imipramine hydrochloride 10 mg
INDICATIONS AND USAGE Depression For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
lupin pharmaceuticals, inc.
ROUND YELLOW LU V11
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HOW SUPPLIED
IMIPRAMINE HYDROCHLORIDE tablets USP, containing 10 mg
IMIPRAMINE HYDROCHLORIDE, are round, biconvex, yellow film-coated tablets debossed with "LU" on one side and "V11" on the other side. They are supplied as follows: NDC 68180-311-01 Bottles of 100's NDC 68180-311-02 Bottles of 500's
IMIPRAMINE HYDROCHLORIDE tablets USP, containing 25 mg
IMIPRAMINE HYDROCHLORIDE, are round, biconvex, green film-coated tablets debossed with "LU" on one side and "V12" on the other side. They are supplied as follows: NDC 68180-312-01 Bottles of 100's NDC 68180-312-02 Bottles of 500's
IMIPRAMINE HYDROCHLORIDE tablets USP, containing 50 mg
IMIPRAMINE HYDROCHLORIDE, are round, biconvex, reddish brown film-coated tablets debossed with "LU" on one side and "V13" on the other side. They are supplied as follows: NDC 68180-313-01 Bottles of 100's NDC 68180-313-02 Bottles of 500's Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Dispense in tight container (USP) with a child-resistant closure. ANIMAL PHARMACOLOGY & TOXICOLOGY A. Acute: Oral LD 50 ranges are as follows: Rat 355 to 682 mg/kg Dog 100 to 215 mg/kg Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death. B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner: Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when
IMIPRAMINE HYDROCHLORIDE is administered orally in doses up to approximately 2-1/2 times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentially free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate, and a reduction in the mean birth weight.
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