Ranbaxy Laboratories Inc.

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Isoptin Sr

Isoptin Sr

Essential Hypertension

The dose of ISOPTIN SR should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCI, ISOPTIN SR, given in the morning. Lower, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people etc.). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of ISOPTIN SR are evident within the first week of therapy.

If adequate response is not obtained with 180 mg of ISOPTIN SR, the dose may be titrated upward in the following manner:

a) 240 mg each morning,

b) 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening

c) 240 mg every twelve hours.

When switching from immediate release ISOPTIN to ISOPTIN SR, the total daily dose in milligrams may remain the same.
Omeprazole Delayed-rele...

Omeprazole Delayed-release

Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole delayed-release capsules.

Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

For patients unable to swallow an intact capsule, alternative administration options are available [ See Dosage and Administration (2.8)].

2.1 Short-Term Treatment of Active Duodenal Ulcer

The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence

Triple Therapy (omeprazole delayed-release capsules/clarithromycin/amoxicillin)-The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy (omeprazole delayed-release capsules/clarithromycin)-The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

2.3 Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

2.4 Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

2.5 Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is 20 mg daily. [ See Clinical Studies (14.4)]

2.6 Pathological Hypersecretory Conditions

The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.

2.7 Pediatric Patients

For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:
Patient Weight Omeprazole Daily Dose 5 < 10 kg 5 mg 10 < 20 kg 10 mg ≥ 20 kg 20 mg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [s ee Dosage and Administration (2.8)].

2.8 Alternative Administration Options

Omeprazole delayed-release capsules are available as a delayed-release capsule.

For patients who have difficulty swallowing capsules, the contents of a omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
Lac-hydrin

Lac-hydrin

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Lac Hydrin

Lac Hydrin

Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Ultravate Pac

Ultravate Pac

Apply a thin layer of Ultravate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Ultravate (halobetasol propionate ointment) Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Ultravate Ointment should not be used with occlusive dressings.
Ultravate Pac-cream

Ultravate Pac-cream

Apply a thin layer of Ultravate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Ultravate (halobetasol propionate cream) Cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Ultravate Cream should not be used with occlusive dressings.
Desquam-x Wash

Desquam-x Wash

Shake well before use. Wash affected areas once or twice daily, avoiding contact with eyes or mucous membranes. Wet skin areas to be treated prior to administration; apply DESQUAM-X WASH, work to a full lather, rinse thoroughly and pat dry. The amount of drying or peeling may be controlled by modification of dose frequency or drug concentration.
Desquam-x Wash

Desquam-x Wash

shake well before use wash affected areas once or twice daily wet the skin areas to be treated prior to administration gently rub the acne cleanser into the skin for 10 to 20 seconds. Do not scrub the skin. Work into a full lather and rinse thoroughly, and then pat dry. If too much drying occurs, you may need to rinse the acne cleanser off sooner or use less often. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day Sensitivity Test for New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs follow the directions above.
Dopamine

Dopamine

Apply a thin film of 0.1% HALOG OINTMENT (Halcinonide Ointment, USP) to the affected area two to three times daily.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG OINTMENT under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG OINTMENT under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Exelderm

Exelderm

A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily.

Symptomatic relief usually occurs within a few days after starting EXELDERM (sulconazole nitrate, USP

) SOLUTION, 1.0%, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks.

If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.
Ximino

Ximino

The recommended dosage of Ximino is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

The following table shows capsule strength and body weight to achieve approximately 1 mg/kg.
Table 1: Dosing Table for Ximino Patient’s Weight (lbs.) Patient’s Weight (kg) Capsule Strength (mg) Actual mg/kg Dose 99 to 122 45 to 55 45 1 to 0.82 123 to 164 56 to 74 67.5 1.21 to 0.91 165 to 212 75 to 96 90 1.20 to 0.94 213 to 276 97 to 125 112.5 1.16 to 0.90 277 to 300 126 to 136 135 1.07 to 0.99
Ximino may be taken with or without food [see Clinical Pharmacology (12)]. The capsules should be swallowed whole without chewing, crushing or splitting. Ingestion of food along with Ximino may help reduce the risk of esophageal irritation and ulceration.

In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.4)].
Ultravate X

Ultravate X

Apply a thin layer of Ultravate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Ultravate (halobetasol propionate) Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Ultravate Ointment should not be used with occlusive dressings.
Kenalog

Kenalog

Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided.

Spray is flammable; avoid heat, flame or smoking when using this product.

Three or four applications daily of Kenalog Spray (Triamcinolone Acetonide Topical Aerosol) are generally adequate.
Exelderm

Exelderm

A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily.

Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence.

If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered.
Westcort

Westcort

Westcort Ointment should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.

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

Westcort Ointment should not be used with occlusive dressings unless directed by a physician. Westcort Ointment should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
Halog

Halog

Apply the 0.1% HALOG (Halcinonide Cream, USP) to the affected area two to three times daily. Rub in gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Ultravate

Ultravate

Apply a thin layer of Ultravate Cream or Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Ultravate (halobetasol propionate) is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Ultravate should not be used with occlusive dressings.
Ultravate X

Ultravate X

Apply a thin layer of Ultravate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Ultravate (halobetasol propionate) Cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Ultravate Cream should not be used with occlusive dressings.
Proctosol-hc

Proctosol-hc

Apply to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Dalan Golden Tropics An...

Dalan Golden Tropics Antibacterial Deodorant

In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application.

In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed.

LOTION: Shake well before using.

DIRECTIONS FOR PATIENTS WITH SCABIES:
• Take a routine bath or shower. Thoroughly massage Eurax cream or lotion into the skin from the chin to the toes including folds and creases. • Put Eurax cream or lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax cream or lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning. • A second application is advisable 24 hours later. • A 60 gram tube or bottle is sufficient for two applications. • Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned, or washed in the hot cycle of the washing machine. • A cleansing bath should be taken 48 hours after the last application
Absorica

Absorica

Healthcare professionals who prescribe ABSORICA must be certified in the iPLEDGE program and must comply with the required monitoring to ensure safe use of ABSORICA [see Warnings and Precautions (5.2)].

The required laboratory testing must be completed prior to dosing ABSORICA [see Dosage and Administration (2.4)].

Pregnancy Testing, and Contraceptive measures must be followed prior to dosing ABSORICA [seeUse in Specific Populations (8.6)].

2.1 Recommended Dosage

The recommended dosage range for ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid [seePatient Counseling Information (17)].

The safety of once daily dosing with ABSORICA has not been established. Once daily dosing is not recommended.
Table 1: ABSORICA Dosing by Body Weight (Based on Administration With or Without Food)
Body Weight

Total Daily (mg)

Kilograms

Pounds

0.5 mg/kg

1 mg/kg

2 mg/kg

405060708090100

88110132154176198220

20253035404550

405060708090100

80100120140160180200

2.2 Dosage Range

In trials comparing 0.1, 0.5, and 1 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects, some of which may be dose-related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated.

2.3 Duration of Use

A normal course of treatment is 15 – 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of ABSORICA, even in low doses, has not been studied, and is not recommended. It is important that ABSORICA be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of ABSORICA on bone loss is unknown [seeWarnings and Precautions (5.12)].

2.4 Laboratory Testing

Pregnancy Testing

[SeeUse in Specific Populations (8.6)]

Lipid Profile

Perform a fasting lipid profile including triglycerides prior to use of ABSORICA [seeWarnings and Precautions (5.8, 5.15)].

Liver Function Test

Perform liver function tests prior to use of ABSORICA [seeWarnings and Precautions (5.10, 5.15)].
Riomet

Riomet

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with Riomet or any other pharmacologic agent. Dosage of Riomet must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of Riomet is 2550 mg (25.5 mL) in adults and 2000 mg (20 mL) in pediatric patients (10 to 16 years of age).

Riomet should be given in divided doses with meals. Riomet should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

During treatment initiation and dose titration [see Dosage and Administration (2.1)], fasting plasma glucose should be used to determine the therapeutic response to Riomet and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Riomet, either when used as monotherapy or in combination with sulfonylurea or insulin.

Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of Riomet may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

2.1 Recommended Dosing Schedule

Adults

In general, clinically significant responses are not seen at doses below 1500 mg (15 mL) per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

The usual starting dose of Riomet (metformin hydrochloride oral solution) is 500 mg (5 mL) twice a day or 850 mg (8.5 mL) once a day, given with meals. Dosage increases should be made in increments of 500 mg (5 mL) weekly or 850 mg (8.5 mL) every 2 weeks, up to a total of 2000 mg (20 mL) per day, given in divided doses. Patients can also be titrated from 500 mg (5 mL) twice a day to 850 mg (8.5 mL) twice a day after 2 weeks. For those patients requiring additional glycemic control, Riomet may be given to a maximum daily dose of 2550 mg (25.5 mL) per day. Doses above 2000 mg (20 mL) may be better tolerated given three times a day with meals.

Pediatrics

The usual starting dose of Riomet is 500 mg (5 mL) twice a day, given with meals. Dosage increases should be made in increments of 500 mg (5 mL) weekly up to a maximum of 2000 mg (20 mL) per day, given in divided doses.

2.2 Transfer From Other Antidiabetic Therapy

When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to Riomet, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

2.3 Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of Riomet monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing Riomet at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).

With concomitant Metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin 500 mg and glyburide 20 mg were titrated to 1000 mg/20 mg, 1500 mg/20 mg, 2000 mg/20 mg or 2500 mg/20 mg of metformin and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response [see Clinical Studies (14)]. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant Riomet and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea).

If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of Riomet and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without Riomet.

2.4 Concomitant Metformin and Insulin Therapy in Adult Patients

The current Insulin dose should be continued upon initiation of Riomet therapy. Riomet therapy should be initiated at 500 mg (5 mL) once daily in patients on insulin therapy. For patients not responding adequately, the dose of Riomet should be increased by 500 mg (5 mL) after approximately 1 week and by 500 mg (5 mL) every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for Riomet is 2500 mg (25 mL). It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and Riomet. Further adjustment should be individualized based on glucose-lowering response.

2.5 Specific Patient Populations

Riomet is not recommended for use in pregnancy. Riomet is not recommended in patients below the age of 10 years.

The initial and maintenance dosing of Riomet should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Riomet.

Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly [see Warnings and Precautions (5.3)].

Ranbaxy Laboratories Inc.

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Ranbaxy Laboratories Inc. Drugs