Anip Acquisition Company
Manufacturer Details
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Anip Acquisition Company Drugs
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![Etoposide Injection [Bluepoint Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=40654d12-56e4-4489-be49-19c60ad918ad&name=40654d12-56e4-4489-be49-19c60ad918ad-06.jpg)
Etoposide
The use of Hydrocortisone Rectal Suspension, USP hydrocortisone retention enema 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 Hydrocortisone Rectal Suspension, USP 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 Hydrocortisone Rectal Suspension, USP treatment. Where the course of therapy extends beyond 21 days, Hydrocortisone Rectal Suspension, USP 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 Hydrocortisone Rectal Suspension, USP, 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 Hydrocortisone Rectal Suspension, USP are enclosed in each box. 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.
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![Opium Tincture Deodorized (Morphine Tincture) Solution [Anip Acquisition Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=674a969a-707d-41a9-b7c3-b90cbf2909e3&name=bd6093ae-figure-01.jpg)
Opium Tincture Deodorized
Usual Adult Dose – 0.6 mL orally 4 times a day.
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![Metoclopramide Solution [Anip Acquisition Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6cef9808-d867-4908-964b-c57ce500dccc&name=d7db6cd8-b2d2-427f-bea7-94df998ffca5-02.jpg)
Metoclopramide Solution
Therapy with metoclopramide oral solution should not exceed 12 weeks in duration.
For the Relief of Symptomatic Gastroesophageal Reflux
Administer from 10 mg to 15 mg metoclopramide orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of metoclopramide injection up to 10 days may be required before symptoms subside at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.
Use in Patients with Renal or Hepatic Impairment
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
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![Cortenema (Hydrocortisone) Enema [Anip Acquisition Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a307448a-ccc4-41a8-977a-11f28f0bded9&name=a307448a-ccc4-41a8-977a-11f28f0bded9-08.jpg)
Cortenema
The use of CORTENEMA® hydrocortisone retention enema 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 CORTENEMA® 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 CORTENEMA® treatment. Where the course of therapy extends beyond 21 days, CORTENEMA® 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 CORTENEMA®, 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 CORTENEMA® are enclosed in each box. 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.
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![Esterified Estrogens And Methyltestosterone Tablet [Anip Acquisition Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d42eeda8-d810-4481-a403-6a3520b9e69a&name=5fd30aae-b052-4182-80e7-ad766bc3443a-02.jpg)
Esterified Estrogens And Methyltestosterone
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. 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. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary. (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Given cyclically for short-term use only
For treatment of moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone.
The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible.
Administration should be cyclic (e.g., three weeks on and one week off).
Attempts to discontinue or taper medication should be made at three- to six-month intervals.
Usual Dosage Range
1 tablet of Esterified Estrogens and Methyltestosterone or 1 to 2 tablets of Esterified Estrogens and Methyltestosterone Half-Strength daily as recommended by the physician.
Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.
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