Silodosin (Rapaflo)

Trade Name : RAPAFLO

Allergan, Inc.

CAPSULE

Strength 8 mg/1

SILODOSIN Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Silodosin (Rapaflo) which is also known as RAPAFLO and Manufactured by Allergan, Inc.. It is available in strength of 8 mg/1 per ml. Read more

Silodosin (Rapaflo) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [n n ]RAPAFLO is not indicated for the treatment of hypertension.
  • RAPAFLO, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO is not indicated for the treatment of hypertension. ()u00a0
  • No data
  • 8 mg capsules taken orally once daily with a meal. ()n
  • 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30-50 mL/min]. ()
  • The 8 mg capsules are white, opaque, hard #1 gelatin capsules imprinted with u201cWATSON 152u201d in green on the cap and u201c8 mgu201d in green on the body.
  • The 4 mg capsules are white, opaque, hard #3 gelatin capsules imprinted with u201cWATSON 151u201d in gold on the cap and u201c4 mgu201d in gold on the body.
  • Capsules: 8 mg and 4 mg. ()
  • No data
  • Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)]. ()n
  • Patients with severe hepatic impairment (Child-Pugh score > 10). ()n
  • Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). ()n
  • Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO. ()
  • No data
  • Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning RAPAFLO treatment. ()n
  • In patients with moderate renal impairment, RAPAFLO dose should be reduced to 4 mg once daily. ()n
  • RAPAFLO should not be used in combination with other alpha-blockers. ()n
  • Examine patients thought to have BPH prior to starting therapy with RAPAFLO to rule out the presence of carcinoma of the prostate. ()n
  • Inform patients planning cataract surgery to notify their ophthalmologist that they are taking RAPAFLO because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS). ()
  • Most common adverse reactions (incidence > 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. ()
  • No data
  • Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. ()n
  • Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. ()n
  • Concomitant use of PDE5 inhibitors with alpha-blockers includingu00a0RAPAFLO can potentially cause symptomatic hypotension.u00a0()u00a0 ()u00a0
  • No data
  • Renal impairment: Dose adjustment in moderate disease (). Contraindicated in severe renal disease. ()n
  • Hepatic impairment: Contraindicated in severe disease. ()
  • RAPAFLO was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension.
  • Should overdose of RAPAFLO lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be used, and renal function should be monitored and supported as needed. Dialysis is unlikely to be of significant benefit since silodosin is highly (97%) protein bound.
  • RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1-indole-7-carboxamide and the molecular formula is CHFNO with a molecular weight of 495.53. The structural formula of silodosin is:
  • Silodosin is a white to pale yellowish white powder that melts at approximately 105 to 109u00b0C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water.
  • Each RAPAFLO 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing FD&C Blue No. 1 Aluminum Lake and yellow iron oxide.
  • Each RAPAFLO 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: D-mannitol, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing yellow iron oxide.
  • No data
  • In a 2-year oral carcinogenicity study in rats administered doses up to 150 mg/kg/day [about 8 times the exposure of the maximum recommended human dose (MRHE) based on AUC of silodosin], an increase in thyroid follicular cell tumor incidence was seen in male rats receiving doses of 150 mg/kg/day. Silodosin induced stimulation of thyroid stimulating hormone (TSH) secretion in the male rat as a result of increased metabolism and decreased circulating levels of thyroxine (T4). These changes are believed to produce specific morphological and functional changes in the rat thyroid including hypertrophy, hyperplasia, and neoplasia. Silodosin did not alter TSH or T4 levels in clinical trials and no effects based on thyroid examinations were noted. The relevance to human risk of these thyroid tumors in rats is not known.
  • In a 2-year oral carcinogenicity study in mice administered doses up to 100 mg/kg/day in males (about nine times the MRHE based on AUC of silodosin) and 400 mg/kg/day in females (about 72 times the MRHE based on AUC), there were no significant tumor findings in male mice. Female mice treated for 2 years with doses of 150 mg/kg/day (about 29 times the MRHE based on AUC) or greater had statistically significant increases in the incidence of mammary gland adenoacanthomas and adenocarcinomas. The increased incidence of mammary gland neoplasms in female mice was considered secondary to silodosin-induced hyperprolactinemia measured in the treated mice. Elevated prolactin levels were not observed in clinical trials. The relevance to human risk of prolactin-mediated endocrine tumors in mice is not known. Rats and mice do not produce glucuronidated silodosin, which is present in human serum at approximately four times the level of circulating silodosin and which has similar pharmacological activity to silodosin.
  • Silodosin produced no evidence of mutagenic or genotoxic potential in the Ames assay, mouse lymphoma assay, unscheduled DNA synthesis assay and the mouse micronucleus assay. A weakly positive response was obtained in two Chinese Hamster Lung (CHL) tests for chromosomal aberration assays at high, cytotoxic concentrations.
  • Treatment of male rats with silodosin for 15 days resulted in decreased fertility at the high dose of 20 mg/kg/day (about twice the MRHE) which was reversible following a two week recovery period. No effect was observed at 6 mg/kg/day. The clinical relevance of this finding is not known.
  • In a fertility study in female rats, the high dose of 20 mg/kg/day (about 1 to 4 times the MRHE) resulted in estrus cycle changes, but no effect on fertility. No effect on the estrus cycle was observed at 6 mg/kg/day.
  • In a male rat fertility study, sperm viability and count were significantly lower after administration of 600 mg/kg/day (about 65 times the MRHE) for one month. Histopathological examination of infertile males revealed changes in the testes and epididymides at 200 mg/kg/day (about 30 times the MRHE).
  • No data
  • White, opaque, hard gelatin 8 mg capsulesn- .
  • Bottles of 30 and 90 capsules are supplied with child-resistant closures.
  • White, opaque, hard gelatin 4 mg capsulesn- .
  • Bottles of 30 capsules are supplied with child-resistant closures.
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F). [See USP controlled room temperature.] Protect from light and moisture.
  • Keep out of reach of children.
  • Patients should be instructed to take RAPAFLO once daily with a meal.
  • Patients should be instructed about the possible occurrence of symptoms related to postural hypotension (such as dizziness), and should be cautioned about driving, operating machinery, or performing hazardous tasks until they know how RAPAFLO will affect them. This is especially important for those with low blood pressure or who are taking antihypertensive medications.
  • The most common side effect seen with RAPAFLO is an orgasm with reduced or no semen. This side effect does not pose a safety concern and is reversible with discontinuation of the product.
  • The patient should be instructed to tell his ophthalmologist about the use of RAPAFLO before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking RAPAFLO.n n n
  • For all medical inquiries contact:
  • Allergan USA, Inc. Irvine, CA 92612
  • 1-800-678-1605
  • Distributed by:Allergan USA, Inc.Irvine, CA 92612
  • Under license from:Kissei Pharmaceutical Co., Ltd.Nagano, Japan
  • Product of Japan
  • Manufactured by
  • Teva Dupnista, Bulgaria
  • u00a9 2017 Allergan. All rights reserved.
  • RAPAFLOu00ae and its design are registered trademarks of Allergan Sales, LLC.
  • Allerganu00ae and its design are trademarks of Allergan, Inc.
  • For additional information see:n n or call 1-866-RAPAFLO (727-2356)
  • Component Number 73346US10
  • Principal Display PanelNDC 0023-6142-30RAPAFLO8 mg per capsule30 CapsulesRx Only
  • Principal Display PanelNDC 0023-6147-30RAPAFLO4 mg per capsule30 CapsulesRx Only

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