What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Cyclomen (Danazol)
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Product Details
Description
Cyclomen (Danazol) is a man-made steroid mainly used to treat endometriosis, a condition that can cause infertility and menstrual pain. It works by interfering with hormone signals between the pituitary gland in the brain and the ovaries. This disruption reduces the release of certain hormones, helping to manage the symptoms of endometriosis. In addition, Cyclomen may be used to treat benign fibrocystic breast disease, a non-cancerous condition in which lumps form in the breast tissue, and prevent hereditary angioedema.
Fact Table
Formula
C22H27NO2
License
US FDA
Bioavailability
Saturable with dosage, higher with food intake
Legal status
Rx-only
Chemical Name
Danazol
Elimination half-life
Acute: 3–10 hours, Chronic: 24–26 hours
Dosage (Strength)
50mg, 100mg, 200mg
Pregnancy
Danazol must not be taken
Brands
Cyclomen
Protein binding
Not Available
PubChem CID
28417
MedlinePlus
a682599
ChEBI
4315
ATC code
G03XA01
DrugBank
DB01406
KEGG
D00289
Routes of administration
By mouth
Directions
The dosage of Cyclomen varies depending on the condition being treated and the severity of the symptoms. It is typically taken as an oral medication multiple times per day for no more than three to six months. Follow your doctor's prescribed dosage and instructions carefully. Your doctor will determine the appropriate dosage for your specific situation.
Ingredients
Cyclomen contains the synthetic steroid danazol, derived from ethisterone. In addition to danazol, Cyclomen capsules may also contain nonmedicinal ingredients, such as cornstarch, gelatin, lactose, magnesium stearate, talc, titanium dioxide, red iron oxide, and yellow iron oxide. These additional ingredients are typically used to improve the stability, appearance, and absorption of the medication.
Contraindications
Avoid taking or using Cyclomen if any of the following apply:
- Undiagnosed vaginal bleeding
- A rare blood disorder called porphyria
- Severe liver disease
- Severe kidney disease
- Severe heart problems
- History of stroke or blood clot
- Cancer of the breast, uterus/cervix, or vagina
- Pregnancy or breastfeeding
- Tumors dependent on male hormones
- Allergic reactions to danazol or any component in the drug
- Use of simvastatin at the same time
Cautions
- Before starting treatment with Cyclomen, consider discussing the following with your doctor:
- Any medications you take, including over-the-counter drugs, prescription medications, vitamins, and herbal supplements.
- Any medical conditions you have or have had, as some may require dosage adjustments or extra monitoring.
- If you are pregnant or planning to become pregnant, discuss this with your doctor, as Cyclomen can cause harm to an unborn baby.
- If you are breastfeeding or planning to breastfeed, consult with your doctor since Cyclomen can pass into breast milk and potentially harm an infant.
- Cyclomen may cause erratic results in thyroid function tests. While it can alter indicators like thyroxine and thyroxine-binding globulin, it usually doesn't interfere with the actual thyroid function.
- Cyclomen may cause changes in plasma levels of several proteins, such as pre-albumin, C1-esterase inhibitor, and transferrin. The clinical significance of these changes is currently undetermined.
- Temporary changes in lipoproteins, specifically a decrease in high-density lipoproteins and a potential increase in low-density lipoproteins, have been reported. Consider the risks of atherosclerosis and coronary artery disease before taking this medication.
- Regular liver and blood tests are advised during treatment.
- Non-hormonal contraception may be advisable after treatment for fibrocystic breast disease until a normal menstrual period occurs.
- Cyclomen may potentiate the effects of coumadin-type anticoagulants. If using these medications together, careful monitoring and dosage readjustment may be necessary.
- Increased plasma levels of carbamazepine and possible interactions with phenytoin and phenobarbital have been observed. Adjust dosage of these medications as needed when co-administering with Cyclomen.
- Concomitant use with cyclosporin and tacrolimus may lead to increased plasma concentrations of these drugs, increasing the risk of kidney problems.
- Cyclomen may cause insulin resistance. Diabetic patients may need to adjust their insulin or oral hypoglycemic agents to maintain blood sugar levels.
- Cyclomen can potentially decrease the effectiveness of antihypertensive agents and may interact with gonadal steroid therapy.
- Changes in laboratory values, including CPK, glucose tolerance, and other plasma proteins, may occur during treatment. Monitoring is advised.
Side Effects
Danazol may cause side effects in some patients. Common Danazol side effects may include acne, swelling in the face, mild increase in body hair, and reduced breast size. Weight gain, deepened voice, and oily skin or hair are also reported side effects.
In addition, Danazol can lead to symptoms related to lower estrogen levels in the body, such as hot flashes, sweating, and issues like itching, dryness, or even minor bleeding in the vaginal area. Some people have also reported feeling more nervous or emotionally unstable while taking this medication.
More serious side effects of Danazol require immediate medical attention. Persistent headaches or ongoing abdominal pain could indicate nervous system or gastrointestinal disorders like pancreatic issues. Very rarely, patients have developed pneumonia or severe skin rashes. There may also be a risk of liver injury, with symptoms like loss of appetite, nausea, yellowing of the skin or eyes, and darkened urine. If you experience any of these serious side effects, consult a healthcare provider immediately.
References:
- Cyclomen (Danazol) Product Monograph. Laval, Quebec: Sanofi-Aventis; 2017.
- Cyclomen (Danazol) Drug Label Information. Parsippany, NJ: Teva Pharmaceuticals; 2022
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 2174
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