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RAPAFLO

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Overview

What is RAPAFLO?

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 109°C. 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.



What does RAPAFLO look like?



What are the available doses of RAPAFLO?

Capsules: 8 mg and 4 mg. ()

What should I talk to my health care provider before I take RAPAFLO?

How should I use RAPAFLO?

RAPAFLO, a selective 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.

The recommended dose is 8 mg orally once daily with a meal.

Patients who have difficulty swallowing pills and capsules may carefully open the RAPAFLO capsule and sprinkle the powder inside on a tablespoonful of applesauce.  The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder.  The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use.  Subdividing the contents of a RAPAFLO capsule is not recommended [ ].


What interacts with RAPAFLO?

Sorry No Records found


What are the warnings of RAPAFLO?

Sorry No Records found


What are the precautions of RAPAFLO?

Sorry No Records found


What are the side effects of RAPAFLO?

Sorry No records found


What should I look out for while using RAPAFLO?

Patients with severe renal impairment [Creatinine Clearance (CCr
Patients with severe hepatic impairment (Child-Pugh score > 10). ()

Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). ()

Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO. ()


What might happen if I take too much RAPAFLO?

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.


How should I store and handle RAPAFLO?

White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.White, opaque, hard gelatin 8 mg capsules. Bottles of 30 and 90 capsules are supplied with child-resistant closures.White, opaque, hard gelatin 4 mg capsules. Bottles of 30 capsules are supplied with child-resistant closures.StorageStore at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.Keep out of reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
Patients with severe renal impairment [Creatinine Clearance (CCr
Patients with severe hepatic impairment (Child-Pugh score > 10). ()

Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). ()

Patients with a history of hypersensitivity to silodosin or any of the ingredients of RAPAFLO. ()

CYP2D6 Inhibitors

Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Oral Solution is achieved [see ].

After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the active metabolite morphine plasma concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression [see ].

If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Acetaminophen and Codeine Phosphate Oral Solution and monitor patients closely at frequent intervals.

If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider increasing the Acetaminophen and Codeine Phosphate Oral Solution as needed.

After stopping use of a CYP2D6 inhibitor, consider reducing the Acetaminophen and Codeine Phosphate Oral Solution and monitor the patient for signs and symptoms of respiratory depression or sedation.

CYP3A4 Inhibitors

The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations, with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Oral Solution is achieved [see ].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine.

If concomitant use of CYP3A4 inhibitor is necessary, consider dosage reduction of Acetaminophen and Codeine Phosphate Oral Solution until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the Acetaminophen and Codeine Phosphate Oral Solution dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

CYP3A4 Inducers

The concomitant use of Acetaminophen and Codeine Phosphate Oral Solution and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence [see ].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase, with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the Acetaminophen and Codeine Phosphate Oral Solution dosage as needed.

If a CYP3A4 inducer is discontinued, consider a Acetaminophen and Codeine Phosphate Oral Solution dosage reduction and monitor for signs of respiratory depression and sedation at frequent intervals.

Benzodiazepines and Other Central Nervous System (CNS) Depressants

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see].

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see ].If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Acetaminophen and Codeine Phosphate Oral Solution if serotonin syndrome is suspected.

Monoamine Oxidase Inhibitors (MAOIs)

The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity.

Advise patients taking Acetaminophen and Codeine Phosphate Oral Solution not to use MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Acetaminophen and Codeine Phosphate Oral Solution and/or precipitate withdrawal symptoms.

Advise patient to avoid concomitant use of these drugs.

Muscle Relaxants

Acetaminophen and Codeine Phosphate Oral Solution may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Acetaminophen and Codeine Phosphate Oral Solution and/or the muscle relaxant as necessary.

Diuretics

Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Acetaminophen and Codeine Phosphate Oral Solution is used concomitantly with anticholinergic drugs.

Postural hypotension, with or without symptoms (e.g., dizziness) may develop when beginning RAPAFLO treatment. As with other alpha-blockers, there is potential for syncope. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy [   and  )].

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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