Lowtiyel 50mg / 1% Testosterone Gel

Lowtiyel 50mg / 1% Testosterone Gel

Product Code: lowtiyel_50mg
Reward Points: 1000
Availability:
In Stock
Price: $150.00
Description

TESTOSTERONE GEL 50MG 1% (LOWTIYEL)

LowTiyel /Testim® (testosterone gel) 14 Sachets per box

 

is a clear to translucent hydroalcoholic topical gel containing 1% testosterone following a single application to intact, clean, dry skin of the shoulders and upper arms.

Black Box Warnings: Secondary Exposure to Testosterone:

Children should avoid contact w/ application sites on men using testosterone gel due to virilization risk from secondary exposure; testosterone gel use instructions should be followed

Indications and Usage for Testosteron Gel

Adult Dosing 

Dosage forms:  1% gel, Packaged 14 sachets of 5.0 Testosterone gel corresponds to 50mg each.
Gel Filled Sachets

Testosterone Replacement Therapy

LOWTIYEL an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary Hypogonadism (Congenital or Acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
  • Hypogonadotropic Hypogonadism (Congenital or Acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

Dosage and Administration

General Dosing

The recommended starting dose of LOWTIYEL GEL is one sachet once daily (preferably in the morning) to clean, dry, intact skin of the shoulders and upper arms and/or abdomen. Do not apply to the genitals. Supplied in individual packets. After applying the gel, the application site should be allowed to dry for a few minutes prior to dressing. Avoid fire, flames or smoking until the gel has dried since alcohol based products are flammable. Hands should be washed with soap and water after Gel has been applied.

Patient Counseling Information

Potential Adverse Reactions with Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions which include:

  • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.
  • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
  • Too frequent or persistent erections of the penis.
  • Nausea, vomiting, changes in skin color, or ankle swelling.

Instructions for Use

  • Patients should be informed to apply the Gel once daily (preferably in the morning) to clean, dry skin of the shoulders and upper arms and/or abdomen. To prevent transfer of testosterone Gel to others, patient should wash their hands after application and cover the application site with clothing.
  • Advise patients that testosterone Gel is an alcohol based product and is flammable, therefore avoid fire, flame or smoking until the gel has dried.
  • Counsel patients on the importance of adhering to all recommended monitoring by their healthcare professional.
  • Advise patients to report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.

FDA-Approved Patient Labeling

LOWTIYEL (testosterone gel) 1% CIII is available packaged in a box of 15 packets with 2.5g or 5g gel.

1. What Disease or Condition Does LOWTIYEL Gel Treat?

Your healthcare provider has prescribed this medication because your body does not produce enough testosterone. The medical term for this condition is hypogonadism.

2. How Should LOWTIYEL Gel (Packet) Be Applied?

It is important that you use as prescribed by your healthcare professional. If you experience serious problems, contact your healthcare professional. Your healthcare professional will tell you how much Testosterone Gel to use each day.

 

Figure3: Site(s) of Gel Application

  • LOWTIYEL should be applied once daily at the same time each day (preferably every morning) to clean, dry, healthy, intact skin of the shoulders, upper arms and/or abdomen. If you take a bath or shower in the morning, use LOWTIYEL after your bath or shower.
  • LOWTIYEL should not be applied to the penis or scrotum, or to skin with open sores, wounds or irritation.
  • Wash your hands with soap and water immediately after application to reduce the chance that the medication will spread from your hands to other people.
  • Let LOWTIYEL dry for a few minutes before you dress.
  • LOWTIYEL is flammable until dry; allow the gel to dry before smoking or going near an open flame.
  • Wait 5 to 6 hours before showering or swimming. This will ensure that the greatest amount of LOWTIYEL is absorbed into your system.

How to use the LOWTIYEL packets?

Open one LOWTIYEL aluminum foil packet by folding the top edge at the perforation and tearing completely across the packet along the perforation. Squeeze the contents into the palm of your hand. Squeeze from the bottom of the packet toward the top. If you like, you may squeeze a portion of the gel from the packet into the palm of your hand and apply to application site(s). Repeat until the entire contents of the packet have been applied.

3. What Should You Discuss With Your Healthcare Professional?

Before you start using LOWTIYEL, tell your healthcare professional if you :

  • Have prostate cancer or breast cancer.
  • Have a known hypersensitivity to any of LOWTIYEL's components, including individuals who are hypersensitive to testosterone that is chemically synthesized from soy.

4. What Other Drugs Should Not Be Used Together With LOWTIYEL?

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. LOWTIYEL can affect how your body handles other drugs. Changes in your dose or careful monitoring may be needed if you are taking any of the following medications:

  • Insulin
  • Corticosteroids
  • Oral Anticoagulants

5. What Are The Side Effects And Risks?

Possible side effects of LOWTIYEL to discuss with your healthcare professional include:

Most common: Skin irritation where gel is applied, breast development or tenderness, acne, prostate enlargement, changes in lab test results and changes in urinary habits.

Contact your healthcare professional if you experience any of the following adverse reactions:

  • Too frequent or persistent erections of the penis.
  • Any nausea, vomiting, changes in skin color or ankle swelling.
  • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
  • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.

The major risks of LowTiyel Gel include:

Prostate Disorders: Patients treated with testosterone may be at an increased risk for prostate enlargement, and prostate cancer. Talk to your healthcare provider for more information on risk factors and ways to monitor for prostate disorders.
 
Testosterone Transfer: Transfer of testosterone to others (including women and children) can occur when vigorous skin-to-skin contact is made with the application site. LOWTIYEL must not be used by women, and exposure to the active ingredient testosterone in pregnancy can cause fetal harm. Notify your healthcare provider if your female partner develops changes in hair distribution, increases in acne or other signs of masculinity.

6. How Should LowTiyel Gel Be Stored?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

7. Is There Anything Else I Need To Know When Using LowTiyel el?

Your healthcare professional has prescribed LOWTIYEL to meet your specific needs; never share your AndroGel with anyone. If you have any questions or concerns about your LOWTIYEL treatment, ask your healthcare provider or pharmacist.

Laboratoires Besins International

Acondicionado y distribuido por:

ITALMEX, S. A.

Bajo licencia de:

Unimed Pharmaceuticals Inc.

Reg. Núm. 330M2006, SSA IV

LEAR-07330022770009/RM2007

INFORMACIÓN REVISADA

Distributed by ABBOTT Labs De Mexico

Reviews (0)

Write a review



Note: HTML is not translated!

Bad            Good

Related Products