AVODART Dutasteride 500mcg SoftGel Capsule 1's
RXDRUG-DR-XY29399-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Dutasteride (Avodart) treats and prevents progression of benign prostatic hyperplasia (BPH) through alleviating symptoms, reducing prostate size (volume), improving urinary flow rate and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery.
Dutasteride (Avodart) in combination with the alpha-blocker tamsulosin, treats and prevents progression of benign prostatic hyperplasia (BPH) by reducing prostate size, alleviating symptoms, improving urinary flow and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Dutasteride (Avodart) in combination with the alpha-blocker tamsulosin, treats and prevents progression of benign prostatic hyperplasia (BPH) by reducing prostate size, alleviating symptoms, improving urinary flow and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Dosage/Direction for Use
Adult males (including elderly): Capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.
Dutasteride (Avodart) may be taken with or without food.
The recommended dose of Dutasteride (Avodart) is one capsule (0.5 mg) taken orally once a day.
Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved.
For treatment of BPH, Dutasteride (Avodart) can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg).
Renal impairment: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Dutasteride (Avodart) may be taken with or without food.
The recommended dose of Dutasteride (Avodart) is one capsule (0.5 mg) taken orally once a day.
Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved.
For treatment of BPH, Dutasteride (Avodart) can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg).
Renal impairment: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Overdosage
In volunteer studies, single doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to patients for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg.
There is no specific antidote for dutasteride, therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate.
There is no specific antidote for dutasteride, therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate.
Administration
May be taken with or without food: Swallow whole, do not chew/open cap.
Contraindications
Dutasteride (Avodart) is contraindicated in patients with known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or any component of the preparation.
Dutasteride (Avodart) is contraindicated for use in women and children (see Use in Pregnancy and Lactation).
Dutasteride (Avodart) is contraindicated for use in women and children (see Use in Pregnancy and Lactation).
Special Precautions
Prostate cancer: In a 4-year study of over 8,000 men aged 50 to 75, with a prior negative biopsy for prostate cancer and baseline PSA between 2.5 ng/mL and 10.0 ng/mL (the REDUCE study), 1,517 men were diagnosed with prostate cancer. There was a higher incidence of Gleason 8-10 prostate cancers in the Dutasteride (Avodart) group (n=29, 0.9%) compared to the placebo group (n=19, 0.6%). There was no increased incidence in Gleason 5-6 or 7-10 prostate cancers. No causal relationship between Dutasteride (Avodart) and high grade prostate cancer has been established. The clinical significance of the numerical imbalance is unknown. Men taking Dutasteride (Avodart) should be regularly evaluated for prostate cancer risk including PSA testing.
In an additional 2-year follow-up study with the original patients from the dutasteride chemoprevention study (REDUCE), a low rate of new prostate cancers were diagnosed (dutasteride [n=14, 1.2%] and placebo [n=7, 0.7%]), with no new identified cases of Gleason 8-10 prostate cancers.
Long-term follow up (up to 18 years) of another 5-ARI (finasteride) in a chemoprevention study showed no statistically significant difference between finasteride and placebo in the rates of overall survival (HR 1.02, 95% CI 0.97-1.08) or survival after prostate cancer diagnoses (HR 1.01, 95% CI 0.85-1.20).
Prostate specific antigen (PSA): Serum prostate-specific antigen (PSA) concentration is an important component of the screening process to detect prostate cancer.
Dutasteride (Avodart) causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment. Patients receiving Dutasteride (Avodart) should have a new PSA baseline established after 6 months of treatment with Dutasteride (Avodart). It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA levels while on Dutasteride (Avodart) may signal the presence of prostate cancer or non-compliance to therapy with Dutasteride (Avodart) and should be carefully evaluated, even if those values are still within the normal range for men not taking a-ARI. In the interpretation of a PSA value for a patient taking Dutasteride (Avodart), previous PSA values should be sought for comparison.
Treatment with Dutasteride (Avodart) does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established.
Total serum PSA levels return to baseline within 6 months of discontinuing treatment.
The ratio of free to total PSA remains constant even under the influence of Dutasteride (Avodart). If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men undergoing Dutasteride (Avodart) therapy, no adjustment to its value is necessary.
Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients prior to initiating therapy with Dutasteride (Avodart) and periodically thereafter.
In an additional 2-year follow-up study with the original patients from the dutasteride chemoprevention study (REDUCE), a low rate of new prostate cancers were diagnosed (dutasteride [n=14, 1.2%] and placebo [n=7, 0.7%]), with no new identified cases of Gleason 8-10 prostate cancers.
Long-term follow up (up to 18 years) of another 5-ARI (finasteride) in a chemoprevention study showed no statistically significant difference between finasteride and placebo in the rates of overall survival (HR 1.02, 95% CI 0.97-1.08) or survival after prostate cancer diagnoses (HR 1.01, 95% CI 0.85-1.20).
Prostate specific antigen (PSA): Serum prostate-specific antigen (PSA) concentration is an important component of the screening process to detect prostate cancer.
Dutasteride (Avodart) causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment. Patients receiving Dutasteride (Avodart) should have a new PSA baseline established after 6 months of treatment with Dutasteride (Avodart). It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA levels while on Dutasteride (Avodart) may signal the presence of prostate cancer or non-compliance to therapy with Dutasteride (Avodart) and should be carefully evaluated, even if those values are still within the normal range for men not taking a-ARI. In the interpretation of a PSA value for a patient taking Dutasteride (Avodart), previous PSA values should be sought for comparison.
Treatment with Dutasteride (Avodart) does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established.
Total serum PSA levels return to baseline within 6 months of discontinuing treatment.
The ratio of free to total PSA remains constant even under the influence of Dutasteride (Avodart). If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men undergoing Dutasteride (Avodart) therapy, no adjustment to its value is necessary.
Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients prior to initiating therapy with Dutasteride (Avodart) and periodically thereafter.
Use In Pregnancy & Lactation
Fertility: The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n=27 dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), two subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient’s fertility is not known.
Use in Pregnancy: Dutasteride is contraindicated for use by women. Dutasteride has not been studied in women because pre-clinical data suggests that the suppression of circulating levels of dihydrotestosterone may inhibit the development of the external genital organs in a male foetus carried by a woman exposed to dutasteride.
Use in Lactation: It is not known whether dutasteride is excreted in breast milk.
Use in Pregnancy: Dutasteride is contraindicated for use by women. Dutasteride has not been studied in women because pre-clinical data suggests that the suppression of circulating levels of dihydrotestosterone may inhibit the development of the external genital organs in a male foetus carried by a woman exposed to dutasteride.
Use in Lactation: It is not known whether dutasteride is excreted in breast milk.
Adverse Reactions
Clinical Trial Data: Dutasteride (Avodart) Monotherapy for BPH: The following investigator-judged drug-related adverse events (with incidence ≥1%) have been reported more commonly in the 3 phase III placebo-controlled studies on Avodart treatment compared to placebo.
No change to the adverse event profile was apparent over a further 2 years in open-label extension studies.
Dutasteride (Avodart) and Tamsulosin Combination Therapy for BPH: The following investigator-judged drug-related adverse events (with a cumulative incidence of greater than or equal to 1%) have been reported in the COMBAT (Combination of Dutasteride (Avodart) and tamsulosin) Study, a comparison of Dutasteride (Avodart) 0.5 mg and tamsulosin 0.4 mg once daily for 4 years in combination or as monotherapy.
Dutasteride (Avodart) and Tamsulosin Combination Therapy for BPH: The following investigator-judged drug-related adverse events (with a cumulative incidence of greater than or equal to 1%) have been reported in the COMBAT (Combination of Dutasteride (Avodart) and tamsulosin) Study, a comparison of Dutasteride (Avodart) 0.5 mg and tamsulosin 0.4 mg once daily for 4 years in combination or as monotherapy.
Post-Marketing Data: Adverse drug reactions are listed as follows by system organ class and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including isolated reports. Frequency categories determined from post-marketing data refer to reporting rate rather than true frequency.
Immune system disorders: Very rare: Allergic reaction including rash, pruritus, urticaria, localized edema and angioedema.
Psychiatric disorders: Very rare: Depressed mood.
Skin and subcutaneous tissue disorders: Rare: Alopecia (primarily body hair loss), hypertrichosis.
Reproductive system and breast disorders: Very rare: Testicular pain and swelling.
Immune system disorders: Very rare: Allergic reaction including rash, pruritus, urticaria, localized edema and angioedema.
Psychiatric disorders: Very rare: Depressed mood.
Skin and subcutaneous tissue disorders: Rare: Alopecia (primarily body hair loss), hypertrichosis.
Reproductive system and breast disorders: Very rare: Testicular pain and swelling.
Drug Interactions
In vitro drug metabolism studies show that dutasteride is metabolised by human cytochrome P450 isoenzyme CYP3A4. Therefore blood concentrations of dutasteride may increase in the presence of inhibitors of CYP3A4.
Phase II data showed a decrease in clearance of dutasteride when co-administered with the CYP3A4 inhibitors verapamil (37%) and diltiazem (44%). In contrast no decrease in clearance was seen when amlodipine, another calcium channel antagonist, was co-administered with dutasteride. A decrease in clearance and subsequent increase in exposure to dutasteride, in the presence of CYP3A4 inhibitors, is unlikely to be clinically significant due to the wide margin of safety (up to 10-times the recommended dose has been given to patients for up to six months), therefore no dose adjustment is necessary.
In vitro, dutasteride is not metabolized by human cytochrome P450 isoenzymes CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19, CYP2B6 and CYP2D6.
Dutasteride neither inhibits human cytochrome P450 drug-metabolizing enzymes in vitro nor induces cytochrome P450 isoenzymes CYP1A, CYP2B, and CYP3A in rats and dogs in vivo.
In vitro studies demonstrate that dutasteride does not displace warfarin, diazepam, acenocoumorol, phenprocoumon, or phenytoin from plasma protein, nor do these model compounds displace dutasteride. Compounds that have been tested for drug interactions in man include tamsulosin, terazosin, warfarin, digoxin, and cholestyramine, and no clinically significant pharmacokinetic or pharmacodynamic interactions have been observed.
Although specific interaction studies were not performed with other compounds, approximately 90% of the subjects in large Phase III studies receiving dutasteride were taking other medications concomitantly. No clinically significant adverse interactions were observed in clinical trials when dutasteride was co-administered with anti-hyperlipidemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors, and quinolone antibiotics.
Phase II data showed a decrease in clearance of dutasteride when co-administered with the CYP3A4 inhibitors verapamil (37%) and diltiazem (44%). In contrast no decrease in clearance was seen when amlodipine, another calcium channel antagonist, was co-administered with dutasteride. A decrease in clearance and subsequent increase in exposure to dutasteride, in the presence of CYP3A4 inhibitors, is unlikely to be clinically significant due to the wide margin of safety (up to 10-times the recommended dose has been given to patients for up to six months), therefore no dose adjustment is necessary.
In vitro, dutasteride is not metabolized by human cytochrome P450 isoenzymes CYP1A2, CYP2A6, CYP2E1, CYP2C8, CYP2C9, CYP2C19, CYP2B6 and CYP2D6.
Dutasteride neither inhibits human cytochrome P450 drug-metabolizing enzymes in vitro nor induces cytochrome P450 isoenzymes CYP1A, CYP2B, and CYP3A in rats and dogs in vivo.
In vitro studies demonstrate that dutasteride does not displace warfarin, diazepam, acenocoumorol, phenprocoumon, or phenytoin from plasma protein, nor do these model compounds displace dutasteride. Compounds that have been tested for drug interactions in man include tamsulosin, terazosin, warfarin, digoxin, and cholestyramine, and no clinically significant pharmacokinetic or pharmacodynamic interactions have been observed.
Although specific interaction studies were not performed with other compounds, approximately 90% of the subjects in large Phase III studies receiving dutasteride were taking other medications concomitantly. No clinically significant adverse interactions were observed in clinical trials when dutasteride was co-administered with anti-hyperlipidemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors, and quinolone antibiotics.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Dutasteride is a dual inhibitor of 5 alpha-reductase. It inhibits both type 1 and type 2, 5α-reductase isoenzymes, which are responsible for the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperplasia of glandular prostatic tissue.
Effects on DHT/Testosterone: The maximum effect of daily doses of Dutasteride (Avodart) on the reduction on DHT is dose-dependent and is observed within 1 to 2 weeks. After 1 week and 2 weeks of daily dosing of Dutasteride (Avodart) 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively.
In BPH patients treated with 0.5 mg dutasteride daily, the median decrease in DHT was 94% at 1 year and 93% at 2 years and the median increase in serum testosterone was 19% at both 1 and 2 years. This is an expected consequence of 5 alpha-reductase inhibition and did not result in any known adverse events.
Clinical Studies: Dutasteride (Avodart) monotherapy for BPH: Dutasteride 0.5 mg/day or placebo was evaluated in 4325 male subjects with enlarged prostates (greater than 30 cc) in three primary efficacy 2-year multicenter, placebo-controlled, double-blind studies.
In men with BPH, Dutasteride (Avodart) treats and prevents disease progression by reducing the risk of both acute urinary retention (AUR) and the need for surgical intervention (SI) and by providing statistically significant improvement of lower urinary tract symptoms (LUTS), maximum urinary flow rate (Qmax) and prostate volume relative to placebo. These improvements in LUTS, Qmax and prostate volume were seen through to 24 months, and LUTS and Qmax continued to improved for a further 2 years in open-label extension studies. In addition, reductions in prostate volume were sustained for a further 2 years in open-label extension studies.
Dutasteride (Avodart) and tamsulosin combination therapy for BPH: Dutasteride (Avodart) 0.5 mg/day, tamsulosin 0.4mg/day or the combination of Dutasteride (Avodart) 0.5mg plus tamsulosin 0.4mg was evaluated in 4844 male subjects with enlarged prostates (greater than or equal to 30cc) in a multicenter, double blind, parallel group study over 4 years. The primary efficacy endpoint at 2 years of treatment was the level of improvement from baseline in the international prostate symptom score (IPSS).
After 2 years of treatment, combination therapy showed a statistically significant adjusted mean improvement in symptom scores from baseline of -6.2 units. The adjusted mean improvements in symptom scores observed with the individual therapies were -4.9 units for Dutasteride (Avodart) and -4.3 units for tamsulosin. The adjusted mean improvement in flow rate from baseline was 2.4 ml/sec for the combination, 1.9 ml/sec for Dutasteride (Avodart) and 0.9 ml/sec for tamsulosin. The adjusted mean improvement in BPH Impact Index (BII) from baseline was -2.1 units for the combination, -1.7 for Dutasteride (Avodart®) and -1.5 for tamsulosin.
The reduction in total prostate volume and transition zone volume after 2 years of treatment was statistically significant for combination therapy compared to tamsulosin monotherapy alone.
Effects on DHT/Testosterone: The maximum effect of daily doses of Dutasteride (Avodart) on the reduction on DHT is dose-dependent and is observed within 1 to 2 weeks. After 1 week and 2 weeks of daily dosing of Dutasteride (Avodart) 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively.
In BPH patients treated with 0.5 mg dutasteride daily, the median decrease in DHT was 94% at 1 year and 93% at 2 years and the median increase in serum testosterone was 19% at both 1 and 2 years. This is an expected consequence of 5 alpha-reductase inhibition and did not result in any known adverse events.
Clinical Studies: Dutasteride (Avodart) monotherapy for BPH: Dutasteride 0.5 mg/day or placebo was evaluated in 4325 male subjects with enlarged prostates (greater than 30 cc) in three primary efficacy 2-year multicenter, placebo-controlled, double-blind studies.
In men with BPH, Dutasteride (Avodart) treats and prevents disease progression by reducing the risk of both acute urinary retention (AUR) and the need for surgical intervention (SI) and by providing statistically significant improvement of lower urinary tract symptoms (LUTS), maximum urinary flow rate (Qmax) and prostate volume relative to placebo. These improvements in LUTS, Qmax and prostate volume were seen through to 24 months, and LUTS and Qmax continued to improved for a further 2 years in open-label extension studies. In addition, reductions in prostate volume were sustained for a further 2 years in open-label extension studies.
Dutasteride (Avodart) and tamsulosin combination therapy for BPH: Dutasteride (Avodart) 0.5 mg/day, tamsulosin 0.4mg/day or the combination of Dutasteride (Avodart) 0.5mg plus tamsulosin 0.4mg was evaluated in 4844 male subjects with enlarged prostates (greater than or equal to 30cc) in a multicenter, double blind, parallel group study over 4 years. The primary efficacy endpoint at 2 years of treatment was the level of improvement from baseline in the international prostate symptom score (IPSS).
After 2 years of treatment, combination therapy showed a statistically significant adjusted mean improvement in symptom scores from baseline of -6.2 units. The adjusted mean improvements in symptom scores observed with the individual therapies were -4.9 units for Dutasteride (Avodart) and -4.3 units for tamsulosin. The adjusted mean improvement in flow rate from baseline was 2.4 ml/sec for the combination, 1.9 ml/sec for Dutasteride (Avodart) and 0.9 ml/sec for tamsulosin. The adjusted mean improvement in BPH Impact Index (BII) from baseline was -2.1 units for the combination, -1.7 for Dutasteride (Avodart®) and -1.5 for tamsulosin.
The reduction in total prostate volume and transition zone volume after 2 years of treatment was statistically significant for combination therapy compared to tamsulosin monotherapy alone.
MedsGo Class
Drugs for Bladder & Prostate Disorders
Features
Brand
Avodart
Full Details
Dosage Strength
500 mcg
Drug Ingredients
- Dutasteride
Drug Packaging
SoftGel Capsule 1's
Generic Name
Dutasteride
Dosage Form
Softgel Capsule
Registration Number
DR-XY29399
Drug Classification
Prescription Drug (RX)
View all variations as list
| CODE | Dosage Strength | Drug Packaging | Availability | Price | ||
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RXDRUG-DR-XY29399-1pc
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In stock
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₱5700 |
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