Important Safety Information for Strut Men’s Dutasteride Hair Loss Topical Formula
Possible Compound Ingredients:
Dutasteride*, Minoxidil, Tretinoin, Fluocinolone, Biotin
*FDA off-label use for hair loss
Overview of Contained Information:
- Ingredient information
- Interactions
- Side effects
- How to take the medication
- How to store the medication
- Other important information you should know prior to starting the medication
Instructions:
This treatment plan may help: Reduce hair loss and increase hair growth when used regularly and as prescribed.
It may take 2-4 months to begin seeing results, and up to 6-12 months for full results. Hair growth will revert to previous state if medication is stopped.
Follow all directions on your prescription label and read all medication guides or instruction sheets.
Use the medicine exactly as directed. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.
Do not take by mouth. Topical medication is to be applied to the indicated area only and not to be ingested. Avoid getting this medication in your eyes or mouth, if this does occur, rinse with water.
Apply once daily at night to dry, clean hair, and wash hands after application. Wash any non-treatment area that this medication may have accidentally come into contact with to avoid unwanted hair growth.
Allow to dry thoroughly and wash off in the morning, or after at least 4 hours.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Avoid using other products that also contain Dutasteride, Minoxidil, or Tretinoin unless directed otherwise by your doctor.
Do not use other scalp medications while using this product unless directed otherwise by your doctor. Do not use on the scalp if the skin is infected, irritated, or has open wounds.
You may experience increased sensitivity to the sun with this medication at the application site.
Contraindications and warnings:
Dutasteride is a medication for men only, women and children should never use Dutasteride containing medications.
Dutasteride is not indicated for use in women or pediatric patients.
Women who are pregnant or potentially may be pregnant should not handle or use Dutasteride containing medications due to the risk of birth defects in a male fetus.
If a pregnant woman comes in contact with Dutasteride medications, wash the contact area with soap and water right away and a healthcare provider should be contacted.
Dutasteride normally causes a decrease in PSA levels. If your PSA levels go up while you are taking Dutasteride it may signal the presence of prostate cancer and should be evaluated by a physician.
5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
Do not take Dutasteride if you are allergic to any of the ingredients in the formulation.
Fluocinolone is a topical steroid, and including Fluocinolone as an ingredient in this formulation may not be appropriate for you if you have ever had Diabetes or Cushing's Syndrome.
Using occlusive dressings over a topical corticosteroid formulation may increase systemic absorption and may increase the risk of side effects.
Allergies:
This medication may cause allergic reactions if you are allergic to a component of the medication or medications similar to the ingredients in this product.
If you are allergic to any of the ingredients listed (Ingredients: Dutasteride, Minoxidil, Tretinoin, Fluocinolone) please stop the compound, reach out to us and contact your doctor.
If you are experiencing any of the following symptoms: hives, difficulty breathing, rapid or weak heartbeat, swelling of your face, lips, tongue, or throat, you may be having an acute allergic reaction and you need to get emergency medical help immediately.
Conditions:
We have evaluated your health history and the specific health information you provided us, however, if anything changes and you develop or discover any new conditions please contact us and your doctor to make sure this medication is still appropriate for you.
This medication may have interactions with certain disease states, tell your doctor if you have any of the following:
- breathing problems
- seizures
- chest pain
- sick sinus syndrome
- AV block
- slow heartbeats
- low blood pressure
- liver disease
- heart disease
- kidney disease
- inability to urinate
- urinary obstruction
- enlarged prostate
- prostate cancer
- diabetes
- Cushing's Syndrome
Pregnancy and Breastfeeding:
Minoxidil, Dutasteride, and Fluocinolone should not be used during pregnancy or breastfeeding. Tretinoin products are to be avoided during pregnancy.
Do not use or come into contact with this medication if you are pregnant, breastfeeding, or planning on becoming pregnant in the near future.
This medication is meant for men only, and should not be used by women or children.
Side Effects:
This is a topically applied medication, and very little medication should be distributed throughout the entire body. However, you may experience side effects with this medication. Side effects may reduce or go away as your body adjusts to the medication with time.
Common side effects:
- Itching
- Burning
- Redness
- Flaking
- Dryness
- Scaling
- Peeling
- Stinging
- Acne
- Changes in the color or texture of your hair or skin of the applied area
- Irritation at the application site
- Increased sensitivity to the sun
- Bruising or shiny skin
- Tiny red bumps or rash around the mouth
- Small white or red bumps on the skin
This is a topically applied medication, so very little of the medication will get into systemic circulation and systemic or severe side effects should be rare.
Uncommon side effects may include:
- low blood pressure
- dizziness when standing up
- drowsiness
- nausea
- diarrhea
- headache
- breast tenderness or enlargement
- depression
- fatigue
- unwanted growth of facial hair
- Decrease in sex drive
- Trouble getting or keeping an erection
- Decrease in the amount of semen
- Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
More serious but less common side effects include:
- severe rash or hives
- little or no urination
- severe scalp irritation
- chest pain
- fast heart rate
- fluttering in your chest
- severe headache
- Potential increased risk of a more serious form of prostate cancer
- Decrease in sex drive that continued after stopping the medication
- Allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face
- Problems with ejaculation that continued after stopping medication
- Testicular pain
- Difficulty in achieving an erection that continued after stopping the medication;
- male infertility and/or poor quality of semen
- In rare cases, male breast cancer
Stop the medication and seek medical treatment right away if any of these occur.
Avoid other products known to cause skin irritation on the area of treatment such as:
medicated or abrasive soaps, chemical hair colorants, removers, or waxes, electrolysis, products with alcohol or astringents, and cosmetics with an irritating or strong drying effect.
Medicines and Supplements:
We have evaluated your health history and the specific health information you provided us, however, if anything changes and you start or discover that you are taking any additional medicines or supplements please contact us and your doctor to make sure this medication is still appropriate for you.
Some medications can have interactions and we will help you evaluate that risk and decide on an appropriate treatment plan.
Dutasteride is contained in this medication, and Dutasteride and other drugs in the same class are also found in oral medications Avodart, Proscar, and Propecia. If you are already taking these medications it may not be appropriate for you to take this medication. Tell your doctor if you are already taking Dutasteride or Finasteride by mouth in tablet or capsule form.
Fluocinolone may be contained in this formulation and Fluocinolone is a topical corticosteroid. Combining this medication with other corticosteroids may be dangerous and increase the risk of side effects. Tell your doctor about all other corticosteroid medications you are using.
Tell your doctor if you are taking:
- amifostine
- anthralin
- rituximab
- topical corticosteroids (e.g., betamethasone, hydrocortisone)
- aminolevulinic acid
- aminolevulinic acid topical
- benzoyl peroxide topical
- isotretinoin
- methoxsalen
- methyl aminolevulinate topical
- resorcinol topical
- salicylic acid topical
- sulfur topical
- verteporfin
- Heart or blood pressure medications
- diltiazem
- duvelisib
- fluconazole
- fluvoxamine
- fostamatinib
- ginseng
- itraconazole
- lefamulin
- nefazodone
- nelfinavir
- saquinavir
- sirolimus
- tacrolimus
- temsirolimus
- terazosin
- voriconazole
Risks:
We have evaluated the specific health information provided by you to identify if this product is appropriate for you.
If you forgot to provide us with any information or incorrectly provided the information we may misdiagnose or fail to diagnose conditions that you may have which could affect our recommendation for treatment.
If you need to update or clarify any information about your health you can call us and update your profile so that we may reevaluate if this is appropriate for you.
Treatment Failure:
This treatment is not 100% effective for every patient. It may not work for every patient or may only work partially to resolve the condition that it is meant to treat.
If the treatment is not working, or if you find that you are experiencing new or worsening symptoms, contact us as well as your doctor to identify if you should continue this treatment.
If it is an emergency, call 911 or seek immediate medical help.
We are providing this treatment for you because the potential benefits outweigh the risks in our estimation based on the medical information provided.
You should evaluate this information and any input from your in-person healthcare team, and any other relevant information to decide if this treatment plan is appropriate for you.
Share with Your Healthcare Team:
We recommend that you update all of your physicians, pharmacists, and the rest of your healthcare team to let them know about any new medicines or supplements that you are taking or any changes in your health.
You can also ask us questions anytime regarding your therapy and we are happy to help you share any information about your health with anyone in your personal healthcare team.
Additional Resources
The following links provide further information on the potential risks and benefits of this medication:
Important Safety Information for Dutasteride Capsules
Ingredients:
Dutasteride* with or without Biotin
*FDA off-label use for hair loss
Contraindications and warnings:
- Dutasteride is a medication for men only, women and children should never take Dutasteride.
- Dutasteride is not indicated for use in women or pediatric patients.
- Women who are pregnant or potentially may be pregnant should not handle whole or crushed Dutasteride capsules due to the risk of birth defects in a male fetus. If a pregnant woman comes in contact with crushed or broken Dutasteride capsules, wash the contact area with soap and water right away and a healthcare provider should be contacted.
- Dutasteride normally causes a decrease in PSA levels. If your PSA levels go up while you are taking Dutasteride it may signal the presence of prostate cancer and should be evaluated by a physician.
- 5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
- Do not take Dutasteride capsules if you are allergic to any of the ingredients in the capsule.
Before taking this medication:
You should not use Dutasteride if you are allergic to it, or:
- If you are a woman or a child.
- If you are a woman who is pregnant or may be pregnant. Dutasteride may harm an unborn baby.
Tell your healthcare provider about:
- Any health conditions that you have, including liver or prostate problems.
- All other medications that you take, including over the counter medications or vitamins and supplements.
- Keep a list of all medications you take to show your healthcare provider and pharmacist.
Drug Interactions:
- Avodart/Propecia/Proscar: Do not take Dutasteride if you are also taking Avodart, Propecia, or Proscar, these medications contain the same active ingredient or an ingredient in the same class and you would be taking too much.
- Dutasteride has no known serious or severe interactions with other drugs.
- Moderate interactions with Dutasteride include: carbamazepine, cimetidine, clarithromycin, erythromycin, isoniazid, itraconazole, ketoconazole, nefazodone, rifabutin, rifampin, and St.John’s wort.
Side Effects:
Get emergency medical help if you have signs of an allergic reaction to Dutasteride:
- Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Potential side effects of Dutasteride capsules:
- Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
Dutasteride capsule side effects may include:
Less common side effects not requiring immediate medical attention:
These side effects may occur during treatment with Dutasteride. These side effects may not require immediate medical attention and may reduce or go away as your body adjusts to the medication with time. Your doctor may be able to help you find ways to reduce or relieve these side effects. Always talk with your doctor about side effects that do not go away or that are bothersome to you.
- Abnormal ejaculation
- Impotence
- Decreased sexual interest
- Decreased sexual performance or desire
- Inability to develop or keep an erection
- Discharge, swelling, soreness, or pain from the breast or breasts
Side effects requiring immediate medical attention:
The following side effects are rare, but if they occur you need to seek immediate medical attention.
- Discomfort or pain in the chest
- Dilated neck vessels
- Irregular breathing or heartrate
- Extreme fatigue
- Swelling of the face, fingers, feet, or lower legs
- Trouble breathing
- Unexpected weight gain
- Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
The following potential side effects have an unknown incidence, but if they do occur you should seek immediate medical attention.
- Blistering, flaking, or peeling skin
- Cough
- Trouble swallowing
- Dizziness
- Rapid heart rate
- Itching, rash, hives, or welts
- Hive-like swelling of the face, eyes, lips, tongue, throat, hands, legs, feet, or sex organs
- Puffiness or swelling of the eyelids, face, eyes, lips, tongue
- Skin redness
- Chest tightness
- Unusual weakness or tiredness
5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
Tell your health care provider if you have any side effect that bothers you or does not go away.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Additional Resources
The following links provide further information on the potential risks and benefits of this medication:
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