What is Flomax used for. How should Flomax be taken. What are the potential side effects of Flomax. Is generic Flomax available. What should patients know about Flomax interactions and precautions.

Understanding Flomax: A Comprehensive Overview

Flomax, known generically as tamsulosin, is a widely prescribed medication primarily used to treat benign prostatic hyperplasia (BPH), also known as an enlarged prostate. This condition is common in older men and can cause urinary symptoms. Flomax belongs to a class of drugs called alpha-adrenoreceptor antagonists, which work by relaxing the muscles in the prostate and bladder neck, making it easier to urinate.

The FDA approved Flomax on April 15, 1997, with Sanofi as the original manufacturer. The standard dosage form is a 0.4 mg oral capsule. Since its initial approval, several generic versions have become available, offering patients more affordable options for treatment.

The Mechanism of Action: How Does Flomax Work?

Flomax’s effectiveness in treating BPH stems from its specific mechanism of action. But how exactly does it work?

• Flomax selectively blocks alpha-1 adrenergic receptors in the prostate and bladder neck
• This blockade leads to relaxation of smooth muscles in these areas
• Muscle relaxation reduces pressure on the urethra, facilitating urine flow
• The drug’s selectivity helps minimize side effects related to blood pressure changes

By targeting these specific receptors, Flomax can alleviate BPH symptoms without significantly affecting other body systems. This selective action contributes to its favorable side effect profile compared to some other BPH treatments.

Dosage and Administration: Getting the Most from Flomax

Proper dosage and administration are crucial for maximizing Flomax’s benefits while minimizing potential side effects. What are the recommended dosing guidelines for Flomax?

• The standard starting dose is 0.4 mg once daily
• Capsules should be taken approximately 30 minutes after the same meal each day
• If needed, the dose may be increased to 0.8 mg once daily after 2-4 weeks
• Capsules should be swallowed whole and not crushed or chewed

It’s important for patients to follow their healthcare provider’s instructions carefully. Some individuals may require dose adjustments based on their response to the medication or other health factors. Consistency in timing and relation to meals can help maintain steady drug levels in the body.

Side Effects and Precautions: What Patients Should Know

While Flomax is generally well-tolerated, like all medications, it can cause side effects in some individuals. What are the most common side effects of Flomax?

• Dizziness or lightheadedness, especially when standing up
• Headache
• Runny or stuffy nose
• Abnormal ejaculation or decreased semen
• Weakness or lack of energy

Most side effects are mild and often improve as the body adjusts to the medication. However, patients should be aware of potential serious side effects, including priapism (prolonged erection) and severe allergic reactions, which require immediate medical attention.

Precautions are also important when taking Flomax. Patients should inform their healthcare provider about all medications they’re taking, as Flomax can interact with certain drugs, particularly other alpha-blockers and some blood pressure medications. Additionally, Flomax may cause dizziness or affect vision, so caution is advised when driving or operating machinery, especially when first starting the medication.

Generic Availability: Expanding Access to Treatment

The availability of generic versions of Flomax has significantly increased access to this important medication. But when did generic versions become available, and who manufactures them?

Generic tamsulosin was first approved by the FDA on March 2, 2010. Since then, multiple manufacturers have received approval to produce generic versions of Flomax. Some of the approved manufacturers include:

• Impax Labs (March 2, 2010)
• Sandoz (April 27, 2010)
• Teva Pharmaceuticals (April 27, 2010)
• Sun Pharmaceutical Industries (July 15, 2010)
• Aurobindo Pharma (April 30, 2013)
• Alkem Labs (August 11, 2017)

All approved generic versions are considered bioequivalent to brand-name Flomax, meaning they have the same active ingredient, strength, dosage form, and route of administration. This equivalence allows patients to receive the same therapeutic benefits at potentially lower costs.

Drug Interactions: Navigating Potential Risks

Understanding potential drug interactions is crucial for patients taking Flomax. What are some important interactions to be aware of?

• Other alpha-blockers: Combining Flomax with other alpha-blockers can increase the risk of low blood pressure
• PDE5 inhibitors (e.g., sildenafil, tadalafil): These medications for erectile dysfunction can interact with Flomax, potentially causing a dangerous drop in blood pressure
• Strong CYP3A4 inhibitors: Drugs like ketoconazole can increase Flomax levels in the body, potentially leading to increased side effects
• Warfarin: Flomax may increase the effects of this blood thinner, requiring careful monitoring

Patients should always provide their healthcare provider with a complete list of medications, including over-the-counter drugs and supplements, to avoid potential interactions. In some cases, dose adjustments or alternative treatments may be necessary to manage these interactions safely.

Special Populations: Considerations for Unique Patient Groups

Certain patient groups may require special considerations when using Flomax. How does Flomax use differ for these populations?

Elderly Patients

Older adults may be more sensitive to the effects of Flomax, particularly dizziness and orthostatic hypotension (a sudden drop in blood pressure upon standing). Careful monitoring and possibly lower starting doses may be necessary.

Patients with Kidney or Liver Problems

Flomax is primarily metabolized in the liver and excreted through the kidneys. Patients with severe kidney or liver impairment may require dose adjustments or closer monitoring.

Women and Children

While Flomax is primarily used in men for BPH, it has been used off-label in women and children for certain urinary conditions. However, its safety and efficacy in these populations are not as well-established, and it should only be used under close medical supervision.

Patients Undergoing Eye Surgery

Flomax use has been associated with a condition called Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery. Patients should inform their eye surgeon if they are taking or have taken Flomax, as special surgical techniques may be necessary.

Long-Term Use and Monitoring: Ensuring Ongoing Safety and Efficacy

For many patients, Flomax is a long-term medication. What should patients and healthcare providers consider for prolonged use?

• Regular follow-up appointments to assess symptom improvement and monitor for side effects
• Periodic evaluations of prostate-specific antigen (PSA) levels to screen for prostate cancer
• Assessment of kidney function and liver enzymes, especially in older patients or those with pre-existing conditions
• Monitoring for changes in sexual function or urinary symptoms

Long-term use of Flomax is generally considered safe and effective for managing BPH symptoms. However, ongoing communication between patients and healthcare providers is essential to ensure the continued appropriateness of the treatment and to address any emerging concerns promptly.

In conclusion, Flomax (tamsulosin) remains an important medication in the management of benign prostatic hyperplasia. Its targeted mechanism of action, generally favorable side effect profile, and the availability of generic options make it a valuable treatment option for many men struggling with BPH symptoms. As with any medication, proper use, awareness of potential side effects and interactions, and regular monitoring are key to maximizing its benefits while minimizing risks. Patients should always consult with their healthcare provider for personalized advice and guidance on using Flomax as part of their BPH management strategy.

Generic Flomax Availability – Drugs.com

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Last updated on May 11, 2023.

Flomax is a brand name of tamsulosin, approved by the FDA in the following formulation(s):

FLOMAX (tamsulosin hydrochloride – capsule;oral)

• Manufacturer: SANOFI
  Approval date: April 15, 1997
  Strength(s): 0.4MG ^[RLD][AB]

Has a generic version of Flomax been approved?

Yes. The following products are equivalent to Flomax:

tamsulosin hydrochloride capsule;oral

• Manufacturer: ALKEM LABS LTD
  Approval date: August 11, 2017
  Strength(s): 0.4MG ^[AB]
• Manufacturer: ANBISON LAB
  Approval date: October 17, 2019
  Strength(s): 0.4MG ^[AB]
• Manufacturer: AUROBINDO PHARMA LTD
  Approval date: April 30, 2013
  Strength(s): 0.4MG ^[AB]
• Manufacturer: IMPAX LABS
  Approval date: March 2, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: MACLEODS PHARMS LTD
  Approval date: January 20, 2017
  Strength(s): 0. 4MG ^[AB]
• Manufacturer: SANDOZ
  Approval date: April 27, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: SUN PHARM INDS LTD
  Approval date: July 15, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: SYNTHON PHARMS
  Approval date: April 27, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: TEVA PHARMS
  Approval date: April 27, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: WOCKHARDT
  Approval date: April 27, 2010
  Strength(s): 0.4MG ^[AB]
• Manufacturer: ZYDUS PHARMS USA INC
  Approval date: April 27, 2010
  Strength(s): 0.4MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Flomax. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

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• Benign Prostatic Hyperplasia

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB	Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Flomax Interactions Checker – Drugs.com

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There are 286 drugs known to interact with
Flomax (tamsulosin), along with
4 disease interactions, and 2 alcohol/food interactions.

Of the total drug interactions,
32 are major, 250 are moderate, and 4 are minor.

Does Flomax interact with my other drugs?

Enter other medications to view a detailed report.

• View all 286 medications that may interact with Flomax
• View Flomax alcohol/food interactions (2)
• View Flomax disease interactions (4)

Most frequently checked interactions

View interaction reports for Flomax (tamsulosin) and the medicines listed below.

• Major
• Moderate
• Minor
• Unknown

• allopurinol
• amlodipine
• aspirin
• Aspirin Low Strength (aspirin)
• atorvastatin
• Crestor (rosuvastatin)
• Cymbalta (duloxetine)
• finasteride
• furosemide
• gabapentin
• hydrochlorothiazide
• Lasix (furosemide)
• levothyroxine
• Lipitor (atorvastatin)
• lisinopril
• losartan
• metformin
• metoprolol
• multivitamin
• omeprazole
• Plavix (clopidogrel)
• prednisone
• simvastatin
• Synthroid (levothyroxine)
• tramadol
• trazodone
• Tylenol (acetaminophen)
• Vitamin B12 (cyanocobalamin)
• Vitamin C (ascorbic acid)
• Vitamin D3 (cholecalciferol)

Flomax alcohol/food interactions

There are 2 alcohol/food interactions with Flomax (tamsulosin).

Flomax disease interactions

There are 4 disease interactions with Flomax (tamsulosin) which include:

• glaucoma
• hypotension
• end-stage renal disease
• severe liver disease

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More about Flomax (tamsulosin)

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• Support group
• Drug class: alpha-adrenoreceptor antagonists
• Breastfeeding
• En español

Related treatment guides

• Benign Prostatic Hyperplasia

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Omnik: instruction, price, analogues | modified release hard capsules Astellas Pharma Europe

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• Pharmacological properties
• Indications Omnic
• Application Omnic
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

pharmacodynamics. Omnic selectively and competitively blocks postsynaptic α ₁ -adrenergic receptors, in particular α _1A and α _1D located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostate part of the urethra and an improvement in the outflow of urine. At the same time, it reduces the severity of symptoms of obstruction and irritation caused by benign prostatic hyperplasia (difficulty starting urination, weakening the urine stream, dripping after urination, a feeling of incomplete emptying of the bladder, frequent urge to urinate, urge to urinate at night, imperative urge to urinate) .

These effects are long-lasting with long-term treatment and greatly discourage surgery or catheterization.

Antagonists α ₁ -adrenergic receptors have the ability to reduce blood pressure by reducing peripheral vascular tone. When conducting studies of the drug Omnic, there was no clinically significant decrease in blood pressure.

Pharmacokinetics. Absorption : Tamsulosin is well absorbed from the gastrointestinal tract, and its bioavailability is almost 100%. Absorption of tamsulosin occurs somewhat more slowly after a meal. Homogeneity of absorption is achieved when the patient uses Omnic at the same time after a meal. The pharmacokinetics of tamsulosin is linear.

After taking a single dose of the drug Omnic after meals C _max tamsulosin in blood plasma is reached after about 6 hours, and a stable concentration – on the 5th day after daily administration of the drug. C _max is approximately ⅔ higher than that achieved after taking a single dose.

Distribution: in men, tamsulosin is approximately 99% bound to plasma proteins. The volume of distribution of the drug is insignificant (about 0.2 l / kg).

Metabolism: tamsulosin hydrochloride is not subject to the first pass effect and is slowly metabolized in the liver to form pharmacologically active metabolites that retain high selectivity for α ₁ -adrenergic receptors. Most of the active substance is present in the blood unchanged.

Elimination: tamsulosin and its metabolites are excreted primarily in the urine. About 9% of the dose remains in the form of unchanged active substance.

After a single dose of the drug Omnic after meals and at a stable plasma concentration T _½ is approximately 10 and 13 hours, respectively.

treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia.

The recommended dose for adults is 1 capsule per day after breakfast daily or after the first meal. The capsule should be swallowed whole and not broken or chewed as this will prevent the modified release of the active ingredient.

Dose adjustment is not required in patients with renal insufficiency. Dose adjustment is not required in patients with moderate to moderate hepatic impairment (see CONTRAINDICATIONS).

hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema, or to any of the excipients; a history of orthostatic hypotension; severe liver failure.

*Noted in the post-registration period.

There have been post-marketing reports of intraoperative iris instability (constricted pupil syndrome) during cataract and glaucoma surgery in patients treated with tamsulosin (see SPECIAL INSTRUCTIONS).

Post-marketing experience : in addition to the above adverse reactions, cases of atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported. Since these reports were spontaneous in nature, their frequency and the role of tamsulosin cannot be reliably established.

As with other α ₁ -adrenergic blockers, in some cases, when using Omnic, a decrease in blood pressure is possible, which can sometimes lead to loss of consciousness. When the first signs of orthostatic hypotension (dizziness, weakness) appear, the patient should take a horizontal position until the above symptoms disappear.

Before starting treatment with Omnic, a medical examination should be performed to look for other comorbid conditions that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment, a rectal examination of the prostate gland and, if necessary, a prostate specific antigen (PSA) test should be performed before and at regular intervals during treatment.

Prescribe the drug to patients with severe renal insufficiency (creatinine clearance <10 ml / min) with extreme caution, since clinical studies with the use of the drug Omnic in such patients have not been conducted.

Some patients who have taken or are taking tamsulosin have experienced atonic pupil syndrome (a variant of constricted pupil syndrome) during cataract and glaucoma surgery, which may increase the number of complications during such surgery.

It is generally recommended to stop tamsulosin treatment 1-2 weeks before cataract and glaucoma surgery. However, the feasibility and timing of discontinuation of tamsulosin treatment has not yet been clearly established. Atonic pupil syndrome has also been reported in patients who discontinued tamsulosin for a long time prior to cataract surgery.

Initiation of tamsulosin hydrochloride is not recommended in patients prior to elective cataract or glaucoma surgery. In preparation for surgery, surgeons and ophthalmologists should be informed whether the patient has taken (or is taking) tamsulosin in order to prevent possible complications associated with atonic pupil syndrome.

Tamsulosin hydrochloride should not be used in combination with strong CYP3A4 inhibitors in patients with low CYP2D6 metabolism.

Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP 3A4 (see Interactions).

Allergic reactions to tamsulosin have been reported in patients with a history of allergy to sulfonamides. Caution should be exercised when using tamsulosin hydrochloride in patients who have previously been allergic to sulfonamides.

Use during pregnancy and lactation. The drug is used only for the treatment of men.

Fertility. During clinical studies of tamsulosin, ejaculatory disorders have been noted for a short and long time. Cases of impaired ejaculation, retrograde ejaculation and insufficient ejaculation were recorded in the post-registration period.

Children. The drug is not used in children.

Ability to influence reaction rate when driving vehicles or working with other mechanisms . Studies of the effect of the drug on the ability to drive vehicles or operate other mechanisms have not been conducted. However, patients should be warned about the possibility of dizziness.

Interaction studies have been conducted in adults only.

Co-administration of tamsulosin hydrochloride with atenolol, enalapril or theophylline did not result in drug interactions. Simultaneous use with cimetidine increases, and with furosemide – reduces the concentration of tamsulosin in the blood plasma, but since these levels remain within the normal range, there is no need for a special dose adjustment of tamsulosin.

In vitro studies diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin does not alter the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinone in human plasma.

However, diclofenac and warfarin may increase the elimination rate of tamsulosin.

Concomitant use of tamsulosin hydrochloride with strong inhibitors of CYP 3A4 may increase the effect of tamsulosin hydrochloride. Simultaneous use with ketoconazole (a known potent inhibitor of CYP 3A4) led to an increase in AUC and an increase in C _max to 2.8 and 2.2 respectively.

Tamsulosin hydrochloride should not be used in combination with strong CYP3A4 inhibitors in patients with low CYP2D6 metabolism.

The drug should be used with caution in combination with strong and moderate inhibitors of CYP 3A4.

Simultaneous use of tamsulosin hydrochloride and paroxetine (a powerful inhibitor of CYP 2D6) leads to an increase in C _max and an increase in AUC to 1.3 and 1.6, respectively, but this is not clinically significant.

Simultaneous use with other blockers α ₁ -adrenergic receptors may enhance the hypotensive effect.

symptoms . An overdose of tamsulosin can potentially cause a severe hypotensive effect. Severe hypotensive effect was noted at various degrees of overdose.

Treatment . In the event of a sharp decrease in blood pressure due to an overdose, maintenance therapy should be carried out aimed at restoring the normal function of the cardiovascular system (for example, the patient should take a horizontal position). If this measure does not work, it is necessary to carry out infusion therapy and prescribe vasopressors. Renal function should be monitored and general supportive therapy administered. Due to the high degree of binding of tamsulosin to plasma proteins, hemodialysis is hardly advisable.