Extra Strength Pain Reliever Pm

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Uses

INDICATIONS: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

DOSE: 0.5 mg per pound of body weight per day for up to 5 days. Each calibration on the syringe' doses 250 lbs of body weight. Administer orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste on the back of the tongue by depressing the plunger. *Use dial edge nearest syringe barrel to mark dose.

ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal , analgesic agent with 1 anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

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Sources

Extra Strength Pain Reliever Pm Manufacturers

L.n.k. International, Inc.

Extra Strength Pain Reliever Pm | Aspen Veterinary Resources, Ltd.

DOSAGE AND ADMINISTRATION: The recommended dose of flunixin meglumine is 0.5 mg per lb of body weight once daily. The VetaMeg™ Equine Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.

DOSAGE TABLE
Syringe Mark* Horse Weight (lbs) VetaMeg™ Equine Paste Delevered (g) mg Flunixin Delivered 0 --- --- --- 250 250 2.5 125 500 500 5.0 250 750 750 7.5 375 1000 1000 10.0 500
* Use dial edge nearest syringe barrel to mark dose.

The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.

Treatment may be given initially by intravenous or intramuscular injection of VetaMeg™ Injectable Solution, followed by VetaMeg™ Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days.

TOXICITY: No toxic effects were observed in rats given oral flunixin meglumine 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for 5 consecutive days.

No Recall
Family Dollar

Extra Strength Pain Reliever Pm | Rite Aid

drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor

No Recall
Nash-finch Company

Extra Strength Pain Reliever Pm | Save-a-lot Food Stores Ltd

adults and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Cardinal Health

Extra Strength Pain Reliever Pm | Cardinal Health

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Army And Air Force Exchange Service

Extra Strength Pain Reliever Pm | Haun Specialty Gases, Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Salado Sales, Inc.

Extra Strength Pain Reliever Pm | American Health Packaging

2.1 General Dosing Recommendations
Ropinirole tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

If a significant interruption in therapy with ropinirole tablets has occurred, retitration of therapy may be warranted.
2.2 Dosing for Parkinson’s Disease
The recommended starting dose for Parkinson’s disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose may be increased by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day weekly up to a maximum recommended total daily dose of 24 mg/day (8 mg three times daily). Doses greater than 24 mg/day have not been tested in clinical trials.
Table 1. Ascending-dose Schedule of Ropinirole Tablets for Parkinson’s Disease
Week

Dosage

Total Daily Dose

1

0.25 mg three times daily

0.75 mg

2

0.5 mg three times daily

1.5 mg

3

0.75 mg three times daily

2.25 mg

4

1 mg three times daily

3 mg

Ropinirole tablets should be discontinued gradually over a 7-day period in patients with Parkinson’s disease. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of ropinirole tablets.
Renal Impairment
No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end-stage renal disease on hemodialysis is 0.25 mg three times a day. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole tablets in patients with severe renal impairment without regular dialysis has not been studied.
2.3 Dosing for Restless Legs Syndrome
The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown in Table 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established.
Table 2. Dose Titration Schedule of Ropinirole Tablets for Restless Legs Syndrome
Day/Week

Dosage to be taken once daily, 1 to 3 hours before bedtime

Days 1 and 2

0.25 mg

Days 3 to 7

0.5 mg

Week 2

1 mg

Week 3

1.5 mg

Week 4

2 mg

Week 5

2.5 mg

Week 6

3 mg

Week 7

4 mg

In clinical trials of patients treated for RLS with doses up to 4 mg once daily, ropinirole tablets were discontinued without a taper.
Renal Impairment
No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end-stage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole tablets in patients with severe renal impairment without regular dialysis has not been studied.

No Recall
Walgreen Co.

Extra Strength Pain Reliever Pm | Msm Repackaging

Table 1. Recommended Daily Dosage by Indication Initial Dose Titration
(Increments) Target Dose Effective
Dose Range Schizophrenia: adults (2.1)
2 mg
1 to 2 mg
4 to 8 mg
4 to 16 mg
Schizophrenia: adolescents (2.2)
0.5 mg
0.5 to 1 mg
3 mg
1 to 6 mg
Bipolar mania: adults (2.2)
2 to 3 mg
1 mg
1 to 6 mg
1 to 6 mg
Bipolar mania: children and adolescents (2.2)
0.5 mg
0.5 to 1 mg
1 to 2.5 mg
1 to 6 mg
Irritability in autistic disorder (2.3)
0.25 mg
Can increase to
0.5 mg by Day 4:
(body weight less
than 20 kg)

0.5 mg
Can increase to
1 mg by Day 4:
(body weight
greater than or
equal to 20 kg)
After Day 4,
at Interval of > 2 weeks:
0.25 mg
(body weight less
than 20 kg)

0.5 mg
(body weight
greater than or
equal to 20 kg)
0.5 mg:
(body weight less
than 20 kg)

1 mg:
(body weight
greater than or
equal to 20 kg)
0.5 to 3 mg

Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily.

May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.
2.1 Schizophrenia
Adults

Usual Initial Dose

Risperidone tablets can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 mg to 16 mg per day. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg per day has not been evaluated in clinical trials [see Clinical Studies (14.1)].

Adolescents

The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to a recommended dose of 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg and 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

Maintenance Therapy

While it is unknown how long a patient with schizophrenia should remain on risperidone tablets, the effectiveness of risperidone tablets 2 mg per day to 8 mg per day at delaying relapse was demonstrated in a controlled trial in adult patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Clinical Studies (14.1)]. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode. Patients should be periodically reassessed to determine the need for maintenance treatment.

Reinitiation of Treatment in Patients Previously Discontinued

Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off risperidone tablets, the initial titration schedule should be followed.

Switching From Other Antipsychotics

There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to risperidone tablets, or treating patients with concomitant antipsychotics.
2.2 Bipolar Mania
Usual Dose

Adults

The inital dose range is 2 mg to 3 mg per day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1 mg to 6 mg per day [see Clinical Studies (14.2,14.3)]. Risperidone tablets doses higher than 6 mg per day were not studied.

Pediatrics

The inital dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to the recommended target dose of 1 mg to 2.5 mg per day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 mg and 6 mg per day, no additional benefit was observed above 2.5 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied.

Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

Maintenance Therapy

There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with risperidone tablets. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of risperidone tablets in such longer-term treatment (i.e., beyond 3 weeks). The physician who elects to use risperidone tablets for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
2.3 Irritability Associated with Autistic Disorder - Pediatrics (Children and Adolescents)
The dosage of risperidone tablets should be individualized according to the response and tolerability of the patient. The total daily dose of risperidone tablets can be administered once daily, or half the total daily dose can be administered twice daily.

For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1.0 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg.

Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use risperidone tablets for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose.
2.4 Dosing in Patients with Severe Renal or Hepatic Impairment
For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10-15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater [see Use in Specific Populations (8.6 and 8.7)].
2.5 Dose Adjustments for Specific Drug Interactions
When risperidone tablets are co-administered with enzyme inducers (e.g., carbamazepine), the dose of risperidone tablets should be increased up to double the patient’s usual dose. It may be necessary to decrease the risperidone tablets dose when enzyme inducers such as carbamazepine are discontinued [see Drug Interactions (7.1)]. Similar effect may be expected with co-administration of risperidone tablets with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital).

When fluoxetine or paroxetine is co-administered with risperidone tablets, the dose of risperidone tablets should be reduced. The risperidone tablets dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, risperidone tablets should be titrated slowly. It may be necessary to increase the risperidone tablets dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued [see Drug Interactions (7.1)].

No Recall
Army And Air Force Exchange Service

Extra Strength Pain Reliever Pm | Army And Air Force Exchange Service

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 gelcaps at bedtime. Do not take more than 2 gelcaps of this product in 24 hours. children under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Supervalu Inc.

Extra Strength Pain Reliever Pm | Supervalu Inc.

do not take more than directed
(see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Fred’s, Inc.

Extra Strength Pain Reliever Pm | Fred's, Inc.

do not take more than directed
(see overdose warning) adults and children 12 years and over: take 2 gelcaps at bedtime. Do not take more than 2 gelcaps of this product in 24 hours. children under 12 years: do not use

No Recall
Safeway

Extra Strength Pain Reliever Pm | Rite Aid

adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor. Children under 12 years: do not use unless directed by a doctor

No Recall