Paddock Laboratories, Llc.

Manufacturer Details

There are currently no manufacturer details available.

Paddock Laboratories, Llc. Drugs

Evamist

Evamist

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.15)].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Evamist therapy should be initiated with one spray per day. Dosage adjustment should be guided by the clinical response.

Before applying the first dose from a new applicator, the pump should be primed by spraying 3 sprays with the cover on. The container should be held upright and vertical for spraying.

One, two or three sprays are applied each morning to adjacent, non-overlapping areas on the inner surface of the forearm, starting near the elbow. Sprays should be allowed to dry for approximately 2 minutes before covering the site with clothing. The site should not be washed for at least one hour. Application of Evamist to other skin surfaces has not been adequately studied. Evamist should not be applied to skin surfaces other than the forearm.

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to estradiol from Evamist-treated skin. Women should cover the Evamist application site with clothing if another person may come into contact with that area of skin after the spray dries. Additional precautions to minimize unintentional secondary exposure are outlined in Patient Counseling Information [see Patient Counseling Information (17.2)] and in the Patient Information Leaflet at the end of the prescribing information.
Viscum Mali

Viscum Mali

Shake well before using.

As an antacid:

Adults and children 12 yrs. and older:

1 to 3 teaspoons with a little water, up to four times a day, or as directed by a doctor.

As a laxative:

Adults and children 12 yrs. and older:

2 to 4 tablespoons followed by a full 8 oz. glass of water.

Children 6 to 11 yrs. of age:

1 to 2 tablespoons followed by a full 8 oz. glass of water.

Children 2 to 5 yrs. of age:

1 to 3 teaspoons followed by a full 8 oz. glass of water.

Children under 2 yrs. of age:

Consult a doctor before use.
Brompheniramine Maleate

Brompheniramine Maleate

Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.
Neptazane

Neptazane

The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.
Neo Polycin Hc

Neo Polycin Hc

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition. Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Acclean Chlorhexidine G...

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

2.1 Initial Dosing

To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

Hydromorphone hydrochloride extended release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Due to the risk of respiratory depression, hydromorphone hydrochloride extended release tablets are only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning hydromorphone hydrochloride extended release tablets therapy. As hydromorphone hydrochloride extended release tablets are only for use in opioid-tolerant patients, do not begin any patient on hydromorphone hydrochloride extended release tablets as the first opioid.

Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with hydromorphone hydrochloride extended release tablets [see Warnings and Precautions (5.2)].

Hydromorphone hydrochloride extended release tablets must be taken whole. Crushing, chewing, or dissolving hydromorphone hydrochloride extended release tablets will result in uncontrolled delivery of hydromorphone and can lead to overdose or death [see Warnings and Precautions (5.2)].

Conversion from Other Oral Hydromorphone Formulations to Hydromorphone Hydrochloride Extended Release Tablets

Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone hydrochloride extended release tablets by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily.

Conversion from Other Oral Opioids to Hydromorphone Hydrochloride Extended Release Tablets

Discontinue all other around-the-clock opioid drugs when hydromorphone hydrochloride extended release tablets therapy is initiated.

While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient’s 24-hour oral hydromorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydromorphone requirements, which could result in adverse reactions.

In a hydromorphone hydrochloride extended release tablets clinical trial with an open-label titration period, patients were converted from their prior opioid to hydromorphone hydrochloride extended release tablets using the Table 1 as a guide for the initial hydromorphone hydrochloride extended release tablets dose. The recommended starting dose of hydromorphone hydrochloride extended release tablets is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.

Consider the following when using the information in Table 1:
• This is not a table of equianalgesic doses. • The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to hydromorphone hydrochloride extended release tablets. • The table cannot be used to convert from hydromorphone hydrochloride extended release tablets to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.
To calculate the estimated hydromorphone hydrochloride extended release tablets dose using Table 1:
• For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the conversion factor to calculate the approximate oral hydromorphone daily dose. • For patients on a regimen of more than one opioid, calculate the approximate oral hydromorphone dose for each opioid and sum the totals to obtain the approximate total hydromorphone daily dose. • For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.
Always round the dose down, if necessary, to the appropriate hydromorphone hydrochloride extended release tablets strength(s) available.

Example conversion from a single opioid to hydromorphone hydrochloride extended release tablets:

Step 1: Sum the total daily dose of the opioid
• 30 mg of oxycodone 2 times daily = 60 mg total daily dose of oxycodone
Step 2: Calculate the approximate equivalent dose of oral hydromorphone based on the total daily dose of the current opioid using Table 1
• 60 mg total daily dose of oxycodone x Conversion Factor of 0.4 = 24 mg of oral hydromorphone daily
Step 3: Calculate the approximate starting dose of hydromorphone hydrochloride extended release tablets to be given every 24 hours, which is 50% of the calculated oral hydromorphone dose. Round down, if necessary, to the appropriate hydromorphone hydrochloride extended release tablet strengths available.
• 50% of 24 mg results in an initial dose of 12 mg of hydromorphone hydrochloride extended release tablets once daily • Adjust individually for each patient
Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to hydromorphone hydrochloride extended release tablets.

Conversion from Transdermal Fentanyl to Hydromorphone Hydrochloride Extended Release Tablets

Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone hydrochloride extended release tablets treatment can be initiated. To calculate the 24-hour hydromorphone hydrochloride extended release tablets dose, use a conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of hydromorphone hydrochloride extended release tablets. Then reduce the hydromorphone hydrochloride extended release tablets dose by 50%.

For example:

Step 1: Identify the dose of transdermal fentanyl.
• 75 mg of transdermal fentanyl
Step 2: Use the conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of hydromorphone hydrochloride extended release tablets.
• 75 mg of transdermal fentanyl : 36 mg total daily dose of hydromorphone hydrochloride extended release tablets
Step 3: Calculate the approximate starting dose of hydromorphone hydrochloride extended release tablets to be given every 24 hours, which is 50% of the converted dose. Round down, if necessary, to the appropriate hydromorphone hydrochloride extended release tablet strengths available.
• 50% of 36 mg results in an initial dose of 18 mg, which would be rounded down to 16 mg of hydromorphone hydrochloride extended release tablets once daily • Adjust individually for each patient
Conversion from Methadone to Hydromorphone Hydrochloride Extended Release Tablets

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

2.2 Titration and Maintenance of Therapy

Individually titrate hydromorphone hydrochloride extended release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydromorphone hydrochloride extended release tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Plasma levels of hydromorphone hydrochloride extended release tablets are sustained for 18 to 24 hours. Dosage adjustments of hydromorphone hydrochloride extended release tablets may be made in increments of 4 to 8 mg every 3 to 4 days as needed to achieve adequate analgesia.

Patients who experience breakthrough pain may require a dose increase of hydromorphone hydrochloride extended release tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the hydromorphone hydrochloride extended release tablets dose.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

2.3 Discontinuation of Hydromorphone Hydrochloride Extended Release Tablets

When a patient no longer requires therapy with hydromorphone hydrochloride extended release tablets, taper doses gradually, by 25% to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the opioid-tolerant patient.

To dispose of unused hydromorphone hydrochloride extended release tablets flush all remaining tablets down the toilet or remit to authorities at a certified drug take-back program.

2.4 Hepatic Impairment

Start patients with moderate hepatic impairment on 25% of the hydromorphone hydrochloride extended release tablets dose that would be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression during initiation of therapy with hydromorphone hydrochloride extended release tablets and during dose titration. Use of alternate analgesics is recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6)].

2.5 Renal Impairment

Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% of the hydromorphone hydrochloride extended release tablets dose that would be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and central nervous system depression during initiation of therapy with hydromorphone hydrochloride extended release tablets and during dose titration. As hydromorphone hydrochloride extended release tablets are only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Use in Specific Populations (8.7)].

2.6 Administration of Hydromorphone Hydrochloride Extended Release Tablets

Instruct patients to swallow hydromorphone hydrochloride extended release tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5.2)].
Tramadol Hydrochloride

Tramadol Hydrochloride

2.1 General Instructions

For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.

Apply diclofenac sodium topical solution, 1.5% w/w to clean, dry skin.

To avoid spillage, dispense diclofenac sodium topical solution, 1.5% w/w 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution, 1.5% w/w evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.

To treat the other knee, if symptomatic, repeat the procedure.

Application of diclofenac sodium topical solution, 1.5% w/w in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

2.2 Special Precautions
• Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution, 1.5% w/w to the treated knee. • Wash and dry hands after use. • Do not apply diclofenac sodium topical solution, 1.5% w/w to open wounds. • Avoid contact of diclofenac sodium topical solution, 1.5% w/w with eyes and mucous membranes. • Do not apply external heat and/or occlusive dressings to treated knees. • Avoid wearing clothing over the diclofenac sodium topical solution, 1.5% w/w-treated knee(s) until the treated knee is dry. • Protect the treated knee(s) from sunlight. • Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution, 1.5% w/w. • Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
Dry Skin Treatment Stud...

Dry Skin Treatment Studio 35

Hyoscyamine Sulfate Tablets 0.125 mg are formulated to be chewed or allowed to orally disintegrate. May be taken with or without water.

Adults and pediatric patients 12 years of age or older:

1 to 2 orally disintegrating tablets three to four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

Pediatric patients 6 to under 12 years of age:

1/2 to 1 orally disintegrating tablet three to four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance. Do not exceed 6 tablets in 24 hours.

Note: This product is not recommended for use in children under six years of age.
Ilotycin

Ilotycin

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of ILOTYCIN® Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
Colocort

Colocort

The use of Colocort® Hydrocortisone Rectal Suspension, USP is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives, antidiarrheal agents, antibacterial therapy, blood replacement if necessary, etc.

The usual course of therapy is one Colocort® nightly for 21 days, or until the patient comes into remission both clinically and proctologically. Clinical symptoms usually subside promptly within 3 to 5 days. Improvement in the appearance of the mucosa, as seen by sigmoidoscopic examination, may lag somewhat behind clinical improvement. Difficult cases may require as long as 2 or 3 months of Colocort® treatment. Where the course of therapy extends beyond 21 days, Colocort® should be discontinued gradually by reducing administration to every other night for 2 or 3 weeks.

If clinical or proctologic improvement fails to occur within 2 or 3 weeks after starting Colocort®, discontinue its use.

Symptomatic improvement, evidenced by decreased diarrhea and bleeding; weight gain; improved appetite; lessened fever; and decrease in leukocytosis, may be misleading and should not be used as the sole criterion in judging efficacy. Sigmoidoscopic examination and X-ray visualization are essential for adequate monitoring of ulcerative colitis. Biopsy is useful for differential diagnosis.

Patient instructions for administering Colocort® are printed on this carton. It is recommended that the patient lie on their left side during administration and for 30 minutes thereafter, so that the fluid will distribute throughout the left colon. Every effort should be made to retain the enema for at least an hour and preferably, all night. This may be facilitated by prior sedation and/or antidiarrheal medication, especially early in therapy when the urge to evacuate is great.
Methazolamide

Methazolamide

The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.
Calcium Acetate

Calcium Acetate

The recommended initial dose of Calcium Acetate Tablets, USP for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3 to 4 tablets with each meal.
No Drip

No Drip

Adults and pediatric patients 12 years of age or older:

1 to 2 sublingual tablets three to four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

Pediatric patients 6 to under 12 years of age:

1/2 to 1 sublingual tablet three to four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance. Do not exceed 6 tablets in 24 hours.

Note: This product is not recommended for use in children under six years of age.
Indomethacin

Indomethacin

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extendedrelease capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.

Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients,

but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.

Always give indomethacin extended-release capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.

Pediatric Use:

Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).

Adult Use:

Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):

Suggested Dosage:

The following recommendations on dosing pertain to immediate-release indomethacin capsules, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.

Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.

In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.

The following information refers to Extended-release Indomethacin Capsules (75 mg): If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.

If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.

If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.

Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.

As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
Kionex

Kionex

Suspension of this drug should be freshly prepared and not stored beyond 24 hours.

The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4levelteaspoons)of Kionex®one to four times daily. One gram of Kionex®contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of Kionex®and 15 mEq of sodium. (A heaping teaspoon may contain as much as 10 g to 12 g of Kionex®.) Since thein vivoefficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup. The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin.

The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure.

The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Kionex®should not be heated for to do so may alter the exchange properties of the resin.
Belladonna And Opium

Belladonna And Opium

Adults:

One belladonna and opium suppository rectally once or twice daily, not to exceed four doses daily or as recommended by the physician. Moisten finger and suppository with water before inserting. Absorption is dependent on body hydration and not on body temperature.

Not recommended for use in children 12 years of age and under.
Hyoscyamine Sulfate

Hyoscyamine Sulfate

Adults and pediatric patients 12 years of age or older:

1 to 2 oral tablets three to four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

Pediatric patients 6 to under 12 years of age:

1/2 to 1 oral tablet three to four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance. Do not exceed 6 tablets in 24 hours.

Note: This product is not recommended for use in children under six years of age.
Hydrocortisone Acetate ...

Hydrocortisone Acetate Suppository

Usual dosage:

One suppository in the rectum twice daily morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Hydrocortisone Acetate ...

Hydrocortisone Acetate Suppository

Usual dosage:

One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
Hydromorphone Hydrochlo...

Hydromorphone Hydrochloride Suppository

Hydromorphone Hydrochloride Suppositories (3 mg) may provide longer duration of relief which could obviate additional medication during the sleeping hours. The usual adult dose is one (1) suppository inserted rectally every 6 to 8 hours or as directed by physician.
Morphine Sulfate Suppos...

Morphine Sulfate Suppository

Usual Adult Dose: 10 to 20 mg every 4 hours or as directed by physician.

Dosage is a patient dependent variable, therefore increased dosage may be required to achieve adequate analgesia.

Note: Medication may suppress respiration in the elderly, the very ill, and those patients with respiratory problems, therefore lower doses may be required.

Morphine Dosage Reduction

During the first two to three days of effective pain relief, the patient may sleep for many hours. This can be misinterpreted as the effect of excessive analgesic dosing rather than the first sign of relief of a pain exhausted patient. The dose, therefore, should be maintained for at least three days before reduction, if respiratory activity and other vital signs are adequate.

Following successful relief of severe pain, periodic attempts to reduce the narcotic dose should be made. Smaller doses or complete discontinuation of the narcotic analgesic may become feasible due to a physiologic change or the improved mental state of the patient.
Irinotecan Hydrochlorid...

Irinotecan Hydrochloride

Prior to initiating testosterone cypionate, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Testosterone cypionate injection is for intramuscular use only.

It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.

The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
Cold And Allergy Maximu...

Cold And Allergy Maximum Strength

The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

2.1 Administration Instructions (Three-Bag Method: Loading, Second and Third Dose)

Dosing for Patients who weigh 5 kg to 20 kg (Table 1):

Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs

* Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

Dosing for Patients who weigh 21 kg to 40 kg (Table 2):

Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs

* Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

Dosing for Patients who weigh 41 kg to 100 kg (Table 3):

Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over 16 hrs

* Acetylcysteine Injection is compatible with the following diluents; 5% Dextrose, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

Patients Weighing More Than 100 kg

No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of Acetylcysteine Injection recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (See Table 3).

Continued Therapy beyond 21 Hours

While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [see Dosage and Administration (2)].

As Acetylcysteine Injection is hyperosmolar (2600 m0smol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.

*Osmolarity should be adjusted to a physiologically safe level, (generally not less than 150m0smol/L in children).

Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

2.3 Renal Impairment

No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

2.4 Hepatic Impairment

Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.
Trospium Chloride Er

Trospium Chloride Er

The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal.

Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) [see WARNINGS AND PRECAUTIONS (5.6), USE IN SPECIFIC POPULATIONS (8.6), and CLINICAL PHARMACOLOGY (12.3)].
Trospium Chloride

Trospium Chloride

The recommended dose is 20 mg twice daily. Trospium Chloride Tablets should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:
• For patients with severe renal impairment (creatinine clearance < 30 mL/min), the recommended dose is 20 mg once daily at bedtime [ see WARNINGS AND PRECAUTIONS (5.5), USE IN SPECIFIC POPULATIONS (8.6), and CLINICAL PHARMACOLOGY (12.3)]. • In geriatric patients ≥ 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [ see USE IN SPECIFIC POPULATIONS (8.5)].
Kionex

Kionex

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Kionex®Suspension one to four times daily. Each 60 mL of Kionex®Suspension contains 1500 mg (65 mEq) of sodium. Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Kionex®Suspension may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

Kionex®Suspension may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. Particular attention should be paid to the cleansing enema, because sorbitol is present in the vehicle.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Kionex®Suspension should not be heated for to do so may alter the exchange properties of the resin.
Acetylcysteine

Acetylcysteine

The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

2.1 Administration Instructions (Three-Bag Method: Loading, Second and Third Dose)

Dosing for Patients who weigh 5 kg to 20 kg (Table 1):

Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs

Dosing for Patients who weigh 21 kg to 40 kg (Table 2):

Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs

Dosing for Patients who weigh 41 kg to 100 kg (Table 3):

Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over 16 hrs

Patients Weighing More Than 100 kg

No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of acetylcysteine recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (See Table 3).

Continued Therapy beyond 21 Hours

While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [see Dosage and Administration (2)].

As acetylcysteine is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.

Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

Note: The color of acetylcysteine may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

2.3 Renal Impairment

No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

2.4 Hepatic Impairment

Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.
Amiloride Hydrocloride

Amiloride Hydrocloride

Amiloride HCl should be administered with food.

Amiloride HCl, one 5 mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of a kaliuretic diuretic. The dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets of amiloride HCl daily usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

In treating patients with congestive heart failure after an initial diuresis has been achieved, potassium loss may also decrease and the need for amiloride HCl should be re-evaluated. Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

If it is necessary to use amiloride HCl alone (See INDICATIONS), the starting dosage should be one 5 mg tablet daily. This dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.
Clotrimazole Lozenge

Clotrimazole Lozenge

Clotrimazole lozenges must be slowly dissolved in the mouth. The recommended dose is one lozenge five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole lozenge after prolonged administration; therefore, therapy should be limited to short term use, if possible.

For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Gentamicin Sulfate Oint...

Gentamicin Sulfate Ointment

Apply a small amount (about 1/2 inch) to the affected eye(s) two to three times a day.
Desloratadine

Desloratadine

Desloratadine tablets 5 mg may be taken without regard to meals. Take tablet immediately after opening the blister.

2.1 Adults and adolescents 12 years of age and over

The recommended dose of desloratadine tablets is one 5-mg tablet once daily.

2.5 Adults with Hepatic or Renal Impairment

In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Repaglinide

Repaglinide

There is no fixed dosage regimen for the management of type 2 diabetes with Repaglinide Tablets, USP.

The patient's blood glucose should be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels are of value in monitoring the patient's longer term response to therapy.

Short-term administration of Repaglinide Tablets, USP may be sufficient during periods of transient loss of control in patients usually well controlled on diet.

Repaglinide Tablets, USP doses are usually taken within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal.

Starting Dose

For patients not previously treated or whose HbA1c is < 8%, the starting dose should be 0.5 mg with each meal. For patients previously treated with blood glucose-lowering drugs and whose HbA1c is ≥ 8%, the initial dose is 1 or 2 mg with each meal preprandially (see previous paragraph).

Dose Adjustment

Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose. Postprandial glucose levels testing may be clinically helpful in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate. The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.

The recommended dose range is 0.5 mg to 4 mg taken with meals. Repaglinide Tablets, USP may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient's meal pattern. The maximum recommended daily dose is 16 mg.

Patient Management

Long-term efficacy should be monitored by measurement of HbA1c levels approximately every 3 months. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia or hyperglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy including hypoglycemia. When hypoglycemia occurs in patients taking a combination of Repaglinide Tablets, USP and a thiazolidinedione, the dose of Repaglinide Tablets, USP should be reduced.

Patients Receiving Other Oral Hypoglycemic Agents

When Repaglinide Tablets, USP are used to replace therapy with other oral hypoglycemic agents, Repaglinide Tablets, USP may be started on the day after the final dose is given. Patients should then be observed carefully for hypoglycemia due to potential overlapping of drug effects. When transferred from longer half-life sulfonylurea agents (e.g., chlorpropamide) to repaglinide, close monitoring may be indicated for up to one week or longer.

Combination Therapy

If Repaglinide Tablets, USP monotherapy does not result in adequate glycemic control, a thiazolidinedione may be added. If thiazolidinedione monotherapy does not provide adequate control, Repaglinide Tablets, USP may be added. The starting dose and dose adjustments for Repaglinide Tablets, USP combination therapy is the same as for Repaglinide Tablets, USP monotherapy. The dose of each drug should be carefully adjusted to determine the minimal dose required to achieve the desired pharmacologic effect. Failure to do so could result in an increase in the incidence of hypoglycemic episodes. Appropriate monitoring of FPG and HbA1c measurements should be used to ensure that the patient is not subjected to excessive drug exposure or increased probability of secondary drug failure.
Morphine Sulfate Soluti...

Morphine Sulfate Solution

Morphine Oral Solution is available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/mL).

Take care when prescribing and administering Morphine Oral Solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Morphine Oral Solution 100 mg per 5 mL (20 mg/mL) to ensure the dose is measured and administered accurately.

Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

2.1 Individualization of Dosage

As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate, give attention to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; • the patient’s degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient’s pain; • risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.

2.2 Initiation of Therapy in Opioid-Naïve Patients

Start patients who have not been receiving opioid analgesics on morphine sulfate in the following dosing range using Oral Solution, 10 mg per 5 mL or 20 mg per 5 mL strengths:

Morphine Sulfate Oral Solution: 10 to 20 mg every 4 hours as needed for pain.

Titrate the dose based upon the individual patient’s response to their initial dose of morphine sulfate. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the morphine by the patient.

The 100 mg per 5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of morphine sulfate and who can benefit from use of a smaller volume of oral solution.

2.3 Conversion to Oral Morphine Sulfate

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of morphine sulfate. It is better to underestimate a patient’s 24-hour oral morphine sulfate dose and make available rescue medication than to overestimate the 24-hour oral morphine sulfate dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Parenteral Morphine to Oral Morphine Sulfate

For conversion from parenteral to oral morphine sulfate, anywhere from 3 to 6 mg of oral morphine sulfate may be required to provide pain relief equivalent to 1 mg of parenteral morphine.

Conversion From Parenteral or Oral Non-Morphine Opioids to Oral Morphine Sulfate

In converting patients from other opioids to morphine sulfate, close observation and adjustment of dosage based upon the patient’s response to morphine sulfate is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Morphine to Oral Morphine Sulfate

For a given dose, the same total amount of morphine sulfate is available from Morphine Sulfate Oral Solution, Morphine Sulfate Tablets, and controlled-release and extended-release morphine capsules. The extended duration of release of morphine sulfate from controlled-release tablets or extended-release tablets results in reduced maximum and increased minimum plasma morphine sulfate concentrations than with shorter acting morphine sulfate products. Conversion from oral solution or immediate-release tablets to the same total daily dose of controlled-release tablets or extended-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

2.4 Maintenance of Therapy

Continual reevaluation of the patient receiving morphine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

2.5 Cessation of Therapy

When the patient no longer requires therapy with morphine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.
Podofilox Solution

Podofilox Solution

In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated, the technique for initial application of the medication should be demonstrated by the prescriber.

Apply twice daily morning and evening (every 12 hours), for 3 consecutive days, then withhold use for 4 consecutive days. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. If there is incomplete response after four treatment weeks, alternative treatment should be considered. Safety and effectiveness of more than four treatment weeks have not been established.

Podofilox Topical Solution 0.5% is applied to the warts with an applicator supplied with the drug. The drug-dampened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Treatment should be limited to less than 10 cm2 of wart tissue and to no more than 0.5 mL of the solution per day. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Care should be taken to allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, the used applicator should be carefully disposed of and the patient should wash his or her hands.
Bacitracin Ointment

Bacitracin Ointment

The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
Colistimethate

Colistimethate

Important:

Colistimethate for injection is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.

Reconstitution for Intravenous or Intramuscular Administration:

The 150 mg vial should be reconstituted with 2 mL Sterile Water for Injection, USP.

The reconstituted solution provides colistimethate sodium at a concentration equivalent to 75 mg/mL colistin base activity.

During reconstitution swirl gently to avoid frothing.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions are observed, the product should not be used.

Dosage

Adults and pediatric patients – Intravenous or Intramuscular Administration:

The dose of Colistimethate for injection should be 2.5 to 5 mg/kg per day of colistin base in 2 to 4 divided doses for patients with normal renal function, depending on the severity of the infection.

In obese individuals, dosage should be based on ideal body weight.

The daily dose and frequency should be reduced for the patients with renal impairment. Suggested modifications of dosage schedule for patients with renal impairment are presented in Table 1.

INTRAVENOUS ADMINISTRATION

1. Direct Intermittent Administration—Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

2. Continuous Infusion—Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of colistimethate for injection to one of the following:
0.9% NaCl 5% dextrose in 0.9% NaCl 5% dextrose in water 5% dextrose in 0.45% NaCl 5% dextrose in 0.225% NaCl Lactated Ringer's solution 10% invert sugar solution
There are not sufficient data to recommend usage of colistimethate for injection with other drugs or other than the above listed infusion solutions.

Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment.

The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management.

Any final intravenous infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

INTRAMUSCULAR ADMINISTRATION
1. For Intramuscular Injection, administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). Store reconstituted solution for intramuscular injection in a refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25° (68° to 77°F) and use within 7 days.
Lorazepam Solution

Lorazepam Solution

Proper Use of Lorazepam Oral Concentrate, USP:

Lorazepam Oral Concentrate, USP is a concentrated oral solution as compared to standard oral liquid medications. It is recommended that Lorazepam Oral Concentrate, USP be mixed with liquid or semi-solid food such as water, juices, soda or soda-like beverages, applesauce and puddings.

Use only the calibrated dropper provided with this product. Draw into the dropper the amount prescribed for a single dose. Then squeeze the dropper contents into a liquid or semi-solid food. Stir the liquid or food gently for a few seconds. Lorazepam Oral Concentrate, USP formulation blends quickly and completely. The entire amount of the mixture, of drug and liquid or drug and food, should be consumed immediately. Do not store for future use.

Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response.

The usual range is 2 mg/day to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 mg/day to 10 mg/day.

For anxiety, most patients require an initial dose of 2 mg/day to 3 mg/day given b.i.d. or t.i.d.

For insomnia due to anxiety or transient situational stress, a single daily dose of 2 mg to 4 mg may be given, usually at bedtime.

For elderly or debilitated patients, an initial dosage of 1 mg/day to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.

The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
Erythromycin Ointment

Erythromycin Ointment

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
Naratriptan Hydrochlori...

Naratriptan Hydrochloride

2.1 Dosing Information

The recommended dose of Naratriptan Tablets, USP is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.

2.2 Dosage Adjustment in Patients With Renal Impairment

Naratriptan Tablets, USP is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.3 Dosage Adjustment in Patients With Hepatic Impairment

Naratriptan Tablets, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Clobetasol Propionate L...

Clobetasol Propionate Lotion

Clobetasol Propionate Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.Clobetasol Propionate Lotion, 0.05%, should be applied to the affected skin areas twice daily and rubbed in gently and completely.The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Clobetasol Propionate Lotion, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and up to 2 additional weeks in localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Lotion, 0.05%. Unless directed by physician, Clobetasol Propionate Lotion, 0.05% should not be used with occlusive dressings.
Dihydroergotamine Mesyl...

Dihydroergotamine Mesylate

Dihydroergotamine Mesylate Injection, USP should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL. Dihydroergotamine mesylate injection should not be used for chronic daily administration.
Vitamin D

Vitamin D

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 USP Units daily.

Hypoparathyroidism: 50,000 to 200,000 USP Units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.

X-rays of the bones should be taken every month until condition is corrected and stabilized.
Sodium Polystyrene Sulf...

Sodium Polystyrene Sulfonate Suspension

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Sodium Polystyrene Sulfonate Suspension, USP one to four times daily. Each 60 mL of Sodium Polystyrene Sulfonate Suspension, USP contains 1500 mg (65 mEq) of sodium. Since the in-vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin’s actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Sodium Polystyrene Sulfonate Suspension, USP may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

Sodium Polystyrene Sulfonate Suspension, USP may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Sodium Polystyrene Sulfonate Suspension, USP should not be heated for to do so may alter the exchange properties of the resin.
Garamycin Gentamicin Su...

Garamycin Gentamicin Sulfate

Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once per hour.
Neomycin And Polymyxin ...

Neomycin And Polymyxin B Sulfates And Dexamethasone

Apply a small amount into the conjunctival sac(s) up to three or four times daily.

How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment:
1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the "V" pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Flavoxate Hydrochloride...

Flavoxate Hydrochloride

Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
Bromocriptine Mesylate

Bromocriptine Mesylate

General

It is recommended that bromocriptine mesylate be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.

Hyperprolactinemic Indications

The initial dosage of bromocriptine mesylate tablets in adults is ½ to one 2.5 mg scored tablet daily. An additional 2.5 mg tablet may be added to the treatment regimen as tolerated every 2-7 days until an optimal therapeutic response is achieved. The therapeutic dosage ranged from 2.5-15 mg daily in adults studied clinically.

Based on limited data in children of age 11 to 15, (see Pediatric Use) the initial dose is ½ to one 2.5 mg scored tablet daily. Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.

In order to reduce the likelihood of prolonged exposure to bromocriptine mesylate tablets should an unsuspected pregnancy occur, a mechanical contraceptive should be used in conjunction with bromocriptine mesylate tablets therapy until normal ovulatory menstrual cycles have been restored. Contraception may then be discontinued in patients desiring pregnancy.

Thereafter, if menstruation does not occur within 3 days of the expected date, bromocriptine mesylate therapy should be discontinued and a pregnancy test performed.

Acromegaly

Virtually all acromegalic patients receiving therapeutic benefit from bromocriptine mesylate tablets also have reductions in circulating levels of growth hormone. Therefore, periodic assessment of circulating levels of growth hormone will, in most cases, serve as a guide in determining the therapeutic potential of bromocriptine mesylate tablets. If, after a brief trial with bromocriptine mesylate therapy, no significant reduction in growth hormone levels has taken place, careful assessment of the clinical features of the disease should be made, and if no change has occurred, dosage adjustment or discontinuation of therapy should be considered.

The initial recommended dosage is ½ to one 2.5 mg bromocriptine mesylate tablet on retiring (with food) for 3 days. An additional ½ to 1 tablet should be added to the treatment regimen as tolerated every 3-7 days until the patient obtains optimal therapeutic benefit. Patients should be reevaluated monthly and the dosage adjusted based on reductions of growth hormone or clinical response. The usual optimal therapeutic dosage range of bromocriptine mesylate tablets varies from 20-30 mg/day in most patients. The maximal dosage should not exceed 100 mg/day.

Patients treated with pituitary irradiation should be withdrawn from bromocriptine mesylate tablets therapy on a yearly basis to assess both the clinical effects of radiation on the disease process as well as the effects of bromocriptine mesylate tablets therapy. Usually a 4-8 week withdrawal period is adequate for this purpose. Recurrence of the signs/symptoms or increases in growth hormone indicate the disease process is still active and further courses of bromocriptine mesylate tablets should be considered.

Parkinson's Disease

The basic principle of bromocriptine mesylate tablets therapy is to initiate treatment at a low dosage and, on an individual basis, increase the daily dosage slowly until a maximum therapeutic response is achieved. The dosage of levodopa during this introductory period should be maintained, if possible. The initial dose of bromocriptine mesylate is ½ of a 2.5 mg tablet twice daily with meals. Assessments are advised at 2-week intervals during dosage titration to ensure that the lowest dosage producing an optimal therapeutic response is not exceeded. If necessary, the dosage may be increased every 14-28 days by 2½ mg/day with meals. Should it be advisable to reduce the dosage of levodopa because of adverse reactions, the daily dosage of bromocriptine mesylate, if increased, should be accomplished gradually in small (2½ mg) increments.

The safety of bromocriptine mesylate has not been demonstrated in dosages exceeding 100 mg/day.
Clindamycin Palmitate H...

Clindamycin Palmitate Hydrochloride Granule

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate hydrochloride contained in Clindamycin Palmitate Hydrochloride for Oral Solution.

Serious infections: 8 to 12 mg/kg/day (4 to 6 mg/lb/day) divided into 3 or 4 equal doses.

Severe infections: 13 to 16 mg/kg/day (6.5 to 8 mg/lb/day) divided into 3 or 4 equal doses.

More severe infections: 17 to 25 mg/kg/day (8.5 to 12.5 mg/lb/day) divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Serious infections due to anaerobic bacteria are usually treated with Clindamycin Phosphate Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clindamycin Palmitate Hydrochloride for Oral Solution.

NOTE: In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Reconstitution Instructions:

When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate hydrochloride equivalent to 75 mg clindamycin.

Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

Storage Conditions:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.
Compound Benzoin Tinctu...

Compound Benzoin Tincture

Adults and children 6 months of age and older: Dry the affected area. Saturate a cotton applicator with medication. Apply the undiluted medication directly to the affected area. Do not use more than every 2 hours.

Children under 6 months of age: Consult a dentist or doctor.
Sulfacetamide Sodium Oi...

Sulfacetamide Sodium Ointment

For conjunctivitis and other superficial ocular Infections: Apply a small amount (approximately one-half inch ribbon) into the conjunctival sac(s) of the affected eye(s) every three to four hours and at bedtime. Dosages may be tapered by increasing the time interval between doses as the condition responds. The ointment may be used as adjunct to the solution. The usual duration of treatment is seven to ten days.
Midazolam Hydrochloride...

Midazolam Hydrochloride Syrup

Midazolam HCl syrup is indicated for use as a single dose (0.25 to 1 mg/kg with a maximum dose of 20 mg) for preprocedural sedation and anxiolysis in pediatric patients.

Midazolam HCl syrup is not intended for chronic administration.
Puralube

Puralube

• pull down the lower lid of the affected eye • apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.
Sivextro

Sivextro

Superficial Dermatophyte Infections

Gently massage Ciclopirox Gel, 0.77% into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

Seborrheic Dermatitis of the Scalp

Apply Ciclopirox Gel, 0.77% to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment.

If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.
Compro

Compro

Adults: Dosage should be increased more gradually in debilitated or emaciated patients.

Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.

Rectal Dosage: 25 mg twice daily.
Hydrocodone Bitartrate

Hydrocodone Bitartrate

Administer Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Oral Solution by the oral route only. Measure Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see WARNINGS AND PRECAUTIONS (5.9)].

2.1 Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.
Bisacodyl Suppository

Bisacodyl Suppository

adults and children 12 years of age and over

1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age

½ suppository in a single daily dose

children under 6 years of age

ask a doctor
Caffeine Citrate Soluti...

Caffeine Citrate Solution Caffeine Citrate

Prior to initiation of caffeine citrate, baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta.

The recommended loading dose and maintenance doses of caffeine citrate follow.
Dose of Caffeine Citrate Volume Dose of Caffeine Citrate mg/kg Route Frequency
Loading Dose

1 mL/kg

20 mg/kg

Intravenous 1 (over 30 minutes)

One Time

Maintenance Dose

0.25 mL/kg

5 mg/kg

Intravenous 1 (over 10 minutes) or Orally

Every 24 hours 2

NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base).

Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Caffeine citrate injection and caffeine citrate oral solution should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded.

DRUG COMPATIBILITY

To test for drug compatibility with common intravenous solutions or medications, twenty (20) mL of caffeine citrate injection were combined with 20 mL of a solution or medication, with the exception of an Intralipid® admixture, which was combined as 80 mL/80 mL. The physical appearance of the combined solutions was evaluated for precipitation. The admixtures were mixed for 10 minutes and then assayed for caffeine. The admixtures were then continually mixed for 24 hours, with further sampling for caffeine assays at 2, 4, 8, and 24 hours.

Based on this testing, caffeine citrate injection, 60 mg/3 mL is chemically stable for 24 hours at room temperature when combined with the following test products.
• Dextrose Injection, USP 5% • 50% Dextrose Injection USP • Intralipid ® 20% IV Fat Emulsion • Aminosyn ® 8.5% Crystalline Amino Acid Solution • Dopamine HCI Injection, USP 40 mg/mL diluted to 0.6 mg/mL with Dextrose Injection, USP 5% • Calcium Gluconate Injection, USP 10% (0.465 mEq/Ca +2/mL) • Heparin Sodium Injection, USP 1000 units/mL diluted to 1 unit/mL with Dextrose Injection, USP 5% • Fentanyl Citrate Injection, USP 50 µg/mL diluted to 10 µg/mL with Dextrose Injection, USP 5%
Podocon 25

Podocon 25

PODOCON-25® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL. Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25® sparingly to lesion. Avoid contact with healthy tissue. Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is a powerful caustic and severe irritant, it is recommended the first application of Podocon-25® be left in contact for only a short time (30-40 minutes) to determine patient’s sensitivity. To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to 4 hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique. Large areas or numerous warts should not be treated at once.

After treatment time has elapsed, remove dried Podocon-25® thoroughly with alcohol or soap and water.
Potassium Chloride

Potassium Chloride

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), Potassium Chloride Extended-Release Capsules USP, 8 mEq and 10 mEq should be taken with meals and with a full glass of water or other liquid.

Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.
Nystop

Nystop

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.
Aspirin Suppository

Aspirin Suppository

Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.
70%

70%

• clean the affected area • apply a small amount of this product on the affected area 1 to 3 times daily (473 mL Only) • apply 1 to 3 times daily (1 gallon Only) • may be covered with a sterile bandage (473 mL Only) • if bandaged, let dry first (473 mL Only)
Actidose

Actidose

Prior to administration of Actidose® with Sorbitol or Actidose®-Aqua, shake the container thoroughly for a minimum of 30 seconds. After administration of either Actidose® with Sorbitol or Actidose®-Aqua, the container should be thoroughly rinsed with water and any residue should be administered to the patient to ensure that the entire dose has been delivered.

Single Dose - Actidose®-Aqua

Under one year of age:

1 gm/kg (5 ml/kg)

1 – 12 years of age:

25-50 gm (120-240 ml)

Adults (over 12 yrs.):

50-100 gm (240-480- ml)

Single Dose - Actidose® with Sorbitol

Under one year of age:

DO NOT USE ACTIDOSE® WITH

SORBITOL IN CHILDREN LESS

THAN ONE YEAR OF AGE.

1 – 12 years of age:

DO NOT USE ACTIDOSE® WITH

SORBITOL 25 GM/120 ML IN

CHILDREN WEIGHING LESS

THAN 16 KG (35 LBS).

DO NOT USE ACTIDOSE® WITH

SORBITOL 50 GM/240 ML IN

CHILDREN WEIGHING LESS

THAN 32 KG (70 LBS).

Adults (over 12 yrs.):

50 gm [96 gm sorbitol]

(240 ml)

Multiple Dose - Actidose®-Aqua

Under one year of age:

1 gm/kg (5 ml/kg)

q 4-6H (every 4-6 hrs)

1 – 12 years of age:

25-50 gm (120-240 ml)

q 4-6H (every 4-6 hrs)

Adults (over 12 yrs.):

50-100 gm (240-480 ml)

q 4-6H (every 4-6 hrs)

Multiple Dose - Actidose® with Sorbitol

ACTIDOSE® WITH SORBITOL

IS NOT RECOMMENDED FOR

CHILDREN OR ADULTS IN

MULTIPLE DOSE ACTIVATED

CHARCOAL THERAPY DUE TO

EXCESSIVE CATHARTIC ACTION.
Castor Oil

Castor Oil

adults and children over 12 years of age: 1 to a maximum of 4 Tablespoons (15 to 60 mL) in a single daily dose

children 2 to under 12 years of age: 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose

under 2 years: consult a doctor
Methocarbamol

Methocarbamol

Clobetasol propionate topical solution USP, 0.05% (spray) is for topical use only, and not for ophthalmic, oral or intravaginal use.

Clobetasol propionate topical solution USP, 0.05% (spray) should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely.

The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day.

Clobetasol propionate topical solution USP, 0.05% (spray) contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with clobetasol propionate topical solution USP, 0.05% (spray). If no improvement is seen within 2 weeks, reassessment of 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.

Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression [see Use in Specific Populations (8.4)].

Unless directed by physician, clobetasol propionate topical solution USP, 0.05% (spray) should not be used with occlusive dressings.
Ez Char

Ez Char

Remove Seal. Reconstitute into an oral suspension by adding 4 oz. of water to bottle, replacing cap and shaking well, or by pouring contents into a separate container, adding 4 oz. water, and stirring thoroughly.

USE IMMEDIATELY, DO NOT STORE RECONSTITUTED PRODUCT.

6 to 12 lb

1 to 2 TBS of reconstituted liquid

12 to 24 lb

2 to 4 TBS of reconstituted liquid

24 to 48 lb

4 to 8 TBS of reconstituted liquid

48 lb +

entire amount of reconstituted liquid

Repeat dose immediately, if necessary.
Mefenamic Acid

Mefenamic Acid

Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with mefenamic acid, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of acute pain in adults and adolescents ≥ 14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week.4

For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.5

Paddock Laboratories, Llc.

Manufacturer Details

Share This Page

Paddock Laboratories, Llc. Drugs