Oceanside Pharmaceuticals

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Oceanside Pharmaceuticals Drugs

Pyridostigmine Bromide

Pyridostigmine Bromide

Pyridostigmine Bromide Extended-release Tablets

each contain 180 mg pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Pyridostigmine Bromide Extended-release Tablet is about equal to that of a 60 mg Pyridostigmine Bromide Tablet; however, its duration of effectiveness, although varying in individual patients, averages 2 ½ times that of a 60 mg dose.

Dosage

The size and frequency of the dosage must be adjusted to the needs of the individual patient.

Pyridostigmine Bromide Extended-release Tablets

One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with extended-release tablets therapy.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon (edrophonium chloride).
Ethacrynic Sodium

Ethacrynic Sodium

Dosage must be regulated carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary. The magnitude of diuresis and natriuresis is largely dependent on the degree of fluid accumulation present in the patient. Similarly, the extent of potassium excretion is determined in large measure by the presence and magnitude of aldosteronism.

Oral Use

Ethacrynic acid is available for oral use as 25 mg tablets.

Dosage: To Initiate Diuresis

In Adults: The smallest dose required to produce gradual weight loss (about 1 to 2 pounds per day) is recommended. Onset of diuresis usually occurs at 50 to 100 mg for adults. After diuresis has been achieved, the minimally effective dose (usually from 50 to 200 mg daily) may be given on a continuous or intermittent dosage schedule. Dosage adjustments are usually in 25 to 50 mg increments to avoid derangement of water and electrolyte excretion.

The patient should be weighed under standard conditions before and during the institution of diuretic therapy with this compound. Small alterations in dose should effectively prevent a massive diuretic response. The following schedule may be helpful in determining the smallest effective dose.

Day 1 — 50 mg once daily after a meal

Day 2 — 50 mg twice daily after meals, if necessary

Day 3 — 100 mg in the morning and 50 to 100 mg following the afternoon or evening meal, depending upon response to the morning dose.

A few patients may require initial and maintenance doses as high as 200 mg twice daily. These higher doses, which should be achieved gradually, are most often required in patients with severe, refractory edema.

In Pediatric Patients (excluding infants, see CONTRAINDICATIONS): The initial dose should be 25 mg. Careful stepwise increments in dosage of 25 mg should be made to achieve effective maintenance.

Maintenance Therapy

It is usually possible to reduce the dosage and frequency of administration once dry weight has been achieved.

Ethacrynic Acid may be given intermittently after an effective diuresis is obtained with the regimen outlined above. Dosage may be on an alternate daily schedule or more prolonged periods of diuretic therapy may be interspersed with rest periods. Such an intermittent dosage schedule allows time for correction of any electrolyte imbalance and may provide a more efficient diuretic response.

The chloruretic effect of this agent may give rise to retention of bicarbonate and a metabolic alkalosis. This may be corrected by giving chloride (ammonium chloride or arginine chloride). Ammonium chloride should not be given to cirrhotic patients.

Ethacrynic acid has additive effects when used with other diuretics. For example, a patient who is on maintenance dosage of an oral diuretic may require additional intermittent diuretic therapy, such as an organomercurial, for the maintenance of basal weight. The intermittent use of ethacrynic acid orally may eliminate the need for injections of organomercurials. Small doses of ethacrynic acid may be added to existing diuretic regimens to maintain basal weight. This drug may potentiate the action of carbonic anhydrase inhibitors, with augmentation of natriuresis and kaliuresis. Therefore, when adding ethacrynic acid the initial dose and changes of dose should be in 25 mg increments, to avoid electrolyte depletion. Rarely, patients who failed to respond to ethacrynic acid have responded to older established agents.

While many patients do not require supplemental potassium, the use of potassium chloride or potassium-sparing agents, or both, during treatment with ethacrynic acid is advisable, especially in cirrhotic or nephrotic patients and in patients receiving digitalis.

Salt liberalization usually prevents the development of hyponatremia and hypochloremia. During treatment with ethacrynic acid, salt may be liberalized to a greater extent than with other diuretics.

Cirrhotic patients, however, usually require at least moderate salt restriction concomitant with diuretic therapy.

Intravenous Use

Intravenous ethacrynate sodium is for intravenous use when oral intake is impractical or in urgent conditions, such as acute pulmonary edema.

The usual intravenous dose for the average sized adult is 50 mg, or 0.5 to 1.0 mg per kg of body weight. Usually only one dose has been necessary; occasionally a second dose at a new injection site, to avoid possible thrombophlebitis, may be required. A single intravenous dose not exceeding 100 mg has been used in critical situations.

Insufficient pediatric experience precludes recommendation for this age group.

To reconstitute the dry material, add 50 mL of 5% Dextrose Injection, or Sodium Chloride Injection to the vial. Occasionally, some 5% Dextrose Injection solutions may have a low pH (below 5). The resulting solution with such a diluent may be hazy or opalescent. Intravenous use of such a solution is not recommended. Inspect the vial containing Intravenous ethacrynate sodium for particulate matter and discoloration before use.

The solution may be given slowly through the tubing of a running infusion or by direct intravenous injection over a period of several minutes. Do not mix this solution with whole blood or its derivatives. Discard unused reconstituted solution after 24 hours.

Ethacrynate sodium should not be given subcutaneously or intramuscularly because of local pain and irritation.
Tretinoin Gel

Tretinoin Gel

For topical use only. Not for ophthalmic, oral, or intravaginal use.

Tretinoin Gel 0.05% should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Tretinoin Gel 0.05% should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy.

Patients treated with Tretinoin Gel 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

When treating with Tretinoin Gel 0.05%, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Tretinoin Gel 0.05% has begun.
Hydrocortisone Butyrate...

Hydrocortisone Butyrate

For corticosteroid-responsive dermatoses in adults, apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition, and rub in gently.

For atopic dermatitis in patients 3 months to 18 years of age, apply a thin film to the affected skin areas two times daily, and rub in gently. Do not apply Hydrocortisone Butyrate Cream (lipid), 0.1% in the diaper area unless directed by a physician.

Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Hydrocortisone Butyrate Cream (lipid), 0.1% has not been established beyond 4 weeks of use [see Warnings and Precautions (5.1)].

Do not use Hydrocortisone Butyrate Cream (lipid), 0.1% with occlusive dressings unless directed by a physician. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Hydrocortisone Butyrate Cream (lipid), 0.1% is not for oral, ophthalmic, or intravaginal use.
Omeprazole And Sodium B...

Omeprazole And Sodium Bicarbonate

Omeprazole and Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. All recommended doses throughout the labeling are based upon omeprazole.

Since both the 20 mg and 40 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of Omeprazole and Sodium Bicarbonate 40 mg; therefore, two 20 mg packets of Omeprazole and Sodium Bicarbonate should not be substituted for one packet of Omeprazole and Sodium Bicarbonate 40 mg.

Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of Omeprazole and Sodium Bicarbonate 40 mg; therefore, two 20 mg capsules of Omeprazole and Sodium Bicarbonate should not be substituted for one capsule of Omeprazole and Sodium Bicarbonate 40 mg.

Omeprazole and Sodium Bicarbonate should be taken on an empty stomach at least one hour before a meal.

For patients receiving continuous Nasogastric (NG)/Orogastric (OG) tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of Omeprazole and Sodium Bicarbonate Powder for Oral Suspension.

Table 1: Recommended Doses of Omeprazole and Sodium Bicarbonateby Indication for Adults 18 Years and Older

Indication

Recommended Dose

Frequency

Short-Term Treatment of Active Duodenal Ulcer

20 mg

Once daily for 4 weeks*,+

Benign Gastric Ulcer

40 mg

Once daily for 4-8 weeks **,+

Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD (with no esophageal erosions)

20 mg

Once daily for up to 4 weeks+

Erosive Esophagitis

20 mg

Once daily for 4-8 weeks+

Maintenance of Healing of Erosive Esophagitis

20 mg

Once daily**

Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients

(40 mg oral suspension only)

40 mg

40 mg initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days**

* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1)]

** Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)]

+ For additional information, [See Indications and Usage (1)]

Special Populations

Hepatic Insufficiency

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]

Administration of Capsules

Omeprazole and Sodium Bicarbonate Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

Preparation and Administration of Suspension

Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

If Omeprazole and Sodium Bicarbonate is to be administered through a nasogastric (NG) or orogastric (OG) tube, the suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately‑sized syringe should be used to instill the suspension in the tube. The suspension should be washed through the tube with 20 mL of water.
Urolet Mb

Urolet Mb

Hypertension

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate tablets to reduce the likelihood of hypotension (see WARNINGS). If the patient’s blood pressure is not controlled with enalapril maleate tablets alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions).

The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate tablets alone, a diuretic may be added. Concomitant administration of enalapril maleate tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).

Dosage Adjustment in Hypertensive Patients with Renal Impairment

The usual dose of enalapril is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
Renal Status Creatinine- Clearance mL/min Initial Dose mg/day
Normal Renal Function

>80 mL/min

5 mg

Mild Impairment

≤80 >30 mL/min

5 mg

Moderate to SevereImpairment

≤30 mL/min

2.5 mg

Dialysis Patients*

-

2.5 mg ondialysis days†

*See WARNINGS, Anaphylactoid reactions during membrane exposure.

†Dosage on nondialysis days should be adjusted depending on the blood pressure response.

Heart Failure

Enalapril maleate tablet is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.

The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.

After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Asymptomatic Left Ventricular Dysfunction

In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia

In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision (see DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS and PRECAUTIONS, Drug Interactions). The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

Pediatric Hypertensive Patients

The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Clinical Pharmacology in Pediatric Patients).

Enalapril maleate tablet is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.

Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)

Add 50 mL of Bicitra®1 to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of enalapril maleate and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60-minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SFTM2 to the concentrate in the PET bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days. Shake the suspension before each use.

1Registered trademark of Alza Corporation

2Trademark of Paddock Laboratories, Inc.
Prednicarbate

Prednicarbate

Apply a thin film of prednicarbate emollient cream 0.1% to the affected skin areas twice daily. Rub in gently.

Prednicarbate emollient cream 0.1% may be used in pediatric patients 1 year of age or older. Safety and efficacy of prednicarbate emollient cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Prednicarbate emollient cream 0.1% should not be used with occlusive dressings unless directed by the physician.

Prednicarbate emollient cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
Metronidazole Gel

Metronidazole Gel

The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once-a-day dosing, Metronidazole Vaginal Gel should be administered at bedtime.
Erythromycin And Benzoy...

Erythromycin And Benzoyl Peroxide Kit

Erythromycin-Benzoyl Peroxide Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
Diltiazem Hydrochloride...

Diltiazem Hydrochloride

Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) at the nearest equivalent total daily dose. Higher doses of Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

Concomitant Use With Other Cardiovascular Agents

1. Sublingual NTG. May be taken as required to abort acute anginal attacks during Diltiazem Hydrochloride Extended-Release (One-a-Day Dosage) therapy.

2. Prophylactic Nitrate Therapy. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) may be safely coadministered with short- and long-acting nitrates.

3. Beta-blockers (see WARNINGS and PRECAUTIONS).

4. Antihypertensives. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) or the concomitant antihypertensives may need to be adjusted when adding one to the other.
Fluorouracil

Fluorouracil

When Fluorouracil 5% Topical Cream is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Fluorouracil 5% Topical Cream should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil 5% Topical Cream is applied with the fingers, the hands should be washed immediately afterward.

Actinic or Solar Keratosis

Apply cream twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Fluorouracil 5% Topical Cream therapy.

Superficial Basal Cell Carcinomas

Only the 5% strength is recommended. Apply cream twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.
Antacid Regular Strengt...

Antacid Regular Strength

Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying Acyclovir to prevent autoinoculation of other body sites and transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.
Tretinoin

Tretinoin

Do NOT use Tretinoin Cream, USP (Emollient) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy Do NOT use Tretinoin Cream, USP (Emollient) if the patient is sunburned or if the patient has eczema or other chronic skin condition(s) Do NOT use Tretinoin Cream, USP (Emollient) if the patient is inherently sensitive to sunlight Do NOT use Tretinoin Cream, USP (Emollient) if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

Tretinoin Cream, USP (Emollient) should be applied to the face once a day before retiring, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Tretinoin Cream, USP (Emollient). The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Tretinoin Cream, USP (Emollient) may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Tretinoin Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Tretinoin Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Tretinoin Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with Tretinoin Cream, USP (Emollient) 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)
Senna-lax

Senna-lax

Because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION sections).

BECAUSE OF THE RISK OF LIVER INJURY AND BECAUSE TOLCAPONE TABLETS WHEN IT IS EFFECTIVE PROVIDES AN OBSERVABLE SYMPTOMATIC BENEFIT, THE PATIENT WHO FAILS TO SHOW SUBSTANTIAL CLINICAL BENEFIT WITHIN 3 WEEKS OF INITIATION OF TREATMENT, SHOULD BE WITHDRAWN FROM TOLCAPONE TABLETS.

Tolcapone tablets therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

Patients who develop evidence of hepatocellular injury while on tolcapone tablets and are withdrawn from the drug for any reason may be at increased risk for liver injury if tolcapone tablets is reintroduced. These patients should not ordinarily be considered for retreatment with tolcapone tablets.

Only prescribe tolcapone tablets for patients taking concomitant carbidopa levodopa therapy. The initial dose of tolcapone tablets is always 100 mg three times per day. The recommended daily dose of tolcapone tablets is also 100 mg tid. In clinical trials, elevations in ALT occurred more frequently at the dose of 200 mg tid. While it is unknown whether the risk of acute fulminant liver failure is increased at the 200-mg dose, it would be prudent to use 200 mg only if the anticipated incremental clinical benefit is justified (see BOXED WARNING, WARNINGS, PRECAUTIONS: Laboratory Tests). If a patient fails to show the expected incremental benefit on the 200-mg dose after a total of 3 weeks of treatment (regardless of dose), tolcapone tablets should be discontinued.

In clinical trials, the first dose of the day of tolcapone tablets was always taken together with the first dose of the day of levodopa/carbidopa, and the subsequent doses of tolcapone tablets were given approximately 6 and 12 hours later.

In clinical trials, the majority of patients required a decrease in their daily levodopa dose if their daily dose of levodopa was >600 mg or if patients had moderate or severe dyskinesias before beginning treatment.

To optimize an individual patient's response, reductions in daily levodopa dose may be necessary. In clinical trials, the average reduction in daily levodopa dose was about 30% in those patients requiring a levodopa dose reduction. (Greater than 70% of patients with levodopa doses above 600 mg daily required such a reduction.)

Tolcapone tablets can be combined with both the immediate and sustained release formulations of levodopa/carbidopa.

Tolcapone tablets may be taken with or without food (see CLINICAL PHARMACOLOGY).

Patients With Impaired Hepatic Function

Tolcapone tablets therapy should not be initiated in any patient with liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. (See BOXED WARNING, WARNINGS, and CLINICAL PHARMACOLOGY).

Patients With Impaired Renal Function

No dose adjustment of tolcapone tablets is recommended for patients with mild to moderate renal impairment. However, patients with severe renal impairment should be treated with caution. The safety of tolcapone has not been examined in subjects who had creatinine clearance less than 25 mL/min (see CLINICAL PHARMACOLOGY).

Withdrawing Patients From Tolcapone tablets

As with any dopaminergic drug, withdrawal or abrupt reduction in the Tolcapone tablets dose may lead to emergence of signs and symptoms of Parkinson's disease or Hyperpyrexia and Confusion, a syndrome complex resembling the neuroleptic malignant syndrome (see PRECAUTIONS: Events Reported With Dopaminergic Therapy). If a decision is made to discontinue treatment with Tolcapone tablets, then it is recommended to closely monitor the patient and adjust other dopaminergic treatments as needed. This syndrome should be considered in the differential diagnosis for any patient who develops a high fever or severe rigidity. Tapering tolcapone tablets has not been systematically evaluated. As the duration of COMT inhibition with tolcapone tablets is generally 5 to 6 hours on average, decreasing the frequency of dosage to twice or once a day may not in itself prevent withdrawal effects.
Coniferyl Alcohol

Coniferyl Alcohol

The usual dosage of pentoxifylline extended-release tablet form is one tablet (400 mg) three times a day with meals.

While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.

Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline extended-release tablet should be discontinued.

In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day. Dosing information cannot be provided for patients with hepatic impairment.
Tretinoin Gel

Tretinoin Gel

TRETINOIN gel microsphere, 0.1% and 0.04%, should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application of excessive amounts of gel may result in "caking" of the gel, and will not provide incremental efficacy.

A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy. Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed.

Patients treated with TRETINOIN gel microsphere, 0.1% and 0.04%, may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
Dihydroergotamine Mesyl...

Dihydroergotamine Mesylate Spray

The solution used in dihydroergotamine mesylate, USP nasal spray (4 mg/mL) is intended for intranasal use and must not be injected.

In clinical trials, Migranal® (dihydroergotamine mesylate, USP) Nasal Spray has been effective for the acute treatment of migraine headaches with or without aura. One spray (0.5 mg) of dihydroergotamine mesylate, USP nasal spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of dihydroergotamine mesylate, USP nasal spray should be administered in each nostril, for a total dosage of four sprays (2.0 mg) of dihydroergotamine mesylate, USP nasal spray. Studies have shown no additional benefit from acute doses greater than 2.0 mg for a single migraine administration. The safety of doses greater than 3.0 mg in a 24 hour period and 4.0 mg in a 7 day period has not been established.

Dihydroergotamine mesylate, USP nasal spray, should not be used for chronic daily administration.

Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use. (See administration instructions).

Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial) after 8 hours.
Chlordiazepoxide Hydroc...

Chlordiazepoxide Hydrochloride And Clidinium Bromide

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide HCl/Clidinium Bromide varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing

Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Chlordiazepoxide HCl/Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated.
Allergy Relief

Allergy Relief

For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Fluocinonide Cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected areas as directed by a physician.
Severe Cold And Flu

Severe Cold And Flu

The recommended initial dose of bexarotene capsules is 300 mg/m2/day (see Table 1). Bexarotene capsules should be taken as a single oral daily dose with a meal. For precautions to prevent pregnancy and birth defects in women of child-bearing potential [see Use in Specific Populations (8.1)].
Table 1: Bexarotene Capsules Initial Dose Calculation According to Body Surface Area
Initial Dose Level (300 mg/m2/day)

Number of 75 mg Bexarotene capsules

Body Surface Area

(m2)

Total Daily Dose

(mg/day)

0.88 – 1.12

300

4

1.13 – 1.37

375

5

1.38 – 1.62

450

6

1.63 – 1.87

525

7

1.88 – 2.12

600

8

2.13 – 2.37

675

9

2.38 – 2.62

750

10

Dose Modification Guidelines: The 300 mg/m2/day dose level of bexarotene capsules may be adjusted to 200 mg/m2/day then to 100 mg/m2/day, or temporarily suspended, if necessitated by toxicity. When toxicity is controlled, doses may be carefully readjusted upward. If there is no tumor response after eight weeks of treatment and if the initial dose of 300 mg/m2/day is well tolerated, the dose may be escalated to 400 mg/m2/day with careful monitoring.

Duration of Therapy: In clinical trials in CTCL, bexarotene capsules were administered for up to 97 weeks.

Bexarotene capsules should be continued as long as the patient is deriving benefit.
Diltiazem Hydrochloride...

Diltiazem Hydrochloride

Diltiazem Hydrochloride Extended-Release Tablets are an extended-release formulation intended for once-a-day administration.

Patients controlled on diltiazem alone or in combination with other medications may be switched to Diltiazem Hydrochloride Extended-Release Tablets once-a-day at the nearest equivalent total daily dose. Higher doses of Diltiazem Hydrochloride Extended-Release Tablets once-a-day dosage may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but the safety and efficacy of doses as high as 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

The tablet should be swallowed whole and not chewed or crushed.

Hypertension.

Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The dosage range studied in clinical trials was 120 to 540 mg once daily. The dosage may be titrated to a maximum of 540 mg daily.

Diltiazem Hydrochloride Extended-Release Tablets should be taken about the same time once each day either in the morning or at bedtime. The time of dosing should be considered when making dose adjustments based on trough effects.

Angina.

Dosage for the treatment of angina should be individualized based on response. The initial dose of 180 mg once daily may be increased at intervals of 7 to 14 days if adequate response is not obtained. Diltiazem Hydrochloride Extended-Release doses above 360 mg appear to confer no additional benefit.

Diltiazem Hydrochloride Extended-Release Tablets can be given once daily, either in the evening or in the morning.

Concomitant Use with Other Cardiovascular Agents
1. Sublingual NTG. May be taken as required to abort acute anginal attacks during Diltiazem Hydrochloride Extended-Release therapy. 2. Prophylactic Nitrate Therapy. Diltiazem Hydrochloride Extended-Release Tablets may be safely coadministered with short-and long-acting nitrates. 3. Beta-blockers (see WARNINGS and PRECAUTIONS). 4. Antihypertensives. Diltiazem Hydrochloride Extended-Release Tablets have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem Hydrochloride Extended-Release Tablets or the concomitant antihypertensives may need to be adjusted when adding one to the other.
Flucytosine

Flucytosine

The usual dosage of Flucytosine is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS).

Flucytosine should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine (See MICROBIOLOGY).
Carbidopa

Carbidopa

Whether given with carbidopa-levodopa or with levodopa, the optimal daily dose of Carbidopa must be determined by careful titration. Most patients respond to a 1:10 proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since clinical experience with larger dosages is limited. If the patient is taking carbidopa-levodopa, the amount of carbidopa in carbidopa-levodopa should be considered when calculating the total amount of Carbidopa to be administered each day.

Patients Receiving Carbidopa-Levodopa Who Require Additional Carbidopa

Some patients taking carbidopa-levodopa may not have adequate reduction in nausea and vomiting when the dosage of carbidopa is less than 70 mg a day, and the dosage of levodopa is less than 700 mg a day. When these patients are taking carbidopa-levodopa, 25 mg of Carbidopa may be given with the first dose of carbidopa-levodopa each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of carbidopa-levodopa. Carbidopa may be given with any dose carbidopa-levodopa as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as Carbidopa and as carbidopa-levodopa), should not exceed 200 mg.

Patients Requiring Individual Titration of Carbidopa and Levodopa Dosage

Although carbidopa-levodopa is the most frequently used of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, Carbidopa should be initiated at a dosage of 25 mg three or four times a day. The two drugs should be given at the same time, starting with no more than one-fifth (20%) to one-fourth (25%) of the previous or recommended daily dosage of levodopa when given without Carbidopa. In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with Carbidopa and levodopa. A convenient way to initiate therapy in these patients is in the morning following a night when the patient has not taken levodopa for at least twelve hours. Health care providers who prescribe separate doses of Carbidopa and levodopa should be thoroughly familiar with the directions for use of each drug.

Dosage Adjustment

Dosage of Carbidopa may be adjusted by adding or omitting one-half or one tablet a day. Because both therapeutic and adverse responses occur more rapidly with combined therapy than when only levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly when Carbidopa and levodopa are given concomitantly than when levodopa is given without Carbidopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

Current evidence indicates other standard antiparkinsonian drugs may be continued while carbidopa and levodopa are being administered. However, the dosage of such other standard antiparkinsonian drugs may require adjustment.

Interruption of Therapy

Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa-levodopa or carbidopa-levodopa Extended Release. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa-levodopa or carbidopa-levodopa Extended-Release is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. When therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be resumed as soon as the patient is able to take medication orally.
Illusion Tinted Moistur...

Illusion Tinted Moisturizer Broad Spectrum Honey Spf 15

Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, usual starting doses are 120 to 240 mg once daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 120 to 540 mg once daily. Current clinical experience with 540 mg dose is limited; however, the dose may be increased to 540 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 mg to 180 mg once daily. Individual patients may respond to higher doses of up to 540 mg once daily. When necessary, titration should be carried out over 7 to 14 days.

Concomitant use with Other Cardiovascular Agents.

1. Sublingual Nitroglycerin (NTG). May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.

2. Prophylactic Nitrate Therapy. Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates.

3. Beta-blockers (see WARNINGS and PRECAUTIONS.)

4. Antihypertensives. Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.

Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Diltiazem hydrochloride extended-release capsules capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.

Sprinkling the Capsule Contents on Food

Diltiazem hydrochloride extended-release capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. Any capsule contents/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a diltiazem hydrochloride extended-release capsules is not recommended.
Methoxsalen

Methoxsalen

CAUTION: Methoxsalen Capsules, USP represents a new dose form of methoxsalen. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Each patient should be evaluated by determining the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form. Human bioavailability studies have indicated the following drug dosage and administration directions are to be used as a guideline only.

PSORIASIS THERAPY

1. DRUG DOSAGE - INITIAL THERAPY: The methoxsalen capsules should be taken 1 1/2 to 2 hours before UVA exposure with some low fat food or milk according to the following table:

Patient’s Weight Dose

(kg)

(lbs)

(mg)

<30

<66

10

30-50

66-110

20

51-65

112-143

30

66-80

146-176

40

81-90

179-198

50

91-115

201-254

60

>115

>254

70

Elderly patients should generally be started at the low end of the dose recommended according to body weight and closely monitored during PUVA therapy. Although clinical experience has not identified differences in response between elderly and younger patients, the use of methoxsalen in older individuals may be affected by the presence or pre-existing medical conditions.

2. INITIAL EXPOSURE: The initial UVA exposure energy level and corresponding time of exposure is determined by the patient’s skin characteristics for sun burning and tanning as follows:
(*Patients with natural pigmentation of these types should be classified into a lower skin type category if the sunburning history so indicates.)
Skin Type

History

RecommendedJoules/cm2

I

Always burn, never tan (patients with erythrodermic psoriasis are to be classed as Type I for determination of UVA dosage.)

0.5 J/cm2

II

Always burn, but sometimes tan

1.0 J/cm2

III

Sometimes burn, but always tan

1.5 J/cm2

IV

Never burn, always tan

2.0 J/cm2

Skin Type

Physician Examination

Joules/cm2

V*

Moderately pigmented

2.5 J/cm2

VI*

Blacks

3.0 J/cm2

If the MPD is done, start at 1/2 MPD.

Additional drug dosage directions are as follows:
a. Weight Change: In the event that the weight of a patient changes during treatment such that he/she falls into an adjacent weight range/dose category, no change in the dose of methoxsalen is usually required. If, in the physician’s opinion, however, a weight change is sufficiently great to modify the drug dose, then an adjustment in the time of exposure to UVA should be made. b. Dose/Week: The number of doses per week of methoxsalen capsules will be determined by the patient’s schedule of UVA exposures. In no case should treatments be given more often than once every other day because the full extent of phototoxic reactions may not be evident until 48 hours after each exposure. c. Dosage Increase: Dosage may be increased by 10 mg. after the fifteenth treatment under the conditions outlined in section XI.B.4.b.
X. UVA RADIATION SOURCE SPECIFICATIONS & INFORMATION

A. IRRADIANCE UNIFORMITY:

The following specifications should be met with the window of the detector held in a vertical plane:
1. Vertical variation: For readings taken at any point along the vertical center axis of the chamber (to within 15 cm from the top and bottom), the lowest reading should not be less than 70 percent of the highest reading. 2. Horizontal variation: Throughout any specific horizontal plane, the lowest reading must be at least 80 percent of the highest reading, excluding the peripheral 3 cm of the patient treatment space.
B. PATIENT SAFETY FEATURES:

The following safety features should be present: (1) Protection from electrical hazard: All units should be grounded and conform to applicable electrical codes. The patient or operator should not be able to touch any live electrical parts. There should be ground fault protection. (2) Protective shielding of lamps: The patient should not be able to come in contact with the bare lamps. In the event of lamp breakage, the patient should not be exposed to broken lamp components. (3) Hand rails and hand holds: Appropriate supports should be available to the patient. (4) Patient viewing window: A window which blocks UV should be provided for viewing the patient during treatment. (5) Door and latches: Patients should be able to open the door from the inside with only slight pressure to the door. (6) Non-skid floor: The floor should be of a non-skid nature. (7) Thermoregulation: Sufficient air flow should be provided for patient safety and comfort, limiting temperature within the UVA radiator cabinet to approximately less than 100° F. (8) Timer: The irradiator should be equipped with an automatic timer which terminates the exposure at the conclusion of a pre-set time interval. (9) Patient alarm device: An alarm device within the UVA irradiator chamber should be accessible to the patient for emergency activation. (10) Danger label: The unit should have a label prominently displayed which reads as follows:

DANGER - Ultraviolet Radiation - Follow your physician’s instructions - Failure to use protective eyewear may result in eye injury.

C. UVA EXPOSURE DOSIMETRY MEASUREMENTS:

The maximum radiant exposure or irradiance (within ± 15 percent) of UVA (320-400 nm) delivered to the patient should be determined by using an appropriate radiometer calibrated to be read in Joules/cm2 or mW/cm2. In the absence of a standard measuring technique approved by the National Bureau of Standards, the system should use a detector corrected to a cosine spatial response. The use and recalibration frequency of such a radiometer for a specific UVA irradiator chamber should be specified by the manufacturer because the UVA dose (exposure) is determined by the design of the irradiator, the number of lamps, and the age of the lamp. If irradiance is measured, the radiometer reading in mW/cm2 is used to calculate the exposure time in minutes to deliver the required UVA in Joules/cm2 to a patient in the UVA irradiator cabinet. The equation is:

Overexposure due to human error should be minimized by using an accurate automatic timing device, which is set by the operator and controlled by energizing and de-energizing the UVA irradiator lamp. The timing device calibration interval should be specified by the manufacturer. Safety systems should be included to minimize the possibility of delivering a UVA exposure which exceeds the prescribed dose, in the event the timer or radiometer should malfunction.

D. UVA SPECTRAL OUTPUT DISTRIBUTION:

The spectral distributions of the lamps should meet the following specifications:
1As a percentage of total irradiance between 320 and 400 nanometers.
Wavelength band (nanometers)

Output1

<310

....................................................................................................

<1

310 to 320

....................................................................................................

1 to 3

320 to 330

....................................................................................................

4 to 8

330 to 340

....................................................................................................

11 to 17

340 to 350

....................................................................................................

18 to 25

350 to 360

....................................................................................................

19 to 28

360 to 370

....................................................................................................

15 to 23

370 to 380

....................................................................................................

8 to 12

380 to 390

....................................................................................................

3 to 7

390 to 400

....................................................................................................

1 to 3

XI. PUVA TREATMENT PROTOCOL

INTRODUCTION:

The Methoxsalen Capsules, USP reach their maximum bioavailability in 1 1/2 to 2 hours after ingestion.

On average, the serum level achieved with Methoxsalen Capsules, USP is twice that obtained with 8-MOP (formerly Oxsoralen) and reach their peak concentration in less than 1/2 the time of the 8-MOP capsules.

As a result the mean MED J/cm2 for the Methoxsalen Capsules, USP is substantially less than that required for 8-MOP (Levins et al., 1984 and private communication1).

Photosensitivity studies demonstrate a shorter time of peak photosensitivity of 1.5 to 2.1 hours vs. 3.9 to 4.25 hours for regular methoxsalen capsules.

A. INITIAL EXPOSURE: The initial UVA exposures should be conducted according to the guidelines presented previously under IX., Psoriasis Therapy, Drug Dosage-Initial Therapy and Initial Exposure.

B. CLEARING PHASE: Specific recommendations for patient treatment are as follows:
1. SKIN TYPES I, II, & III. Patients with skin types I, II, and III may be treated 2 or 3 times per week. UVA exposure may be held constant or increased by up to 1.0 Joule/cm 2 at each treatment, according to the patient’s response. If erythema occurs, however, do not increase exposure time until erythema resolves. The severity and extent of the patient’s erythema may be used to determine whether the next exposure should be shortened, omitted, or maintained at the previous dosage. See Adverse Reactions section for additional information. 2. SKIN TYPES IV, V, & VI. Patients with skin types IV, V, and VI may be treated 2 or 3 times per week. UVA exposure may be held constant or increased by up to 1.5 Joules/cm 2 at each treatment unless erythema occurs. If erythema occurs, follow instructions outlined above in the procedures for patients with skin types I, II, and III. 3. ERYTHRODERMIC PSORIASIS. Patients with erythrodermic psoriasis should be treated with special attention because pre-existing erythema may obscure observations of possible treatment-related phototoxic erythema. These patients may be treated 2 or 3 times per week, as a Type I patient. 4. MISCELLANEOUS SITUATIONS: a. If there is no response after a total of 10 treatments, the exposure of UVA energy may be increased by an additional 0.5-1.0 Joules/cm 2 above the prior incremental increases for each treatment. (Example: a patient whose exposure dosage is being increased by 1.0 Joule/cm 2 may now have all subsequent doses increased by 1.5-2.0 Joules/cm 2.) b. If there is no response, or only minimal response, after 15 treatments, the dosage of methoxsalen may be increased by 10 mg (a one-time increase in dosage). This increased dosage may be continued for the remainder of the course of treatment but should not be exceeded. c. If a patient misses a treatment, the UVA exposure time of the next treatment should not be increased. If more than one treatment is missed, reduce the exposure by 0.5 Joules/cm 2 for each treatment missed. d. If the lower extremities are not responding as well as the rest of the body and do not show erythema, cover all other body areas and give 25 percent of the present exposure dose as an additional exposure to the lower extremities. This additional exposure to the lower extremities should be terminated if erythema develops on these areas. e. Non-responsive psoriasis: If a patient’s generalized psoriasis is not responding, or if the condition appears to be worsening during treatment, the possibility of a generalized phototoxic reaction should be considered. This may be confirmed by the improvement of the condition following temporary discontinuance of this therapy for two weeks. If no improvement occurs during the interruption of treatment, this patient may be considered a treatment failure.
C. ALTERNATIVE EXPOSURE SCHEDULE:

As an alternative to increasing the UVA exposure at each treatment, the following schedule may be followed; this schedule may reduce the total number of Joules/cm2 received by the patient over the entire course of therapy.
1. Incremental increases in UVA exposure for all patients may range from 0.5 to 1.5 Joules/cm 2, according to the patient’s response to therapy. 2. Once Grade 2 clearing (see Table 2) has been reached and the patient is progressing adequately, UVA dosage is held constant. This dosage is maintained until Grade 4 clearing is reached. 3. If the rate of clearing significantly decreases, exposure dosage may be increased at each treatment (0.1-1.5 Joules/cm 2) until Grade 3 clearing and a satisfactory progress rate is attained. The UVA exposure will be held constant again until Grade 4 clearing is attained. These increases may be used also if the rate of clearing significantly decreases between Grade 3 and Grade 4 response. However, the possibility of a phototoxic reaction should be considered; see Non-responsive Psoriasis, above. 4. In summary, this schedule raises slightly the increments (Joules/cm 2) of UVA dosage, but limits these increases to those periods when the patient is not responding adequately. Otherwise, the UVA exposure is held at the lowest effective dose.
D. MAINTENANCE PHASE:

The goal of maintenance treatment is to keep the patient as symptom-free as possible with the least amount of UVA exposure.
1. SCHEDULE OF EXPOSURES: When patients have achieved 95 percent clearing, or Grade 4 response ( Table 2), they may be placed on the following maintenance schedules (M 1 - M 4), in sequence. It is recommended that each maintenance schedule be adhered to for at least 2 treatments (unless erythema or psoriatic flare occurs, in which case see (2a) and (2b) below).
Maintenance Schedules

                                M1 - once/week

                                M2 - once/2 weeks

                                M3 - once/3 weeks

                                M4 - p.r.n. (i.e., for flares)
2. LENGTH OF EXPOSURE: The UVA exposure for the first maintenance treatment of any schedule (except M 4 as noted below) is the same as that of the patient’s last treatment under the previous schedule. For skin types I-IV, however, it is recommended that the maximum UVA dosage during maintenance treatments not exceed the following:
Skin Types

Joules/cm2/treatment

I

12

II

14

III

18

IV

22
If the patient develops erythema or new lesions of psoriasis, proceed as follows: a. Erythema: During maintenance therapy, the patient’s tan and threshold dose for erythema may gradually decrease. If maintenance treatments produce significant erythema, the exposure to UVA should be decreased by 25 percent until further treatments no longer produce erythema. b. Psoriasis: If the patient develops new areas of psoriasis during maintenance therapy (but still is classified as having a Grade 4 response), the exposure to UVA may be increased by 0.5-1.5 Joules/cm 2 at each treatment; this is appropriate for all types of patients. These increases are continued until the psoriasis is brought under control and the patient is again clear. The exposure being administered when this clearing is reached should be used for further maintenance treatment. 3. FLARES DURING MAINTENANCE: If the patient flares during maintenance treatment (i.e., develops psoriasis on more than 5 percent of the originally involved areas of the body), his maintenance treatment schedule may be changed to the preceding maintenance or clearing schedule. The patient may be kept on his schedule until again 95 percent clear. If the original maintenance treatment schedule is unable to control the psoriasis, the schedule may be changed to a more frequent regimen. If a flare occurs less than 6 weeks after the last treatment, 25 percent of the maximum exposure received during the clearing phase, with the clearing schedule received during the clearing phase, may be used and then proceed with the clearing schedule previously followed for this patient. (At 95 percent clearing, follow regular maintenance until the optimum maintenance schedule is determined for the patient.) If more than 6 weeks have elapsed since the last treatment was given, treat patients as if they were beginning therapy insofar as exposure dosages are concerned, since their threshold for erythema may have decreased. Table 1. Grades of Erythema
Grade

Erythema

0

    No erythema

1

    Minimally perceptible erythema – faint pink

2

    Marked erythema but with no edema

3

    Fiery erythema with edema

4

    Fiery erythema with edema and blistering
Table 2. Response To Therapy
Grade

Criteria

Percent Improvement(compared to originalextent of disease)

-1

Psoriasis worse. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

0

0

No change. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

0

1

Minimal improvement – slightly less scaleand/or erythema. . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-20

2

Definite improvement – partial flatteningof all plaques – less scaling and lesserythema. . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .

20-50

3

Considerable improvement – nearly completeflattening of all plaques but bordersof plaques still palpable. . . . . . . . . . . . . . . . . . . . . . .

50-95

4

Clearing; complete flattening of plaquesincluding borders; plaques may be outlinedby pigmentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

95
Fenofibrate

Fenofibrate

2.1 General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

The initial dose of fenofibrate tablets is 145 mg once daily.

2.3 Severe Hypertriglyceridemia

The initial dose is 48 to 145 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 145 mg once daily.

2.4 Impaired Renal Function

Treatment with fenofibrate tablets should be initiated at a dose of 48 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.5 Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].
Enalapril Maleate And H...

Enalapril Maleate And Hydrochlorothiazide

Enalapril and hydrochlorothiazide are effective treatments for hypertension. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily. The side effects (see WARNINGS) of enalapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of enalapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects but the addition of enalapril in clinical trials blunted the hypokalemia normally seen with diuretics. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with either enalapril or hydrochlorothiazide monotherapy may be given Enalapril Maleate and Hydrochlorothiazide Tablets 10-25. Further increases of enalapril, hydrochlorothiazide or both depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. In general, patients do not require doses in excess of 20 mg of enalapril or 50 mg of hydrochlorothiazide. The daily dosage should not exceed two tablets of Enalapril Maleate and Hydrochlorothiazide Tablets 10-25.

Replacement Therapy: The combination may be substituted for the titrated components.

Use in Renal Impairment: The usual regimens of therapy with Enalapril Maleate and Hydrochlorothiazide Tablets need not be adjusted as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine approximately ≤ 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so enalapril maleate-hydrochlorothiazide is not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).
Atropine Sulfate Soluti...

Atropine Sulfate Solution

Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem HCl CD capsules at the nearest equivalent total daily dose. Higher doses of diltiazem HCl CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

Concomitant Use With Other Cardiovascular Agents
1. Sublingual NTG. May be taken as required to abort acute anginal attacks during diltiazem HCl CD (diltiazem hydrochloride) therapy. 2. Prophylactic Nitrate Therapy. Diltiazem HCl CD may be safely coadministered with short- and long-acting nitrates. 3. Beta-blockers (see WARNINGS and PRECAUTIONS). 4. Antihypertensives. Diltiazem HCl CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem HCl CD or the concomitant antihypertensives may need to be adjusted when adding one to the other.

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