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  • Title: Pharmacokinetics of norethindrone in Indian Women.
    Author: Prasad KV, Rao BS, Sivakumar B, Prema K.
    Journal: Contraception; 1979 Jul; 20(1):77-90. PubMed ID: 477319.
    Abstract:
    Pharmacokinetics of norethindrone (NET) was evaluated in eleven women belonging to a low socio-economic group and in five womem belonging to the high socio-economic group after the administration of an oral dose of 0.35 mg NET minipill on an empty stomach. Blood samples were collected at different intervals of time over a period of 24 hours. Plasma NET was estimated by radioimmunoassay. In all women, peak levels of NET occurred within 1-2 hours and a semi-log plot of plasma NET levels showed a biexponential decline. The half-life of plasma NET clearance was relatively shorter in women of low socio-economic group with poor nutritional status as indicated by anthropometric indices, as compared to that in well nourished women of high socio-economic group. There was a significant positive correlation between weight/(height) 2x 100 index on the one hand and t1/2 (beta) on the other in all the women studied, thereby suggesting a role for nutritional status in the metabolic handling of NET. A correlation between nutritional levels and norethindrone pharmacokinetics was evaluated in 11 women of low socioeconomic status (SES) and 5 women of high SES. An oral dose of .35 mg of norethindrone was administered on an empty stomach in mini-pill form. Radioimmunoassay was used to measure plasma norethindrone from blood samples collected at different intervals over 24 hours. Peak norethindrone levels occurred in all women within 1-2 hours, and a semilog plot of plasma norethindrone concentration showed a biexponential decline. Peak values ranged from 7.7-12.3 ng/ml and 4.7-l4.8 ng/ml in high SES and low SES, respectively. Plasma levels of norethindrone at 12 hours were very low in low SES and could not be detected in 8 women at 25 hours. In contrast was the finding that all 5 high SES subjects had more than detectable levels of drug throughout the experimental period. Anthropometric indexes showed the low SES group with poor nutritional status had shorter half-life clearances than the relatively well-nourished high SES group. There was also a significant correlation between weight/(height) sq. times 100 index on the one hand and the time l/2-beta on the other in all women studied, thereby suggesting a role for nutritional status in the metabolic handling of norethindrone.
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