Introduction to Pharmacokinetics

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1 - 1 - Introduction to Pharmacokinetics Outline accompanies required webcast for Marie Biancuzzo s Lactation Exam Review and Marie Biancuzzo s Comprehensive Lactation Course Notes We will not cover this material in detail in the live course. Rather, you will need to apply this information in the live course to examples of specific medications and clinical problems. Also, for further reading, you should read Breastfeeding the Newborn: Clinical Strategies for Nurses, Chapter 13. The material is similar, but presented a little differently. Everyone learns a little differently, so you may want to take a look at the book chapter.

2 - 2 - I. Pharmacology & Toxicology A Primer for the Lactation Consultant A. Limitations of the Lactation Consultant s Role Unless licensed by the state in which he or she practices, the person who holds the IBCLC credential must strictly limit what he or she does or says with respect to medications for the lactating mother and nursling. B. DOs Presuming he or she holds no other credential, the IBCLC may: 1. Actively listen to and empathize with the mother. The fact that she needs pharmacological therapy implies that she is not completely well. 2. Clarify any terminology which the mother might have heard or seen as related to pharmacological therapy and breastfeeding. 3. Direct the mother or her physician to printed information and/or give verbatim quotes of the printed information. 4. Help the mother and/or physician to explore nonpharmacological treatment, if reasonably appropriate. 5. Respect the mother and/or physician s determination of the risk/benefit of pharmacological recommendations. 6. Provide support for the mother to maintain, interrupt, or reestablish the breastfeeding relationship, as appropriate. C. DON Ts Presuming he or she holds no other credential, the IBCLC may NOT: 1. Pronounce a drug to be safe. 2. Prescribe an herbal remedy. 3. Conspire to provide a drug that is not prescribed for the woman. 4. Undermine the advice of the physician. 5. Make or pretend to make the decision regarding medications for the mother. 6. Dispute the need for artificial supplementation.

3 - 3 - II. D. The Drug s Journey: Note the SEQUENCE 1. The Drug: What Happens in the Mother? a. Drug goes into mother, some way, some how (route of administration). b. Drug is absorbed from site of administration (extravascular, unless given IV) to the mother s systemic circulation (intravascular). c. Drug is distributed via maternal circulation. d. Drug passes from maternal plasma to the milk. e. Drug is metabolized (drug is inactivated). f. Drug is excreted through the urine and the milk. 2. The Drug: What Happens in Nursling? a. Through his mouth, the baby ingests his mother s milk that contains the drug. b. Drug goes into his GI tract where it is absorbed. c. Drug is distributed. d. Drug is metabolized. e. Drug is excreted. Pharmacokinetics: What the Body Does to the Drug A. Absorption 1. Absorption is the process by which a drug moves from its site of administration (extravascular) to the systemic circulation (intravascular.) Routes of Administration Intravenous (IV) Oral (PO) Sublingual (SL) Rectal (PR) Intramuscular (IM) Transdermal Subcutaneous (SC) Inhalation Topical 2. Another definition: the process by which the drug progresses from its pharmaceutical dosage form to a biologically available ( bioavailable ) substance that can then pass through or across cell membranes. 3. Rates of Absorption a. Different rates of absorption for different drugs. Different rates of absorption for the same drug if given by a different route. b. Factors affecting the rate and extent of absorption include solubility characteristics, route of administration, dosage form, peak plasma concentration. c. The time to peak plasma concentration is an indicator of the rate of absorption. 4. Mechanisms of Drug Absorption a. passive diffusion b. carrier-mediated diffusion c. convective absorption d. active transport e. pinocytosis 5. Safety: Infant Age and Lactational Maturity a. In the mother, the gaps are larger when she is early postpartum. b. Gaps get smaller later, so likelihood of drugs passing is smaller.

4 - 4 - c. Younger infants have less mature systems to excrete the drug. d. Brain is so vulnerable in children. B. Distribution 1. Distribution is the movement of a medication from the systemic circulation to different tissues sites (e.g., mammary tissue; breast is an organ). Factors that affect the rate and extent of distribution are solubility characteristics, molecular weight, plasma protein binding capacity, ionization, blood flow, local ph, and volume of distribution. 2. Lipid Solubility of the Drug a. Drugs that are more lipophilic are more soluble in fat than they are in water. b. Conversely, those that are hydrophilic are more soluble in water than in fat. (1) Alveolar epithelium is a lipid layer. (2) Lipophilic drugs are more likely to be concentrated in the milk because the fat content of milk is fairly high. c. In preterm babies (who have comparatively less body fat than term infants), larger amounts of lipophilic meds may be distributed in the brain because the brain has lipid-rich tissue. d. Fat content of the milk is also a factor. More fatty milk, more drug. 3. Molecular Weight of the Drug a. Size of drug influences distribution; the smaller the molecular weight, the more likely it is to cross the membrane and enter the maternal milk. b. Most drugs have molecular weight of Daltons. c. Insulin and heparin have very high molecular weights (>1000 Daltons) so therefore are VERY unlikely to pass into the mother s milk. (Theoretically possible, but very unlikely.) 4. Volume of Distribution * a. Following absorption, drugs are distributed in plasma compartments. b. Volume of distribution is a calculation. Volume of distribution = total drug mass in body divided by the concentration in the blood. c. A way to think of volume of distribution is this: It s the amount of space that the drug must occupy in the body for it to be measurable (and clinically meaningful) in the blood. d. Low volume of distribution is defined as less than 1L/kg. An example is caffeine, which easily passes into the mother s milk. e. High volume of distribution is defined as > 3 L/kg. An example is digoxin, which does not easily pass into the mother s milk. 5. Ionization a. An ionized substance has an electrical charge, either positive or negative. * The shaded information is not covered in the webcast or in the live course. I do not feel that it is relevant to the role of the lactation consultant, or to the exam. However, since people often ask me about it, I did include it here.

5 - 5 - b. Ionization is a ph-dependent characteristic. c. Different molecules are ionized at different ph levels. d. If a drug is ionized in the bloodstream, it tends to stay ionized in the bloodstream; hence, it diffuses more slowly across the membrane. (See Biancuzzo page 374 Figure 13-3.) e. According to Lawrence & Lawrence, Drugs that are non-ionized are excreted in the milk in greater amounts than are ionized compounds. 6. Protein Binding in the Maternal Circulation a. Drug can be either free or bound to protein. Protein binding can be minimal to extensive. b. Portion of drug that is bound to protein is not freely available, and there is no pharmacologic effect from this protein-bound portion. Example: Warfarin is about 97% bound to protein. 7. M/P Ratio a. Milk-to-plasma ratio is the ratio of the concentration of the substance in the milk to the concentration of the same substance in the maternal plasma. b. M/P ratio in real life may not be the same as it is in textbook. c. M/P ratio can change as it moves back and forth between maternal systemic circulation and the milk. d. M/P ratio is related to timing of the dose(s) and the number of doses given. e. M/P ratio is NOT the same as the total amount passed in the milk. See Biancuzzo pages f. Blood Level Achieved in Maternal Circulation (1) The mother s breast (organ tissue) is separate from her blood. This prevents or slows the passage of the drug from the mother s circulation into her milk. (2) Milk is secreted by lacteal (alveolar) cells in the alveoli. (3) From the alveoli, drugs pass into the milk by passive diffusion, facilitated diffusion, or active diffusion. (4) Most drugs cross the alveolar membrane primarily by passive diffusion. (5) Passive diffusion is easier in the first few days postpartum, because of the very loose junctions between the alveolar cells. (6) Although it is easier, the concept of easier is relative to the ease with which is passes later on in lactation. (7) The absolute amount of drug that passes might be low, even in those first few days. (Alveolar cells enlarge about 4-14 days, so junctions are tighter.) C. Metabolism 1. Metabolism, also called biotransformation, is the process by which the body inactivates the drug.

6 Factors that affect the rate and extent of metabolism include age, sex, nutritional status, body temperature, genetics and presence of disease. 3. Drug metabolism occurs primarily in the liver. 4. Metabolites, produced as a result of metabolism, may have pharmacologic and toxicological effects. D. Excretion 1. Excretion is the elimination of the metabolites of the drug and, in some cases, the active drug itself. 2. Half-life is the time it takes for the concentration of a drug to decrease by 50%. Most drugs have about 4 to 5 half lives before they have been virtually eliminated from the adult body. 3. Half-Life: Elimination of the drug is accomplished by half life 4. Routes of Excretion a. Major Routes of Excretion (1) Renal (2) Biliary/alimentary (3) Pulmonary (a major route for inhalation agents only) b. Minor Routes of Excretion (1) Sweat (2) Milk 5. Factors that Influence Amount of Drug Excreted Human Milk 6. Absorption a. Route of administration is a biggie. b. IV route is about 100% absorbed by the mother. c. In the infant, the GI system must be able to absorb it, because that s the route of administration for the baby! d. General Principles of OTC Therapy e. Don t use combination products if you can avoid it. III. Summary and Conclusions

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