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Librax Indications, Dosage, Storage, Stability - Chlordiazepoxide and Clidinium

Librax Indications, Dosage, Storage, Stability - Chlordiazepoxide and Clidinium

INDICATIONS

Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:

“Possibly” effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Final classification of the less-than-effective indications requires further investigation.

DOSAGE AND ADMINISTRATION

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Librax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

HOW SUPPLIED

Librax is available in green capsules, each containing 5 mg chlordiazepoxide hydrochloride (Librium) and 2.5 mg clidinium bromide (Quarzan):

REFERENCES

1. Schallek W, et al. Arch Int Pharmacodyn. 1964; 149: 467-483.
2. Himwich HE, et al. J Neuropsych. Aug 1962; 3 (Suppl. 1): S15-S26.
3. Morillo. A, et. al. Psychopharmacologia. 1962; 3 (No. 5): 386-394.
4. MacLean PD. Psychosomatic Afed. Sept 1955; l7: 355-366.
5. Morgan CT. Physiological Psychology. 3rd ed. New York McGraw-Hill; 1965.
6. Randall LO, et al. J Pharm 4 Exper Therap. June 1960; 129: 163-171.
7. Miller LC and Tainter MC. Proc Soc Exp Biol E Med. 1944; 57: 261.
8. Zbinden G, et al. Toxicology and Applied Pharmacology. Nov 1961; 3.619-637.
9, Data on file, Hoffmann-La Roche Inc., Nutley, N. J.
10. Bibliography and References available on request from Roche Laboratories.
11. Rickels K, et al. Med Timhs. Mar 1965; 93: 238-245.
12. Tobin JM, et al. J Amer Med Assoc. Nov 1960; 174: 1242-1249.
13. Jenner FA, et al. J Ment Sci. May 1961; 107: 575-582.
14. Robinson RCV. Dis Nerv System. Mar 1960; 21: 43-45.
15. Rose JT. Amer J Psychiat. Mar 1964; 120: 899-900.
16. Hines LR. Corr Therap Res. June 1960; 2: 227-236.
17. Gibbs FA, Gibbs EL. J Neuropsych. Aug 1962; 3 (Suppl 1): S73-S78.
18. Kaelbling R, et al. J Amer Med Assoc. Dec 1960; 174: 1863-1865.
19. Cacioppo J, et al. Amer J Psychiat. May 1961; 117: 1040-1041.

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