racadotril, Rifaximin, Sulphasalazine, Clistin sulphate

Nalidixic Acid

1. May cause GI upset; take with food.

2. May produce drowsiness,dizziness, or blurred vision; observe caution while driving or performing other tasks requiring alertness,coordination or physical dexterity.

3. Avoid prolonged exposure to sunlight; photosensitivity may occur.

4. If seizure,psychotic behaviour(eg. hallucinations, incoherent speech, confusion) or severe headaches occur,while on nalidixic acid, contact the physician immediately

5.Allergies- tell your doctor if you have ever had any unusual or allergic reaction to nalidixic acid or related medicines. Also tell your doctor if you are allergic to any other substances, such as foods, presrvatives or dyes.

6.Pregnancy - not recommended for use in pregnancy.

7.Breast feeding- nalidixic acid passes into breast milk and may cause blod problems in nursing babies with glucose-6PD deficiency.

8. Children - not recommeded for use in infants up to 3 months of age since nalidixic acid has been shown to cause bone problems in young children.

9. Elderly- elderly patients has not been shown to cause different side effects or problems in older people than it does in younger adults.

10. Other medicines - Anticoagulants- patients taking nalidixic acid with anticoagulants may have an increased chance of bleeding

11. Other medical problems - Tell your doctor if you have any other medical problems especially - Convulsive disorders- or Hardening of the arteries in the brain- patients with these medical problems may have an increas chance of side effects affecting the nervous system. Glucose G6PD- patients with G6PD deficiency may have an increased chance of side effects affecting the blood. Kidney disease- or Liver disease- patients with liver disease may have an increase in side effects.

12. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.

13. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.

14. Outdated medicines - Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.n