*Indications*: Restasis® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
*Dosage*: Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of Restasis® ophthalmic emulsion twice a day in each eye approximately 12 hours apart. Restasis® can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
*Contraindications*: Restasis® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
*Precautions*: -Potential for Eye Injury and Contamination
To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces.
-Use with Contact Lenses
Restasis® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of Restasis® ophthalmic emulsion.
*Adverse Reactions*: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the most common adverse reaction following the use of Restasis® was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
*Classification*: Restasis® (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects.
*Action*: Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
*Drug Interactions*: There are no known drug interactions for Restasis (cyclosporine ophthalmic)
However, this does not necessarily mean no interactions exist. ALWAYS consult with your doctor or pharmacist.
*Nursing Considerations (pt teaching)*: Handling the Container–Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. To avoid the potential for injury to the eye, advise patients to not touch the vial tip to their eye.
Use with Contact Lenses–Restasis® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of Restasis® ophthalmic emulsion.
Many other eye drops have vasoconstrictors or harsh chemicals that may actually worsen symptoms if used more than directed. Complete Eye Relief works in harmony with your body to boost your natural defenses, so you can feel good about using it on you or your child. It is also gentle enough to use as needed when symptoms occur, making it a perfect addition for every medicine cabinet. Similasan Complete Eye Relief is family doctor-recommended as a complementary treatment for managing your symptoms. Try Similasan and feel good about helping your eyes feel better. Some eye drops contain the chemicals Tetrahydrozoline or Naphazoline hydrochloride known as vasoconstrictors or redness relievers. These ingredients constrict the muscular walls of the eye, shrinking the blood vessels to reduce the appearance of redness. With extended use, vasoconstrictors can cause rebound redness and even make the problem worse. Instead of masking the symptoms with vasoconstrictors, Similasan eye drops work differently to target the root cause of the problem. Our eye drops work by stimulating the body to temporarily relieve itself with naturally occurring active ingredients. Keep your eyes happy and healthy with Similasan!
*Scientific Name(s)*:Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
*Common Name(s)*: Marine oils , marine oil fatty acids , n-3 fatty acids , omega-3 fatty acids , omega-3 polyunsaturated fatty acids ( PUFAs ), long-chain PUFAs ( LCPUFAs ), Lovaza
*Indications*: Clinical benefit is strongest for lowering the risk of coronary artery disease and decreasing serum triglycerides. Reductions in the risk for all-cause mortality, cardiac death, and sudden death have been established for omega-3 fatty acid supplementation for at least 1 year’s duration. The United States Food and Drug Administration (FDA) has approved the use of fish oil for reducing very high triglyceridemia (at least 5.65 mmol/L) in adults as an adjunct to diet. Evidence for use of parenteral fish oil lipid emulsion is mounting in severely ill and surgical patients. Evidence for a role in rheumatoid arthritis remains equivocal but promising. No consistent relationship between fish oil consumption and reduction in the risk of stroke or maintenance in inflammatory bowel disease has been established. Other areas of interest in the therapeutic use of fish oils requiring further study include asthma and allergy, dysmenorrhea, mental health, and the promotion of postnatal growth and development.
*Dosing*: The American Heart Association (AHA) recommends a minimum of 2 fatty fish meals per week. Clinical trials suggest fish oil supplementation of omega-3 fatty acids 1 g/day in coronary heart disease, and where triglycerides are elevated, a minimum of omega-3 fatty acids 2 g/day up to a maximum of 4 g/day. Fish oil 1,000 mg approximates to omega-3 fatty acids (eicosapentaenoic acid [EPA]/docosahexaenoic acid [DHA]) 300 to 400 mg.
*Contraindications*: Contraindications have not yet been identified.
*Interactions*: None well documented.
*Adverse Reactions*: Fish oil at dosages of EPA/DHA 2 to 5.4 g/day is well accepted and tolerated. Mild GI discomfort was reported in clinical trials.
*Uses and Pharmacology*: Omega-3 fatty acids are metabolized into eicosanoids, which have important physiologic properties and include prostaglandins, prostacyclins, thromboxanes, and leukotrienes. Eicosanoids are potent regulators of blood pressure, blood clotting, childbirth, and gastric secretions, as well as immune and inflammatory responses. The actual location of the double bond in the fatty acid chain affects its metabolism such that the structure and function of omega-3-derived eicosanoids differ from those derived from omega-6 fatty acids (eg, arachidonic acid). For example, omega-3-derived eicosanoids tend to decrease blood clotting and inflammatory responses. This contrasts with the arachidonic acid (omega-6)-derived eicosanoids, which increase clotting and inflammatory responses. 2 , 3 , 15.
*Dosage*: The AHA recommends a minimum of 2 fatty fish meals per week. 1 , 34 Clinical trials suggest fish oil supplementation of omega-3 fatty acid 1 g/day in coronary heart disease, and where triglycerides are elevated, a minimum of omega-3 fatty acid 2 g/day up to a maximum of 4 g/day. Fish oil 1,000 mg approximates to omega-3 fatty acid 300 to 400 mg (EPA/DHA). Emulsified oral preparations have been developed to improve the taste over encapsulated fish oils and may increase digestion and absorption of the fatty acids via modifications in solubility. 103 Encapsulated oils have been found to oxidize and become rancid over time and with processing method, which may have an effect on total EPA/DHA delivered.
*Interactions*: The anticoagulant effect of warfarin may be increased by fish oil ingestion, although case reports are limited.
*Adverse Reactions*: Fish oil at dosages of EPA/DHA 2 to 5.4 g/day is well accepted and tolerated. In clinical trials, only mild GI-related adverse effects were reported, including dyspepsia, diarrhea, and nausea. 30 , 31 , 56 , 75 An increased risk of diarrhea was noted in a meta-analysis of trials conducted among patients with inflammatory bowel disease who were given enteric-coated, time-released capsules.
-A safety study found adverse events similar for intervention (EPA 2 g/day for 12 weeks) and placebo groups. An increased body mass index and increased (but modest) bleeding time were reported.
-An increase in LDL cholesterol has been reported occasionally; however, evidence does not suggest that the risk is greater than the health benefits related to increased fish oil consumption.
*Classification*: Anticholinergic, bronchodilator
*Indications & Dosages*:
Adults & adolescents. 2-4 inhalations (36-72 mcg) tid or qid. Max: Up to 12 inhalations (216 mcg)/ 24 hr.
Inhalation Solution For Nebulizer:
Adults & adolescents. 250-500 mcg dissolved in preservative-free sterile NS sol every 6-8 hrs. For severe COPD exac, 500 mcg every 4-8 hrs.
Adults & children age 6 and over. 2 sprays of 0.03% (21 mcg/spray) per nostril bid or tid. Max: 12 sprays (252 mcg)/24 hrs.
Adults and children age 5 and over. 2 sprays of 0.06% (42 mcg/spray) per nostril tid or qid for up to 4 days. Max: 16 sprays (672 mcg)/24 hrs.
*Adverse Reactions*: CNS: dizziness, insomnia
CV: Atrial fib (oral inhalation), bradycardia (nasal spray), edema, HTN, palpitations, supraventricular tachycardia (oral inhalation), tachycardia
EENT: Acute eye pain, dry mouth or pharyngeal area, increased intraocular pressure, laryngospasm, taste perversion, oropharyngeal edema (all drug forms); blurred vision, conjunctival and corneal congestion, eye irritation and pain, mydriasis, visual halos (if nasal spray comes in contact w eyes); epistaxis, mydriasis, nasal dryness and irritation, pharyngitis, rhinitis, sinusitis, tinnitus (w nasal spray)
GI: Bowel obstruction, constipation, diarrhea, ileus, n/v
GU: Prostatitis, urine retention
RESP: Bronchitis, bronchospasm, cough, dyspnea, increased sputum production, wheezing
SKIN: Dermatitis, pruritus, rash, urticaria
Other: Anaphylaxis, angioedema, flulike symptoms
Anticholinergics: Increased anticholinergic effects
Tacrine: Decreased effects of both drugs
*Contraindications/Precautions*: Hypersensitivity to atropine, ipratropium bromide, or their components; hypersensitivity to peanuts, soya lecithin, soybeans, or related products (w aerosol inhaler)
*Action*: After acetylcholine is released from cholinergic fibers, ipratropium prevents it from attaching to muscarinic receptors on membranes of smooth-muscle cells. By blocking acetycholine’s effects in bronchi and bronchioles, ipratropium relaxes smooth muscles and causes bronchodilation.
-Used cautiously in pts w angle-closure glaucoma, benign prostatic hyperplasia, or bladder neck obstruction and in pts w hepatic or renal dysfunction
-As prescribed, mex inhalation solution w preservative-free albuterol, and preservative-free ipratroppium inhalation sol. w cromolyn inhalation sol. Use within 1 hr.
-When using a nebulizer, apply a mouthpiece to prevent drug from leaking out around mask and causing blurred vision or eye pain
-WARNING: Monitor pt for hypersensitivity reactions that could be life-threatening. If present, stop drug use immediately, notify prescriber, and provide supportive care, as needed
-Caution pt not to use to treat acute bronchospasm
-Inform pt that although some ppl feel felief within 24 hrs of drug use, max effect may take up to 2 wks
-Teach pt to use inhaler or nasal spray. Tell him to shake inhaler well at each use
-Advise pt to keep spray out of his eyes bc it may irritate them or blur vision. If spray comes in contact w eyes, instruct pt to flush them w cool tap water for sev min and to contact prescriber
-Instruct pt to rinse mouth after each nebulizer or inhaler tx to help minimize throat dryness and irritation
-If pt is using 0.06% nasal spray for a common cold, advise against use for longer than 4 days
-Teach pt to track canister contents by counting and recording number of doses
-Advise pt to report decreased response to drug as well as difficulty voiding, eye pain, nasal dryness, nose bleeds, palpitations, and vision changes
Classifications: central nervous system (cns) agent; analgesic; narcotic (opiate) agonist
Prototype: Morphine sulfate
Pregnancy Category: C
50 mg tablets; 50 mg orally disintegrating tablets
Centrally acting opiate receptor agonist that inhibits the uptake of norepinephrine and serotonin, suggesting both opioid and nonopioid mechanisms of pain relief. May produce opioid-like effects, but causes less respiratory depression than morphine.
Effective agent for control of moderate to moderately severe pain.
Management of moderate to moderately severe pain.
Hypersensitivity to tramadol or other opioid analgesics; patients on MAO inhibitors; patients acutely intoxicated with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs; substance abuse; patients on obstetric preoperative medication; abrupt discontinuation; alcohol intoxication; pregnancy (category C); lactation; children <16 y.
Debilitated patients; chronic respiratory disorders; respiratory depression; older adults; liver disease; renal impairment; myxedema, hypothyroidism, or hypoadrenalism; GI disease; acute abdominal conditions; increased ICP or head injury, increased intracranial pressure; history of seizures; patients >75 y.
Route & Dosage
Adult: PO 50-100 mg q4-6h prn (max: 400 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up to 200 mg/d
Geriatric: PO 50-100 mg q4-6h prn (max: 300 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up to 200 mg/d
Clcr <30 mL/min: decrease to 50-100 mg q12h Hepatic Impairment Cirrhosis decrease to 50-100 mg q12h Administration Oral Note: Dosage reduction is recommended for patients with renal insufficiency and hepatic impairment. Store at 15°-30° C (59°-86° F). Adverse Effects (1%) CNS: Drowsiness, dizziness vertigo, fatigue, headache, somnolence, restlessness, euphoria, confusion, anxiety, coordination disturbance, sleep disturbances, seizures. CV: Palpitations, vasodilation. GI: Nausea, constipation, vomiting, xerostomia, dyspepsia, diarrhea, abdominal pain, anorexia, flatulence. Body as a Whole: Sweating, anaphylactic reaction (even with first dose), withdrawal syndrome (anxiety, sweating, nausea, tremors, diarrhea, piloerection, panic attacks, paresthesia, hallucinations) with abrupt discontinuation. Skin: Rash. Special Senses: Visual disturbances. Urogenital: Urinary retention/frequency, menopausal symptoms. Diagnostic Test Interference Increased creatinine, liver enzymes; decreased hemoglobin; proteinuria. Interactions Drug: Carbamazepine significantly decreases tramadol levels (may need up to twice usual dose). Tramadol may increase adverse effects of mao inhibitors. tricyclic antidepressants, cyclobenzaprine, phenothiazines, selective serotonin-reuptake inhibitors (ssris), mao inhibitors may enhance seizure risk with tramadol. May increase CNS adverse effects when used with other cns depressants. Herbal: St. John's wort may increase sedation. Pharmacokinetics Absorption: Rapidly absorbed from GI tract; 75% reaches systemic circulation. Onset: 30-60 min. Peak: 2 h. Duration: 3-7 h. Distribution: Approximately 20% bound to plasma proteins; probably crosses blood-brain barrier; crosses placenta; 0.1% excreted into breast milk. Metabolism: Metabolized extensively in liver by cytochrome P450 system. Elimination: Excreted primarily in urine. Half-Life: 6-7 h. Nursing Implications Assessment & Drug Effects Assess for level of pain relief and administer prn dose as needed but not to exceed the recommended total daily dose. Monitor vital signs and assess for orthostatic hypotension or signs of CNS depression. Discontinue drug and notify physician if S&S of hypersensitivity occur. Assess bowel and bladder function; report urinary frequency or retention. Use seizure precautions for patients who have a history of seizures or who are concurrently using drugs that lower the seizure threshold. Monitor ambulation and take appropriate safety precautions. Patient & Family Education Exercise caution with potentially hazardous activities until response to drug is known. Understand potential adverse effects and report problems with bowel and bladder function, CNS impairment, and any other bothersome adverse effects to physician. Do not breast feed while taking this drug.
*Brand Name*: Examples include Capzasin-P and Zostrix
Capsaicin cream is used for: Temporary relief of muscle and joint pain associated with arthritis, simple backaches, sprains, strains, and bruises. It may also be used for other conditions as determined by your doctor.
Capsaicin cream is a topical analgesic. Exactly how it works is unknown, but it is thought to decrease the amount of a certain substance (substance P) that transmits pain in the body
Do NOT use capsaicin cream if: You are allergic to any ingredient in capsaicin cream
Before using capsaicin cream: Some medical conditions may interact with capsaicin cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
-if you are pregnant, planning to become pregnant, or are breast-feeding
-if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
-if you have allergies to medicines, foods, or other substances
-if you have an open wound or damaged, broken, or irritated skin
Some MEDICINES MAY INTERACT with capsaicin cream. Because little, if any, of capsaicin cream is absorbed into the blood, the risk of it interacting with another medicine is low.
Important safety information:
-For external use only. Avoid contact with the eyes, nose, and mouth. If capsaicin cream gets into your eyes, rinse immediately with cool water.
-Do not use more than the recommended dose, use for longer than prescribed, or use large amounts of capsaicin cream without checking with your doctor.
-Do not inhale any residue from capsaicin cream after it has dried. Coughing, sneezing, or throat or respiratory irritation may occur.
-Capsaicin cream may be harmful if swallowed. If you may have taken capsaicin cream by mouth, contact your local poison control center or emergency room immediately.
-If condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use of this product and contact your health care provider.
-If redness is present or if irritation develops, check with your doctor before using any more of capsaicin cream.
-If severe burning or itching occurs, remove product by thoroughly washing the area with soap and cold water.
-Capsaicin cream should not be used in CHILDREN younger than 18 years old without checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using capsaicin cream while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use capsaicin cream, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of capsaicin cream: All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
-Temporary burning or stinging at the application site that usually disappears in a few days.
-Seek medical attention right away if any of these SEVERE side effects occur:
-Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty breathing or swallowing; irritation, redness, blistering, or severe or persistent burning at the application site.
Arthritis creams are effective, but they only provide temporary pain relief. The main types of arthritis pain relief creams are:
According to a review published in the journal BMJ, creams containing salicylates have been shown to work moderately well in treating arthritis pain. Some brands of salicylate ointment contain other ingredients like menthol, eucalyptus oil, and cinnamon oil. These are counterirritants, which warm the skin and distract the brain from pain.
Capsaicin, an element found in hot chili peppers, reduces pain by blocking the skin’s pain receptors.
Always follow package directions when applying an arthritis cream. Cover the affected area, but don’t wrap it tightly. Wash your hands before and after application, and never touch your eyes or mucus membranes when you have arthritis cream on your hands.
Most arthritis creams suggest limiting use to four times a day. Stop using the cream if it causes any irritation. Ask your doctor if you should avoid salicylates if you’re sensitive or allergic to aspirin, or if you take prescription blood thinners.
*Bengay for pain*: It contains salicylates, camphor, and menthol. Salicylate penetrates the affected area, while the latter two ingredients bring on a cooling sensation followed by warming. Bengay is available in a variety of strengths. Bengay Arthritis Cream has relieved muscle and bone pain effectively.
*Icy Hot Vanishing Gel*: The name says it all. Icy Hot provides an initial cooling sensation followed by a deeper, comforting feeling of heat. Icy Hot contains menthol and salicylates. It’s recommended for occasional pain relief. Icy Hot’s Vanishing Gel is ideal if you don’t like the minty smell of menthol on your skin.
*Aspercreme Odor Free Topical Analgesic Gel*: Aspercreme is right for you if you don’t like the smell of some arthritis creams. It works by sending salicylates through your skin to the source of the pain. It doesn’t contain counterirritants that cause cooling or warming sensations, so it’s a good choice if your skin is sensitive to those ingredients.
*Myoflex Odorless Pain Relieving Cream*: Myoflex is a great pain relief option if you have arthritis and you don’t like the greasy feel of many creams. It’s an odorless gel containing salicylates that quickly absorbs into your skin. It provides pain relief without an unpleasant scent or lotion feel.
*Capzasin-HP Arthritis Cream*: The active ingredient in Capzasin HP Arthritis is capsaicin, an element of those hot chili peppers you either love to eat or can’t tolerate. People who enjoy eating peppers report a feeling of mild euphoria. That’s because capsaicin blocks pain receptors.
The burning sensation in Capzasin HP Arthritis is much milder than the one you feel when you eat peppers. Stop using it if you find it irritates your skin.
*Sportscreme Deep Penetrating Pain Relieving Rub*: Sportscreme has a fresh, clean scent and effectively delivers pain relief to aching joints and muscles. The active ingredient is salicylates. This cream has a thicker consistency than most. That means it takes a little more rubbing to apply it, which aids pain relief like a mini-massage.
Choices: With so many arthritis pain relief creams on the market, it can be difficult to know which is right for you. If you’re sensitive to aspirin, ask your doctor before using creams containing salicylates. If you notice skin sensitivity while using any cream containing the heat-and-cold ingredients of capsaicin or menthol, discontinue use.
And finally, if you don’t want to smell like you’re using an arthritis pain relief cream, you might consider unscented options. Continue experimenting until you’ve found the pain relief cream that’s right for you.
Available Dosage Forms:
*Therapeutic Class*: Antibacterial
*Uses For neomycin*: Neomycin belongs to the family of medicines called antibiotics. Neomycin topical preparations are used to help prevent infections of the skin. neomycin may be used for other problems as determined by your doctor. Neomycin topical preparations are available without a prescription.
*Before Using neomycin*: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For neomycin, the following should be considered:
Allergies Tell your doctor if you have ever had any unusual or allergic reaction to neomycin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric: Studies on neomycin have been done only in adult patients, and there is no specific information comparing use of topical neomycin in children with use in other age groups.
Geriatric: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical neomycin in the elderly with use in other age groups.
Pregnancy Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
Breast Feeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
*Interactions with Medicines*: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
*Proper Use of neomycin*: If you are using neomycin without a prescription, do not use it to treat deep wounds, puncture wounds, serious burns, or raw areas without first checking with your health care professional.
-Do not use neomycin in the eyes.
-Before applying neomycin, wash the affected area with soap and water, and dry thoroughly.
*For patients using the cream form of neomycin*:
-Apply a generous amount of cream to the affected area, and rub in gently until the cream disappears.
-For patients using the ointment form of neomycin:
-Apply a generous amount of ointment to the affected area, and rub in gently.
-After neomycin is applied, the treated area may be covered with a gauze dressing if desired.
-To help clear up your infection completely, keep using neomycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.
*For topical dosage forms (cream or ointment)*: For minor bacterial skin infections:
Adults and children—Apply to the affected area(s) of the skin one to three times a day.
*Missed Dose*: If you miss a dose of neomycin, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
-Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. -Keep from freezing.
-Keep out of the reach of children.
-Do not keep outdated medicine or medicine no longer needed.
Precautions While Using neomycin
-If your skin problem does not improve within 1 week, or if it becomes worse, check with your health care professional.
neomycin Side Effects
-Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
*eck with your doctor immediately if any of the following side effects occur*: More common-
Itching, rash, redness, swelling, or other sign of skin irritation not present before use of neomycin
Any loss of hearing
*Therapeutic Category*: antiulcer
*Clinical Pharmacology*: Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of Sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
1.Studies in human subjects and with animal models of ulcer disease have shown that Sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.2.In vitro, a Sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.3.In human subjects, Sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.4.In vitro, Sucralfate adsorbs bile salts.
These observations suggest that Sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of Sucralfate.
*Indications and Usage*: Sucralfate tablets, USP are indicated in:
•Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.•Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
*Contraindications*: Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
*Precautions* The physician should read the PRECAUTIONS section when considering the use of this drug in pregnant or pediatric patients, or patients of childbearing potential.
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Sucralfate can result in complete healing of the ulcer, a successful course of treatment with Sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.
Isolated reports of Sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, Sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.
Chronic Renal Failure and Dialysis Patients
When Sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract.
Concomitant use of Sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of Sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
*Drug Interactions*: Some studies have shown that simultaneous Sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and Sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of Sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from Sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before Sucralfate eliminated the interaction. Because of the potential of Sucralfate to alter the absorption of some drugs, Sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
*Pregnancy category*: B–Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to Sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sucralfate is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical studies of Sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see
*DOSAGE ANDADMINISTRATION*: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see PRECAUTIONS, SpecialPopulations, Chronic Renal Failureand Dialysis Patients). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
*Adverse Reactions*: Adverse reactions to Sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate tablets, adverse effects were reported in 129 (4.7%).
Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:
Gastrointestinal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth
Dermatological: pruritus, rash
Nervous System: dizziness, insomnia, sleepiness, vertigo
Other: back pain, headache
Postmarketing cases of hypersensitivity have been reported with the use of Sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria.
Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of Sucralfate.
Bezoars have been reported in patients treated with Sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
Inadvertent injection of insoluble Sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.
*Sucralfate Dosage and Administration*:
Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate.
While healing with Sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
*Maintenance Therapy*: The recommended adult oral dosage is 1 g twice a day.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.