Finasteride
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Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms
- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).
Finasteride tablets are not approved for the prevention of prostate cancer.
History
There is currently no drug history available for this drug.
Other Information
Finasteride, USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:
Finasteride is a white to off-white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water.
Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, docusate sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), titanium dioxide and triacetin.
Sources
Finasteride Manufacturers
- Mylan Institutional Inc.
![Finasteride Tablet, Film Coated [Mylan Institutional Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Finasteride | Mylan Institutional Inc.
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Remedyrepack Inc.
Finasteride | Remedyrepack Inc.
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Kaiser Foundation Hospitals
Finasteride | Kaiser Foundation Hospitals
Finasteride tablets USP may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Remedyrepack Inc.
Finasteride | Remedyrepack Inc.
Finasteride tablets USP, 5 mg may be administered with or without meals.
The recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)] .
The recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)] .
- American Health Packaging
Finasteride | American Health Packaging
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Preferred Pharmaceuticals, Inc.
Finasteride | Preferred Pharmaceuticals, Inc.
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Cipla Usa Inc.
Finasteride | Cipla Usa Inc.
Finasteride tablets, USP may be administered with or without meals.
The recommended dose of Finasteride tablets, USP is one tablet taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Proficient Rx Lp
Finasteride | Proficient Rx Lp
Finasteride tablets USP, 5 mg may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ] .
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2) ] .
- Mckesson Packaging Services Business Unit Of Mckesson Corporation
Finasteride | Mckesson Packaging Services Business Unit Of Mckesson Corporation
The recommended dose is 5 mg orally once a day.
Finasteride may be administered with or without meals. No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Camber Pharmaceuticals Inc.
Finasteride | Camber Pharmaceuticals Inc.
The recommended dose is 5 mg orally once a day.
Finasteride tablets USP may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Northstar Rx Llc
Finasteride | Northstar Rx Llc
The recommended dose is 5 mg orally once a day.
Finasteride may be administered with or without meals. No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Physicians Total Care, Inc.
Finasteride | Physicians Total Care, Inc.
The recommended dose is 5 mg orally once a day.
Finasteride may be administered with or without meals. No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Hetero Drugs Limited
Finasteride | Hetero Drugs Limited
Finasteride tablets USP may be administered with or without meals. 2.1 Monotherapy
The recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)]. - Ingenus Pharmaceuticals, Llc
Finasteride | Ingenus Pharmaceuticals, Llc
Finasteride tablets USP, 5 mg may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Dr. Reddy’s Laboratories Limited
Finasteride | Dr. Reddy's Laboratories Limited
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Northstar Rx Llc
Finasteride | Apotheca Company
Directions: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
- Bryant Ranch Prepack
Finasteride | Bryant Ranch Prepack
The recommended dose is 5 mg orally once a day. Finasteride may be administered with or without meals. No dosage adjustment is necessary for patients with renal impairment or for the elderly (see ).
CLINICAL PHARMACOLOGY, Pharmacokinetics - Dr Reddys Laboratories Inc
Finasteride | Dr Reddys Laboratories Inc
Finasteride tablets USP may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Dr. Reddy’s Laboratories Limited
Finasteride | Dr. Reddy's Laboratories Limited
Finastedride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Legacy Pharmaceutical Packaging
Finasteride | Legacy Pharmaceutical Packaging
The recommended dose is 5 mg orally once a day.
Finasteride tablets USP may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Unit Dose Services
Finasteride | Unit Dose Services
Finasteride tablets 5 mg may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets 5 mg is one tablet (5 mg) taken once a day .
[see Clinical Studies ( )] 14.1 2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets 5 mg is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin
[see Clinical Studies ( )]. 14.2 - Remedyrepack Inc.
Finasteride | Remedyrepack Inc.
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
The recommended dose of finasteride is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Remedyrepack Inc.
Finasteride | Remedyrepack Inc.
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
The recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Clinical Solutions Wholesale
Finasteride | Clinical Solutions Wholesale
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination With Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Sun Pharma Global Fze
Finasteride | The Service Center Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
- Exelan Pharmaceuticals Inc.
Finasteride | Pharmaceutics Corporation
Apply directly to effected area. Do not use more than four times per day.
- Remedyrepack Inc.
Finasteride | Remedyrepack Inc.
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
The recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Actavis Inc.
Finasteride | Actavis Inc.
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Sun Pharma Global Fze
Finasteride | Jubilant Cadista Pharmaceuticals Inc.
Irbesartan may be administered with other antihypertensive agents and with or without food.
HypertensionThe recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic PatientsThe recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted PatientsA lower initial dose of irbesartan (75 mg) is recommended in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
- New Horizon Rx Group, Llc
Finasteride | New Horizon Rx Group, Llc
The recommended dose is 5 mg orally once a day.
Finasteride tablets USP, 5 mg may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
- Aidarex Pharmaceuticals Llc
Finasteride | Aidarex Pharmaceuticals Llc
Finasteride tablets USP may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- American Health Packaging
Finasteride | American Health Packaging
Oxycodone hydrochloride tablets are intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.
Patients who have not been receiving opioid analgesics should be started on oxycodone hydrochloride tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their initial dose of oxycodone hydrochloride tablets. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, oxycodone hydrochloride tablets should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.
As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of oxycodone hydrochloride tablets, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion From Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs:When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of oxycodone hydrochloride tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose oxycodone hydrochloride tablets should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy:If a patient has been receiving opioid-containing medications prior to taking oxycodone hydrochloride tablets, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to oxycodone hydrochloride tablets close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride tablets is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride tablets may be necessary, especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy:Continual re-evaluation of the patient receiving oxycodone hydrochloride tablets 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), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
Cessation of Therapy:When a patient no longer requires therapy with oxycodone hydrochloride tablets or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see DRUG ABUSE AND DEPENDENCE section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of oxycodone hydrochloride tablets that treatment may be discontinued without risk of the opioid abstinence syndrome.
- Avkare, Inc.
Finasteride | Avkare, Inc.
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination With Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Preferred Pharmaceuticals, Inc.
Finasteride | Preferred Pharmaceuticals, Inc.
Finasteride tablets USP may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablet USP are one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of Finasteride tablets USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Preferred Pharmaceuticals, Inc.
Finasteride | Preferred Pharmaceuticals, Inc.
Finastedride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Qualitest Pharmaceuticals
Finasteride | Qualitest Pharmaceuticals
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of Finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of Finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Mylan Pharmaceuticals Inc.
Finasteride | Mylan Pharmaceuticals Inc.
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Greenstone Llc
Finasteride | Greenstone Llc
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Aurobindo Pharma Limited
Finasteride | Aurobindo Pharma Limited
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Camber Pharmaceuticals, Inc.
Finasteride | Camber Pharmaceuticals, Inc.
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. - Cardinal Health
Finasteride | Cardinal Health
The recommended dose is 5 mg orally once a day.
Finasteride tablets can be administered alone (see CLINICAL PHARMACOLOGY: Clinical Studies).
Finasteride tablets may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
- Camber Pharmaceuticals, Inc.
Finasteride | Pfizer Laboratories
The dose, concentration, and infusion rate of CEREBYX should always be expressed as phenytoin sodium equivalents (PE). There is no need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. CEREBYX should always be prescribed and dispensed in phenytoin sodium equivalent units (PE). 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg PE. The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents (mg PE).
Do not confuse the concentration of CEREBYX with the total amount of drug in the vial.
Caution must be used when administering CEREBYX due to the risk of dosing errors (see WARNINGS). Medication errors associated with CEREBYX have resulted in patients receiving the wrong dose of fosphenytoin. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE and 10 mL vials containing a total of 500 mg PE. Both vials contain a concentration of 50 mg PE/mL. Errors have occurred when the concentration of the vial (50 mg PE/mL) was misinterpreted to mean that the total content of the vial was 50 mg PE. These errors have resulted in two- or ten-fold overdoses of CEREBYX since each of the vials actually contains a total of 100 mg PE or 500 mg PE. In some cases, ten-fold overdoses were associated with fatal outcomes. To help minimize confusion, the prescribed dose of CEREBYX should always be expressed in milligrams of phenytoin equivalents (mg PE). Additionally, when ordering and storing CEREBYX, consider displaying the total drug content (i.e., 100 mg PE/ 2 mL or 500 mg PE/ 10 mL) instead of concentration in computer systems, pre-printed orders, and automated dispensing cabinet databases to help ensure that total drug content can be clearly identified. Care should be taken to ensure the appropriate volume of CEREBYX is withdrawn from the vial when preparing the dose for administration. Attention to these details may prevent some CEREBYX medication errors from occurring.
Prior to IV infusion, dilute CEREBYX in 5% dextrose or 0.9% saline solution for injection to a concentration ranging from 1.5 to 25 mg PE/mL. The maximum concentration of CEREBYX in any solution should be 25 mg PE/mL. When CEREBYX is given as an intravenous infusion, CEREBYX needs to be diluted and should only be administered at a rate not exceeding 150 mg PE/min.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Status Epilepticus The loading dose of CEREBYX is 15 to 20 mg PE/kg administered at 100 to 150 mg PE/min. Because of the risk of hypotension, CEREBYX should be administered no faster than 150 mg PE/min. Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential and the patient should be observed throughout the period where maximal serum phenytoin concentrations occur, approximately 10 to 20 minutes after the end of CEREBYX infusions. Because the full antiepileptic effect of phenytoin, whether given as CEREBYX or parenteral phenytoin, is not immediate, other measures, including concomitant administration of an IV benzodiazepine, will usually be necessary for the control of status epilepticus. The loading dose should be followed by maintenance doses of either CEREBYX or phenytoin.If administration of CEREBYX does not terminate seizures, the use of other anticonvulsants and other appropriate measures should be considered.
Even though loading doses of CEREBYX have been given by the IM route for other indications when IV access is impossible, IM CEREBYX should ordinarily not be used in the treatment of status epilepticus because therapeutic phenytoin concentrations may not be reached as quickly as with IV administration.
Nonemergent Loading and Maintenance DosingBecause of the risks of cardiac and local toxicity associated with intravenous CEREBYX, oral phenytoin should be used whenever possible.
The loading dose of CEREBYX is 10 – 20 mg PE/kg given IV or IM. The rate of administration for IV CEREBYX should be no greater than 150 mg PE/min. Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential and the patient should be observed throughout the period where maximal serum phenytoin concentrations occur (approximately 20 minutes after the end of CEREBYX infusion).
The initial daily maintenance dose of CEREBYX is 4 – 6 mg PE/kg/day in divided doses.
IM or IV Substitution For Oral Phenytoin TherapyWhen treatment with oral phenytoin is not possible, CEREBYX can be substituted for oral phenytoin at the same total daily dose. Dilantin capsules are approximately 90% bioavailable by the oral route. Phenytoin, supplied as CEREBYX, is 100% bioavailable by both the IM and IV routes. For this reason, plasma phenytoin concentrations may increase modestly when IM or IV CEREBYX is substituted for oral phenytoin sodium therapy. The rate of administration for IV CEREBYX should be no greater than 150 mg PE/min. In controlled trials, IM CEREBYX was administered as a single daily dose utilizing either 1 or 2 injection sites. Some patients may require more frequent dosing.
Dosing in Special Populations Patients with Renal or Hepatic DiseaseDue to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution (see CLINICAL PHARMACOLOGY: Special Populations). Unbound phenytoin concentrations may be more useful in these patient populations. After IV CEREBYX administration to patients with renal and/or hepatic disease, or in those with hypoalbuminemia, fosphenytoin clearance to phenytoin may be increased without a similar increase in phenytoin clearance. This has the potential to increase the frequency and severity of adverse events (see PRECAUTIONS).
Elderly PatientsAge does not have a significant impact on the pharmacokinetics of fosphenytoin following CEREBYX administration. Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required.
PediatricThe safety and efficacy of CEREBYX in pediatric patients have not been established.
- Teva Pharmaceuticals Usa Inc
Finasteride | Teva Pharmaceuticals Usa Inc
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination With Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Bryant Ranch Prepack
Finasteride | Bryant Ranch Prepack
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Dr Reddys Laboratories Inc
Finasteride | Dr Reddys Laboratories Inc
Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Mylan Institutional Inc.
Finasteride | Mylan Institutional Inc.
The recommended dose is 5 mg orally once a day.
Finasteride tablets can be administered alone (see CLINICAL PHARMACOLOGY: Clinical Studies).
Finasteride tablets may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
- Citron Pharma Llc
Finasteride | Citron Pharma Llc
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
- Accord Healthcare, Inc.
Finasteride | Accord Healthcare, Inc.
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride tablets is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
- Citron Pharma Llc
Finasteride | Mckesson
use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Actavis Pharma, Inc.
Finasteride | Actavis Pharma, Inc.
Finasteride tablets may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see ClinicalStudies (14.2)].
- Accord Healthcare, Inc.
Finasteride | Accord Healthcare, Inc.
Finasteride tablets USP, 5 mg may be administered with or without meals.
2.1 MonotherapyThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)] .
2.2 Combination with Alpha-BlockerThe recommended dose of finasteride tablets USP, 5 mg is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)] .
- Aurobindo Pharma Limited
Finasteride | Aurobindo Pharma Limited
Finasteride tablets may be administered with or without meals.
The recommended dose of finasteride is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. - Avpak
Finasteride | Avpak
The recommended dose is 5 mg orally once a day.
Finasteride tablets USP may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
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![Finasteride Tablet, Film Coated [Sun Pharma Global Fze]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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