Tamlocept Uses

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What is Tamlocept?

Tamlocept 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.

Tamlocept 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, Tamlocept 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 Tamlocept may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future.

Tamlocept 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, Tamlocept is used in certain patients with the following medical conditions:

Tamlocept indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Tamlocept hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamlocept hydrochloride capsules, USP are not indicated for the treatment of hypertension.

How should I use Tamlocept?

Use Tamlocept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Tamlocept.

Uses of Tamlocept in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Tamlocept 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).

Tamlocept 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.

Tamlocept 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 Tamlocept

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.

Tamlocept 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.

Tamlocept description

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Each tablet contains Tamsulosin HCl 400 mcg equivalent to Tamlocept 367 mcg.

Tamlocept HCl, an α1-adrenoceptor blocking agent, has a high affinity for the α1A-receptor subtype predominantly present in the human prostate.

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

Tamlocept 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.

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

Tamlocept dosage

Tamlocept Dosage

Applies to the following strength(s): 0.4 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Benign Prostatic Hyperplasia

Initial Dose: 0.4 mg orally once a day

Maximum Dose: 0.8 mg orally once a day

Comments:

-If use is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, treatment should be initiated again with the 0.4 mg once a day dose.

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

Renal Dose Adjustments

Renal impairment (CrCl greater than 10 mL/min): No adjustment recommended

End-stage renal disease (CrCl less than 10 mL/min): Data not available

Liver Dose Adjustments

Mild or moderate hepatic impairment: No adjustment recommended

Severe hepatic impairment: Data not available

Dose Adjustments

For patients who do not respond to the 0.4 mg dose after 2 to 4 weeks, the dose may be increased to 0.8 mg orally once a day.

Precautions

Safety and effectiveness have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

-This drug should be administered on an empty stomach approximately a half hour following the same meal each day.

-Capsules should not be crushed or chewed.

-Dosage units should be swallowed whole and not crushed, chewed, broken, or opened.

-If therapy is discontinued 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 a day dose.

General:

-This drug is not indicated in women or children.

Patient advice:

-Patients should be cautioned about driving, operating machinery, or performing hazardous tasks.

-Patients should seek immediate medical attention if priapism occurs.

More about Tamlocept

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Tamlocept interactions

See also:
What other drugs will affect Tamlocept?

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Drugs Known to Interact with Tamlocept: Concomitant cimetidine leads to a rise in plasma levels of Tamlocept, while furosemide leads to a fall (about 12% following a single 20-mg IV dose). However, as levels remain within the normal range, dosage need not be adjusted.

Concurrent administration of Tamlocept with other α1-adrenoceptor antagonists is contraindicated because of the potential for hypotensive effects.

Drugs which may Interact with Tamlocept: Tamlocept binds extensively to plasma proteins and may displace other protein-bound drugs. Clinical trial data are not available.

No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P-450-linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamlocept.

Drugs which do not Interact Significantly with Tamlocept: Tamlocept did not affect the pharmacokinetics of a single IV dose of digoxin 0.5 mg.

No interactions have been seen when Tamlocept HCl was given concomitantly with either atenolol, enalapril, nifedipine or theophylline.

General: Tamlocept is metabolised in the liver and may be expected to interact with other hepatically metabolised drugs.

Pharmacokinetic studies in healthy volunteers revealed that concomitant administration with strong inhibitors of CYP3A4 or CYP2D6 may lead to increased exposure to Tamlocept. Concomitant administration with ketoconazole (a known CYP3A4 inhibitor) resulted in an increased Cmax and AUC of Tamlocept. Tamlocept 400 μg should not be used in combination with strong inhibitors of CYP3A4 in patients known to be CYP2D6 poor metabolizers. Concomitant administration with paroxetine (a known CYP2D6 inhibitor) resulted in an increased Cmax and AUC of Tamlocept. Tamlocept should therefore be used with caution in patients who are taking other drugs, particularly those which undergo hepatic metabolism.

Other In Vitro Findings: In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin, change the free fraction of Tamlocept in human plasma. Neither does Tamlocept change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

An in vitro study using human liver microsomal fractions showed no effect of amitriptyline, salbutamol, glibenclamide and finasteride on the rate of disappearance of Tamlocept. The clinical relevance of these findings is uncertain.

Tamlocept side effects

See also:
What are the possible side effects of Tamlocept?

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 Tamlocept hydrochloride 0.1-0.8 mg were used. These studies evaluated safety in 1783 patients treated with Tamlocept hydrochloride and 798 patients administered placebo. Table 2 below summarizes the treatment emergent adverse events that occurred in ≥2% of patients receiving either Tamlocept 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 Tamlocept 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 Tamlocept 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 Tamlocept 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 Tamlocept 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 Tamlocept 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 Tamlocept hydrochloride 0.4 mg once daily group, 92 of the 491 patients (19%) in the Tamlocept 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 Tamlocept 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 Tamlocept hydrochloride administration and was dose-related.

Withdrawal from these clinical studies of Tamlocept 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.

Tamlocept contraindications

See also:
What is the most important information I should know about Tamlocept?

Tamlocept hydrochloride capsules, USP are contraindicated in patients known to be hypersensitive to Tamlocept hydrochloride or any component of Tamlocept hydrochloride capsules, USP. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms.

Active ingredient matches for Tamlocept:

Tamsulosin in India.


Unit description / dosage (Manufacturer)Price, USD
Tamlocept 0.2mg CAP / 10$ 0.79
Tamlocept 0.4mg CAP / 10$ 1.27
Tamlocept 0.4 mg Capsule$ 0.13
Tamlocept 0.2 mg Tablet$ 0.08
TAMLOCEPT 0.4 MG CAPSULE 1 strip / 15 capsules each (Lupin Ltd)$ 2.28
TAMLOCEPT cap 0.2 mg x 10's (Lupin)$ 0.79
TAMLOCEPT cap 0.4 mg x 10's (Lupin)$ 1.27
Tamlocept 0.4mg Capsule PR (Lupin Ltd)$ 0.17

List of Tamlocept substitutes (brand and generic names):

Tamlosin 0.2 mg x 1000's
Tamosol 0.4mg TAB / 10x10 (Avyukt)$ 10.11
TAMOSOL tab 0.4 mg x 10's (Avyukt)$ 1.01
Tampres 0.4mg MR-TAB / 10 (Olcare)$ 0.71
TAMPRES modified-release tab 0.4 mg x 10's (Olcare)$ 0.71
Tampres-D Tamsulosin 0.4 mg, dutasteride0.5 mg MR-TAB / 10 (Olcare)$ 1.98
TAMPRES-D modified-release tab 10's (Olcare)$ 1.98
Tamscure 0.4mg Tablet (Stallion Laboratories Pvt Ltd)$ 0.12
Tamscure -D 0.4mg/5mg Tablet (Stallion Laboratories Pvt Ltd)$ 0.29
Tamsilon ER tab 200 mcg 28's (Kyung Dong Pharm)
Tamsilon ER tab 200 mcg 30's (Kyung Dong Pharm)
0.4 mg x 10's (Higlance Laboratories Pvt. Ltd.)$ 0.87
Tamsin 0.5 mg Capsule (Higlance Laboratories Pvt. Ltd.)$ 0.09
Tamsin 0.4 mg Tablet (Higlance Laboratories Pvt. Ltd.)$ 0.06
Tamsin 0.4mg CAP / 10 (Higlance Laboratories Pvt. Ltd.)$ 0.87
TAMSIN 0.4 MG TABLET 1 strip / 15 tablets each (Higlance Laboratories Pvt. Ltd.)$ 2.21
TAMSIN cap 0.4 mg x 10's (Higlance Laboratories Pvt. Ltd.)$ 0.87
Tamsin 0.4mg Tablet (Higlance Laboratories Pvt. Ltd.)$ 0.16
Tamso 0.2 mg x 1000's
Tamsol 0.4mg - 10 Capsule (Apex)$ 18.80
Tamsol 0.4mg - 30 Capsule (Apex)$ 36.40
Tamsolin 400 mcg x 10's (Getz Pharma)

References

  1. PubChem. "TAMSULOSIN". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "TAMSULOSIN". http://www.drugbank.ca/drugs/DB00706 (accessed September 17, 2018).
  3. MeSH. "Urological Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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