Pregnancy catagories

1. Pregnancy catagories

2. The FDA has a categorization of drug risks to the fetus that runs from: "Category A" (safest)  to "Category  X" (known danger--do not use!)

3. Category A • Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.

4. Category B • Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).

5. Category C • Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

6. Category D • There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

7. Category X • Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

8. **Effects of drugs on the CNS • What is the CNS? • Organ system that consists of the brain & spinal cord

9. PNS • What is the PNS? • Peripheral Nervous system • It connects the CNS to other body parts

10. CNS stimulants • Sympathomimetics • Used to treat ADHD, narcolepsy and obesity • Highly addictive!!

11. Sympathomimetics Adverse effects Contraindications & Interactions History of drug abuse Severely agitated Hyperthyroidism Diabetes mellitus Moderate to severe hypertension Advanced arteriosclerosis Angina pectoris glaucoma • Headache • Palpitations • Cardiac dysrhythemias • Hypertension • Nervousness • nausea

12. Sympathomimetics • Important points patients should know: • Advise patients taking CNS stimulants for a prolonged period, withdrawal symptoms could occur. • A gradual decrease is essential to prevent withdrawal effects.

13. Anxiety • Very common disorder • Signs of anxiety are: • Excessive, ongoing worry and tension • An unrealistic view of problems • Restlessness or a feeling of being "edgy" • Irritability • Muscle tension • Headaches • Sweating • Difficulty concentrating • Nausea • The need to go to the bathroom frequently • Tiredness • Trouble falling or staying asleep • Trembling • Being easily startled

14. What causes anxiety? • The exact cause of GAD is not fully known, but a number of factors -- including genetics, brain chemistry and environmental stresses -- appear to contribute to its development. • Genetics: Some research suggests that family history plays a part in increasing the likelihood that a person will develop GAD. This means that the tendency to develop GAD may be passed on in families. • Brain chemistry: GAD has been associated with abnormal levels of certain neurotransmitters in the brain. Neurotransmitters are special chemical messengers that help move information from nerve cell to nerve cell. If the neurotransmitters are out of balance, messages cannot get through the brain properly. This can alter the way the brain reacts in certain situations, leading to anxiety. • Environmental factors: Trauma and stressful events, such as abuse, the death of a loved one, divorce, changing jobs or schools, may lead to GAD. GAD also may become worse during periods of stress. The use of and withdrawal from addictive substances, including alcohol, caffeine, and nicotine, can also worsen anxiety.

15. ***Benzodiazepine • Medication: Drugs are available to treat GAD and may be especially helpful for people whose anxiety is interfering with daily functioning. The medications most often used to treat GAD in the short-term are from a class of drugs called benzodiazepines. These medications are sometimes referred to as "tranquilizers," because they leave you feeling calm and relaxed. They work by decreasing the physical symptoms of GAD, such as muscle tension and restlessness. Common benzodiazepines include Xanax, Librium, Valium and Ativan. Antidepressants, such as Paxil, Effexor, Prozac, Lexapro, and Zoloft, are also being used to treat GAD. These antidepressants may take a few weeks to start working but they're more appropriate for long-term treatment of GAD. • Used a hypnotic

16. ***Antipsychotics • Neuroleptic drugs that can improve thought disorders

17. Seizures • What is a seizure? • Abnormal electrical activity in the brain. • Diazepam (Valium) is given to stop the repetitive seizure activity, and then, long-acting drugs such as phenytoin (Dilantin) are given to prevent the recurrence of seizures

18. Did you Know? • Treatment for lice effects the CNS and causes the lice to have seizures, so these types of drugs are not recommended for people with seizure disorders

19. Barbiturates How are they used? Primarily used to treat insomnia Partial epilepsy Tonic clonic seizures • Classified as CNS agents, anticonvulsants and sedative-hypnotic drugs.

20. ***Insomnia • Inability to sleep • Previously Barbiturates were used to treat insomnia

21. Epilepsy Types of seizures Some causes of Epilepsy Epilepsy is a permanent, recurrent seizure disorder. Brain injury at birth Head injuries Inborn errors of metabolism Some patients the cause is never determined • Tonic clonic seizures -Previously termed grand-mal seizures • Generalized absence seizures- previously called petit mal • Generalized myoclonic seizures • Partial seizures

22. Antiseizure drugs (Anticonvulsants) • Phenytoin-Dilantin • Diazepam-Valium • Lorazepam-Ativan • Phenobarbital-Barbital • Carbamazepine-Tegretol • Valproate-Depakote • Valproic acid-Depakene

23. **Phenytoin (most common drug in the hydantoin group) Interactions with this drug Important points patients should know: Urine might become discolored to a pink or red-brown color. Blood glucose levels should be checked more closely because phenytoin can inhibit insulin release. • Antacids • Antidiabetic agents • Antipsychotics • Barbiturates • Calcium channel blockers • Corticosteroids • Estrogens • Oral contraceptives • Antidepressants • Vitamin D analogues

24. ***Valproic acid (Depakote) How is it used? Important points patients should know May irritate the mouth, throat and stomach Take with meals or snacks to reduce stomach upset • Management of absence and mixed seizures • Mania • Migraine headache prophylaxis • Most common drug of choice for childhood absence seizures

25. **Atropine • Patients receiving atropine should be encouraged to use frequent mouth rinses, gum or candy to relieve dry mouth.

26. Parkinson’s Disease What is it? Signs of the disease Slowness in initiating movement Shuffling gait Skeletal muscle rigidity • Nervous system disorder characterized by movement abnormalities such as tremor of the extremities and head, and great difficulty in coordination of fine muscle movement. • Lack of dopamine in the brain

27. **Michael J. Fox • At this time there is no cure for Parkinson's disease • The cause is unknown

28. Drugs to treat Parkinson's disease • Levodopa- approved in 1970 and is the most commonly used drug to date for treatment of Parkinson's disease • Levodopa readily crosses the blood-brain barrier, unlike dopamine.

29. Dopanimergic Drugs Adverse effects Important points patients should know Levodopa may discolor urine and perspiration Avoid foods rich in Vitamin B6 such as beans and cereal. Regular dental checkups are needed to prevent dental problems caused by inhibition of salivation. Rebound of parkinsonism can occur if medication stops abruptly. • Dyskinesia- is a movement disorder which consists of effects including diminished voluntary movements and the presence of involuntary movements • Hallucinations • Mental confusion

30. ***Parkinsonism • The symptoms that are produced by certain drugs, poisons, and traumatic lesions in the basic ganglia

31. Schizophrenia What is it? Negative symptoms include: Social withdrawal Anhedonia (the inability to experience pleasure) Apathy This illness is chronic Less than 20% of patients recover fully from a single episode of psychosis • One of the most common psychotic disorders • Cause is unknown • Hearing or seeing things that are not real • Distortions of thought process • delusions

32. ****Antipsychotic drugs How are they used? Adverse effects Sedation Dry mouth Sexual dysfunction Akathisia-difficulty in initiating muscle movement Bradykinesia Tardive Dyskinesia-slowed ability to make voluntary movement • Schizophrenia • Antiemetic • Antinausea agents

33. Antipsychotic drugs • Haloperidol-Haldol • Aripiprazole-abilify • Olanzapine-zyprexa • Quetiapine-zyprexa • Quetiapine-seroquel • Risperidone-risperdal

34. Depression • One of the most common psychiatric disorders in the United States • Symptoms include: • Feeling of doom • Lack of self worth • Inability to sense pleasure • Inability to concentrate • Changes in sleep

35. Antidepressant drugs • Amitriptyline- Elavil • Citalopram-celexa • Fluozetine-prozac • Paroxetine-paxil • Sertraline-zoloft

36. MAOIs • Are second or third line antidepressants because of the numerous interactions with prescriptions and OTC medications, as well as with certain foods and beverages. • Cheese • Sour cream • Yogurt • Chicken liver • Beef • Coffee • Tea • Caffeinated sodas • Chocolate • Soy sauce • Figs • Raisins • Bananas and raspberries

37. ***What is a sedative drug? • A drug that diminishes the activity of the CNS

38. Effects of drugs on the ANS • The ANS regulates: Muscles • in the skin (around hair follicles; smooth muscle) • around blood vessels (smooth muscle) • in the eye (the iris; smooth muscle) • in the stomach, intestines and bladder (smooth muscle) • of the heart (cardiac muscle) • Glands • The ANS is divided into three parts: • The sympathetic nervous system • The parasympathetic nervous system • The enteric nervous system.

39. ANS • The organs (the "viscera") of our body, such as the heart, stomach and intestines, are regulated by a part of the nervous system called the autonomic nervous system (ANS). The ANS is part of the peripheral nervous system and it controls many organs and muscles within the body. In most situations, we are unaware of the workings of the ANS because it functions in an involuntary, reflexive manner. For example, we do not notice when blood vessels change size or when our heart beats faster. However, some people can be trained to control some functions of the ANS such as heart rate or blood pressure.

40. ANS • The ANS is most important in two situations: • In emergencies that cause stress and require us to"fight" or take "flight" (run away) and • In nonemergencies that allow us to "rest" and "digest."

41. **Sympathetic nervous system • It is a nice, sunny day...you are taking a nice walk in the park. Suddenly, an angry bear appears in your path. Do you stay and fight OR do you turn and run away? These are "Fight or Flight" responses. In these types of situations, your sympathetic nervous system is called into action - it uses energy - your blood pressure increases, your heart beats faster, and digestion slows down

42. The Parasympathetic Nervous System • It is a nice, sunny day...you are taking a nice walk in the park. This time, however, you decide to relax in comfortable chair that you have brought along. This calls for "Rest and Digest" responses. Now is the time for the parasympathetic nervous to work to save energy - your blood pressure decreases, your heart beats slower, and digestion can start

43. **Alpha2-receptors • Are often used to reduce blood pressure

44. Parasympathetic

45. Enteric nervous system • Ever had diarrhea when you felt frightened? Had a stomach cramp before an important exam? Seen a snake barf a beetle meal when surprised? • If you've answered 'yes' to any question in this little quiz, you've already noticed the handiwork of an obscure piece of neurological networking called the enteric nervous system.

46. Sympathomimetic Drugs • Dopamine- used to treat shock • Epinephrine- asthma, cardiac arrest • Norepinephrine-shock • Clonidine-hypertension • Albuterol-asthma • Amphetamine-narcolepsy, ADD, obesity

47. ***Cholinergic receptors • Cholinergic receptors that affect the skeletal muscles are nicotinic receptors • The nicotine molecule is very similar in shape to the neurotransmitter acetylcholine, which affects many bodily functions, including breathing, heart rate, learning and memory. Acetylcholine in turn also affects other neurotransmitters that have influence over appetite, mood, and memory. When nicotine gets into the brain, it attaches to nerve cells in places where acetylcholine would, creating the same effects.

48. Ecstasy and the ANS • Ecstasy is an illegal drug known as 3,4, MDMA are Adam, XTC, Doves, or just E. • Originally patented as an appetite suppressant • Data now shows that MDMA may be toxic to the brain • Studies have shown a 20 to 60% reduction in healthy serotonin cells in the brains of MDMA users, damaging their ability to remember and to learn. • Test on monkeys showed that brain damage was visible 7 years after they were given MDMA

49. Ecstasy

50. **Drug cautions • Many drugs discussed in this chapter can cause dizziness, and patients are strongly advised to be careful when making changes in body position.