Thailand FDA approved registration # 1C 137/51 –
Approved June 19th 2008
CAS Name: (5a,17b)-17-Methyl-2¢H-androst-2-eno[3,2-c]pyrazol-17-ol
Additional Names: 1,2,3,3a,3b,4,5,5a,6,8,10,10a,10b,11,12,12a-hexadecahydro-1,10a,1
2a-trimethylcyclopenta[7,8]phenanthro[2,3-c]pyrazol-1-ol;17b-hydroxy-17a-methylandrostano[3,2-c]pyrazole; androstanazole; stanazol
Molecular Formula: C21H32N2O
Molecular Weight: 328.49.
Percent Composition: C 76.78%, H 9.82%, N 8.53%, O 4.87%
Each uncoated tablet contains:
Stanozolol USP 10mg
Stanztab 10 (Stanozolol tablets) is a light blue tablet that contains 10 mg of the anabolic steroid Stanozolol.
Anabolic steroids such as Stanozolol are synthetic derivatives of testosterone.
Stanozolol has been found to increase low-density lipoproteins and decrease high-density lipoproteins. These changes are not associated with any increase in total cholesterol or triglyceride levels and revert to normal on discontinuation of treatment.
Hereditary angioedema (HAE) is an autosomal dominant disorder caused by a deficient or nonfunctional C1 esterase inhibitor (C1 INH) and clinically characterized by episodes of swelling of the face, extremities, genitalia, bowel wall, and upper respiratory tract.
In small clinical studies, Stanozolol was effective in controlling the frequency and severity of attacks of angioedema and in increasing serum levels of C1 INH and C4. Stanozolol is not effective in stopping HAE attacks while they are under way. The effect of stanozolol on increasing serum levels of C1 INH and C4 may be related to an increase in protein anabolism.
INDICATION AND USES
Hereditary Angioedema: Stanztab 10 is indicated prophylactically to decrease the frequency and severity of attacks of angioedema.
The use of Stanztab 10 is contraindicated in the following:
- Male patients with carcinoma of the breast or with known or suspected carcinoma of the prostate.
- Carcinoma of the breast in females with hypercalcemia; androgenic anabolic steroids, may stimulate osteolytic resorption of bone.
- Nephrosis or the nephrotic phase of nephritis.
- Stanztab 10 can cause fetal harm when administered to a pregnant woman. Stanztab 10 is contraindicated in women who are or may become pregnant while taking this drug; the patient should be apprised of the potential hazard to the fetus.
General: Anabolic steroids may cause suppression of clotting factors II, V, VII and X and an increase in prothrombin time.
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, and clitoromegaly). To prevent irreversible change, drug therapy must be discontinued, or the dosage significantly reduced when mild virilism is first detected. Such virilization is usual following androgenic anabolic steroid use of high doses. Some virilizing changes women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularities may also occur.
Oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.
Stanztab 10 may increase sensitivity to anticoagulants; therefore, dosage of anticoagulants may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.
Hepatic: Cholestatic jaundice with rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long term androgenic anabolic steroid. Reversible changes in liver function tests also occur including increased bromsulphalein (BSP) retention and increases in serum bilirubin, glutamic oxaloacetic transaminase (SGOT), and alkaline phosphatase.
Genitourinary System (Prepubertal men): Phallic enlargement and increased frequency of erections.
Genitourinary System (Post pubertal men): Inhibition of testicular functions, testicular atrophy, and oligospermia, impotence, chronic priapism, epididymitis and bladder irritability.
Genitourinary System (Women): Clitoral enlargement, menstrual irregularities.
In both sexes: increased or decreased libido.
CNS: Habituation, excitation, insomnia, and depression.
Gastrointestinal: Nausea, vomiting, diarrhea.
Hematologic: Bleeding in patients on concomitant anticoagulant therapy.
Larynx: Deepening of the voice in women.
Hair: Hirsutism and male pattern baldness in women.
Skin: Acne (especially in women and prepubertal boys.)
Skeletal: Premature closure of epiphyses in children.
Fluid and Electrolytes: Edema, retention of serum electrolytes (Sodium chloride, potassium, phosphate, and calcium).
DOSAGE AND ADMINISTRATION
The use of anabolic steroids may be associated with serious adverse reactions. Many of which are dose related; therefore patients should be placed on the lowest possible effective dose.
Hereditary Angioedema. The dosage requirements for continuous treatment of hereditary angioedema with stanozololÂ should be individualized on the basis of clinical response of the patient. It is recommended the patient be started on 2 mg three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage at intervals of one to three months to a maintenance dosage of 2 mg alternate day schedule. During the dose-adjusting phase close monitoring of the patient’s has a history of airway involvement.
The prophylactic dose of stanozolol to be used prior to dental extraction or other traumatic or stressful situations has not been established and may be substantially larger.
10mg tablets in blister packs of 10 tablets – 5 packs per box (50 tablets)
Formerly available as 10 mg Tablets in bottles of 100 – Bottles discontinued.
Store in a cool dry place. Protect from light.
Manufactured by: Unigen Life Sciences Co. Ltd.