ANNAVAIL

ANNAVAIL 10mg

What is this medicine?

ANNAVAIL 10mg TABLETS contain Oxandrolone, which is an anabolic steroid. It is primarily used as adjunctive therapy to:

• Promote weight gain in people who have lost too much weight due to surgery, chronic infections, trauma, or being underweight for unknown reasons.
• Treat bone pain in people with osteoporosis (a condition where bones become thin and weak).
• Counteract protein breakdown (catabolism) associated with prolonged corticosteroid use.
• In some cases, it may be used to improve muscle growth and strength, though this is often an off-label use with significant risks.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• An unusual or allergic reaction to oxandrolone, other anabolic steroids, or any other ingredients in this medicine.
• Prostate cancer or breast cancer (in men).
• Breast cancer with high blood calcium levels (in women).
• Severe heart disease or heart failure.
• High cholesterol or a history of heart disease, heart attack, or stroke in you or your family.
• Liver disease or liver problems (including liver tumors or cysts).
• Kidney disease, especially a certain type of kidney inflammation (nephritis).
• High blood calcium levels (hypercalcemia).
• Chronic Obstructive Pulmonary Disease (COPD).
• Diabetes (as it can affect blood sugar levels).
• If you are pregnant, planning to become pregnant, or could become pregnant (this medicine can harm the fetus).
• If you are breast-feeding.

How should I use this medicine?

Take this medicine by mouth as a tablet, usually two to four times a day, or as directed by your doctor. Take your doses at regular intervals. Follow the directions on your prescription label carefully. Do not take your medicine more often or for longer than directed. Your doctor will likely prescribe it for a specific period (e.g., 2 to 4 weeks). Do not stop taking this medicine except on the advice of your doctor or health care professional.

Overdosage: If you think you have taken too much of this medicine, contact a poison control center or emergency room at once. Symptoms of overdose may include severe nausea, vomiting, stomach pain, extreme tiredness, yellowing of the skin or eyes (jaundice), or dark urine.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

This medicine may interact with:

• Blood thinners (anticoagulants) like warfarin, increasing the risk of bleeding.
• Oral diabetes medications (as it can affect blood sugar levels).
• Corticosteroids (e.g., prednisone).
• Insulin.
• Medications that affect liver enzymes.
• Certain other medications that can be affected by liver function.

This list may not describe all possible interactions.

What should I watch for while using this medicine?

• Visit your doctor or health care professional for regular checks on your progress. This may include blood tests to check liver function, cholesterol levels, blood sugar, and calcium levels.
• If you are a woman, be aware of potential virilizing effects, such as deepening of the voice, increased facial or body hair, male pattern baldness, or clitoral enlargement. These effects can be irreversible. Report them to your doctor immediately.
• Men may experience breast enlargement (gynecomastia), changes in sex drive or ability, or painful/persistent erections.
• Children taking this medicine will have their growth monitored regularly with X-rays, as it can cause bones to mature too quickly, potentially limiting adult height.
• Watch for signs of liver problems such as yellowing of the skin or eyes (jaundice), unusual tiredness, dark urine, pale stools, severe stomach pain, nausea, or vomiting. Report these immediately to your doctor.
• This medicine can affect cholesterol levels, potentially increasing “bad” cholesterol (LDL) and decreasing “good” cholesterol (HDL), which may increase your risk of heart disease. Regular monitoring is important.
• If you experience unusual bruising or bleeding, tell your doctor.
• You may experience changes in mood, including feeling restless, excited, or depressed, or having trouble sleeping.
• Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you.
• Avoid alcohol as it can exacerbate liver problems.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions like skin rash, hives, itching, swelling of the face, lips, tongue, or throat, or difficulty breathing/swallowing.
• Severe or persistent stomach pain, nausea, or vomiting.
• Yellowing of the skin or eyes (jaundice), dark urine, or pale stools (signs of liver problems).
• Unusual tiredness or weakness.
• Easy bruising or bleeding (e.g., nosebleeds, bleeding gums).
• Swelling of the ankles or feet (edema).
• Chest pain, shortness of breath.
• Changes in sex drive or ability (e.g., increased/decreased libido, erection problems, testicular atrophy in men, clitoral enlargement in women).
• Mood changes (excitation, insomnia, depression).
• Deepening of voice or increased body/facial hair (in women).
• Persistent or painful erection (priapism) in men.
• Changes in menstrual periods (in women).

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Nausea or vomiting (mild).
• Acne.
• Male pattern baldness (in both men and women).
• Difficulty falling asleep or staying asleep.

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature in a cool and dry place, protected from moisture and light.

Throw away any unused medicine after the expiration date.