Tamsulosin (Lexi-Drugs)

Pronunciation

(tam SOO loe sin)

Brand Names: US

Flomax

Brand Names: Canada

APO-Tamsulosin CR; Flomax CR; MYLAN-Tamsulosin [DSC]; RATIO-Tamsulosin; SANDOZ Tamsulosin; SANDOZ Tamsulosin CR; TEVA-Tamsulosin; TEVA-Tamsulosin CR

Pharmacologic Category

Alpha 1 Blocker

Dosing: Adult

Note: Tamsulosin capsules should be administered ~30 minutes following the same meal each day. The controlled-release (oral controlled absorption system [OCAS]) tablet formulation [Canadian product] should be administered at the same time each day with or without food.

Benign prostatic hyperplasia (BPH): Oral:

Capsule: Initial and Maintenance: 0.4 mg once daily. If response is inadequate after 2 to 4 weeks, may increase to 0.8 mg once daily. If therapy is discontinued or interrupted for several days, restart with 0.4 mg once daily.

Controlled-release tablet [Canadian product]: Initial and maximum dose: 0.4 mg once daily

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in males (off-label use): Oral: Initial: 0.4 mg once daily in combination with antibiotic treatment; antibiotic is given for initial 6 weeks (Pontari 2018). If response to initial therapy is inadequate, referral to a urologist is recommended (Anothaisintawee 2011; Nickel 2012; Pontari 2018).

Lower urinary tract symptoms (LUTS) in males (off-label use): Bladder outlet obstruction (BOO) and low postvoid residual (PVR): Oral: Initial: 0.4 mg once daily; may combine with an anticholinergic agent if symptoms of overactive bladder persist (Athanasopoulos 2003; Dimitropoulos 2015; Drake 2015; Van Kerrebroeck 2013).

Ureteral calculi expulsion (off-label use):

Medical expulsive therapy (MET) for distal (lower) ureteral calculi to facilitate spontaneous stone passage: Stones ≤10 mm: Oral: 0.4 mg once daily until stone passage occurs or for up to 30 days (Ahmed 2010; Campschroer 2014; Hollingsworth 2006; Pickard 2015).

Adjunctive therapy following shock wave lithotripsy to facilitate clearance of residual stones: Oral: 0.4 mg once daily; initiate therapy immediately after extracorporeal shock wave lithotripsy; duration of therapy in trials ranged from 14 days to 3 months (Agrawal 2009; Chen 2015; Falahatkar 2011; Vicentini 2011).

Ureteral stent-related urinary symptoms, treatment (off-label use): Oral: 0.4 mg once daily; treatment was initiated following stent placement and duration of therapy in trials ranged from 1 to 6 weeks (Damiano 2008; Wang 2009a; Wang 2009b; Yakoubi 2011); may also be given in combination with an anticholinergic agent (Dellis 2017).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥10 mL/minute: No dosage adjustment necessary.

CrCl <10 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

Mild-to-moderate impairment: No dosage adjustment is necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Pediatric

Nephrolithiasis, distal stones: Limited data available; optimal dose not established (Mokhless 2012; Tasian 2014):

Children 2 to 4 years: Oral: 0.2 or 0.4 mg once daily at bedtime

Children >4 years and Adolescents: Oral: 0.4 mg once daily at bedtime

Dosing based on two studies. The larger was a multi-institutional retrospective cohort study of pediatric patients with stones up to 10 mm; patients received either tamsulosin 0.4 mg once daily (n=99, median age: 14.8 years) or analgesics alone (n=175). Spontaneous stone passage was higher in the treatment group (55% vs 44%, p=0.03); treatment group was older and had smaller, more distal stones. When adjusted for stone size and location as part of analysis of 99 case matched pairs, success was also higher in the treatment group (OR 3.31, 95% CI: 1.49 to 7.34) (Tasian 2014). The smaller study was a prospective, randomized controlled trial of pediatric patients with stones up to 12 mm; patients received either tamsulosin 0.4 mg once daily (0.2 mg if ≤4 years old) (n=33, age: 2 to 15 years) or placebo (n=28). In this study, 45% of the treatment group had previously received either extracorporeal shock wave lithotripsy (ESWL) or percutaneous nephrolithotomy, but none in the control group had received these therapies; however, stone size at the start of treatment was similar between groups. Treatment resulted in higher expulsion rate (87.8% vs 64.2%, p<0.01), less days to expulsion (mean: 8.2 vs 14.5 days, p<0.001), less pain episodes (mean: 1.4 vs 2.2, p<0.02) and less need for analgesia (mean: 0.7 vs 1.4, p<0.02) (Mokhless 2012). In both studies, tamsulosin was well tolerated and there were no reported adverse effects.

Primary bladder neck dysfunction: Limited data available: Children ≥3 years and Adolescents: Oral: Initial dose: 0.2 mg once daily, increase by 0.2 mg increments based on response (symptoms and urodynamic studies) and tolerability. Mean effective dose: 0.4 mg daily; maximum reported daily dose: 0.8 mg/day. Dosing based on two trials evaluating treatment with alpha blockers, including over 50 pediatric patients who received tamsulosin. Treatment resulted in improved urine flow rates and decreased post-void residual urine volume; values returned to pretreatment levels when therapy was discontinued. Tamsulosin was well tolerated with no major adverse effects and benefits continued for at least 3 years (Donohoe 2005; Van Batavia 2010).

Dosing: Renal Impairment: Pediatric

There are no pediatric-specific recommendations. Based on experience in adult male patients with CrCl ≥10 mL/minute, data suggest no adjustment needed; for more severe renal impairment, use has not been studied.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations. Based on experience in adult male patients with mild to moderate hepatic impairment, data suggest no adjustment needed; for more severe hepatic impairment, use has not been studied.

Use: Labeled Indications

Benign prostatic hyperplasia: Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Limitations of use: Not indicated for the treatment of hypertension.

Use: Off-Label: Adult

  Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in malesLevel of Evidence [C]

Data from a meta-analysis and clinical experience suggests the utility of tamsulosin, in combination with antibiotics, for improvement in symptoms (eg, pain, urinary symptoms) associated with CP/CPPS Ref.

  Lower urinary tract symptoms (LUTS) in malesLevel of Evidence [B]

Data from a prospective, randomized, controlled study in males with lower urinary tract symptoms suggestive of bladder outlet obstruction (BOO) and concomitant detrusor instability receiving tamsulosin in combination with an anticholinergic agent showed an improvement in quality of life Ref.

  Ureteral calculi expulsionLevel of Evidence [A, G]

Use of alpha-1 blockers, including tamsulosin, for treating ureteral calculi is recommended by US and European guidelines and is supported by data from meta-analyses as well as numerous controlled trials. Tamsulosin has been shown to be effective in facilitating expulsion of ureteral stones (less than 10 mm) as medical therapy alone or as an adjunct to shock wave lithotripsy and ureteroscopy. Some trials indicate a class effect of alpha-1 adrenergic blockers, with tamsulosin reported to be equally effective as terazosin, doxazosin, and alfuzosin. Access Full Off-Label Monograph

  Ureteral stent-related urinary symptoms, treatmentLevel of Evidence [B]

Data from prospective, randomized trials and a meta-analysis support the use of tamsulosin for improvement in stent-related urinary symptoms and quality of life in patients undergoing ureteral stent placement Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Administration: Oral

Administer capsules 30 minutes after the same mealtime each day. Capsules should be swallowed whole; do not crush, chew, or open. The controlled-release tablet [Canadian product] should be administered at the same time each day with or without food, and should be swallowed whole.

Administration: Pediatric

Oral: Per the manufacturer, capsules should be swallowed whole; do not crush, chew, or open. In pediatric trials, capsules were opened and the contents mixed with food (eg, yogurt or pudding) or juice (Donohoe 2005; Tasian 2014).

Storage/Stability

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, sexual dysfunction, back pain, diarrhea, rhinorrhea, or loss of strength and energy. Have patient report immediately to prescriber severe dizziness, passing out, chills, pharyngitis, or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  International issues:
Contraindications

Hypersensitivity (eg, angioedema, rash, urticaria, pruritus, respiratory symptoms) to tamsulosin or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with strong CYP3A4 inhibitors (including ketoconazole)

Warnings/Precautions

Concerns related to adverse effects:

• Angina: Discontinue if symptoms of angina occur or worsen.

• Floppy iris syndrome: Intraoperative floppy iris syndrome (IFIS) is characterized by a combination of flaccid iris that billows with intraoperative currents, progressive intraoperative miosis despite dilation, and potential iris prolapse. IFIS has been observed in cataract and glaucoma surgery patients who were on or were previously treated with alpha1-blockers, particularly with tamsulosin use (Abdel-Aziz 2009); in some cases, patients had discontinued the alpha1-blocker 5 weeks to 9 months prior to the surgery. The benefit of discontinuing alpha-blocker therapy prior to cataract or glaucoma surgery has not been established. IFIS may increase the risk of ocular complications during and after surgery. May require modifications to surgical technique; instruct patients to inform ophthalmologist of current or previous alpha1-blocker use when considering eye surgery. Initiation of tamsulosin therapy in patients with planned cataract or glaucoma surgery is not recommended.

• Orthostatic hypotension/syncope: May cause significant orthostatic hypotension and syncope, especially with first dose; anticipate a similar effect if therapy is interrupted for a few days, if dosage is rapidly increased, or if another antihypertensive drug (particularly vasodilators) or a PDE-5 inhibitor (eg, sildenafil, tadalafil, vardenafil) is introduced. “First-dose” orthostatic hypotension may occur 4 to 8 hours after dosing; may be dose related. Patients should be cautioned about performing hazardous tasks, driving, or operating heavy machinery when starting new therapy or adjusting dosage upward.

• Priapism: Priapism has been associated with use (rarely).

• Sulfonamide allergy: Rarely, patients with a sulfa allergy have also developed an allergic reaction to tamsulosin; avoid use when previous reaction has been severe or life-threatening.

Disease-related concerns:

• Heart failure: In a scientific statement from the American Heart Association, tamsulosin has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]).

• Prostate cancer: It is recommended to rule out prostatic carcinoma with screening before beginning therapy and then screen at regular intervals.

Concurrent drug therapy issues:

• Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Limitation of use: Not intended for use as an antihypertensive drug.

Geriatric Considerations

Metabolism of tamsulosin may be slower, and older patients may be more sensitive to the orthostatic hypotension caused by this medication. A 40% higher exposure (AUC) is anticipated in patients between 55 and 75 years of age as compared to younger subjects (20-32 years).

Warnings: Additional Pediatric Considerations

Tamsulosin has been well tolerated in pediatric patients during trials when used for management of nephrolithiasis and primary bladder neck dysfunction (Donohoe 2005; Mokhless 2012; Tasian 2014; Van Batavia 2010). Studies using tamsulosin for the management of elevated detrusor leak point pressure in pediatric patients (ages 2 to 16 years) with a known neurological disorder (eg, spina bifida) failed to show efficacy. In two pooled trials, adverse events occurring in ≥5% of patients included urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation.

Pregnancy Considerations

Information related to the use of tamsulosin for treating ureteral calculi in pregnancy is limited (Bailey 2016). Other treatments such as stents or ureteroscopy, are currently recommended if stone removal is needed (Assimos 2016; Lloyd 2016).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Cardiovascular: Orthostatic hypotension (first dose: 6% to 19%; symptomatic orthostatic hypotension (chronic therapy) <1%)

Central nervous system: Headache (19% to 21%), dizziness (15% to 17%)

Genitourinary: Ejaculation failure (8% to 18%)

Infection: Infection (9% to 11%)

Respiratory: Rhinitis (13% to 18%)

1% to 10%:

Central nervous system: Drowsiness (3% to 4%), insomnia (1% to 2%), vertigo (≤1%)

Endocrine & metabolic: Loss of libido (2%)

Gastrointestinal: Diarrhea (6%), nausea (4%)

Neuromuscular & skeletal: Weakness (8% to 9%), back pain (7% to 8%)

Ophthalmic: Blurred vision (≤2%)

Respiratory: Pharyngitis (6%), cough (3% to 5%), sinusitis (4%)

<1%, postmarketing, and/or case reports: Constipation, decreased visual acuity, epistaxis, erythema multiforme, exfoliation of skin, exfoliative dermatitis, hypersensitivity reaction, hypotension, intraoperative floppy iris syndrome, palpitations, priapism, syncope, vomiting, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Alpha-/Beta-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation.Risk C: Monitor therapy

Alpha1-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Risk X: Avoid combination

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).Risk C: Monitor therapy

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

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta-Blockers: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

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

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

Calcium Channel Blockers: Alpha1-Blockers may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

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

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

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

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

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tamsulosin. Risk X: Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. Risk C: Monitor therapy

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

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

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

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

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

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

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

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

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

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

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

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

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

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

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

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: Alpha1-Blockers (Uroselective) may enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Rilmenidine: Alpha1-Blockers may enhance the hypotensive effect of Rilmenidine. Risk C: Monitor therapy

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

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

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

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

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

Food Interactions

Capsules: Fasting increases bioavailability by 30% and peak concentration 40% to 70%. Management: Administer 30 minutes after the same meal each day.Note: The controlled-release tablet formulation [Canadian product] is not affected by food and can be taken with or without food at the same time each day.

Monitoring Parameters

Blood pressure; urinary symptoms

Advanced Practitioners Physical Assessment/Monitoring

Not for use as an antihypertensive. Obtain thorough medication list to make sure patient is not taking similar medications. Assess potential for interactions with pharmacological agents that may increase risk of hypotension. Monitor for improved urine flow. Monitor for “first dose” orthostatic hypotension, headache, or gastrointestinal disturbance (nausea, vomiting) at beginning of therapy and on a regular basis.

Nursing Physical Assessment/Monitoring

Assess blood pressure and monitor for hypotension, dizziness, somnolence, and impotence at beginning of therapy and on a regular basis.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Flomax: 0.4 mg [contains fd&c blue #2 (indigotine)]

Generic: 0.4 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral:

Generic: 0.4 mg

Tablet Extended Release 24 Hour, Oral:

Flomax CR: 0.4 mg [contains FD&C BLUE #2 (INDIGOTINE), POLYSORBATE 80]

Generic: 0.4 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • G04CA02
Generic Available (US)

Yes

Pricing: US

Capsules (Flomax Oral)

0.4 mg (per each): $9.30

Capsules (Tamsulosin HCl Oral)

0.4 mg (per each): $0.47 – $4.22

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Tamsulosin is an antagonist of alpha1A-adrenoreceptors in the prostate. Smooth muscle tone in the prostate is mediated by alpha1A-adrenoreceptors; blocking them leads to relaxation of smooth muscle in the bladder neck and prostate causing an improvement of urine flow and decreased symptoms of BPH. Approximately 75% of the alpha1-receptors in the prostate are of the alpha1A subtype.

Pharmacodynamics/Kinetics

Note: Pharmacokinetics in pediatric patients (ages 2 to 16 years) were found to be similar to adult values (Tsuda 2010).

Absorption: >90%

Distribution: Vd: 16 L

Protein binding: 94% to 99%, primarily to alpha-1 acid glycoprotein (AAG)

Metabolism: Hepatic (extensive) via CYP3A4 and 2D6; metabolites undergo extensive conjugation to glucuronide or sulfate

Bioavailability: Fasting: 30% increase

Steady-state: By the fifth day of once-daily dosing

Half-life elimination: Healthy volunteers: 9 to 13 hours; Target population: 14 to 15 hours

Time to peak: Fasting: 4 to 5 hours; With food: 6 to 7 hours

Excretion: Urine (76%, <10% as unchanged drug); feces (21%)

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: AUC is 40% higher in subjects 55 to 75 years of age compared with subjects 20 to 32 years of age.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Rare occurrence of xerostomia; normal salivary flow resumes upon discontinuation; infrequent occurrence of pharyngitis. Patients may experience orthostatic hypotension as they stand up after treatment; especially if lying in dental chair for extended periods of time. Use caution with sudden changes in position during and after dental treatment.

Effects on Bleeding

No information available to require special precautions

Index Terms

Tamsulosin HCl; Tamsulosin Hydrochloride

FDA Approval Date
April 15, 1997
References

Abdel-Aziz S, Mamalis N. Intraoperative floppy iris syndrome. Curr Opin Ophthalmol. 2009 Jan;20(1):37-41.[PubMed 19077827]

Agrawal M, Gupta M, Gupta A, Agrawal A, Sarkari A, Lavania P. Prospective randomized trial comparing efficacy of alfuzosin and tamsulosin in management of lower ureteral stones. Urology. 2009;73(4):706-709.[PubMed 19193417]

Ahmed AF, Al-Sayed AY. Tamsulosin versus alfuzosin in the treatment of patients with distal ureteral stones: prospective, randomized, comparative study. Korean J Urol. 2010;51(3):193-197.[PubMed 20414396]

Anothaisintawee T, Attia J, Nickel JC, et al. Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA. 2011;305(1):78-86.[PubMed 21205969]

Assimos D, Krambeck A, Miller NL, et al. Surgical management of stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016;196(4):1153-1160. doi: 10.1016/j.juro.2016.05.090.[PubMed 27238616]

Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003;169(6):2253-2256.[PubMed 12771763]

Bailey G, Vaughan L, Rose C, et al. Perinatal outcomes with tamsulosin therapy for symptomatic urolithiasis. J Urol. 2016;195(1):99-103. doi: 10.1016/j.juro.2015.06.097.[PubMed 26144335]

Campschroer T, Zhu Y, Duijvesz D, Grobbee DE, Lock MT. Alpha-blockers as medical expulsive therapy for ureteral stones. Cochrane Database Syst Rev. 2014;(4):CD008509.[PubMed 24691989]

Chang DF and Campbell JR, “Intraoperative Floppy Iris Syndrome Associated With Tamsulosin,” J Cataract Refract Surg, 2005, 31(4):664-73.[PubMed 15899440]

Chen K, Mi H, Xu G, et al. The efficacy and safety of tamsulosin combined with extracorporeal shockwave lithotripsy for urolithiasis: a systematic review and meta-analysis of randomized controlled trials. J Endourol. 2015;29(10):1166-1176.[PubMed 25915454]

Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D’Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008;22(4):651-656.[PubMed 18338955]

Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, solifenacin, and their combination for the treatment of stent-related symptoms: a randomized controlled study. J Endourol. 2017;31(1):100-109.[PubMed 27809592]

Dimitropoulos K, Gravas S. Solifenacin/tamsulosin fixed-dose combination therapy to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia. Drug Des Devel Ther. 2015;9:1707-1716.[PubMed 25834406]

Drake MJ, Chapple C, Sokol R, et al.; NEPTUNE Study Group. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. Eur Urol. 2015;67(2):262-270.[PubMed 25070148]

Falahatkar S, Khosropanah I, Vajary AD, Bateni ZH, Khosropanah D, Allahkhah A. Is there a role for tamsulosin after shock wave lithotripsy in the treatment of renal and ureteral calculi? J Endourol. 2011;25(3):495-498.[PubMed 21166579]

Flomax (tamsulosin) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; December 2018.

Flomax CR (tamsulosin) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; February 2014.

Hollingsworth JM, Rogers MA, Kaufman SR, et al. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet. 2006;368(9542):1171-1179.[PubMed 17011944]

Lloyd GL, Lim A, Hamoui N, et al. The use of medical expulsive therapy during pregnancy: a worldwide perspective among experts. J Endourol. 2016;30(3):354-358. doi: 10.1089/end.2015.0587.[PubMed 26482104]

Nickel JC, Touma N. α-Blockers for the treatment of chronic prostatitis/chronic pelvic pain syndrome: an update on current clinical evidence. Rev Urol. 2012;14(3-4):56-64.[PubMed 23526487]

Page RL 2nd, O’Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association [published correction appears in Circulation. 2016;134(12):e261]. Circulation. 2016;134(6):e32-e69.[PubMed 27400984]

Pickard R, Starr K, MacLennan G, et al. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial. Lancet. 2015;386(9991):341-349.[PubMed 25998582]

Pontari, M. Chronic prostatitis and chronic pelvic pain syndrome. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 22, 2018.

Rossi C, Kortmann BB, Sonke GS, et al, “Alpha-Blockade Improves Symptoms Suggestive of Bladder Outlet Obstruction But Fails to Relieve It,” J Urol, 2001, 165(1):38-41.[PubMed 11125359]

Tsuda Y, Tatami S, Yamamura N, et al. Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. Br J Clin Pharmacol. 2010;70(1):88-101.[PubMed 20642551]

Van Kerrebroeck P, Haab F, Angulo JC, et al. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013;64(3):398-407.[PubMed 23537687]

Vicentini FC, Mazzucchi E, Brito AH, Chedid Neto EA, Danilovic A, Srougi M. Adjuvant tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for renal stones: a double blind, randomized, placebo-controlled trial. Urology. 2011;78(5):1016-1021.[PubMed 21802124]

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Brand Names: International

Adenorm (UA); Alna (AT, DE); Bazetham (HR); Bestflo (LK); Comadex (EC); Contiflo OD (QA, ZW); Curepro XR (EG); Eziflo (BD); Flectone XL (GB); Flomax (BB, NZ, TR); Flomaxtra (AU, NZ); Flomaxtra XL (GB); Flosin (LV, UA); Flosure (LK); Fokusin (LV, RO); Harnal (CN, HK, JP); Harnal D (ID, PH); Harnal OCAS (HK, ID, MY, PH, SG, TH, VN); Harnalidge D (TW); Harusin SR (KR); Inreq (ES); Josir (FR); Kirnom (IE); Libert (CR, DO, GT, HN, NI, PA, SV); Losiprost (EG); Lostam (EC); Lutsnal (KR); Maxflow (LK); Maxrin (LK); Mecir LP (FR); Mingo (LB); Omexel LP (FR); Omic (BE, LU); Omix Ocas (CH); Omnexel (IE); Omnic (AE, AR, BH, BR, CL, CO, CZ, DE, DK, EE, EG, ES, FI, GR, HR, HU, IL, IS, IT, JO, KW, LT, MT, NL, NO, PE, PL, PT, QA, RO, RU, SA, SI, SK, UA); Omnic OCAS (CY, EG, IL, KW, LB, QA, SA); Omnic Tocas (BG); Omsal (LV); Petyme (GB); Pimax (PH); Pinexel PR (MT); Promnix (IL); Prosta-Tab PR (BH); Prozelax (PH); Ranomax (BE); Sasolin (BD); Sebrane (ES); Secotex (AR, BR, CL, CO, CR, DO, GT, HN, MX, NI, PA, PE, PY, SV, UY, VE); Secotex OCAS (CR, DO, EC, GT, HN, NI, PA, SV); Sulosin (KR); Sultam (PH); Tabphyn MR (GB); Talusin (LB); Tamic (EG); Tamlosin (TW); Tamlosin SR (KR); Tamnexyl (IE); Tamodof (VN); Tamsin (LK); Tamsnal SR (KR); Tamsol (BD); Tamsu (IE); Tamsulid (UA); Tamsulin (IL, KW); Tamsulo (KR); Tamsulon (CR, DO, EC, GT, HN, NI, PA, SV); Tamsustad (VN); Tamunal (KR); Tarunal (KR); Urimax (IN); Urnal (TW); Uroflo (BD); Uroflow (TH); Urostad (LV); Urotams SR (KR); Xalgetz (VN); Zotan (TW); Zuantrip (ES)

Tamsulosin (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(tam SOO loe sin)

Brand Names: US

Flomax

Brand Names: Canada

Flomax CR

What is this drug used for?
  • In men, it is used to treat the signs of an enlarged prostate.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to tamsulosin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this drug.
  • If you are taking or will be taking another drug like this one.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • If you are having cataract surgery or other eye procedure, talk with your doctor.
  • Have your blood pressure checked often. Talk with your doctor.
  • If taking for an enlarged prostate, have a rectal exam (to check prostate gland) and blood work (PSA test) as you have been told by the doctor.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • This drug is not approved for use in women. If you are a woman using this drug, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
  • Children:
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Fever or chills.
  • Sore throat.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Back pain.
  • Diarrhea.
  • Dizziness.
  • Runny nose.
  • Throat irritation.
  • Feeling tired or weak.
  • Orgasm with less or no semen.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take 30 minutes after the same meal every day.
  • Swallow whole. Do not chew, break, or crush.
  • Do not open the capsules.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you miss taking this drug for a few days in a row, call your doctor before you start taking it again.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Tamsulosin (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(tam SOO loe sin)

Brand Names: US

Flomax

Brand Names: Canada

Flomax CR

What is this drug used for?
  • It is used to treat kidney stones.
  • It is used to treat certain bladder problems.
  • It may be given to your child for other reasons. Talk with the doctor.
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug.
  • If your child is taking or will be taking another drug like this one.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • If your child is having cataract surgery, talk with the doctor.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
  • If your child is pregnant or breast-feeding a baby:
  • This drug is not approved for use in females. If your child is a female using this drug, talk with the doctor if your child is pregnant, plans on getting pregnant, or is breast-feeding.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Fever or chills.
  • Sore throat.
  • Call your child’s doctor right away if your child gets a painful erection (hard penis) or gets an erection that lasts for longer than 4 hours. If this is not treated right away, it may lead to lasting sex problems and your child may not be able to have sex in the future.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Back pain.
  • Diarrhea.
  • Dizziness.
  • Runny nose.
  • Throat irritation.
  • Feeling tired or weak.
  • If your child is or may be sexually active:
  • Orgasm with less or no semen.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug at the same time of day.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Do not open the capsules.
  • Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • If you miss giving this drug to your child for a few days in a row, call the doctor before you start giving it again.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.