ADDITIONAL IMPORTANT SAFETY INFORMATION
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
· See full prescribing information for complete boxed warning
· Virilization has been reported in children with secondary exposure to topical testosterone products
· Children should avoid contact with unwashed or unclothed application sites in men using topical testosterone products
· Healthcare providers should advise patients to strictly adhere to recommended instructions for use
Disclaimer: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.
Warnings and Precautions:
· Possible increased risk of heart attack or stroke.
· Male Excel’s testosterone products are not meant for use by women.
· It is not known if Male Excel’s testosterone products are safe or effective in children younger than 18 years old. Improper use of testosterone in children may affect bone growth.
· Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Male Excel’s Testosterone Lipoderm Cream is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Your doctor will check you for signs of abuse before and during treatment.
· Keep your Male Excel products in a safe place to protect them.
· Never give your Male Excel products to anyone else, even if they have the same symptoms you have.
· Selling or giving away this medicine may harm others and is against the law.
These are not all the possible side effects. See the Full Prescribing Information for more.
What Should You Know Before Taking Male Excel’s Testosterone Lipoderm Cream?
It is not known if Male Excel’s Testosterone Lipoderm Cream is safe or effective in treating men who have low testosterone due to aging.
It is not known if Male Excel’s Testosterone Lipoderm Cream is safe or effective in children younger than 18 years old.
Male Excel l’s Testosterone Lipoderm Cream is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it, and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.
Male Excel’s Testosterone Lipoderm Cream is not meant for use in women.
Male Excel’s Testosterone Lipoderm Cream can transfer from your body to others, including children and women. Transference can happen if other people come into contact with the area where Male Excel’s Testosterone Lipoderm Cream is applied. Children and women should avoid contact with the unwashed or uncovered (unclothed) areas where Male Excel’s Testosterone Lipoderm Cream has been applied to your skin.
Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Male Excel’s Testosterone Lipoderm Cream.
Signs and symptoms of early puberty in a child who has come in direct contact with Male Excel’s Testosterone Lipoderm Cream may include:
· Abnormal sexual changes.
· Enlarged penis or clitoris.
· Early hair growth near the vagina or around the penis (pubic hair).
· Erections or acting out sexual urges (sex drive).
· Behavior problems, including acting aggressively or behaving angrily or violently.
Signs and symptoms in a woman who has come in direct contact with Male Excel’s Testosterone Lipoderm Cream may include:
· Changes in body hair.
· An abnormal increase in pimples (acne).
To lower the risk of transfer of Male Excel’s Testosterone Lipoderm Cream from your body to others, you should follow these important instructions:
· Apply Male Excel’s Testosterone Lipoderm Cream only to areas of your shoulders, upper arms, or stomach area (abdomen) that a short-sleeve t-shirt will cover.
· Wash your hands right away with soap and water after applying testosterone cream
· After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed or showered the application area well.
· If you expect skin-to-skin contact with another person, wash the application area well with soap and water.
· If a child or woman touches the area where you have applied testosterone cream, that area on the child or woman should be washed thoroughly with soap and water immediately.
Stop using Male Excel’s Testosterone Lipoderm Cream and call your healthcare provider immediately if you see any signs and symptoms of puberty in a child or changes in body hair. The same applies if you notice increased acne in a woman that may have happened through accidental touching of the area where you have applied Male Excel’s Testosterone Lipoderm Cream.
Do not use Male Excel’s Testosterone Lipoderm Cream if you:
· Have breast cancer or have or might have prostate cancer.
· Are pregnant. Male Excel’s Testosterone Lipoderm Cream may harm your unborn baby. Pregnant women should avoid contact with the area of skin where Male Excel’s Testosterone Lipoderm Cream has been applied.
Before using Male Excel’s Testosterone Lipoderm Cream, inform your healthcare provider about all of your medical conditions, including if you have breast cancer, prostate cancer, urinary problems due to an enlarged prostate, heart, kidney, or liver problems, or problems breathing while you sleep (sleep apnea).
Inform your healthcare provider of all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
Male Excel’s Testosterone Lipoderm Cream can cause serious side effects, including:
· If you already have an enlarged prostate gland, your signs and symptoms can worsen while using Male Excel’s Testosterone Lipoderm Cream (including changes in urination).
· Possible increased risk of prostate cancer.]
· Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
· Possible increased risk of heart attack or stroke.[sw4]
· In large doses, Male Excel’s Testosterone Lipoderm Cream may lower your sperm count.
· Swelling in your ankles, feet, or body, with or without heart failure. This may cause serious problems for people with heart, kidney, or liver disease.
· Enlarged or painful breasts.
· Having problems breathing while you sleep (sleep apnea).
The most common side effects of Male Excel’s Testosterone Lipoderm Cream include increased prostate-specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, acne, and skin irritation where the gel is applied.
This is the most important information to know about Male Excel’s Testosterone Lipoderm Cream. For further information, talk with your healthcare provider.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Male Excel’s Testosterone Lipoderm Cream. For more information, ask your healthcare provider or pharmacist.
Please click here to see full prescribing information, Medication Guide, and complete boxed warnings for the product.
You are encouraged to report any adverse side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
ADDITIONAL IMPORTANT SAFETY INFORMATION AND BLACK BOX WARNING
WARNING: Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
What Should You Know Before Taking Male Excel’s desiccated thyroid [tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine)]?
PLEASE NOTE: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.
This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
What is Male Excel’s desiccated thyroid?
· Male Excel’s desiccated thyroid is a prescription medicine used to treat a condition called hypothyroidism from any cause, except for cases of temporary hypothyroidism, which is usually associated with an inflammation of the thyroid (thyroiditis). It is meant to replace or supplement a hormone that is usually made by your thyroid gland.
When should I not take Male Excel’s desiccated thyroid?
· Male Excel’s desiccated thyroid should not be used for weight loss. Do not use Male Excel’s desiccated thyroid if you have hyperthyroidism, overactive thyroid, uncorrected adrenal problems, or are allergic to any of its ingredients.
What warnings should I know about Male Excel’s desiccated thyroid?
· Large doses of Male Excel’s desiccated thyroid may cause serious or life-threatening side effects, including chest pain, increased pulse rate, rapid, strong, irregular heartbeat, and excessive sweating.
· Male Excel’s desiccated thyroid should be used with caution in people with heart disease, on diabetes medication, or on blood thinning medication.
· Children may experience partial hair loss in the first few months of thyroid therapy, but this will usually go away on its own.
What should I tell my healthcare provider?
· Tell your doctor immediately if you experience chest pain, increased pulse rate, rapid, strong, irregular heartbeat, excessive sweating, or any other unusual event.
· Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking Male Excel’s desiccated thyroid.
· If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor and immediately tell your doctor if there are any changes.
· Tell your doctor if you are allergic to any foods or drugs, are pregnant or plan to become pregnant, are breastfeeding or are taking any other drugs, as well as prescription and over-the-counter products.
What are the side effects of Male Excel’s desiccated thyroid?
· Side effects may include chest pain, increased pulse rate, rapid, strong, irregular heartbeat, or excessive sweating. If you experience these side effects, immediately contact your doctor.
What other medications might interact with Male Excel’s desiccated thyroid?
· Male Excel’s desiccated thyroid can interact with some medications, such as oral anticoagulants, which are medicines used to thin the blood, insulin or oral medications used to treat diabetes, certain medications used to treat high cholesterol levels, and estrogen-containing birth control pills.
IMPORTANT RISK INFORMATION
Thyroid hormones, including Male Excel’s desiccated thyroid, should not be used alone or in combination with other drugs to treat obesity or weight loss. In patients with normal thyroid levels, doses of Male Excel’s desiccated thyroid used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when combined with certain other drugs used to reduce appetite.
· Male Excel’s desiccated thyroid is contraindicated in patients with uncorrected adrenal insufficiency, untreated thyrotoxicosis, and hypersensitivity to any component of the product.
· In the elderly and patients with cardiovascular disease, Male Excel’s desiccated thyroid should be used with greater caution than younger patients or those without cardiovascular disease.
· Use of Male Excel’s desiccated thyroid in patients with diabetes mellitus or adrenal cortical insufficiency may worsen the intensity of their symptoms.
· The therapy of myxedema coma requires simultaneous administration of glucocorticoids.
· Concomitant use of Male Excel’s desiccated thyroid with oral anticoagulants alters the sensitivity of oral anticoagulants. Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants.
· In infants, excessive doses of Male Excel’s desiccated thyroid may produce craniosynostosis.
· Partial loss of hair may be experienced by children in the first few months of therapy but is usually transient.
· Adverse reactions associated with Male Excel’s desiccated thyroid therapy are primarily those of hyperthyroidism due to therapeutic overdosage.
· Many drugs and some laboratory tests may alter the therapeutic response to Male Excel’s desiccated thyroid. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption.
Please click here to see full prescribing information, including BOXED WARNING and important safety information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088
