Wyeth Pharmaceuticals Inc.

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Wyeth Pharmaceuticals Inc. Drugs

Pipracil

Pipracil

PIPRACIL may be administered by the intramuscular route (see NOTE) or intravenously as a three- to five-minute intravenous injection or as a 20- to 30-minute infusion. The usual dosage of PIPRACIL for serious infections is 3 to 4 g given every four to six hours as a 20- to 30-minute infusion. For serious infections, the intravenous route should be used.

PIPRACIL should not be mixed with an aminoglycoside in a syringe or infusion bottle since this can result in inactivation of the aminoglycoside.

The maximum daily dose for adults is usually 24 g/day, although higher doses have been used.

Intramuscular injections (see NOTE) should be limited to 2 g per injection site. This route of administration has been used primarily in the treatment of patients with uncomplicated gonorrhea and urinary tract infections.
DOSAGE RECOMMENDATIONS Type of Infection Usual Total Daily Dose
†One g of probenecid should be given orally one-half hour prior to injection.
Serious infections such as septicemia, nosocomial pneumonia, intra-abdominal infections, aerobic and anaerobic gynecologic infections, and skin and soft tissue infections 12 – 18 g/d I.V. (200 – 300 mg/kg/d) in divided doses every 4 to 6 h Complicated urinary tract infections 8 – 16 g/d I.V. (125 – 200 mg/kg/d) in divided doses every 6 to 8 h Uncomplicated urinary tract infections and most community-acquired pneumonia 6 – 8 g/d I.M. or I.V. (100– 125 mg/kg/d) in divided doses every 6 to 12 h Uncomplicated gonorrhea infections 2 g I.M.† as a one-time dose
The average duration of PIPRACIL treatment is from seven to ten days, except in the treatment of gynecologic infections, which is from three to ten days; the duration should be guided by the patient's clinical and bacteriological progress. For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for S. pyogenes infections should be maintained for at least ten days to reduce the risk of rheumatic fever.

When PIPRACIL is given concurrently with aminoglycosides, both drugs should be used in full therapeutic doses.

Renal Impairment
Dosage in Renal Impairment CreatinineClearancemL/min Urinary TractInfection(uncomplicated) Urinary TractInfection(complicated) SeriousSystemicInfection >40 No dosage adjustment necessary 20-40 No dosage adjustment necessary 9 g/day3 g every 8 h 12 g/day4 g every 8 h <20 6 g/day3 g every 12 h 6 g/day3 g every 12 h 8 g/day4 g every 12 h
For patients on hemodialysis, the maximum daily dose is 6 g/day (2 g every 8 hours). In addition, because hemodialysis removes 30% to 50% of piperacillin in 4 hours, a 1-g additional dose should be administered following each dialysis period.

For patients with renal failure and hepatic insufficiency, measurement of serum levels of piperacillin will provide additional guidance for adjusting dosage.

Prophylaxis

When possible, PIPRACIL should be administered as a 20- to 30-minute infusion just prior to anesthesia. Administration while the patient is awake will facilitate identification of possible adverse reactions during drug infusion. (See PRECAUTION, Drug Interactions.)
INDICATION 1st Dose 2nd Dose 3rd Dose Intra-abdominal Surgery 2 g I.V. just prior to surgery 2 g during surgery 2 g every 6 h Post-Op for no more than 24 h Vaginal Hysterectomy 2 g I.V. just prior to surgery 2 g 6 h after 1st dose 2 g 12 h after 1st dose Cesarean Section 2 g I.V. after cord is clamped 2 g 4 h after 1st dose 2 g 8 h after 1st dose Abdominal Hysterectomy 2 g I.V. just prior to surgery 2 g on return to recovery room 2 g after 6 h

Pediatric patients. Dosages in pediatric patients under 12 years of age have not been studied in adequate and well-controlled clinical trials (See CLINICAL PHARMACOLOGY).

¶Either Parabens or Benzyl Alcohol.#For Intramuscular Use Only. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
PRODUCT RECONSTITUTION/DOSAGE PREPARATION Conventional Vials: Diluents for Reconstitution Sterile Water for Injection Bacteriostatic¶ Water for Injection Sodium Chloride InjectionBacteriostatic¶ Sodium Chloride Injection Dextrose 5% in Water Dextrose 5% and 0.9% Sodium Chloride Lidocaine# HCl 0.5-1% (without epinephrine)
††When PIPRACIL®is further diluted with Lactated Ringer's Injection, the diluted solution must be administered within 2 hours.
Conventional Vials: Intravenous Solutions Intravenous Admixtures Dextrose 5% in Water 0.9% Sodium Chloride Dextrose 5% and 0.9% Sodium Chloride Lactated Ringer's Injection†† Dextran 6% in 0.9% Sodium Chloride Normal Saline [+ KCl 40 mEq]5% Dextrose in Water [+ KCl 40 mEq]5% Dextrose/Normal Saline [+ KCl 40 mEq]Ringer's Injection [+ KCl 40 mEq]Lactated Ringer's Injection [+ KCl 40 mEq]††
Intravenous Administration

Reconstitution Directions for Conventional Vials: Reconstitute each gram of PIPRACIL with at least 5 mL of a suitable diluent (except Lidocaine HCl 0.5%-1% without epinephrine) listed above. Shake well until dissolved. Reconstituted solution may be diluted to the desired volume (eg, 50 or 100 mL) in the above listed intravenous solutions and admixtures.

DIRECTIONS FOR ADMINISTRATIONIntermittent IV Infusion Infuse diluted solution over period of about 30 minutes. During infusion, it is desirable to discontinue the primary intravenous solution.

Intravenous Injection (Bolus) Reconstituted solution should be injected slowly over a 3-to 5-minute period to help avoid vein irritation.

Intramuscular Administration
(Conventional Vials Only)
Reconstitution Directions:Reconstitute each gram of PIPRACIL with 2 mL of a suitable diluent listed above to achieve a concentration of 1 g per 2.5 mL. Shake well until dissolved.

DIRECTIONS FOR ADMINISTRATIONWhen indicated by clinical and bacteriological findings, intramuscularadministration of 6 to 8 g daily of PIPRACIL, in divided doses, may be utilized for initiation of therapy. In addition, intramuscular administration of the drug may be considered for maintenance therapy after clinical and bacteriologic improvement has been obtained with intravenous piperacillin sodium treatment. Intramuscular administration should not exceed 2 g per injection at any one site.

The preferred site is the upper outer quadrant of the buttock (ie, gluteus maximus).

The deltoid area should be used only if well-developed, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower or mid-third of the upper arm.

Stability of PIPRACIL Following Reconstitution

PIPRACIL is stable in both glass and plastic containers when reconstituted with recommended diluents and when diluted with the intravenous solutions and intravenous admixtures indicated above.

Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20° to 25°C [68° to 77°F]), or after 48 hours if stored at refrigerated temperature (2° to 8°C [36° to 46°F]). Vials should not be frozen after reconstitution.
Inderal La

Inderal La

General

Inderal® LA provides propranolol hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from Inderal Tablets to Inderal LA Capsules, care should be taken to assure that the desired therapeutic effect is maintained. Inderal LA should not be considered a simple mg-for-mg substitute for Inderal. Inderal LA has different kinetics and produces lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval.

Hypertension

The usual initial dosage is 80 mg Inderal LA once daily, whether used alone or added to a diuretic. The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required. The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.

Angina Pectoris

Starting with 80 mg Inderal LA once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily. In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established.

If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see “WARNINGS”).

Migraine

The initial oral dose is 80 mg Inderal LA once daily. The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Inderal LA therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of Inderal LA.

Hypertrophic Subaortic Stenosis

The usual dosage is 80 to 160 mg Inderal LA once daily.
Phospholine Iodide Opht...

Phospholine Iodide Ophthalmic

DIRECTIONS FOR PREPARING EYEDROPS

1. Use aseptic technique.

2. Tear off aluminum seals, and remove and discard rubber plugs from both drug and diluent containers.

3. Pour diluent into drug container.

4. Remove dropper assembly from its sterile wrapping. Holding dropper assembly by the screw cap and, WITHOUT COMPRESSING RUBBER BULB, insert into drug container and screw down tightly.

5. Shake for several seconds to ensure mixing.

6. Do not cover nor obliterate instructions to patient regarding storage of eyedrops.

Glaucoma

Selection of Therapy – The medication prescribed should be that which will control the intraocular pressure around-the-clock with the least risk of side effects or adverse reactions. “Tonometric glaucoma” (ocular hypertension without other evidence of the disease) is frequently not treated with any medication, and echothiophate iodide for ophthalmic solution is certainly not recommended for this condition. In early chronic simple glaucoma with field loss or disc changes, pilocarpine is generally used for initial therapy and can be recommended so long as control is thereby maintained over the 24 hours of the day.

When this is not the case, echothiophate iodide for ophthalmic solution 0.03% may be effective and probably has no greater potential for side effects. If this dosage is inadequate, epinephrine and a carbonic anhydrase inhibitor may be added to the regimen. When still more effective medication is required, the higher strengths of echothiophate iodide for ophthalmic solution may be prescribed with the recognition that the control of the intraocular pressure should have priority regardless of potential side effects. In secondary glaucoma following cataract surgery, the higher strengths of the drug are frequently needed and are ordinarily very well tolerated.

The dosage regimen prescribed should call for the lowest concentration that will control the intraocular pressure around-the-clock. Where tonometry around-the-clock is not feasible, it is suggested that appointments for tension-taking be made at different times of the day so that inadequate control may be more readily detected. Two doses a day are preferred to one in order to maintain as smooth a diurnal tension curve as possible, although a single dose per day or every other day has been used with satisfactory results. Because of the long duration of action of the drug, it is never necessary or desirable to exceed a schedule of twice a day. The daily dose or one of the two daily doses should always be instilled just before retiring to avoid inconvenience due to the miosis.

Early Chronic Simple Glaucoma – Echothiophate iodide for ophthalmic solution 0.03% instilled twice a day, just before retiring and in the morning, may be prescribed advantageously for cases of early chronic simple glaucoma that are not controlled around-the-clock with other less potent agents. Because of prolonged action, control during the night and early morning hours may then sometimes be obtained. A change in therapy is indicated if, at any time, the tension fails to remain at an acceptable level on this regimen.

Advanced Chronic Simple Glaucoma and Glaucoma Secondary to Cataract Surgery – These cases may respond satisfactorily to echothiophate iodide for ophthalmic solution 0.03% twice a day as above. When the patient is being transferred to echothiophate iodide for ophthalmic solution because of unsatisfactory control with pilocarpine, carbachol, epinephrine, etc., one of the higher strengths, 0.06%, 0.125%, or 0.25% will usually be needed. In this case, a brief trial with the 0.03% eyedrops will be advantageous in that the higher strengths will then be more easily tolerated.

Concomitant Therapy – Echothiophate iodide for ophthalmic solution may be used concomitantly with epinephrine, a carbonic anhydrase inhibitor, or both.

Technique – Good technique in the administration of echothiophate iodide for ophthalmic solution requires that finger pressure at the inner canthus should be exerted for a minute or two following instillation of the eyedrops, to minimize drainage into the nose and throat. Excess solution around the eye should be removed with tissue and any medication on the hands should be rinsed off.

Accommodative Esotropia (Pediatric Use)

In Diagnosis – One drop of 0.125% may be instilled once a day in both eyes on retiring, for a period of two or three weeks. If the esotropia is accommodative, a favorable response will usually be noted which may begin within a few hours.

In Treatment – Echothiophate iodide for ophthalmic solution is prescribed at the lowest concentration and frequency which gives satisfactory results. After the initial period of treatment for diagnostic purposes, the schedule may be reduced to 0.125% every other day or 0.06% every day. These dosages can often be gradually lowered as treatment progresses. The 0.03% strength has proven to be effective in some cases. The maximum usually recommended dosage is 0.125% once a day, although more intensive therapy has been used for short periods.

Technique – (See “DOSAGE AND ADMINISTRATION, Glaucoma.”)

Duration of Treatment – In diagnosis, only a short period is required and little time will be lost in instituting other procedures if the esotropia proves to be unresponsive. In therapy, there is no definite limit so long as the drug is well tolerated. However, if the eyedrops, with or without eyeglasses, are gradually withdrawn after about a year or two and deviation recurs, surgery should be considered. As with other miotics, tolerance may occasionally develop after prolonged use. In such cases, a rest period will restore the original activity of the drug.

Wyeth Pharmaceuticals Inc.

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Wyeth Pharmaceuticals Inc. Drugs