STANOZOLOL TABLETS

NAME OF THE MEDICINAL PRODUCT

Stanozolol Tablets ip 2 mg,

Stanozolol Tablets USP 2 mg,

Stanozolol Tablets USP 10 mg

Package leaflet:

Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet
1. What Stanozolol is and what it is used for
2. What you need to know before you take Stanozolol
3.How to take Stanozolol
4. Possible side effects
5. How to store Stanozolol
6. Other information

WHAT STANOZOLOL IS AND WHAT IT IS USED FOR

Stanozolol is a man-made steroid, similar to the a naturally occurring steroid testosterone.
Stanozolol is used in the treatment of hereditary angioedema, which causes episodes of swelling of the face, extremities, genitals, bowel wall, and throat. Stanozolol may decrease the frequency and severity of these attacks.
Stanozolol may also be used for purposes other than those listed here.
In rare cases, serious and even fatal cases of liver problems have developed during treatment with stanozolol. Contact your doctor immediately if you experience abdominal pain, light colored stools, dark colored urine, unusual fatigue, nausea or vomiting, or yellowing of the skin or eyes. These may be early signs of liver problems.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE STANOZOLOL

Do not take stanozolol without first talking to your doctor if you have
–prostate cancer;
–breast cancer; or
–a high level of calcium in the blood (hypercalcemia).

Before taking stanozolol, talk to your doctor if you
–have heart or blood vessel disease;
–have had a heart attack;
–have a high level of cholesterol in the blood;
–have bleeding or blood clotting problems;
–have diabetes;
–take an oral anticoagulant (blood thinner);
–have liver problems; or
–have kidney problems.

You may not be able to take stanozolol, or you may require a dosage adjustment or special monitoring during treatment.

Stanozolol is in the FDA pregnancy category X. This means that stanozolol is known to cause birth defects in an unborn baby. Do not take this medication if you are pregnant or could become pregnant during treatment.

It is not known whether stanozolol passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

 HOW TO TAKE STANOZOLOL

DOSAGE:

For oral dosage form (tablets):

To prevent hereditary angioedema, which causes swelling of the face, arms, legs, throat, windpipe, bowels, or sexual organs:
Adults and teenagers—At first, 2 milligrams (mg) three times a day to 4 mg four times a day for five days. Then, your doctor may slowly lower the dose to 2 mg once a day or once every other day.

Take stanozolol exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.
Take stanozolol with a full glass of water.
Stanozolol can be taken with or without food.
It is important to take stanozolol regularly to get the most benefit.
Your doctor may want you to have blood tests or other medical evaluations during treatment with stanozolol to monitor progress and side effects.
Store stanozolol at room temperature away from moisture, heat, and direct light.

Usual Adult Dose for Angioedema


Prophylactic use to decrease frequency and severity of attacks of hereditary angioedema.

Initial dose: 2 mg orally 3 times a day.

Dose Adjustments


Decrease dose at intervals of 1 to 3 months to a maintenance dose of 2 mg/day.

Missed Dose


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed, and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Overdosage


An overdose of this medication is unlikely to threaten life. Contact an emergency room or poison control center for advice if an overdose is suspected.
Symptoms of an stanozolol overdose are not known.

 

POSSIBLE SIDE EFFECTS

In rare cases, serious and even fatal cases of liver problems have developed during treatment with stanozolol. Contact your doctor immediately if you experience abdominal pain, light colored stools, dark colored urine, unusual fatigue, nausea or vomiting, or yellowing of the skin or eyes. These may be early signs of liver problems.

If you experience any of the following serious side effects, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • swelling of the arms or legs (especially ankles);
  • frequent or persistent erections, or breast tenderness or enlargement (male patients); or
  • voice changes (hoarseness, deepening), hair loss, facial hair growth, clitoral enlargement, or menstrual irregularities (female patients).

Other less serious side effects may also occur. Talk to your doctor if you experience

  • new or worsening acne;
  • difficulty sleeping;
  • headache; or
  • changes in sexual desire.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Cardiovascular

Cardiovascular effects may be precipitated in patients adversely affected by fluid retentionEdema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

Genitourinary

Genitourinary effect following chronic administration and/or large dosages of anabolic steroids can result in oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop.

In female patients the use of anabolic steroids may result in virilization including deepening voice, hirsutismacne, clitomegaly (not reversible), and menstrual abnormalities
Discontinuation of medication at signs of mild virilization may prevent irreversible virilization.
Alterations in libido may occur (increased/decreased).
Hepatic
Life-threatening peliosis hepatis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas have occurred following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal.
Cholestatic hepatitis, jaundice, and abnormal liver function tests occur at relatively low doses.

 

Other

In female patients the use of anabolic steroids has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of stanozolol at signs of mild virilization may prevent irreversible virilization.

Musculoskeletal

Androgenic activity associated with anabolic steroids is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during stanozolol use in prepubertal patients.
Oncologic

Oncologic effects following prolonged therapy with large doses of anabolic steroids have included hepatic neoplasms and hepatocellular carcinomas.

Hematologic


Hematologic effects occurring during anabolic steroid therapy include alteration in clotting factors II, V, VII and X , prolonged prothrombin time (PT), and increased red cell production.

Endocrine

During exogenous administration of anabolic steroids, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous anabolic steroids may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone(FSH).

Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred in diabetic patients during anabolic steroid therapy.

Metabolic


Metabolic effects occurring during anabolic steroid therapy in immobilized patients or those with metastatic breast disease include osteolytic-induced hypercalcemia.
Anabolic steroids effect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.
The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal
Anabolic steroids cause retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decrease urinary excretion of calcium. Patients should be instructed to report edema.

Gastrointestinal
Gastrointestinal effects occurring during stanozolol therapy include nausea and vomiting.

Other Drugs and stanozolol


Before taking stanozolol, talk to your doctor if you are taking any of the following medicines:

  • an anticoagulant (blood thinner) such as warfarin (Coumadin); or
  • insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (DiaBeta, Glynase, Micronase), glimepiride (Amaryl), chlorpropamide (Diabinese), acetohexamide (Dymelor), tolbutamide (Orinase), tolazamide (Tolinase), and others.

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with stanozolol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

 HOW TO STORE STANOZOLOL

It should be stored in a dry place away from heat and humidity. 15° to 25° C (59° to 77° F)
Keep Stanozolol out of the reach of children and away from pets. Do not refrigerate or freeze
Store in the original package in order to protect from light
Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

 Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

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