Tamfil-S

The main glucocorticoid secreted by the adrenal cortex. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

Each tablet contains Tamsulosin (Tamfil-S) HCl 400 mcg equivalent to Tamsulosin (Tamfil-S) 367 mcg.

Tamsulosin (Tamfil-S) HCl, an α₁-adrenoceptor blocking agent, has a high affinity for the α_1A-receptor subtype predominantly present in the human prostate.

Tamsulosin (Tamfil-S) HCl is (R)-5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. The molecular weight is 444.98.

Tamsulosin (Tamfil-S) also contains the following excipients: Macrogol 7,000,000 and 8000, magnesium stearate, butylated hydroxytoluene, anhydrous colloidal silica, hypromellose and yellow iron oxide. None of these is derived from animal sources.

Tamsulosin (Tamfil-S) HCl is sparingly soluble in water (1:85) and slightly soluble in alcohol. It is stable in an acid environment.

Deflazacort (Tamfil-S) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

Tamsulosin (Tamfil-S) (Tamsulosin (Tamfil-S) hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin (Tamfil-S) capsules are not indicated for the treatment of hypertension.

Deflazacort (Tamfil-S) is a steroid that reduces inflammation in the body.

Deflazacort (Tamfil-S) is used to treat Duchenne muscular dystrophy in adults and children who are at least 5 years old.

Deflazacort (Tamfil-S) is not a cure for muscular dystrophy, but this medicine may improve muscle strength and slow the progression of disability.

Deflazacort (Tamfil-S) may also be used for purposes not listed in this medication guide.

Tamsulosin (Tamfil-S) is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.

Tamsulosin (Tamfil-S) helps relax the muscles in the prostate and the opening of the bladder. This may help increase the flow of urine or decrease the symptoms. However, Tamsulosin (Tamfil-S) will not shrink the prostate. The prostate may continue to get larger. This may cause the symptoms to become worse over time. Therefore, even though Tamsulosin (Tamfil-S) may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future.

Tamsulosin (Tamfil-S) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Tamsulosin (Tamfil-S) is used in certain patients with the following medical conditions:

• Ureteric stone (a kidney stone that has moved down into the ureter).

2.1 Dosing Information

The recommended oral dosage of Deflazacort (Tamfil-S) is approximately 0.9 mg/kg/day once daily. If tablets are used, round up to the nearest possible dose. Any combination of the four Deflazacort (Tamfil-S) tablet strengths can be used to achieve this dose. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL).

2.2 Discontinuation

Dosage of Deflazacort (Tamfil-S) must be decreased gradually if the drug has been administered for more than a few days.

2.3 Important Preparation and Administration Instructions

Deflazacort (Tamfil-S) Tablets and

Oral Suspension can be taken with or without food.

Deflazacort (Tamfil-S) Tablets

Deflazacort (Tamfil-S) Tablets can be administered whole or crushed and taken immediately after mixing with applesauce.

Deflazacort (Tamfil-S)

Oral Suspension

Shake Deflazacort (Tamfil-S)

Oral Suspension well before administration.

Use only the oral dispenser provided with the product. After withdrawing the appropriate dose into the oral dispenser, slowly add the Deflazacort (Tamfil-S)

Oral Suspension into 3 to 4 ounces of juice or milk and mix well. The dose should then be administered immediately. Do not administer Deflazacort (Tamfil-S) with grapefruit juice.

Discard any unused Deflazacort (Tamfil-S)

Oral Suspension remaining after 1 month of first opening the bottle.

2.4 Dosage Modification for Use with CYP3A4 Inhibitors and Inducers

CYP3A4 Inhibitors

Give one third of the recommended dosage when Deflazacort (Tamfil-S) is administered with moderate or strong CYP3A4 inhibitors. For example, a 36 mg per day dose would be reduced to a 12 mg per day dose when used with moderate or strong CYP3A4 inhibitors.

CYP3A4 Inducers

Avoid use with moderate or strong CYP3A4 inducers with Deflazacort (Tamfil-S).

Tamsulosin (Tamfil-S) capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin (Tamfil-S) capsules should not be crushed, chewed or opened.

For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of Tamsulosin (Tamfil-S) capsules can be increased to 0.8 mg once daily. Tamsulosin (Tamfil-S) capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole).

If Tamsulosin (Tamfil-S) capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

How supplied

Dosage Forms And Strengths

Capsule: 0.4 mg, olive green and orange hard gelatin, imprinted on one side with Tamsulosin (Tamfil-S) 0.4 mg and on the other side with BI 58

Storage And Handling

Tamsulosin (Tamfil-S) capsules 0.4 mg are supplied in high density polyethylene bottles containing 100 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with Tamsulosin (Tamfil-S) 0.4 mg and on the other side with BI 58.

Tamsulosin (Tamfil-S) capsules 0.4 mg, 100 capsules (NDC 0597-0058-01)

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F).

Keep Tamsulosin (Tamfil-S) capsules and all medicines out of reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Rev: January 2016

See also:
What is the most important information I should know about Deflazacort (Tamfil-S)?

Deflazacort (Tamfil-S) is contraindicated in patients with known hypersensitivity to Deflazacort (Tamfil-S) or to any of the inactive ingredients. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy.

See also:
What is the most important information I should know about Tamsulosin (Tamfil-S)?

You should not use this medication if you are allergic to Tamsulosin (Tamfil-S). Do not take Tamsulosin (Tamfil-S) with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

Tamsulosin (Tamfil-S) may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

If you stop taking Tamsulosin (Tamfil-S) for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin (Tamfil-S) can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using Tamsulosin (Tamfil-S) before surgery unless your surgeon tells you to.

There are many other drugs that can interact with Tamsulosin (Tamfil-S). Tell your doctor about all medications you use.

Use Tamsulosin (Tamfil-S) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Tamsulosin (Tamfil-S). Talk to your pharmacist if you have questions about this information.
• Take Tamsulosin (Tamfil-S) by mouth 30 minutes after eating the same meal each day.
• Swallow Tamsulosin (Tamfil-S) whole. Do not break, crush, chew, or open capsules before swallowing.
• If you miss a dose of Tamsulosin (Tamfil-S), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking Tamsulosin (Tamfil-S) for several days, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Tamsulosin (Tamfil-S).

Deflazacort (Tamfil-S) is used to treat various types of inflammations including asthma, arthritis and allergies, problems of the digestive system, skin, eyes, kidney, heart or blood. It is also used to suppress immune response (to prevent rejections in organ transplants) and in various tumors.

Tamsulosin (Tamfil-S) is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night).

Tamsulosin (Tamfil-S) belongs to a class of drugs known as alpha blockers.

Do not use this medication to treat high blood pressure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Tamsulosin (Tamfil-S) may also be used to help your body "pass," or get rid of, kidney stones through urination. It has also been used to help treat bladder problems in women.

How to use Tamsulosin (Tamfil-S)

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily, 30 minutes after the same meal each day. Swallow this medication whole. Do not crush, chew, or open the capsules.

The dosage is based on your medical condition and response to treatment.

Tamsulosin (Tamfil-S) may cause a sudden drop in your blood pressure, which could lead to dizziness or fainting. This risk is higher when you first start taking this drug, after your doctor increases your dose, or if you restart treatment after you stop taking it. During these times, avoid situations where you may be injured if you faint.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you have not taken this drug for several days, contact your doctor to see if you need to be restarted at a lower dose.

It may take up to 4 weeks before your symptoms improve. Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Deflazacort (Tamfil-S)?

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification

Axicabtagene Ciloleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. Consider therapy modification

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Monitor therapy

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

CYP3A4 Inducers (Moderate): May decrease serum concentrations of the active metabolite(s) of Deflazacort (Tamfil-S). Avoid combination

CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Deflazacort (Tamfil-S). Avoid combination

CYP3A4 Inhibitors (Moderate): May increase serum concentrations of the active metabolite(s) of Deflazacort (Tamfil-S). Management: Administer one third of the recommended Deflazacort (Tamfil-S) dose when used together with a strong or moderate CYP3A4 inhibitor. Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Deflazacort (Tamfil-S). Management: Administer one third of the recommended Deflazacort (Tamfil-S) dose when used together with a strong or moderate CYP3A4 inhibitor. Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Fexinidazole [INT]: Corticosteroids (Systemic) may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Management: Decrease oral dexamethasone or methylprednisolone dose by 50% during coadministration with fosaprepitant/aprepitant. Reduce intravenous methylprednisolone dose by 25% during coadministration with fosaprepitant/aprepitant. Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Grapefruit Juice: May increase the serum concentration of Deflazacort (Tamfil-S). Avoid combination

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Avoid combination

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Monitor therapy

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Somatropin: Corticosteroids (Systemic) may diminish the therapeutic effect of Somatropin. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tisagenlecleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome). Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Deflazacort (Tamfil-S) may enhance the adverse/toxic effect of Vaccines (Live). Deflazacort (Tamfil-S) may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating Deflazacort (Tamfil-S). Live vaccines should be administered at least 4 to 6 weeks prior to initiating Deflazacort (Tamfil-S). Inactivated vaccines may be administered concurrently. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Corticosteroids (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

See also:
What other drugs will affect Tamsulosin (Tamfil-S)?

Cytochrome P450 Inhibition

Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6

Tamsulosin (Tamfil-S) is extensively metabolized, mainly by CYP3A4 and CYP2D6.

Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in an increase in the Cmax and AUC of Tamsulosin (Tamfil-S) by a factor of 2.2 and 2.8, respectively. The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of Tamsulosin (Tamfil-S) have not been evaluated.

Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in an increase in the Cmax and AUC of Tamsulosin (Tamfil-S) by a factor of 1.3 and 1.6, respectively. A similar increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in Tamsulosin (Tamfil-S) exposure exists when Tamsulosin (Tamfil-S) 0.4 mg is co-administered with strong CYP3A4 inhibitors in CYP2D6 PMs, Tamsulosin (Tamfil-S) 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole).

The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of Tamsulosin (Tamfil-S) have not been evaluated.

The effects of co-administration of both a CYP3A4 and a CYP2D6 inhibitor with Tamsulosin (Tamfil-S) capsules have not been evaluated. However, there is a potential for significant increase in Tamsulosin (Tamfil-S) exposure when Tamsulosin (Tamfil-S) 0.4 mg is co-administered with a combination of both CYP3A4 and CYP2D6 inhibitors.

Cimetidine

Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of Tamsulosin (Tamfil-S) hydrochloride, which resulted in a moderate increase in Tamsulosin (Tamfil-S) hydrochloride AUC (44%).

Other Alpha Adrenergic Blocking Agents

The pharmacokinetic and pharmacodynamic interactions between Tamsulosin (Tamfil-S) capsules and other alpha adrenergic blocking agents have not been determined; however, interactions between Tamsulosin (Tamfil-S) capsules and other alpha adrenergic blocking agents may be expected.

PDE5 Inhibitors

Caution is advised when alpha adrenergic blocking agents including Tamsulosin (Tamfil-S) are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.

Warfarin

A definitive drug-drug interaction study between Tamsulosin (Tamfil-S) hydrochloride and warfarin was not conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin (Tamfil-S) capsules.

Nifedipine, Atenolol, Enalapril

Dosage adjustments are not necessary when Tamsulosin (Tamfil-S) capsules are administered concomitantly with nifedipine, atenolol, or enalapril.

Digoxin And Theophylline

Dosage adjustments are not necessary when a Tamsulosin (Tamfil-S) capsule is administered concomitantly with digoxin or theophylline.

Furosemide

Tamsulosin (Tamfil-S) capsules had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in Tamsulosin (Tamfil-S) hydrochloride Cmax and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the Tamsulosin (Tamfil-S) capsules dosage.

See also:
What are the possible side effects of Deflazacort (Tamfil-S)?

The following serious adverse reactions are discussed in more detail in other sections:

• Alterations in Endocrine Function

• Immunosuppression and Increased Risk of Infection

• Alterations in Cardiovascular/Renal Function

• Gastrointestinal Perforation

• Behavioral and Mood Disturbances

• Effects on Bones

• Ophthalmic Effects

• Vaccination

• Serious Skin Rashes

• Effects on Growth and Development

• Myopathy

• Kaposi’s Sarcoma

• Risk of Serious Adverse Reactions in Infants because of Benzyl Alcohol Preservative

• Thromboembolic Events

• Anaphylaxis

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Study 1, the adverse reactions that were associated with Deflazacort (Tamfil-S) treatment discontinuation, in decreasing order of frequency, were weight increased, obesity, cataract, and sleep disorder.

Most Common Adverse Reactions in Clinical Studies

Table 1 lists the adverse reactions that occurred in ≥ 5% of patients in the 0.9 mg/kg/day Deflazacort (Tamfil-S)-treated group and that occurred more frequently than in placebo patients in Study 1, which included patients with DMD between the ages of 5 and 15 years.

1 At 12 weeks placebo patients were re-randomized to receive either Deflazacort (Tamfil-S) or an active comparator.

Common adverse reactions (≥ 5% of Deflazacort (Tamfil-S)-treated patients) that occurred over 52 weeks of exposure to Deflazacort (Tamfil-S) 0.9 mg/kg/day in Study 1 and at a higher rate than Deflazacort (Tamfil-S) 0.9 mg/kg/day in the 12-week placebo-controlled phase of the trial include Cushingoid appearance (60%), hirsutism (35%), weight increased (28%), erythema (28%), central obesity (25%), abdominal pain/abdominal pain upper (18% combined), pollakiuria (15%), constipation (10%), irritability (10%), abnormal behavior (9%), pyrexia (9%), back pain (7%), rash (7%), contusion (6%), nausea (6%), psychomotor hyperactivity (6%), epistaxis (6%), and skin striae (6%).

Study 1 also evaluated a higher dosage of Deflazacort (Tamfil-S) (1.2 mg/kg/day). Compared with the 0.9 mg/kg/day dosage, Deflazacort (Tamfil-S) 1.2 mg/kg/day over 52 weeks was associated with a higher incidence of certain adverse reactions, including Cushingoid appearance (69%), erythema (49%), hirsutism (37%), headache (34%), weight increased (32%), constipation (15%), abdominal pain upper (14%), skin striae (11%), acne (11%), and abdominal discomfort (8%). As there was no additional benefit with the 1.2 mg/kg/day dose of Deflazacort (Tamfil-S), use of Deflazacort (Tamfil-S) 1.2 mg/kg/day is not recommended for the treatment of DMD.

In an additional clinical study of two years duration with extended follow-up (Study 2), many of the same adverse reactions were observed. In addition, musculoskeletal events associated with long-term steroid use were also observed, including muscle weakness, tendon disorder, and osteopenia.

Less Common Adverse Reactions Observed in Clinical Studies

Other adverse reactions (≥ 1% frequency in any Deflazacort (Tamfil-S) treatment group and greater than placebo) that were observed during the 12-week placebo-controlled phase of Study 1 are shown below.

Eye Disorders: Lacrimation increased

Gastrointestinal Disorders: Dyspepsia, nausea, gastrointestinal disorder

General Disorders and Administration Site Conditions: Thirst

Infections: Hordeolum, impetigo, influenza, otitis externa, pharyngitis, tooth abscess, urinary tract infection, viral infection

Injury, Poisoning and Procedural Complications: Back injury, contusion, face injury, fibula fracture, greenstick fracture, heat exhaustion

Investigations: Glucose urine present, heart rate irregular

Musculoskeletal and Connective Tissue Disorders: Back pain, muscle spasms, myalgia, neck mass, neck pain, pain in extremity

Nervous System Disorders: Dizziness, psychomotor hyperactivity

Psychiatric Disorders: Affect lability, aggression, depression, emotional disorder, middle insomnia, mood altered, mood swings, sleep disorder

Renal and Urinary Disorders: Chromaturia, dysuria, hypertonic bladder

Reproductive System and Breast Disorders: Testicular pain

Respiratory, Thoracic, and Mediastinal Disorders: Hypoventilation, rhinorrhea

Skin and Subcutaneous Tissue Disorders: Acne, alopecia, dermatitis acneiform

Vascular Disorders: Hot flush

6.2 Postmarketing Experience

The following adverse reactions have been reported during post-approval use of Deflazacort (Tamfil-S) worldwide or during post-approval use of other corticosteroids. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Leukocytosis

Cardiac Disorder: Heart failure

Eye Disorders: Chorioretinopathy, corneal or scleral thinning

Gastrointestinal Disorders: Acute pancreatitis (especially in children), hemorrhage, peptic ulceration, perforation of peptic ulcer

General Disorders and Administration Site Conditions: Edema, impaired healing

Immune System Disorders: Hypersensitivity including anaphylaxis

Metabolism and Nutrition Disorders: Impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, negative protein and calcium balance, potassium loss and hypokalemic alkalosis when co-administered with beta 2-agonist and xanthines

Musculoskeletal and Connective Tissue Disorders: Avascular necrosis, muscle wasting, negative nitrogen balance, tendonitis and tendon rupture when co-administered with quinolones, vertebral and long bone fractures

Nervous System Disorders: Aggravation of epilepsy, increased intra-cranial pressure with papilledema in children (pseudotumor cerebri) usually after treatment withdrawal, vertigo

Psychiatric Disorders: Anxiety, cognitive dysfunction including confusion and amnesia, delusions, hallucinations, mania, suicidal thoughts

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis

Vascular Disorders: Thromboembolism, in particular in patients with underlying conditions associated with increased thrombotic tendency, benign intracranial hypertension

See also:
What are the possible side effects of Tamsulosin (Tamfil-S)?

The incidence of treatment-emergent adverse events has been ascertained from 6 short-term U.S. and European placebo-controlled clinical trials in which daily doses of Tamsulosin (Tamfil-S) hydrochloride 0.1-0.8 mg were used. These studies evaluated safety in 1783 patients treated with Tamsulosin (Tamfil-S) hydrochloride and 798 patients administered placebo. Table 2 below summarizes the treatment emergent adverse events that occurred in ≥2% of patients receiving either Tamsulosin (Tamfil-S) hydrochloride 0.4-, or 0.8-mg, and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials conducted in 1487 men.

Table: Treatment Emergent Adverse Events Occurring In ≥2% Of Tamsulosin (Tamfil-S) hydrochloride Or Placebo Patients in 2 U.S. Short-Term Placebo Controlled Clinical Studies.

The following adverse reactions have been reported during the use of Tamsulosin (Tamfil-S) hydrochloride: Dizziness, abnormal ejaculation and less frequently (1-2%) headache, asthenia, postural hypotension, palpitations and rhinitis.

Gastrointestinal reactions eg, nausea, vomiting, diarrhea and constipation can occasionally occur. Hypersensitivity reactions eg, rash, pruritus and urticaria can occur occasionally. As with other α-blockers, drowsiness, blurred vision, dry mouth or oedema can occur. Syncope has been reported rarely, and there have been very rare reports of angioedema and priaprism.

During cataract surgery a small pupil situation, known as IFIS, has been associated with therapy of Tamsulosin (Tamfil-S) hydrochloride during post-marketing surveillance.

Signs and Symptoms of Orthostasis: In the 2 U.S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group and by no patients in the placebo group. Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group and 0.6% of patients (3 of 493) in the placebo group. Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group and 10% of patients (50 of 493) in the placebo group. Vertigo was reported by 0.6% of patients (3 of 502) in the 0.4 mg group, 1% of patients (5 of 492) in the 0.8 mg group and by 0.6% of patients (3 of 493) in the placebo group.

Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met ≥1 of the following criteria: (1) a decrease in systolic blood pressure of ≥20 mmHg upon standing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure ≥10 mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test; (3) an increase in pulse rate of ≥20 bpm upon standing with a standing pulse rate ≥100 bpm during the orthostatic test and (4) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo or postural hypotension) upon standing during the orthostatic test.

Following the 1st dose of double-blind medication, a positive orthostatic test result at 4 hrs post-dose was observed in 7% of patients (37 of 498) who received Tamsulosin (Tamfil-S) hydrochloride 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. At 8 hrs post-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received Tamsulosin (Tamfil-S) hydrochloride 0.4 mg once daily and 4% (9 of 250) who received placebo.

At least 1 positive orthostatic test result was observed during the course of the studies for 81 of the 502 patients (16%) in the Tamsulosin (Tamfil-S) hydrochloride 0.4 mg once daily group, 92 of the 491 patients (19%) in the Tamsulosin (Tamfil-S) hydrochloride 0.8 mg once daily group and 54 of the 493 patients (11%) in the placebo group.

Because orthostasis was detected more frequently in Tamsulosin (Tamfil-S) hydrochloride treated patients than in placebo recipients, there is a potential risk of syncope.

Abnormal Ejaculation: Includes ejaculation failure and ejaculation disorder, retrograde and decrease ejaculation. As shown in Table 2, abnormal ejaculation was associated with Tamsulosin (Tamfil-S) hydrochloride administration and was dose-related.

Withdrawal from these clinical studies of Tamsulosin (Tamfil-S) hydrochloride because of abnormal ejaculation was also dose-dependent with 8 of 492 patients (1.6%) in the 0.8 mg group, and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation.

Post-Marketing Experience: Allergic-type reactions eg, skin rash, pruritus, angioedema of tongue, lips and face and urticaria have been reported with positive rechallenge in some cases.

Priapism has been reported rarely. Infrequent reports of palpitations, constipation and vomiting have been received during the post-marketing period.

During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with α-₁-blocker therapy.