INTRODUCTION
ANDROTAS 1% GEL contains Testosterone which belongs to the group of medicines called Androgens. It is used in adult men to replace testosterone in male hypogonadism (various health problems caused by a deficiency of testosterone). Male hypogonadism is characterized by symptoms like impotence, infertility, decreased sex drive, tiredness, depressive moods and bone loss due to low hormone levels.
ANDROTAS 1% GEL is not recommended for use if you have known or suspected prostate or breast cancer. Consult your doctor before using it.
ANDROTAS 1% GEL should be used with caution in patients with high blood pressure, chronic lung diseases, severe liver, kidney or heart disease, diabetes, urinary problems due to enlarged prostate. Consult your doctor before using it.
ANDROTAS 1% GEL is intended for use by men only. It is not indicated for use in pregnant and breastfeeding women. Consult your doctor before using it.
ANDROTAS 1% GEL is not recommended for use in children and adolescents (under 18 years of age) and it should be used with caution in elderly patients. Consult your doctor before using it.
The most common side effects of using ANDROTAS 1% GEL are burning or prickling sensation, dryness, rash, redness or itchiness at the site of application. Contact your doctor if any of the side effects worsen.
USES OF ANDROTAS 1% GEL
To replace testosterone in male hypogonadism in adult men
HOW ANDROTAS 1% GEL WORKS
ANDROTAS 1% GEL works by replacing testosterone in adult male patients with hypogonadism (various health problems caused by a lack of testosterone, a natural male hormone). Thus, helps to improve clinical symptoms such as impotence, infertility, low sex drive, tiredness, depressive moods, bone loss caused by low hormone levels.
DIRECTIONS FOR USE
Always apply ANDROTAS 1% GEL as directed by your physician. It is for external use only. Apply to clean, dry, intact skin of the shoulders and/or upper arms. Application should be limited to the area that will be covered by your short sleeve T-shirt. Cover the application sites with clothing (Ex. a t-shirt) after the medicine has dried.
Wash your hands properly with soap and water after application. Do not apply this medicine to the genitals. Avoid showering or washing the administration site for a minimum of 2 hours after application.
SIDE EFFECTS OF ANDROTAS 1% GEL
COMMON
Burning or prickling sensation, dryness, rash, redness or itchiness at the site of application
Swelling of hands or feet
Headache
High blood pressure
Prostate changes
Increased body hair growth
Increase in breast size
RARE
Stop receiving ANDROTAS 1% GEL and contact your doctor immediately if you experience any of the following side effects:
Signs and symptoms of the enlarged prostate gland or prostate cancer include increased urination at night, trouble starting your urine stream, having to pass urine many times during the day or urge to go to the bathroom right away and being unable to pass urine or weak urine flow
Signs and symptoms of a blood clot in your legs or lungs can include leg pain, swelling or redness, difficulty breathing or chest pain
Swelling of your ankles, feet or body, with or without heart failure
Enlarged or painful breasts
Signs and symptoms of heart attack or stroke
Trouble breathing while you sleep (sleep apnoea)
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if the headache did not improve.
Itchy skin:
Avoid hot baths because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the itching worsens.
WARNING & PRECAUTIONS
PREGNANCY
ANDROTAS 1% GEL is intended for use by men only. It is not indicated for use in pregnant women and may cause harm or abnormalities in the unborn baby. Consult your doctor before receiving it.
BREASTFEEDING
ANDROTAS 1% GEL is not indicated for use in breastfeeding women. Consult your doctor before using it.
DRIVING AND USING MACHINES
ANDROTAS 1% GEL does not affect your ability to drive or use machinery.
KIDNEY
ANDROTAS 1% GEL should be used with caution in patients with severe kidney disease as this medicine may cause water retention in the body. Consult your doctor before using it.
LIVER
ANDROTAS 1% GEL should be used with caution in patients with severe liver diseases as this medicine may cause water retention in the body. Consult your doctor before using it.
ALLERGY
Do not use ANDROTAS 1% GEL if you are allergic to Testosterone or any of the other ingredients of this medicine.
LUNGS
ANDROTAS 1% GEL should be used with caution in patients with chronic lung diseases as it may worsen sleep apnea (temporary cessation of breathing during sleep). Consult your doctor before using it.
HEART DISEASE
ANDROTAS 1% GEL should be used with caution in patients with high blood pressure, severe heart disease as this medicine may cause water retention in the body accompanied by heart failure. Consult your doctor before using it.
OTHERS
ANDROTAS 1% GEL is not recommended for use if you:
Have known or suspected prostate or breast cancer
Before receiving ANDROTAS 1% GEL, inform your doctor if you:
Have urinary problems due to enlarged prostate
Have swollen hands and feet
Are overweight
Have diabetes
Have epilepsy or fits
Have migraine
Have bone cancer
Have high levels of blood calcium
Have or have ever had blood clotting problems
Have or had blood clotting problems like abnormal blood coagulation that increases the risk of blood clots in blood vessels
Have a risk of developing blood clots (smoking, obesity, cancer, immobility, family history of a blood clot in the leg, lung or other organs at a young or older age)
Use in pediatrics:
ANDROTAS 1% GEL is not recommended for use in children and adolescents (under 18 years of age) as safety and efficacy have not been established. Consult your doctor before using it.
Use in geriatrics:
ANDROTAS 1% GEL should be used with caution in elderly patients (aged above 65 years) due to the increased risk of enlargement of the prostate gland or prostate cancer. Consult your doctor before using it.
INTERACTIONS
A. Drug – Drug interactions:
Before using ANDROTAS 1% GEL, inform your doctor if you are taking any of the following medicine:
Anticoagulants (medicines used to thin the blood) Ex. warfarin, acenocoumarol
Insulin (medicines used to treat diabetes)
Corticosteroids (medicines used to treat rheumatism, arthritis, allergic conditions and asthma) Ex. hydrocortisone, dexamethasone
Overdosage:
If you or anyone else accidentally use too much of ANDROTAS 1% GEL, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
Drug : Testosterone
Pharmacological Category : Androgen
Therapeutic Indication : Male hypogonadism
Dosage Forms : Tablet, Capsule, Injection, Gel, Spray
MORE INFORMATION
Keep ANDROTAS 1% GEL out of reach of children
Store below 25°C
FAQs ABOUT ANDROTAS 1% GEL
Does ANDROTAS 1% GEL cause breathing difficulty?
Yes, ANDROTAS 1% GEL may cause breathing difficulty during sleep (sleep apnea), especially in patients with risk factors such as obesity or chronic lung diseases. Contact your doctor if you experience any difficulty in breathing during sleep.
What if a child accidentally gets exposed to the area where ANDROTAS 1% GEL is applied?
Children should avoid contact with the unwashed or uncovered areas where ANDROTAS 1% GEL is applied. This may cause signs and symptoms of early puberty in young children, like enlarged penis or clitoris, early pubic hair growth, erections or extreme sexual urges, aggression or behave in an angry or violent way. Wash the exposed area well with soap and water and then consult your doctor.
Can I go for a swim after applying ANDROTAS 1% GEL?
You should not go for showering, swimming or bathing for at least 2 hours after ANDROTAS 1% GEL application. If you have any more doubts regarding the use of this medicine, ask your doctor.
Can I change the dose of ANDROTAS 1% GEL?
Do not change the dose of ANDROTAS 1% GEL without consulting your doctor. Your doctor will do it depending on your condition. If you have any more doubts regarding the use of this medicine, ask your doctor.
What if a woman accidentally gets exposed to the area where ANDROTAS 1% GEL is applied?
Women should avoid contact with the unwashed or uncovered areas where ANDROTAS 1% GEL is applied. This may cause changes in body hair or an abnormal increase in pimples. Wash the exposed area well with soap and water and then consult your doctor.
Can ANDROTAS 1% GEL affect fertility?
Treatment with high doses of ANDROTAS 1% GEL may affect fertility by reducing sperm production. So reduced fertility is observed in some men taking testosterone replacement therapy. Consult your doctor before using it.
Can I have any erection problems while using ANDROTAS 1% GEL?
ANDROTAS 1% GEL can cause side effects like more erections than what’s usual for you or erections that last a long time. Consult your doctor if you experience these or any other erection problems.
When is the best time to apply ANDROTAS 1% GEL?
Always use ANDROTAS 1% GEL as directed by your physician. Apply for the medicine once daily at approximately the same time each day. It should be applied preferably after showering or bathing.
Does ANDROTAS 1% GEL cause edema?
Yes, ANDROTAS 1% GEL may cause edema or swelling of the body, arms and legs by promoting the retention of sodium and water. Hence, ANDROTAS 1% GEL should be used with caution in patients with preexisting cardiac, renal or hepatic disease due to the increased risk of edema accompanied by heart failure. If the edema occurs discontinue the medicine and contact your doctor immediately.
REFERENCES
1. KD. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 299.
2. Lakshman KM, Basaria S. Safety and efficacy of testosterone gel in the treatment of male hypogonadism. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. November 2009. [Accessed on 29th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2785864/
3. Leichtnam ML, Rolland H, Wüthrich P, Guy RH. Formulation and evaluation of a testosterone transdermal spray. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed.gov. August 2006. [Accessed on 29th June 2022] https://pubmed.ncbi.nlm.nih.gov/16795012/
4. PHARBIL Waltrop GmbH. Electronic Medicines Compendium (EMC). [Revised in December 2019] [Accessed on 29th June 2022] https://www.medicines.org.uk/emc/files/pil.332.pdf
5. AbbVie Inc. Testosterone. [Revised in May 2019]. [Accessed on 29th June 2022] https://www.rxabbvie.com/pdf/androgel_PI.pdf
6. Testosterone gel, spray. DailyMed: National Library of Medicine: National Institute of Health. [Revised in April 2020]. [Accessed on 29th June 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2dd150f6-cdfd-4d51-8888-12b288f26262&type=display
7. Central Drugs Standard Control Organization (CDSCO). Testosterone. [Accessed on 29th June 2022] https://cdscoonline.gov.in/CDSCO/Drugs
8. Drugbank. Testosterone. [Accessed on 29th June 2022] https://go.drugbank.com/drugs/DB00624
USEFUL DIAGNOSTIC TESTS
Blood testosterone level
Digital rectal examination (DRE)
Prostate-specific antigen (PSA)
Complete blood count
Liver function tests
Net Qty
1 N
Ingredient
TESTOSTERONE 1%
Hsn Code
30043990
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