Term
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Definition
Actions/Pharmacodynamics
Morphine Sulfate is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
Indications(s)
Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
Contraindictions
Morphine Sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product.
Morphine Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.
Morphine Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.
Morphine Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.
Adverse Effects
Respiratory depression is the primary risk of Morphine Sulfate. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
Morphine Sulfate should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Morphine Sulfate may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-opioid analgesics should be considered, and Morphine Sulfate should be employed only under careful medical supervision at the lowest effective dose in such patients.
Serious adverse reactions associated with Morphine Sulfate use include: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
The common adverse reactions seen on initiation of therapy with morphine sulfate are dose-dependent and are typical opioid-related side effects. The most frequent of these include constipation, nausea, and somnolence. Other commonly observed adverse reactions include: lightheadedness, dizziness, sedation, vomiting, and sweating. The frequency of these events depends upon several factors including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. These events should be anticipated and managed as part of opioid analgesia therapy.
Nursing Considerations
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Term
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Definition
Actions/Pharmacodynamics
Narcan prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension. Also, Narcan can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
Narcan is an essentially pure opioid antagonist, i.e., it does not possess the “agonistic” or morphine-like properties characteristic of other opioid antagonists. When administered in usual doses and in the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Following parenteral administration, Narcan is rapidly distributed in the body and readily crosses the placenta. Plasma protein binding occurs but is relatively weak. Plasma albumin is the major binding constituent but significant binding of naloxone also occurs to plasma constituents other than albumin. It is not known whether naloxone is excreted into human milk.
Indications(s)
Narcan is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Narcan is also indicated for diagnosis of suspected or known acute opioid overdosage.
Narcan may be useful as an adjunctive agent to increase blood pressure in the management of septic shock
Contraindictions
Narcan is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in Narcan.
Adverse Effects
The following adverse events have been associated with the use of Narcan in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of Narcan in postoperative patients may result in significant reversal of analgesia and may cause agitation
Nursing Considerations
Narcan may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, which is recommended in emergency situations.
Since the duration of action of some opioids may exceed that of Narcan, the patient should be kept under continued surveillance. Repeated doses of Narcan should be administered, as necessary.
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Term
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Definition
Actions/Pharmacodynamics
Hydromorphone hydrochloride is a pure opioid agonist with the principal therapeutic activity of analgesia. A significant feature of the analgesia is that it can occur without loss of consciousness. Opioid analgesics also suppress the cough reflex and may cause respiratory depression, mood changes, mental clouding, euphoria, dysphoria, nausea, vomiting and electroencephalographic changes. Many of the effects described below are common to this class of mu-opioid agonist analgesics which includes morphine, oxycodone, hydrocodone, codeine and fentanyl. In some instances, data may not exist to distinguish the effects of Dilaudid ORAL LIQUID and Dilaudid TABLETS from those observed with other opioid analgesics. However, in the absence of data to the contrary, it is assumed that Dilaudid ORAL LIQUID and Dilaudid TABLETS would possess all the actions of mu-agonist opioids.
Indications(s)
Dilaudid ORAL LIQUID and Dilaudid TABLETS are indicated for the management of pain in patients where an opioid analgesic is appropriate.
Contraindictions
Dilaudid ORAL LIQUID and Dilaudid TABLETS are contraindicated in: patients with known hypersensitivity to hydromorphone, patients with respiratory depression in the absence of resuscitative equipment, and in patients with status asthmaticus. Dilaudid ORAL LIQUID and Dilaudid TABLETS are also contraindicated for use in obstetrical analgesia.
Adverse Effects
The major hazards of Dilaudid ORAL LIQUID and Dilaudid TABLETS include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.
The most frequently observed adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.
Nursing Considerations
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Term
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Definition
Actions/Pharmacodynamics
The precise mechanism of action of Baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although Baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, Baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.
Indications(s)
Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that Baclofen treatment will aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of Baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
Contraindictions
Patients hypersensitive to Baclofen
Adverse Effects
The most common is transient drowsiness (10 to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving Baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%).
Nursing Considerations
a. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of Baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
b. Impaired Renal Function: Because Baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
d. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
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Term
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Definition
Actions/Pharmacodynamics
Reversible lipase inhibitor for obesity management that acts by inhibiting absorption of dietary fats.
Indications(s)
Rx
Obesity management, including weight loss and weight maintenance, when used in combination with a reduced-calorie diet; reduction of the risk for weight regain after prior weight loss.
OTC
Weight loss in overweight adults 18 yr of age and older along with a reduced-calorie and low-fat diet.
Contraindictions
Chronic malabsorption syndrome; reduction of cholestasis; standard considerations.
Adverse Effects
- Abdominal pain or discomfort
- back pain
- difficulty with moving
- gas with leaky bowel movements
- inability to hold bowel movement
- increases in bowel movements
- loss of bowel control
- oily bowel movements
- oily spotting of underclothes
Nursing Considerations
Patients with anorexia nervosa or bulimia should not take orlistat because of the potential for misuse. Exercise caution when prescribing orlistat to patients with a history of hyperoxaluria orcalcium oxalate nephrolithiasis because of the risk of development of increased levels of urinary oxalate following treatment with orlistat.
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Term
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Definition
Actions/Pharmacodynamics
Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3-receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine-induced bronchoconstriction effects were dose-dependent and lasted longer than 24 hours. The bronchodilation following inhalation of tiotropium is predominantly a site-specific effect.
Tiotropium is administered by dry powder inhalation. In common with other inhaled drugs, the majority of the delivered dose is deposited in the gastrointestinal tract and, to a lesser extent, in the lung, the intended organ.
Indications(s)
Spiriva HandiHaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Contraindictions
SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product.
Adverse Effects
The most commonly reported adverse drug reaction was dry mouth. Dry mouth was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma (new onset or worsening), urinary difficulty, and urinary retention.
Nursing Considerations
As an anticholinergic drug, Spiriva HandiHaler (tiotropium bromide inhalation powder) may potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction and should be used with caution in patients with any of these conditions.
As a predominantly renally excreted drug, patients with moderate to severe renal impairment (creatinine clearance of ≤50 mL/min) treated with Spiriva HandiHaler should be monitored closely
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Term
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Definition
Actions/Pharmacodynamics
Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of Heparin in combination with antithrombin III (Heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of Heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin-stabilizing factor.
Bleeding time is usually unaffected by Heparin. Clotting time is prolonged by full therapeutic doses of Heparin; in most cases, it is not measurably affected by low doses of Heparin.
Indications(s)
Heparin sodium injection is indicated for:
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION);
Prophylaxis and treatment of pulmonary embolism;
Atrial fibrillation with embolization;
Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism.
As an anticoagulant in blood transfusions, extracorporeal circulation, dialysis procedures, and in blood samples for laboratory purposes.
Contraindictions
Adverse Effects
Heparin sodium should not be used in patients:
— Severe thrombocytopenia;
— When suitable blood coagulation tests — e.g., the whole-blood clotting time, partial thromboplastin time, etc.
— cannot be performed at appropriate intervals (this contraindication refers to full-dose Heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose Heparin);
— An uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation
Nursing Considerations
Do not use Heparin Sodium Injection as a “catheter lock flush” product. Heparin Sodium Injection is supplied in vials and sterile cartridges that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all Heparin Sodium Injection vials and cartridges to confirm the correct product choice prior to administration of the drug.
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Term
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Definition
Actions/Pharmacodynamics
Mechanism of Action
Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptideangiotensin II (Ang II) by angiotensin-converting enzyme (ACE) and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS). Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other RAAS components, e.g., ACE or non-ACE pathways, is not known.
Pharmacokinetics
Aliskiren is a poorly absorbed (bioavailability about 2.5%) drug with an approximate accumulation half life of 24 hours. Steady-state blood levels are reached in about 7-8 days.
Indications(s)
Tekturna® (aliskiren) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Use with maximal doses of ACE inhibitors has not been adequately studied.
Contraindictions
Adverse Effects
Nursing Considerations
USE IN PREGNANCY: When used in pregnancy drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Tekturna should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
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Term
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Definition
Actions/Pharmacodynamics
Aricept® ODT is bioequivalent to Aricept® Tablets. Donepezil is well absorbed with a relative oral bioavailability of 100% and reaches peak plasma concentrations in 3 to 4 hours. Pharmacokinetics are linear over a dose range of 1-10 mg given once daily. Neither food nor time of administration (morning vs. evening dose) influences the rate or extent of absorption of Aricept® Tablets. A food effect study has not been conducted with Aricept® ODT; however, the effect of food with Aricept® ODT is expected to be minimal. Aricept® ODT can be taken without regard to meals.
Indications(s)
Aricept® is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer's disease, as well as in patients with severe Alzheimer's disease.
Contraindictions
Aricept® is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
Adverse Effects
The most common adverse events, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by Aricept®'s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. These adverse events were often of mild intensity and transient, resolving during continued Aricept® treatment without the need for dose modification.
Nursing Considerations
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Term
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Definition
Actions/Pharmacodynamics
Ocusert Pilo is a choline ester miotic and a positively charged quaternary ammonium compound. Ocusert Pilo, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands and the mucous cells of the respiratory tract may be stimulated. When applied topically to the eye as a single dose it causes miosis, spasm of accommodation, and may cause a transitory rise in intraocular pressure followed by a more persistent fall. Dose-related smooth muscle stimulation of the intestinal tract may cause increased tone, increased motility, spasm, and tenesmus. Bronchial smooth muscle tone may increase. The tone and motility of urinary tract, gallbladder, and biliary duct smooth muscle may be enhanced. Ocusert Pilo may have paradoxical effects on the cardiovascular system. The expected effect of a muscarinic agonist is vasodepression, but administration of pilocarpine may produce hypertension after a brief episode of hypotension. Bradycardia and tachycardia have both been reported with use of pilocarpine.
Indications(s)
Glaucoma, open-angle (treatment)—Pilocarpine is indicated primarily for the treatment of open-angle (chronic simple) glaucoma. It may be used in conjunction with a carbonic anhydrase inhibitor, epinephrine, timolol, fluorescein, or anesthetic, antibiotic, or anti-inflammatory steroid ophthalmic solutions. {08} {33} {38}
Glaucoma, angle-closure {01} (treatment)—Pilocarpine (hydrochloride or nitrate) ophthalmic solution is indicated for use alone or in combination with carbonic anhydrase inhibitors or hyperosmotic agents to lower intraocular pressure in the emergency treatment of acute angle-closure glaucoma prior to surgery or laser iridotomy. In addition, pilocarpine may be indicated for the treatment of chronic angle-closure glaucoma.
Glaucoma, angle-closure, during or after iridectomy (treatment)— Pilocarpine (hydrochloride or nitrate) ophthalmic solution may be indicated for the treatment of angle-closure glaucoma during or after iridectomy. {01}
Glaucoma, secondary {01} (treatment)—Pilocarpine may be indicated for the treatment of nonuveitic secondary glaucoma.
Miosis induction, postoperative or
Miosis induction, following ophthalmoscopy—Pilocarpine (hydrochloride or nitrate) ophthalmic solution is indicated to produce miosis in order to counteract the effects of cycloplegics and mydriatics following surgery or ophthalmoscopic examination.
Contraindictions
SALAGEN® Tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma
Adverse Effects
Increased sweating, muscle tremors, nausea, vomiting, diarrhea, watering of mouth, eye pain
Nursing Considerations
Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop.
To avoid excessive systemic absorption, patient should press finger to the lacrimal sac during and for 1 or 2 minutes following instillation of the solution.
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Term
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Definition
Actions/Pharmaco
Nitroglycerin, in common with other nitrates, produces generalized vasodilation, thereby decreasing venous return and workload on the heart. Both arterial and venous dilation occur, although venous effects predominate. Coronary vasodilation also occurs even in the presence of atherosclerosis. Relaxation of vascular smooth muscle is a result of stimulation of cyclic guanosine monophosphate (GMP) production as well as inhibition of thromboxane synthetase, permitting preferential formation of prostacyclin. Left ventricular end-diastolic pressure and volume are decreased, resulting in reduction of ventricular size and wall tension. Therapeutic doses reduce systolic, diastolic and mean arterial blood pressure; reflex tachycardia may occur, presumably in response to these effects.
Indication(s)
Acute symptomatic relief of angina pectoris; prophylactic management in situations likely to provoke angina attacks; long-term prophylactic management of angina pectoris.
I.V.: Congestive heart failure associated with acute MI, control of blood pressure during surgical procedures, especially cardiovascular; treatment of angina unresponsive to oral nitrates or b-blockers.
Contraindictions
Nitroglycerin should not be administered to individuals with: a known hypersensitivity to nitroglycerin or a known idiosyncratic reaction to organic nitrates; severe anemia because of potential for reduced hemoglobin level and impaired oxygen delivery; early MI (long-acting forms of nitroglycerin); hypotension or uncorrected hypovolemia, as the use of nitroglycerin in such states could produce severe hypotension or shock; open- or closed-angle glaucoma, although pressure is at most increased only briefly and drainage of aqueous humor is not impeded; head trauma or cerebral hemorrhage (to avoid increased intracranial pressure); constrictive pericarditis and pericardial tamponade.
Adverse Effects
The most frequent adverse reaction to nitroglycerin is headache which occurs in up to 50% of patients at the beginning of therapy and is a result of dilation of cerebral vessels. Headache usually disappears within several days with continued treatment. Acetaminophen may be used to treat nitrate headaches.
Other adverse reactions occurring in less than 1% of patients are: Allergic: itching, wheezing, tracheobronchitis, contact dermatitis with topical dosage forms.
Considerations
Nitroglycerin ointment, transdermal or oral tablets are not intended for immediate relief of acute attacks of angina pectoris. Sublingual, metered dose spray, or buccal nitroglycerin preparations should be used for this purpose.
Caution should be exercised in using the drug in patients who are volume depleted or have low systolic blood pressure. Severe hypotension, especially postural, may occur. Nitroglycerin can act as a physiological antagonist to norepinephrine, acetylcholine and histamine. Alcohol may accentuate cerebral ischemic symptoms.
Nitroglycerin should be used with caution in patients with severe liver or renal disease. In patients with gastrointestinal hypermotility or malabsorption syndrome, avoid extended release preparations.
Headaches or symptoms of hypotension, such as weakness or dizziness, particularly when arising suddenly from a recumbent position, may be due to overdosage. If this occurs the dose should be reduced or the frequency of topical application should be reduced.
Warnings: The use of nitroglycerin in acute myocardial infarction or congestive heart failure requires careful clinical and/or hemodynamic monitoring.
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Term
INH
( Isonicotinic Acid Hydrazide ) |
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Definition
Actions/Pharmaco
Interferes with lipid and nucleic acid biosynthesis in actively growing tubercle bacilli.
Indication(s)
Treatment of all forms of tuberculosis.
Unlabeled Uses
Improvement of severe tremor in multiple sclerosis.
Contraindictions
Previous isoniazid-associated hepatic injury, drug fever, chills, or arthritis; acute liver disease.
Adverse Effects
Dermatologic
Morbilliform, maculopapular, purpuric, or exfoliative skin eruptions.
GI
Nausea; vomiting; epigastric distress.
Hematologic
Agranulocytosis; hemolytic, sideroblastic, or aplastic anemia; thrombocytopenia; eosinophilia.
Hepatic
Hepatotoxicity, including elevated serum transaminase levels, bilirubinemia, bilirubinuria, jaundice, severe and sometimes fatal hepatitis.
Metabolic
Pyridoxine deficiency; pellagra; hyperglycemia; metabolic acidosis; hypocalcemia; hypophosphatemia.
Miscellaneous
Gynecomastia; rheumatic syndrome; systemic lupus erythematosus-like syndrome; local irritation at IM injection site.
Considerations
Severe and sometimes fatal hepatitis may occur during and many mo after treatment. Risk is related to age and increased with daily alcohol consumption. If reinitiated, start in small and gradual doses. Not for use in patients with active liver disease. Careful monitoring and monthly interviews are recommended.
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Term
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Definition
Actions/Pharmaco/Indication(s)
1.1 Monotherapy and Combination Therapy
Avandia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.2 Important Limitations of Use
Due to its mechanism of action, Avandia is active only in the presence of endogenous insulin. Therefore, Avandia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
The coadministration of Avandia and insulin is not recommended.
The use of Avandia with nitrates is not recommended.
Contraindictions
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered.
Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4) and Warnings and Precautions (5.1).]
A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive
Adverse Effects
Edema, Weight-gain, Macular Edema, bone fractures, Upper respiratory tract infection,
Considerations
A whole crap load of it... |
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Term
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Definition
Actions/Pharmaco
Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis, proteolysis, and enhances protein synthesis.
Indication(s)
Management of type 1 diabetes mellitus (insulin-dependent) and type 2 diabetes mellitus (non–insulin-dependent) not properly controlled by diet, exercise, and weight reduction. In hyperkalemia, infusions of glucose and insulin lower serum potassium levels. IV or IM regular insulin may be given for rapid effect in severe ketoacidosis or diabetic coma. Highly purified (single component) and human insulins are used for treatment of local insulin allergy, immunologic insulin resistance, lipodystrophy at injection site, temporary insulin administration, and in newly diagnosed diabetic patients.
Contraindictions
Hypersensitivity to any ingredient of the product; during episodes of hypoglycemia.
Adverse Effects
Lipodystrophy, Hypokalemia, Hypoglycemia, Hypersensitivity (anaphylaxis, angioedema, fast pulse, hypotension, rash, shortness of breath, sweating)
Drug Interactions
ACE inhibitors, anabolic steroids, clofibrate, disopyramide, fibrates, fluoxetine, guanethidine, MAOIs, oral antidiabetics, propoxyphene, salicylates, sulfinpyrazone, sulfonamide antibiotics, tetracyclines
May increase hypoglycemic effects of insulin.
Alcohol, beta-blockers, clonidine, lithium salts
May increase or decrease the blood glucose-lowering effect of insulin.
Atypical antipsychotics, corticosteroids, danazol, diazoxide, diltiazem, glucagon, isoniazid, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics, thyroid hormone
May decrease hypoglycemic effects of insulin.
Beta-blockers, clonidine, guanethidine, reserpine
Signs and symptoms of hypoglycemia may be reduced or absent.
Pentamidine
May cause hypoglycemia, which may be followed by hyperglycemia.
Laboratory Test Interactions
None well documented.
Considerations
Check blood sugar frequently and observe for signs of hypoglycemia and hyperglycemia. Periodically measure glycosylated hemoglobin (A 1c ) to monitor long-term glycemic control. Check urine for ketones in patient at risk for ketoacidosis and observe for signs and symptoms of ketoacidosis (eg, drowsiness, frequent urination, fruit-like breath, thirst). |
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Term
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Definition
Actions/Pharmaco
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.
Indication(s)
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Respiratory Diseases
Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
Contraindictions
Prednisone tablets and oral solutions are contraindicated in systemic fungal infections and known hypersensitivity to components.
Adverse Effects
Allergic Reactions
anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema.
Cardiovascular System
bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic
acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria.
Endocrine
Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine), suppression of growth in pediatric patients.
Fluid and Electrolyte Disturbances
congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema.
Gastrointestinal
abdominal distention, abdominal pain,anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting.
Hematologic
anemia, neutropenia (including febrile neutropenia).
Metabolic
negative nitrogen balance due to protein catabolism.
Musculoskeletal
arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures.
Neurological/Psychiatric
amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior.
Ophthalmic
blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic), optic nerve damage, papilledema.
Other
abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection), hiccups, immunosuppresion, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia.
Considerations
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that Prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
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Term
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Definition
Actions/Pharmaco
Inhibits synthesis of thyroid hormones
Indication(s)
Long-term therapy of hyperthyroidism; amelioration of hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy; when thyroidectomy is contraindicated or not advisable.
Contraindictions
Hypersensitivity to antithyroid drugs; lactating women.
Adverse Effects
Hematologic
Inhibition of myelopoiesis (eg, agranulocytosis, leukopenia, granulocytopenia, thrombocytopenia); aplastic anemia; hypoprothrombinemia; periarteritis.
Miscellaneous
Abnormal hair loss; arthralgia; myalgia; edema; lymphadenopathy; drug fever; interstitial pneumonitis; insulin autoimmune syndrome (hypoglycemia).
Considerations
Pregnancy
Category D .
Lactation
Avoid breast-feeding. However, if antithyroid drug is essential, propylthiouracil is preferred antithyroid agent while breast-feeding.
Children
Hepatotoxicity has occurred in children. Discontinue drug immediately if signs and symptoms of hepatic function impairment develop.
Agranulocytosis
Potentially most serious adverse reaction. Discontinue drug if agranulocytosis, aplastic anemia, hepatitis, fever, or exfoliative dermatitis occur.
Hemorrhagic effects
May cause hypoprothrombinemia and bleeding.
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