Megestrol Acetate Suspension

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Megestrol Acetate Suspension Recall

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Uses

Megestrol Acetate Oral Suspension (125 mg/mL) is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

1.1 Limitations of Use

Other Treatable Causes

Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.

Prophylactic Use

Megestrol acetate is not intended for prophylactic use to avoid weight loss.

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History

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Other Information

Megestrol Acetate Oral Suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methyl pregna-4,6-diene-3,20-dione acetate. Solubility at 37° C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52.

The chemical formula is C24H32O4 and the structural formula is represented as follows:

Megestrol acetate oral suspension contains 125 mg of megestrol acetate per mL.

Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, hydroxypropyl methylcellulose (hypromellose), natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose.

Sources

Megestrol Acetate Suspension Manufacturers

Par Pharmaceutical, Inc.

Megestrol Acetate Suspension | Par Pharmaceutical, Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension (125 mg/mL) is 625 mg/day (5 mL/day or one teaspoon daily). Shake the container well before using.

This strength (125 mg/mL) is not substitutable with other strengths (e.g., 40 mg/mL). Refer to the prescribing information of the 40 mg/mL product for dosage recommendations for the 40 mg/mL strength.

No Recall
Cardinal Health

Megestrol Acetate Suspension | Elevate Oral Care

DOSAGE & ADMINISTRATION SECTION
Directions: adults and pediatric patients 6 and older, apply a thin ribbon of FluoriMax toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bed time. After use, adults spit, do not eat, drink or rinse for 30 minutes. Pediatric patients 6-16 spit after use and rinse mouth thoroughly.

No Recall
Twi Pharmaceuticals, Inc.

Megestrol Acetate Suspension | Amneal Pharmaceuticals Of New York, Llc

Niacin extended-release tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

Table 1. Recommended Dosing

Week(s)

Daily dose

Niacin Extended-Release Tablets Dosage

INITIAL

TITRATION

1 to 4

500 mg

1 Niacin Extended-Release Tablet 500 mg at bedtime

SCHEDULE

5 to 8

1000 mg

1 Niacin Extended-Release Tablet 1000 mg or

2 Niacin Extended-Release Tablets 500 mg at bedtime

*

1500 mg

3 Niacin Extended-Release Tablets 500 mg at bedtime

*

2000 mg

2 Niacin Extended-Release Tablets 1000 mg or

4 Niacin Extended-Release Tablets 500 mg at bedtime

* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.

Maintenance Dose
The daily dosage of niacin extended-release tablets should not be increased by more than 500 mg in any 4–week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower niacin extended-release tablets doses than men [see Clinical Studies (14.2)].

Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.

Tolerance to flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of niacin extended-release tablets ingestion.

Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.

If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).

Niacin extended-release tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

Dosage in Patients with Renal or Hepatic Impairment

Use of niacin extended-release tablets in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment [see Warnings and Precautions (5)].

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Precision Dose Inc.

Megestrol Acetate Suspension | Precision Dose Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension, USP is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

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Physicians Total Care, Inc.

Megestrol Acetate Suspension | Physicians Total Care, Inc.

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/ day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Precision Dose Inc.

Megestrol Acetate Suspension | Precision Dose Inc.

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/ day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Cardinal Health

Megestrol Acetate Suspension | Cardinal Health

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/ day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

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Roxane Laboratories, Inc

Megestrol Acetate Suspension | Roxane Laboratories, Inc

There is no fixed dosage regimen for the management of diabetes mellitus with acarbose or any other pharmacologic agent. Dosage of acarbose must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d. Acarbose should be taken three times daily at the start (with the first bite) of each main meal. Acarbose should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to acarbose and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of acarbose, either as monotherapy or in combination with sulfonylureas, insulin or metformin.

Initial Dosage

The recommended starting dosage of acarbose is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d.

Maintenance Dosage

Once a 25 mg t.i.d. dosage regimen is reached, dosage of acarbose should be adjusted at 4 to 8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d. However, since patients with low body weight may be at increased risk for elevated serum transaminases, only patients with body weight > 60 kg should be considered for dose titration above 50 mg t.i.d. (see PRECAUTIONS). If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg t.i.d., consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage

The maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

No Recall
Vistapharm, Inc.

Megestrol Acetate Suspension | Vistapharm, Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Par Pharmaceutical, Inc.

Megestrol Acetate Suspension | Par Pharmaceutical, Inc.

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Cardinal Health

Megestrol Acetate Suspension | The Wellness Center For Research And Education

5 drops orally 2 to 3 times daily between meals. Administer orally, day 1 through 24 of the monthly menstrual cycle, even if menses has ceased. If cycle dates are unknown, day 1 is the first day of the calendar month. Use between 7:30 and 8:30 pm and upon waking. Consult a physician for use in children under 12 years of age.

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Pharmaceutical Associates, Inc.

Megestrol Acetate Suspension | Pharmaceutical Associates, Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension USP is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Morton Grove Pharmaceuticals, Inc.

Megestrol Acetate Suspension | Morton Grove Pharmaceuticals, Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension, USP is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience.

No Recall
Mckesson Packaging Services A Business Unit Of Mckesson Corporation

Megestrol Acetate Suspension | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Precision Dose Inc.

Megestrol Acetate Suspension | Precision Dose Inc.

The recommended adult initial dosage of Megestrol Acetate Oral Suspension, USP is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall
Atlantic Biologicals Corps

Megestrol Acetate Suspension | Atlantic Biologicals Corps

The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

No Recall