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Side Effects & Adverse Reactions
The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, supp. 2: 747-830, 1970).
UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy.
Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
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Uses
Glipizide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
History
There is currently no drug history available for this drug.
Other Information
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. It has the following structural formula:
Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths.
Each tablet for oral administration contains 5 mg or 10 mg of glipizide. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, and starch (corn).
Sources
Topcare Zzz Sleep Manufacturers
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Topco Associates Llc
Topcare Zzz Sleep | Preferred Pharmaceuticals, Inc.
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.
Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.
In general, glipizide should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
Initial DoseThe recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
TitrationDosage adjustments should ordinarily be in increments of 2.5 to 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg.
MaintenanceSome patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 15 mg should ordinarily be divided. Total daily doses above 30 mg have been safely given on a b.i.d. basis to long-term patients.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).
Patients Receiving InsulinAs with other sulfonylurea-class hypoglycemics, many stable non-insulin-dependent diabetic patients receiving insulin may be safely placed on glipizide. When transferring patients from insulin to glipizide, the following general guidelines should be considered:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide therapy may begin at usual dosages. Several days should elapse between glipizide titration steps. For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between glipizide titration steps.During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.
Patients Receiving Other Oral Hypoglycemic AgentsAs with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide due to potential overlapping of drug effect.
When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide tablets should be administered at least 4 hours prior to colesevelam.
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Topco Associates Llc
Topcare Zzz Sleep | Boehringer Ingelheim Vetmedica, Inc.
Infuse the entire contents of one syringe (10 mL) into each infected quarter immediately after the quarter has been completely milked out. Repeat once only in 12 hours. If definite improvement is not noted within 48 hours after treatment, the causal organism should be further investigated. Consult your veterinarian.
Milk out udder completely. Wash the udder and teats thoroughly with warm water containing a suitable dairy antiseptic and dry, preferably using individual paper towels. Carefully scrub the teat end and orifice with 70% alcohol, using a separate swab for each teat. Allow to dry.
ToDAY (cephapirin sodium) is packaged with the Opti-Sert® Protective Cap.
For partial insertion: Twist off upper portion of the Opti-Sert Protective Cap to expose 3–4 mm of the syringe tip.
For full insertion: Remove protective cap to expose the full length of the syringe tip.
Insert syringe tip into the teat canal and expel the entire contents of one syringe into each infected quarter. Withdraw the syringe and gently massage the quarter to distribute the suspension into the milk cistern. Do not milk out for 12 hours.
Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert Protective Cap is broken or damaged.
Reinfection –The use of antibiotics, however effective, for the treatment of mastitis will not significantly reduce the incidence of this disease in the herd unless their use is fortified by good herd management, and sanitary and mechanical safety measures are practiced to prevent reinfection.
DOSIS E INSTRUCCIONES DE USO
Introducir por infusión todo el contenido de una jeringa (10 mL) en cada cuarto infectado inmediatamente después de haberlo ordeñado por completo. Repetir la operación una sola vez 12 horas después. En caso de no observar una mejoría notoria dentro de las 48 horas posteriores al tratamiento será necesario investigar más a fondo al organismo causal. Consulte a su médico veterinario.
Ordeñar completamente la ubre. Lavar la ubre y los pezones a fondo con agua tibia mezclada con un antiséptico adecuado para ganado lechero y secar utilizando de preferencia toallas de papel individuales. Con cuidado frotar la punta del pezón y el orificio con una solución de alcohol al 70%, empleando una torunda distinta para cada pezón. Dejar secar.
ToDAY (cefapirina sódica) viene empacada con un Tapón Protector Opti-Sert®.
Para una inserción parcial: Romper torciendo la parte superior del Tapón Protector Opti-Sert para dejar expuestos de 3 a 4 mm de la punta de la jeringa.
Para una inserción completa: Retirar el tapón para exponer completamente la punta de la jeringa.
Insertar la punta de la jeringa en el ducto del pezón y expulsar todo el contenido de una jeringa dentro de cada cuarto infectado. Retirar la jeringa y masajear suavemente el cuarto para distribuir la suspensión en la cisterna de la leche. No ordeñar durante un lapso de 12 horas.
No introducir por infusión el contenido de la jeringa para tratar la mastitis en el ducto del pezón si el Tapón Protector Opti-Sert está roto o dañado.
Reinfección – No obstante su eficacia, el empleo de antibióticos para el tratamiento de mastitis no disminuirá significativamente la incidencia de esta enfermedad en el hato a menos que su empleo esté reforzado por un buen manejo del hato y siempre y cuando se practiquen medidas de seguridad sanitarias y mecánicas para prevenir la reinfección.
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